.

IBP Performance Report: II

ALGORITHM V3.0.0

Production Launch Date: April 8th, 2016

Updated: April 19th, 2016 11:35 AM PT

For reference, we conduct internal studies guided by the ANSI/AAMI/ISO 81060-2:2013 internationally-accepted protocol for blood pressure cuff performance assessment to develop the performance characteristics of the technology powering Instant Blood Pressure. The performance characteristics of Instant Blood Pressure and other important safety and intended use information are included below.

DETAILS & RESULTS

These performance characteristics are developed through an in-house study using the ANSI/AAMI/ISO 81060-2:2013 protocol modified to compare Instant Blood Pressure to reference upper-arm, oscillometric blood pressure cuff devices. The results of this study find that Instant Blood Pressure does not yet meet the performance standards set forth by the ANSI/AAMI/ISO 81060-2:2013 protocol and, for this reason, it provides an estimate of blood pressure only. Furthermore, traditional automated upper-arm blood pressure monitors are currently more accurate and provide blood pressure readings over a greater range than Instant Blood Pressure.

IBP-v3.0.0-Performance-Graphs.png

Systolic BP Supported Range†:

  • 83 - 178 (mmHg)
  • Total Range: 95 (mmHg)

Systolic BP Accuracy*:

  • Mean: +2.7 (mmHg)
  • SD (Sm): 12.8 (mmHg)
  • SD (Sn): 13.9 (mmHg)
  • RMSD: 14.1 (mmHg)
  • Pearson: r=0.755 (P<0.0001)

Systolic Data:

  • Number of Determination Pairs: 266
  • Subjects:
    • Number (n): 99
    • Number Males: 65
    • Age (years): 37 ± 15 (Min: 18, Max: 79)
    • Weight (lbs): 180.7 ± 44.8 (Min: 116.0, Max: 305.0)
    • Height (in): 66.9 ± 3.6 (Min: 59.0, Max: 75.0)

Diastolic BP Supported Range†:

  • 58-107 (mmHg)
  • Total Range: 49 (mmHg)

Diastolic BP Accuracy*:

  • Mean: +2.6 (mmHg)
  • SD (Sm): 8.4 (mmHg)
  • SD (Sn): 8.8 (mmHg)
  • RMSD: 9.2 (mmHg)
  • Pearson r=0.744 (P<0.0001)

Diastolic Data:

  • Number of Determination Pairs: 258
  • Subjects:
    • Number (n): 97
    • Number Males: 63
    • Age (years): 37 ± 15 (Min: 18, Max: 79)
    • Weight (lbs): 180.6 ± 45.3 (Min: 116.0, Max: 305.0)
    • Height (in): 66.9 ± 3.7 (Min: 59.0, Max: 75.0)

Pulse Rate Range†:

  • 39-240 (bpm)
  • Total Range: 201 (bpm)

Pulse Rate Accuracy*:

  • Mean: +0.9 (bpm)
  • SD (Sm): 3.0 (bpm)
  • SD (Sn): 3.6 (bpm)
  • RMSD: 3.7 (bpm)
  • Pearson r=0.955 (P<0.0001)

Pulse Rate Data:

  • Number of Determination Pairs: 268
  • Subjects:
    • Number: 99
    • Number Males: 65
    • Age (years): 37 ± 15 (Min: 18, Max: 79)
    • Weight (lbs): 180.7 ± 44.8 (Min: 116.0, Max: 305.0)
    • Height (in): 66.9 ± 3.6 (Min: 59.0, Max: 75.0)

† Instant Blood Pressure will not produce an estimate outside of its supported range. Do not attempt to use Instant Blood Pressure to produce a reading outside of its range. If you know your blood pressure or pulse rate to fall outside this range or if you intend to estimate blood pressure or pulse rate outside of this range, Instant Blood Pressure is not suitable for your use.

* Mean = mean difference compared to reference, SD = standard deviation of difference. RMSD = root mean squared deviation. Pearson = Pearson correlation coefficient with reference. This accuracy characteristic is representative of the supported range only. Accuracy performance may be poor outside of the supported range.


caution: Important Safety & USE Information

Use Instant Blood Pressure to estimate blood pressure and pulse rate immediately before, during, or after a recreational activity.

For example, Instant Blood Pressure may be used to estimate cool-­down and recovery from cardiovascular exercise or estimate the impact of a meditation session or breathing exercise on pulse rate and blood pressure. Instant Blood Pressure is intended to be used by adults 18 years of age or older and it has not been tested for use on children or pregnant women.

Do not rely on Instant Blood Pressure for medical advice or diagnosis. 

Instant Blood Pressure is intended for recreational use only. It is not a replacement or substitute for a cuff or other blood pressure monitor. Instant Blood Pressure’s performance and accuracy characteristics do not meet international standards for a blood pressure monitor intended for clinical use.

Instant Blood Pressure is not a replacement or substitute for a cuff or other blood pressure monitor. 

Blood pressure cuffs and other blood pressure monitors are medical devices intended for clinical use. Instant Blood Pressure is intended for recreational use only. Blood pressure cuffs and other blood pressure monitors are currently more accurate than Instant Blood Pressure and provide a wider range of measurement. Instant Blood Pressure provides an estimate of blood pressure only.

Consult your doctor if you have any health concern. Do not self-­adjust medications.

Take medications as prescribed by your doctor. Only a doctor is qualified to diagnose and treat disease such as hypertension (i.e. high blood pressure). Self-­diagnosis and self-­treatment may lead to deterioration of your health.

Do not use Instant Blood Pressure if you wear a pacemaker or any internal electronic medical device. 

Use of a cell phone in close proximity to a pacemaker or other internal electronic medical device can interfere with its normal operation.

What you need to know: The Plante et al. Study

Updated: April 17th, 2016 4:34 PM PT

At AuraLife, we welcome third party researchers taking an active interest in assessing our technologies. Further, we believe open discussion with researchers is important in advancing health technology.

On March 1, 2016 our team became aware of a research letter titled "How Well Did an Instant Blood Pressure App Work?" which was published by JAMA Internal Medicine on March 2, 2016. A thorough review has been conducted of the study led by Timothy B. Plante, MD. We feel that critical flaws and deficiencies were present in how this study was conducted and the way its data analysis was performed. Here we present our concerns. 

DEFICIENCIES & Concerns

  • Supported Range: The authors failed to disclose that approximately 20% of their data were associated with reference blood pressures outside IBP’s supported measurement range. As published on our our website [1] and App Store description prior to the start of the authors’ data collection, IBP will not produce estimates outside of its supported range (Systolic 102-158 mmHg, Diastolic 65-99 mmHg). We believe the authors’ failure to disclose or mention IBP’s supported range misled readers. 
  • Key National Guidelines: The authors did not properly implement key national guidelines [2] which help ensure the reliability of comparative measures. The same-arm sequential measurement technique, defined by those guidelines in section 5.2.4.2, requires BPs to be collected as determination pairs with a reference device measurement taken before and after each test device measurement. This was not done. The ‘bounding’ of test device measurements ensures that any drift in a subject’s true BP during the protocol is properly accounted for and not incorrectly attributed to test device inaccuracies. 
  • Study Controls: Proper study controls are required in conducting any sound scientific research. The authors failed to control for the most fundamental variable in their experiment – the version of the IBP algorithm itself. IBP is updated periodically, remotely on our servers, independent of any updates to a user’s phone. While each IBP algorithm update reflects an overall system improvement, each version is subject to unique data variability. The IBP algorithm was updated at least 5 times during the authors’ subject enrollment period. 
     
  • Intended Use: The authors investigated the effectiveness of IBP in diagnosing hypertension [3]. However, as published within the app, on its website, and on its App Store description prior to the start of the authors’ study, IBP is not intended for such use. IBP is intended for use in estimating blood pressure before, during, or after recreational activity. For example, IBP may be used to better understand one’s natural, daily blood pressure rhythms or to estimate the impact of a meditation session or breathing exercise on blood pressure. 

OUR VIEW

We share the authors’ concern at the idea of individuals, against the will of their physician, titrating their own therapies. We believe such a public health concern can be tackled through education. Many consumers understand that only a doctor is qualified to diagnose and treat disease such as hypertension and that they should not be self-treating or self-diagnosing. Nonetheless, we take an active and prominent role in ensuring our users understand Instant Blood Pressure’s specific intended use as demonstrated by our extensive in app disclosures and online materials.

It is our company’s mission to help people better access health insight. We envision a future where mobile technology plays a central role in helping people pursue their health and wellness goals. Instant Blood Pressure is a novel and constantly improving system which leverages recent advances across industry and academia in mobile sensor technology, machine learning techniques, and physiological understanding.


HOW THE INSTANT BP ALGORITHM WORKS

Through years of physiological data collection, research, and development we have built a digital bio-marker processing platform which leverages pulse activity, mechanical cardiac activity, and proprietary vascular indices. All of this bio-data can be collected using the everyday sensor suite present in a modern smartphone device. Many of these features represent new discoveries on our team's part while others represent features that have been well documented in peer-reviewed clinical research. Instant Blood Pressure's algorithm leverages our unique discoveries, well understood biometrics, and each user's unique anthropometric data to produce each blood pressure estimate. No smartphone hardware accessory required!


IBP Performance Report Archive


caution: Important Safety & USE Information

Use Instant Blood Pressure to estimate blood pressure and pulse rate immediately before, during, or after a recreational activity.

For example, Instant Blood Pressure may be used to estimate cool-­down and recovery from cardiovascular exercise or estimate the impact of a meditation session or breathing exercise on pulse rate and blood pressure. Instant Blood Pressure is intended to be used by adults 18 years of age or older and it has not been tested for use on children or pregnant women.

Do not rely on Instant Blood Pressure for medical advice or diagnosis. 

Instant Blood Pressure is intended for recreational use only. It is not a replacement or substitute for a cuff or other blood pressure monitor. Instant Blood Pressure’s performance and accuracy characteristics do not meet international standards for a blood pressure monitor intended for clinical use.

Instant Blood Pressure is not a replacement or substitute for a cuff or other blood pressure monitor. 

Blood pressure cuffs and other blood pressure monitors are medical devices intended for clinical use. Instant Blood Pressure is intended for recreational use only. Blood pressure cuffs and other blood pressure monitors are currently more accurate than Instant Blood Pressure and provide a wider range of measurement. Instant Blood Pressure provides an estimate of blood pressure only.

Consult your doctor if you have any health concern. Do not self-­adjust medications.

Take medications as prescribed by your doctor. Only a doctor is qualified to diagnose and treat disease such as hypertension (i.e. high blood pressure). Self-­diagnosis and self-­treatment may lead to deterioration of your health.

Do not use Instant Blood Pressure if you wear a pacemaker or any internal electronic medical device. 

Use of a cell phone in close proximity to a pacemaker or other internal electronic medical device can interfere with its normal operation.

Citations & References

  1. About the App. Instant Blood Pressure. http://www.instantbloodpressure.com/the-app. Accessed April 11, 2016.
  2. Graves JW, Quinn D. Noninvasive Sphygmomanometers, Part 2: Clinical Investigation of Automated Measurement Type. Vol 81060-2. Geneva, Switzerland: ANSI/AAMI/ISO; 2013.
  3. Plante T, Urrea B, MacFarlane Z et al. Validation of the Instant Blood Pressure Smartphone App. JAMA Internal Medicine. 2016. doi:10.1001/jamainternmed.2016.0157.

IBP Performance Report: I

ALGORITHM V2.0.0

Production Launch Date: October 1st, 2015

Updated: April 17th, 2016 4:37 PM PT

For reference, we conduct internal studies guided by the ANSI/AAMI/ISO 81060-2:2013 internationally-accepted protocol for blood pressure cuff performance assessment to develop the performance characteristics of the technology powering Instant Blood Pressure. The performance characteristics of Instant Blood Pressure and other important safety and intended use information are included below.

DETAILS & RESULTS

These performance characteristics are developed through an in-house study using the ANSI/AAMI/ISO 81060-2:2013 protocol modified to compare Instant Blood Pressure to reference upper-arm, oscillometric blood pressure cuff devices. The results of this study find that Instant Blood Pressure does not yet meet the performance standards set forth by the ANSI/AAMI/ISO 81060-2:2013 protocol and, for this reason, it provides an estimate of blood pressure only. Furthermore, traditional automated upper-arm blood pressure monitors are currently more accurate and provide blood pressure readings over a greater range than Instant Blood Pressure.

Systolic BP Supported Range†:

  • Low Range: 102 (mmHg)

  • High Range: 158 (mmHg)

  • Total Range: 56 (mmHg)

Systolic BP Accuracy*:

  • Mean Difference: ± 1.6 (mmHg)

  • Standard Deviation (Sm): 11.1 (mmHg)

  • Standard Deviation (Sn): 11.3 (mmHg)

  • Pearson: r=0.580 (P<0.0001)

Systolic Data:

  • Number of  Subject: 68

  • Determination Pairs: 174

Diastolic BP Supported Range†:

  • Low Range: 65 (mmHg)

  • High Range: 99 (mmHg)

  • Total Range: 34 (mmHg)

Diastolic BP Accuracy*:

  • Mean Difference: ± 2.1 (mmHg)

  • Standard Deviation (Sm): 6.9 (mmHg)

  • Standard Deviation (Sn): 7.0 (mmHg)

  • Pearson: r=0.652 (P<0.0001)

Diastolic Data:

  • Number of  Subject: 68

  • Determination Pairs: 174

Pulse Rate Range†:

  • Low Range: 39 (bpm)

  • High Range: 240 (bpm)

  • Total Range: 201 (bpm)

Pulse Rate Accuracy*:

  • Mean Difference: ± 1.0 (bpm)

  • Standard Deviation (Sm): 2.9 (bpm)

  • Standard Deviation (Sn): 3.7 (bpm)

  • Pearson: r=0.955 (P<0.0001)

Pulse Rate Data:

  • Number of  Subject 99

  • Determination Pairs: 275

† Instant Blood Pressure will not produce an estimate outside of its supported range. Do not attempt to use Instant Blood Pressure to produce a reading outside of its range. If you know your blood pressure or pulse rate to fall outside this range or if you intend to estimate blood pressure or pulse rate outside of this range, Instant Blood Pressure is not suitable for your use.

* Mean = mean difference compared to reference, SD = standard deviation of difference. RMSD = root mean squared deviation. Pearson = Pearson correlation coefficient with reference. This accuracy characteristic is representative of the supported range only. Accuracy performance may be poor outside of the supported range.


caution: Important Safety & USE Information

Use Instant Blood Pressure to estimate blood pressure and pulse rate immediately before, during, or after a recreational activity.

For example, Instant Blood Pressure may be used to estimate cool-­down and recovery from cardiovascular exercise or estimate the impact of a meditation session or breathing exercise on pulse rate and blood pressure. Instant Blood Pressure is intended to be used by adults 18 years of age or older and it has not been tested for use on children or pregnant women.

Do not rely on Instant Blood Pressure for medical advice or diagnosis. 

Instant Blood Pressure is intended for recreational use only. It is not a replacement or substitute for a cuff or other blood pressure monitor. Instant Blood Pressure’s performance and accuracy characteristics do not meet international standards for a blood pressure monitor intended for clinical use.

Instant Blood Pressure is not a replacement or substitute for a cuff or other blood pressure monitor. 

Blood pressure cuffs and other blood pressure monitors are medical devices intended for clinical use. Instant Blood Pressure is intended for recreational use only. Blood pressure cuffs and other blood pressure monitors are currently more accurate than Instant Blood Pressure and provide a wider range of measurement. Instant Blood Pressure provides an estimate of blood pressure only.

Consult your doctor if you have any health concern. Do not self-­adjust medications.

Take medications as prescribed by your doctor. Only a doctor is qualified to diagnose and treat disease such as hypertension (i.e. high blood pressure). Self-­diagnosis and self-­treatment may lead to deterioration of your health.

Do not use Instant Blood Pressure if you wear a pacemaker or any internal electronic medical device. 

Use of a cell phone in close proximity to a pacemaker or other internal electronic medical device can interfere with its normal operation.