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K Number
K993623
Device Name
GEMINI E
Manufacturer
ALLEN MEDICAL INSTRUMENTS CORP.
Date Cleared
2000-06-23

(241 days)

Product Code
DQD
Regulation Number
870.1875
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Normal auscultation of the cardiovascular system, pulmonary system or gastro-intestinal system by a health care professional.
  2. Normal auscultation as above by a health care professional who wears hearing aids.
  3. To allow four other listeners (e.g. students) to listen together with a health care professional.
Device Description

An electronic stethoscope utilizing conventional stethoscope components but amplifying auscultated sounds by means of a 3 volt electronic circuit. An output jack is provided for headphone use. The stethoscope is controlled by a single button which turns the unit on and adjusts the amplitude through four levels.

AI/ML Overview

The provided document states that no clinical tests were performed for the GEMINI E Electronic Stethoscope.

Therefore, the following information cannot be extracted from the document:

  1. A table of acceptance criteria and the reported device performance: Not applicable as no clinical tests were performed to establish performance metrics against acceptance criteria.
  2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable.
  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.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
  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. The device is an electronic stethoscope, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

The document indicates that the determination of substantial equivalence was based on non-clinical tests, specifically:

  • Emissions testing conducted by Acme Laboratories in Acme, Washington.
  • Safety testing in accordance with government requirements conducted by Intertek Testing Services in Laguna Niquel, California.

The conclusion states that the GEMINI E stethoscope is substantially equivalent to the Simulscope Bedside Auscultation System in its applications and that safety has been established through these non-clinical tests.

§ 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.