(112 days)
The RNK PCP/PC Stethoscope is intended for use as a remote monitoring device, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient at a different location on the IP network with the signal carried on an IP connection between the two locations.
The RNK PCP/PC Stethoscope is intended to transmit auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient at a different location on an IP network with the signal carried on an IP connection between the two locations.
The PCP/PC Stethoscope is comprised of a PCP/PC Chest Piece that plugs into a generic PC on an IP network (e.g. the Internet) and the streaming Stethoscope Over IP (sSOIP) software application running on the PC. It provides remote auscultation between a patient at one location and a clinician at another location.
The PCP/PC Chest Piece derives operating voltage from the bias voltage on the Microphone port of the PC. PCP/PC Chest Piece contains an embedded amplifier which amplifies the auscultation signal from the piezo sensor and presents it as an analog signal to the Microphone input of the PC.
Under direction of the sSOIP program, the analog signal is digitized in the PC, formatted and converted to IP packets for transport. At the receive end PC, the sSOIP program directs the acceptance of the IP packets, conversion of the signal back to analog and presentation of the analog signal to the Headset port of the PC.
The provided text is a 510(k) summary for the RNK PCP/PC Stethoscope. It aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting detailed performance data from a specific study against such criteria. The document explicitly states: "Bench testing and clinical testing was performed to verify specification and performance." However, it does not provide the details of these tests, including specific acceptance criteria or the reported performance metrics.
Therefore, many of the requested details cannot be extracted from the given document.
Here's an analysis of what information can be extracted and what information cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "Bench testing and clinical testing was performed to verify specification and performance," but does not list any specific acceptance criteria or the reported device performance against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "clinical testing" but does not specify the sample size used, the country of origin, or if the data was retrospective or prospective.
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)
- Cannot be provided. The document does not describe the establishment of a "ground truth" using experts for the clinical testing mentioned. This type of detail is usually associated with studies evaluating diagnostic accuracy, which is not implicitly described here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No information on adjudication methods for a test set is present.
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
- Cannot be provided. The device is an electronic stethoscope for remote auscultation; there's no mention or implication of "AI assistance" or "human readers" in the context of a diagnostic interpretation task that would typically necessitate an MRMC study. The study described seems to be a performance verification against predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Cannot be fully determined. The device is a stethoscope, which fundamentally involves a human clinician for interpretation. While it transmits an analog signal to a PC for digitization and transport, the "standalone" performance of an "algorithm" in the typical sense (e.g., for automated diagnosis) is not described or implied by this document. The "device performance" would refer to the clarity and fidelity of the transmitted sound.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. The document does not describe the use of any specific "ground truth" type as would be relevant for diagnostic accuracy studies. For a stethoscope, "ground truth" might refer to the actual body sounds, which are then compared to the transmitted sounds. However, no such comparison methodology is detailed.
8. The sample size for the training set
- Not Applicable/Cannot be provided. This document does not describe a machine learning or AI algorithm that would require a "training set." The device is a hardware and software system for sound transmission.
9. How the ground truth for the training set was established
- Not Applicable/Cannot be provided. As there's no training set mentioned, there's no information on how its ground truth was established.
Summary of available information:
The document focuses on establishing substantial equivalence to predicate devices (RNK Products TR-1 Telephonic Stethoscope K034046 and RNK Products Precordial Stethoscope K072026). It states:
- The RNK PCP/PC Stethoscope uses similar amplifier and chest piece sensor technology as the predicates.
- It has the same intended use, principles of operation, and technological characteristics as the predicate devices.
- "Bench testing and clinical testing was performed to verify specification and performance."
However, the specific acceptance criteria and the detailed results of these tests are not included in this summary. The 510(k) summary format often emphasizes the comparison to predicates and a high-level statement of testing, rather than detailed study results. The purpose is to confirm the device is as safe and effective as legally marketed predicate devices, not always to prove absolute performance against strict numerical criteria in the public summary.
§ 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.