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The Audicor® System, when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. The Audicor recording may be obtained at any location specified by a physician including home, hospital or clinic.

The measurements provided and interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over-read as well as consideration of other relevant patient data.

The device is intended for use only under the direct supervision of a physician.

The Audicor System is an ambulatory device that can be used to capture up to 48 hours of continuous data or 10-second snapshots of ECG and heart sounds data. The Audicor System includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The analysis package includes heart rate variability and performs ECG beat classification, editing and reporting of arrhythmias.

The Audicor System analyzes and reports the following parameters:
Heart rate distributions of heart sound parameters
Heart rate and associated events
Atrial fibrillation
ECG beat classification and morphology grouping
Ventricular and atrial ectopic beat arrhythmias
Heart rate variability

The Inovise Medical, Inc. 510(k) Notification for the AUDICOR System describes the device's functionality and its substantial equivalence to predicate devices, focusing on regulatory compliance and intended use rather than specific acceptance criteria for performance metrics. Therefore, a table of acceptance criteria and reported device performance, information about sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance information, and ground truth definitions cannot be fully extracted from the provided text.

Based on the document, here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding device performance values against those criteria. Instead, it states that the Audicor System has been tested to applicable requirements of several standards and "shown to comply." It also asserts "substantial equivalence" to predicate devices for specific functionalities. This suggests that the acceptance criteria are implicitly met by complying with these standards and demonstrating equivalence to already approved devices.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The assessment appears to be based on compliance with established industry standards and internal protocols rather than a specific clinical validation study to establish performance metrics against a defined patient dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The regulatory submission focuses on engineering and regulatory compliance, and equivalence to predicate devices, rather than detailed performance studies with expert-adjudicated ground truth.

4. Adjudication method for the test set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document refers to the device's role in providing interpretations "for consideration by physicians" and emphasizes that measurements and interpretations "are only significant when used in conjunction with physician over-read." This indicates the device is an aid, but no study on the effect of this aid on human reader performance is detailed.

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

The document describes the Audicor System as performing "ECG beat classification, editing and reporting of arrhythmias" and providing "interpretation of the data." While this implies standalone algorithmic functions, no specific standalone clinical performance study to quantify these algorithms' accuracy (e.g., sensitivity, specificity) is provided in the text. The emphasis is on physician oversight ("under the direct supervision of a physician" and "physician over-read").

7. The type of ground truth used

The type of ground truth used for any potential testing is not specified. Given the focus on compliance with standards like ANSI/AAMI EC38 and EC57, it's likely that the "ground truth" for the technical aspects (e.g., arrhythmia detection accuracy) would be based on expertly annotated ECG databases or simulated signals as per those standards, but this is not explicitly stated.

8. The sample size for the training set

The document does not provide any information about the sample size used for training the device's algorithms.

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

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

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