(50 days)
For projecting the sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to enhance the acoustical sounds of the device.
This electronic stethoscope electronically amplifies sound with fingertip control; it is turned on by pressing and holding a button on the back of the diaphragm housing. The stethoscope has a volume control and a two position frequency response switch.
The provided text describes a 510(k) summary for the Labtron Electromax Electronic Stethoscope (K961857). This submission is for a traditional medical device, not an AI/ML-driven device. As such, many of the requested categories in the prompt are not applicable or cannot be extracted from this type of document, which focuses on substantial equivalence to a predicate device based on non-clinical performance and intended use, rather than complex clinical studies or AI algorithm performance.
Here's an analysis based on the information provided:
- A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state quantitative clinical acceptance criteria. Instead, the "acceptance criteria" for substantial equivalence are inferred from the comparison to the predicate device and adherence to general medical device safety and performance standards.
- Reported Device Performance: The primary "performance" reported is its electronic amplification capability and its functional similarity to the predicate. No quantitative clinical performance metrics (e.g., sensitivity, specificity for detecting specific heart sounds) are provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electronic amplification of sound | Device electronically amplifies sound with fingertip control. |
| Functional similarity to predicate (Littmann Electronic Stethoscope K771653) | Basic design is comparable in both operation and functionality. |
| Adherence to electrical, mechanical, and environmental performance standards | Testing conducted in accordance with FDA's guidelines "Reviewer Guidance for PMN Submissions", DCRND outlining electrical, mechanical and environmental performance standards. |
| Safety and effectiveness established | Safety and effectiveness have been established (conclusion based on non-clinical tests and comparison to predicate). |
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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. This summary does not describe a clinical test set with human subjects/data for evaluating performance metrics.
- Data Provenance: Not applicable. The "testing" referred to is non-clinical engineering and performance testing of the device itself, not data from patients.
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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 ground truth was established by experts for a clinical test set as part of this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was performed.
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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 is not an AI-assisted device, and no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a standalone medical device (electronic stethoscope), but not an algorithm. Its performance is inherent to its physical and electronic design.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For a traditional medical device like this, "ground truth" in the clinical sense (e.g., for disease detection or diagnosis) is not established within the 510(k) summary. The "ground truth" for the device's function is its ability to electronically amplify sounds as per its design specifications.
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The sample size for the training set
- Not applicable. This device does not have a "training set" in the context of machine learning.
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How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.