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The ibiomedi Electronic Stethoscope ES-2020 is used to detect sound from the heart, arteries, veins, breathing sounds from the anterior/lateral chest and throat sounds in the neck. The chest piece is designed for children who are over two years old, teenagers and adults. It can be applied to any body type and can only be used for the purpose of medical diagnosis in clinics or hospitals.

The ibiomedi Electronic Stethoscope ES-2020 detects sounds from the heart, arteries, veins, breathing sounds from the anterior/posterior/lateral chest and throat sounds in the neck of patients. The sounds are transmitted to the user's ears through accessories such as earphones.

User interface includes A: Power button, frequency response mode button, volume button B: Power indicator, wireless transmission indicator, frequency response mode indicator, volume indicator.

Turn on the ibiomedi Electronic Stethoscope ES-2020 and connect to the wireless device via Bluetooth to transmit and store sounds. When the ibiomedi Electronic Stethoscope ES-2020 and the connected wireless device have walls, human bodies and other barriers, the effective range of Bluetooth transmission will be affected. It is recommended to reduce the distance between the ibiomedi Electronic Stethoscope ES-2020 and the connected wireless device to improve Bluetooth connection.Power to the device is provided by two AAA 1.5V batteries.

The associated accessories include.

• Small chest piece: For children with diaphragm. .
• Large chest piece: For adult with diaphragm.
• Audio line: For connecting external speakers.
• . 1MORE Earphones: For medical personnel to connect the ibiomedi Electronic Stethoscope ES-2020.

The provided text describes the ibiomedi Electronic Stethoscope ES-2020 which is used to detect sounds from the heart, arteries, veins, breathing sounds, and throat sounds. The text focuses on establishing substantial equivalence to a predicate device, as required by a 510(k) submission.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for direct clinical efficacy or diagnostic accuracy. Instead, the performance data provided focuses on:

• Followed modified ISO 10993-10:2010 (Irritation and Skin Sensitization), ISO 10993-5:2009 (Cytotoxicity).
• Tests included Guinea Pig Maximization Test (GPMT), Skin irritation test in rabbits, and Cytotoxicity study. |
  | Electrical Safety & Electromagnetic Compatibility (EMC) | - Complies with IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012; EN 60601-1: 2006 + A1: 2013; AAMI/IEC 60601-1:2005 + AMD 1:2012; CAN/CSA-C22.2 No. 60601-1:14 (for safety).
• Complies with IEC 60601-1-2: 2014 / EN 60601-1-2: 2015 (for EMC). |
  | Software Verification & Validation | - Level of concern identified as "Minor" (unlikely to cause injury).
• Software passed tests and met requirements of relevant standards. |
  | Performance Testing (Sound Amplification) | - Tests determined that sound amplification was not affected by the use of earphones.
• Performance data presented by traditional stethoscope and the subject device are "similar." |
  | Usability Study | - Acceptance Criteria: At least 85% of participants with no experience in this type of product will be able to use it properly after reading Instruction Manual for around 30 minutes.
• Summary: The summative evaluation objective of usability was met. |

2. Sample size used for the test set and the data provenance

• Usability Study: The sample size was 15 doctors and 15 nurses.
• Data Provenance: Not explicitly stated, but given that the applicant is Sound Land Corp. in Taiwan, it is likely that the usability study participants were from Taiwan. The document does not specify if the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not describe an expert-based ground truth establishment for the "Performance Testing" or "Usability Study" beyond the participants in the usability study being "doctors and nurses."

For the "Performance Testing" which compared the device to a traditional stethoscope, it's mentioned that their performance data are "similar," implying an unquantified comparison, not a ground truth derived from expert adjudication of sound quality or diagnostic outcomes.

4. Adjudication method for the test set

There is no mention of an adjudication method for establishing a ground truth.

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

There is no information about an MRMC comparative effectiveness study in the provided text. The device is an electronic stethoscope, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images with or without AI assistance. The "doctors and nurses" in the usability study were likely evaluating ease of use, not diagnostic improvement with AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable as the ibiomedi Electronic Stethoscope ES-2020 is a sound detection and amplification device, not an algorithm that performs standalone analysis or diagnosis without human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not report the use of a formal ground truth (like expert consensus, pathology, or outcomes data) for evaluating the diagnostic accuracy or clinical effectiveness of the stethoscope. The tests focused on safety, EMC, software functionality, and usability, as well as a general comparison to traditional stethoscopes regarding sound amplification.

8. The sample size for the training set

No information about a training set is provided. This is consistent with the nature of the device, which is an electronic stethoscope rather than a machine learning or AI-based diagnostic system that would require a distinct training set.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set or ground truth for such a set.

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