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The Zargis Acoustic Cardioscan, (ZAC) is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.

The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds. that may be present. Identified sounds include S1, S2, and suspected murmurs.

The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.

The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds.

The complete system is a CD comprising software and instructions for use with an included USB transceiver for connection with a PC and capable of wireless communication with a Bluetooth-enabled electronic stethoscope.

Here's an analysis of the acceptance criteria and study information for the Zargis Acoustic Cardioscan (ZAC), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K083309) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance metrics for a novel technology. Therefore, specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding numerical performance results are not explicitly stated in this document.

The document broadly states: "non-clinical performance testing has been conducted to demonstrate the performance of the modified ZAC device and that it meets its intended use." and "A clinical software validation was performed to insure the performance of the enhanced software algorithm."

Based on the limited information, we can infer the implied performance goal is to "identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs." However, no specific metrics for the accuracy of this identification are provided.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "A clinical software validation was performed," but does not provide the number of cases or patients included in this validation.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The device's intended use emphasizes "physician over-read" and "consideration of all other relevant patient data," implying medical professionals are involved in the overall diagnostic process, but their role in establishing ground truth for the validation study is not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated. The document does not describe how discrepancies in ground truth or interpretation were resolved, if multiple experts were involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• MRMC Study: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect Size: Therefore, no effect size of human readers improving with AI assistance is provided. The device is intended to "provide support to the physician" and is "not intended as a sole means of diagnosis," requiring "physician over-read." This implies human-in-the-loop, but a comparative study assessing its impact is not described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance Study: The document does not explicitly present standalone (algorithm-only) performance metrics such as sensitivity or specificity. While "analysis procedure will identify specific heart sounds," the performance of this identification in isolation is not separately quantified. The emphasis is on its use "in conjunction with physician over-read."

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated. Given the nature of heart sound analysis, it's highly probable that the ground truth would have been established by expert clinical assessment (e.g., cardiologists interpreting auscultation, possibly combined with other diagnostic tests like echocardiography), but this is an inference, not a direct statement from the document.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not mentioned or provided in the document.

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

• Ground Truth for Training Set Establishment: Not mentioned or provided in the document.

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