(72 days)
The RNK Telephonic Stethoscope Model TR-1 is intended for use to transmit auscultation sounds, whereby a clinician at one location can listen to the auscultation sounds of a patient at a different location with the signal carried over a data communications channel between the two locations.
The RNK Telephonic Stethoscope Model TR-1 consists of a Chest Piece Assembly, a standard audio Headset, a wall-mount power adapter and an electronics Module containing amplifiers, filters, CODEC, UART and RS232 interface. The power adapter, Chest Piece Assembly and Headset are detachable and can plug into the electonics Module. The electronics Module is capable of operating as a transmitting unit sending digitized auscultation signals from the attached Chest Piece, or as a receiving unit accepting the digitized auscultation signals. converting them to analog audio and presenting them to the attached Headset.
The provided text is a 510(k) summary for the RNK Telephonic Stethoscope TR-1. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria.
The 510(k) pathway for medical devices in the US (and similar regulatory pathways elsewhere) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria in the same way one might for a novel device with a PMA (Premarket Approval) submission.
Therefore, the requested information cannot be extracted from the provided document because it is not present. The document focuses on establishing equivalence and not on reporting specific performance study results for acceptance criteria.
Response regarding the absence of information:
The provided 510(k) summary for the RNK Telephonic Stethoscope TR-1 does not contain information on specific acceptance criteria or an associated study proving the device meets those criteria. The 510(k) submission process relies on demonstrating substantial equivalence to a predicate device, and the document focuses on this aspect rather than presenting detailed performance study results against pre-defined acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not included in the provided text.
§ 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.