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The Physiotrace™Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotrace™ Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotrace™ Smart is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional.

The Physiotrace™ Smart is not indicated for use on critical care patients. The Physiotrace™ Smart is not indicated for diagnosis of cardiac conditions.

The Physiotrace™ Smart has a wearable design that can be wrapped and fastened around the torso. The device uses dry ECG electrodes and embeds an ECG acquisition unit with a Bluetooth Low Energy transmitter. A mobile application controls the data acquisition, displays the status of the device, heart rate and optionally the ECG waveform during a recording session. The mobile App also stores the ECG and the exercise session information and relays it to a cloud server for permanent storage and review by healthcare staff. The Physiotrace™ Smart is designed to be used without electrolytic gels and without adhesives that necessitate skin preparation.

The Physiotrace™ Smart device is a wearable ECG monitor. The provided text outlines its acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and meeting recognized standards, rather than providing specific quantitative acceptance criteria for ECG performance parameters in a table format. However, based on the text, we can infer some key performance aspects and how "acceptance" was determined:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not explicitly state the sample size (number of participants) used for the clinical study. It mentions "a clinical study was performed," implying a test set was used.
• Data Provenance: The document does not specify the country of origin. The study was described as a "clinical study performed during the exercise scenario." It is presented as a prospective study given it was an evaluation of the device in use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study. It mentions the data is transmitted to "a server for review by healthcare team," implying professional review, but specifics are lacking.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication methods like 2+1, 3+1, etc., for the test set interpretation in the clinical study.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The device is an ECG monitor, not an AI-powered diagnostic tool, and the focus is on the accuracy of physiological data acquisition and transmission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The document implies a form of "standalone" assessment in that the device acquires and transmits data for "review by healthcare team." While the device itself doesn't perform diagnosis, its ability to accurately record ECG data for up to 60 minutes was evaluated. The performance comparisons against standards (e.g., 60601-2-47) are a form of standalone performance assessment for the device's signal acquisition capabilities.

7. Type of Ground Truth Used:

For the clinical study, the ground truth for device performance (safety and effectiveness) would likely be based on:

• Clinical observation and assessment: To determine safety and effectiveness during exercise.
• Comparison against reference standards/predicate device: The document states "device performance and safety and effectiveness was found to be equivalent or better than the predicate device," suggesting direct comparison.
• Compliance with recognized physiological monitoring standards: As mentioned for ECG performance (e.g., 60601-2-47).

8. Sample Size for the Training Set:

The document does not mention a training set, as this is typically relevant for machine learning or AI-based devices. The Physiotrace™ Smart appears to be a physiological data acquisition and transmission device, not one that relies on a trained algorithm for its primary function.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set is mentioned for this device.

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