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The CliniCloud Stethoscope is a digital stethoscope intended for periodic recording of lung and heart sounds to a smartphone device, via the CliniCloud app. It is intended to be used for persons of all ages. The device is for medical diagnostic purposes only.

Device Description

The CliniCloud stethoscope is a battery powered electronic stethoscope intended for the periodic recording of lung and heart sounds to a smartphone via a CliniCloud micro-USB to 4-pole audio cable. The CliniCloud Stethoscope features no user interface or speaker and must be used in conjunction with the CliniCloud app on a compatible smartphone. It is intended to be used for persons of all ages.

AI/ML Overview

This is a 510(k) premarket notification for the CliniCloud Stethoscope. The document indicates that no clinical performance data was required for this submission. Therefore, it does not contain a study proving the device meets specific acceptance criteria through clinical trials or human-in-the-loop performance. The approval is based on non-clinical testing demonstrating substantial equivalence to a predicate device.

Here's the breakdown of the information requested, based on the provided text:

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

Since no clinical study was conducted with specific acceptance criteria for a human user or algorithm performance, a traditional table comparing acceptance criteria to reported device performance from such a study cannot be generated. However, the non-clinical tests conducted aimed to prove the device met design specifications and was substantially equivalent to the predicate. The performance aspects assessed are listed:

Acceptance Criteria (Implied from Non-Clinical Testing)	Reported Device Performance (Summary from Non-Clinical Testing)
Compliance with general safety and essential performance standards (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11)	Device complies with all relevant standards.
Compliance with usability engineering standards (IEC 62366)	Device complies with usability engineering standards.
Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10)	All biocompatibility requirements were met.
Equivalence of frequency response (20 to 2000Hz) to a reference 510(k) cleared stethoscope	Demonstrated frequency response equivalence.
Accuracy of heart rate estimation benchmarked with a 510(k) cleared pulse oximeter	Heart rate estimation accuracy validated against a cleared pulse oximeter.
Validation of device cleaning instructions	Cleaning instructions validated.
Validation that frequencies across entire functional range can be reproduced on the smartphone and transmitted remotely	Frequencies reproduced on smartphone and transmitted remotely across full functional range validated.
Software contained in medical devices guidance compliance	Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Home use design considerations guidance compliance	Compliance with "Design Considerations for Devices Intended for Home Use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable. No human test set for performance evaluation was used. The non-clinical tests involved laboratory-based evaluations of the device's physical and functional characteristics.
Data Provenance: Not applicable for a human test set. The non-clinical testing was conducted to verify design specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No human test set requiring expert ground truth establishment was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No human test set requiring adjudication was used.

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

No. An MRMC comparative effectiveness study was not performed. The device is a digital stethoscope, not an AI diagnostic algorithm for image or signal interpretation by human readers.

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

Yes, in a way. The performance tests for the device itself (e.g., frequency response, heart rate estimation accuracy, signal transmission) can be considered "standalone" evaluations of the device's technical capabilities, without direct human intervention in the performance measurement. However, it's not a standalone AI algorithm performance evaluation in the typical sense.

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

For the non-clinical performance evaluations:

Heart rate estimation: Ground truth was established by comparison to a "510(k) cleared pulse oximeter."
Frequency response: Ground truth was established by comparison against a "reference 510(k) cleared stethoscope."
Other tests relied on engineering specifications and compliance with established standards (e.g., for safety, EMC, biocompatibility).

8. The sample size for the training set

Not applicable. This device is a digital stethoscope, not an AI algorithm that requires a training set for machine learning.

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

Not applicable. This device is a digital stethoscope, not an AI algorithm that requires a training set.

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