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The physIQ Heart Rhythm and Respiration Module (Version 2.0) is intended for use by a physician or other qualified medical professionals for the calculation of heart rate variability, the detection of atrial fibrillation and determination of respiration rate using ambulatory ECG and triaxial accelerometer data. The physIQ Heart Rhythm and Respiration Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices using "wet" electrode technology and triaxial accelerometers when assessment of rhythm and respiration rate is desired. The physIQ Heart Rhythm and Respiration Module is for use in adult patients in subacute clinical and nonclinical settings for remote patient monitoring. The physIQ Heart Rhythm and Respiration Module is not for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices.

The physIQ Heart Rhythm and Respiration Module (Version 2.0) is a computerized all-software callable function library in the Python programming language that is designed for calculating heart rate and heart rate variability and for detecting atrial fibrillation and determining respiration rate determined by automated analysis of any single electrocardiogram (ECG) channel collected by commercially-available ECG biosensor devices with triaxial accelerometers. The physIQ Heart Rhythm and Respiration Module will be integrated by the customer organization into an end-to-end system (biosensor data collection to clinician display) that makes calls into the product, most typically via a Python middleware script. The "middleware" accesses the source ECG and triaxial accelerometer data from a customer's data collection system, most likely via its own application programming interface (API), and makes calls to the phys/Q Heart Rhythm and Respiration Module to input ECG and triaxial accelerometer data for processing into the vital sign outputs of the product. These outputs are returned to the middleware, which may insert these results into a downstream monitoring system for clinical use.

The physIQ Heart Rhythm and Respiration Module (Version 2.0) was assessed for its performance in calculating heart rate variability, detecting atrial fibrillation, and determining respiration rate. The study followed guidelines of ANSI/AAMI EC57-2012 for heart rate variability and atrial fibrillation, while respiration rate was evaluated using internal acceptance criteria and comparison to a predicate device due to a lack of FDA-recognized consensus standards.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample size for the test set used for the respiration rate algorithm or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "performance validation was performed using clinical and bench testing."

For heart rate variability and atrial fibrillation, performance testing followed ANSI/AAMI EC57-2012 guidelines in a previous submission (K180234), but the specific sample size and provenance for that previous test are not detailed in this document.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method:

The document does not specify the adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention if an MRMC comparative effectiveness study was done or the effect size of human readers' improvement with AI vs. without AI assistance. The device is a "computerized all-software callable function library" and its output is intended for use by medical professionals, suggesting it's an assistive tool, but a comparative effectiveness study with human readers is not detailed.

6. Standalone Performance:

Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The "Performance Testing" section states that the device contains "a collection of algorithms intended to be applied to ECG data." The validation was performed on these algorithms, and the results were compared to acceptance criteria.

7. Type of Ground Truth Used:

The type of ground truth used is not explicitly stated. However, for heart rate variability and atrial fibrillation, the reference to ANSI/AAMI EC57-2012 suggests established standards and potentially expert consensus or validated physiological measurements for ground truth. For respiration rate, it was compared to "internal acceptance criteria" and a "predicate device," implying a form of reference standard or clinical gold standard might have been used for the internal criteria.

8. Sample Size for Training Set:

The document does not provide the sample size used for the training set.

9. How Ground Truth for Training Set Was Established:

The document does not provide information on how the ground truth for the training set was established.

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