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The AUSCO ES-3100 Electronic Stethoscope is intended for medical diagnostic purposes. It may be used for the amplification of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment.

The AUSCO ES-3100 Electronic Stethoscope is a healthcare device that electronically filters and amplifies sounds of the heart, lungs, arteries, veins and other internal organs, and transfers them to the user's ears through an active speaker and passive sound tubes. The AUSCO ES-3100 provides two filter frequency modes for auscultation: Bell (20 to 200Hz) and Diaphragm (20 to 1000Hz). The AUSCO ES-3100 incorporates electronics and embedded software, which controls all of the various features such as volume control, frequency mode selection, and automatic powering off of the stethoscope. Active high and low pass filtering circuits are employed to produce the bell and diaphragm frequency response modes that are used to listen to the heart, lungs and other body sounds, while reducing frictional noises. The AUSCO ES-3100 does not employ any off-the-shelf-software. The AUSCO ES-3100 uses two (2) AAA alkaline batteries.

This pre-market notification for the AUSCO ES-3100 Electronic Stethoscope primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel acceptance criteria through a specific clinical study with performance metrics. The submission highlights similarities in characteristics, materials, features, intended use, and indications for use.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes, expert involvement, and ground truth establishment, as typically seen for devices with new performance claims or requiring clinical validation, is not explicitly detailed in this 510(k) summary.

However, based on the provided text, here's an attempt to categorize the information where applicable:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the characteristics and performance of the predicate devices. The device is deemed acceptable if it is "similar if not identical in materials, technological characteristics, and has the same intended use as the predicate devices," and if "Any differences in technological characteristics... do not raise any new questions of safety or effectiveness."

Study Details

Based on the provided document, the "study" conducted for this 510(k) submission is a comparative analysis demonstrating substantial equivalence to predicate devices, rather than a standalone clinical performance study with specific metrics.

1. Sample size used for the test set and the data provenance: Not applicable in the context of a comparative analysis. The "test set" implicitly refers to the characteristics and performance data of the predicate devices used for comparison. No new patient data or test set was generated for direct evaluation of the AUSCO ES-3100's diagnostic performance beyond its technical specifications aligning with predicates.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the predicate devices' performance was established through their original clearance and market use, not through a new expert panel for this submission.
3. Adjudication method for the test set: Not applicable for a comparative analysis.
4. 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: Not applicable. This device is an electronic stethoscope, not an AI-assisted diagnostic tool for interpretation.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone clinical performance study was described for the AUSCO ES-3100 in the sense of evaluating its diagnostic accuracy independently. The "standalone" evaluation was primarily limited to engineering and safety testing (biocompatibility, electrical safety, EMC).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for the AUSCO ES-3100's performance validation here. The "ground truth" for substantial equivalence rests on the established regulatory approval and clinical acceptance of the predicate devices.
7. The sample size for the training set: Not applicable. This device does not involve machine learning or an algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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