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The JABES Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.

The JABES Electronic Stethoscope is intended for use as a diagnostic aid in patients diagnosis, treatment and monitoring. It provides three filter frequency modes: Bell (20-200Hz), Diaphragm (200-500Hz). Wide (20-800Hz). Bell Mode is similar to the acoustic bell-type stethoscope and optimized for heart and other cardiology related sound. Diaphragm Mode is similar to the acoustic diaphragm-type stethoscope and optimized for higher pitched sound such as lung and bronchial sounds. Wide Mode is a combination of Bell and Diaphragm Modes. Wide Mode provides wider frequency range compare to the typical acoustic stethoscope including the Bell-type and Diaphragm-type. The JABES amplifies sounds up to 18 times bigger than an ordinary acoustic stethoscope in a broad frequency range, including a range higher than the traditional diaphragm mode. It looks similar to the traditional stethoscope including parts like a diaphragm, binaural pipes and ear tips. However, it has four (4) buttons on top of the chest set (opposite to the diaphragm side). Each of the buttons has a function of controlling the modes, volume up/down and power on/off. As an electronic stethoscope, it needs two (2) batteries (AAA type, 1.5V) to operate. The stethoscope has power saving functions for longer battery life and has a low battery indicator to prevent the use in malfunctioning condition due to the low power.

Here's a breakdown of the acceptance criteria and the study information for the JABES Electronic Stethoscope based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a substantial equivalence comparison, so the "acceptance criteria" for the JABES Electronic Stethoscope are its ability to meet or exceed the performance of the predicate electronic stethoscopes in key functional areas. The acceptance criteria are implicit in the comparison points.

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

The provided text does not specify a sample size for a test set in the conventional sense of a clinical trial for diagnostic performance. The document describes "bench and user testing data" and "electrical safety, EMC" data. These types of tests typically involve a limited number of devices or a specific test setup, not a patient-based test set with a defined sample size for diagnostic accuracy.

• Data Provenance: The study appears to be an internal validation effort by GS Technology Co., Ltd. The document does not explicitly state the country of origin of the data beyond the manufacturer being from South Korea. It is a report submitted for a 510(k) premarket notification, implying it's a retrospective analysis of tests conducted on the device.

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

This information is not provided in the document. The document refers to "user testing," but it does not detail the nature of this testing, how ground truth (if any for diagnostic performance) was established, or the qualifications of the users. For an electronic stethoscope, "user testing" might relate more to usability and perceived sound quality rather than a formal diagnostic accuracy study with expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the submission (510(k) for substantial equivalence based on functional comparison and safety, rather than a diagnostic accuracy study), a formal adjudication method for a test set is unlikely to have been a primary component.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to existing predicate devices based on technical specifications and general safety/effectiveness rather than a study evaluating diagnostic improvement with AI assistance. The device is the stethoscope; there is no AI component described.

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

N/A. This device is an electronic stethoscope that amplifies and filters sounds for human interpretation. It is not an algorithm that performs a diagnostic task independently.

7. The Type of Ground Truth Used

The document does not explicitly describe the type of ground truth used in the context of diagnostic performance. The "testing" mentioned ("bench and user testing") likely focused on:

• Bench Testing: Verifying technical specifications (frequency response, amplification, sound level, battery life, etc.) against design requirements. The "ground truth" here would be the measured physical properties of the device.
• User Testing: Evaluating the subjective experience of using the stethoscope (e.g., sound quality, comfort, ease of use). The "ground truth" here would be user feedback and satisfaction, which is not a clinical ground truth for diagnostic accuracy.

There is no mention of pathology, expert consensus on patient cases, or outcomes data being used to establish ground truth for diagnostic accuracy in this submission.

8. The Sample Size for the Training Set

N/A. The JABES Electronic Stethoscope is a hardware device, not an algorithm that requires a training set.

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

N/A. As stated above, this device does not involve a training set.

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