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The SERENO 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 SERENO electronic stethoscope is intended for use as a diagnostic aid in patient diagnosis and monitoring. The SERENO electronic stethoscope amplifies sounds up to 20 times bigger than 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 probe head, binaural pipes and ear tips. It has four (4) buttons on the top of the chest set (opposite to the probe). 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 automatic power off function for longer battery life and has a LCD display to show volume level, frequency mode and low battery indicator. With the enclosed audio cable. utilizing a personal computer, the user can store sound signals in the PC and transmit diagnosis data via e-mail. This stethoscope is a stand-alone unit, has no software and operates using an analog audio system with a digital timer for power saving and a digital control for the volume and the filter mode selection. It can be connected to audio input of a sound card in a computer to use the PC software functions. However, the software does not operate nor control the stethoscope in any manner. In fact, the stethoscope's audio output can be connected to any ordinary audio equipment such as a cassette recorder, a hi-fi audio component and portable audio.

The provided text describes the SERENO Electronic Stethoscope (K062481) and its substantial equivalence to predicate devices, but it does not contain detailed acceptance criteria or a dedicated study report proving the device meets specific acceptance criteria in the manner typically expected for AI/ML medical devices.

Instead, the documentation focuses on demonstrating substantial equivalence to existing predicate devices (3M™ Littmann™ Electronic Stethoscope K003723 and JABES Electronic stethoscope K031446) through a comparison of technological characteristics and general safety and effectiveness claims.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not define explicit "acceptance criteria" but rather presents a comparative table with performance characteristics of the new device against predicate devices. The "reported device performance" is essentially the listed characteristics of the SERENO, and the "acceptance" is implicitly the demonstration of equivalence to the predicate devices' characteristics.

Conclusion stated in the document: "After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Pishon High Tech Co., Ltd., that the SERENO Electronic is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

Missing Information (Not Present in the Provided Text):

2. Sample size used for the test set and the data provenance: Not mentioned. The document refers to "bench and user testing" but provides no details on samples, specific tests, or data sources.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. Ground truth establishment is not described for any testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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: Not applicable. This device is an electronic stethoscope, not an AI/ML algorithm requiring human-in-the-loop performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as "a stand-alone unit, has no software and operates using an analog audio system." It's a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. No specific ground truth methodology is described.
8. The sample size for the training set: Not applicable and not mentioned. As it's not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established: Not applicable and not mentioned.

Summary of what the provided text does convey about the study:

• Type of Study: The filing relies on a "comparison to predicate device," "bench," "electrical safety," "EMC," and "user testing" to demonstrate substantial equivalence. It is primarily a comparative study against legally marketed devices, focusing on functional specifications and safety rather than a clinical trial with specific performance metrics for diagnosis.
• Device Type: The SERENO Electronic Stethoscope is a hardware device for amplifying body sounds. It explicitly states it "has no software and operates using an analog audio system." Therefore, standard AI/ML study components like training sets, test sets with ground truth, MRMC studies, or standalone algorithm performance are not applicable to this submission.
• Purpose: To achieve substantial equivalence with existing electronic stethoscopes, thereby allowing it to be marketed as a Class II medical device.

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