(203 days)
The SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.
The SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.
The provided text is a 510(k) summary for the SimulScope® Bedside Auscultation System. It focuses on demonstrating substantial equivalence to predicate devices based on product features and intended use. The document does not describe acceptance criteria, the results of a study to meet those criteria, or any of the detailed study information requested in your prompt.
Specifically, the document omits information such as:
- Acceptance Criteria Table: No such table is present.
- Sample Size and Data Provenance for Test Set: No test set is mentioned.
- Number of Experts for Ground Truth: No ground truth experts are mentioned.
- Adjudication Method: No adjudication method is mentioned.
- MRMC Comparative Effectiveness Study: No MRMC study is mentioned.
- Standalone Performance Study: No standalone performance study is mentioned.
- Type of Ground Truth: No ground truth beyond general performance characteristics (acoustic/electronic operation, frequency range, etc.) is mentioned.
- Training Set Sample Size: No training set is mentioned.
- Ground Truth for Training Set: No information is provided.
The document's primary purpose is to compare the new device's features and principles of operation to existing, legally marketed devices to establish substantial equivalence, rather than to present data from a performance study demonstrating specific acceptance criteria.
§ 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.