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The Peerbridge Corns System family of products is intended to capture and transmit events and continuous external electrocardiogram (ECG) information for 24 hours and up to 7 days (long term monitoring). The Peerbridge CorTM System continuous external electrocardiogram (ECG) recorder with a patient-activated events button. It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient. symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The reported ECG metrics supports 2-channel ECG analysis on a beat-by-beat basis. heart rate measurement and rhythm analysis by FDA cleared algorithms. The report generated does not contain diagnostic interpretation; the report is provided for review by intended users to render a diagnosis based on their clinical judgment and experience.

The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient's electrocardiogram (ECG) data to the clinician.

The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient's chest and records the patient's ECG continuously. This device can collect two (2) channels of ECG data continuously for up to seven (7) days. In addition, patients can report symptomatic events by pressing the Event Button on the Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician's interface.

The Peerbridge System Cor XT and Cor Event have identical functionalities and components while differing in post-data acquisition clinical workflow. These configurations are presented in Table 1 with their respective tests. Through the two configurations, the system supports three tests based on medical necessity determined by the prescribing clinician.

The provided text describes the Peerbridge Cor™ System and its FDA 510(k) premarket notification. However, it does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, details about ground truth establishment (number of experts, qualifications, adjudication method), or information about MRMC studies, standalone performance, or training set details.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (iRhythm Technologies, Inc. ZIO® SkyRunner) based on shared intended use, similar technological characteristics, and non-clinical bench testing.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states that nonclinical bench testing was "performed and passed" but does not report specific quantitative acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity for ECG analysis). It doesn't mention any clinical performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document explicitly states: "Clinical testing is not provided in support of this premarket notification." Therefore, there is no test set in the clinical performance sense described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. Since no clinical testing was performed for this premarket notification, there was no test set requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. As no clinical testing was performed, no adjudication method was used for a clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Cannot be provided. The document does not mention any MRMC studies or AI assistance for human readers. The device provides "ECG analysis by FDA cleared algorithms" and "The report generated does not contain diagnostic interpretation; the report is provided for review by intended users to render a diagnosis based on their clinical judgment and experience." This suggests the device's algorithms analyze ECG data, but it doesn't describe an AI-assisted human reading workflow.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Partially Answered. The document mentions "ECG analysis by FDA cleared algorithms" and that the system "supports 2-channel ECG analysis on a beat-by-beat basis, heart rate measurement and rhythm analysis by FDA cleared algorithms." While this implies the algorithms perform standalone analysis, specific performance metrics for this standalone functionality are not provided in the document. The general statement is that "nonclinical testing demonstrate that the device meets its performance requirements."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. As no clinical testing was performed, there isn't a described ground truth type for a clinical test set. For the "FDA cleared algorithms" that perform ECG analysis, the nature of their ground truth for development or validation is not detailed.

8. The sample size for the training set

• Cannot be provided. The document does not provide details about the training set for the device's algorithms.

9. How the ground truth for the training set was established

• Cannot be provided. The document does not provide details about the training set or its ground truth establishment.

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