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Intended for use as a diagnostic aid in patient diagnosis, treatment, and monitoring. It amplifies sounds from the body's internal organs, mainly the heart and lungs. Included with the system is a manual visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is not intended for diagnostic use. The system also includes computer-aided recordings and storage of these sounds along with other patient information.

The Meditron electronic stethoscope system is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, plays back, and transmits sounds associated with the heart, arteries, and veins and other internal organs. The modification involves the addition of a 5-lead electrocardiograph to produce an ECG on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle.

This 510(k) summary for the Meditron II Thestethoscope System (K013725) unfortunately lacks detailed information regarding specific acceptance criteria and the comprehensive study results that would typically prove the device meets these criteria. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance validation report.

However, based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative or qualitative acceptance criteria for each category (e.g., specific thresholds for biocompatibility tests, electrical leakage limits, EMC emission/immunity levels, software robustness metrics).
• Detailed results or metrics showing how these criteria were met for each category.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical study information was gathered for the purpose of demonstrating substantial equivalence," but it does not specify the number of patients or cases included in this study.
• Data Provenance: Not explicitly stated. It's unclear if the data was retrospective or prospective, or from which country.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study is not noted as being performed. The clinical information gathered was for the purpose of demonstrating substantial equivalence to predicate devices, not for comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not explicitly reported. The device is described as a "diagnostic aid" for a healthcare practitioner, implying a human-in-the-loop context. The summary does not provide any isolated algorithm performance metrics.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated in detail for the clinical study. Given the objective of demonstrating substantial equivalence to other electronic stethoscopes with integrated ECGs, the "ground truth" would likely be derived from a comparison to clinical judgment and/or established diagnostic methods, but specifics are absent.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not mentioned. This device does not appear to employ a machine learning algorithm that requires a "training set" in the conventional sense. Its function is to amplify, record, play back, and transmit sounds, and to produce an ECG for synchronization. It's an electronic measurement and display device, not an AI-driven diagnostic system.

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

• Ground Truth for Training Set: Not applicable/Not mentioned, as there is no apparent training set for an AI algorithm.

Summary of what the document does convey regarding acceptance and studies:

The primary "study" mentioned is the gathering of "clinical study information" to demonstrate substantial equivalence to existing legally marketed electronic stethoscopes with integrated ECG. The acceptance criteria, while not quantified, seem to be met if:

1. The device adheres to established standards for biocompatibility, electrical safety, electromagnetic compatibility, and product specifications.
2. The software is verified and validated.
3. Its indications for use and technological characteristics are "minor" and do not raise new safety or effectiveness issues compared to predicate devices.

The 510(k) pathway relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical trials to prove efficacy against a specific "gold standard" or to quantify AI performance improvements. The provided text strongly aligns with this approach.

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