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The RNK Telephonic Stethoscope Model TR-USB 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-USB is intended for use as remote monitoring device, 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 communication channel between the two locations.

The RNK Telephonic Stethoscope Model TR-USB consists of a Chest Piece Assembly, a standard audio Headset and an electronics Module containing amplifiers, filters, CODEC, UART and communication interface. The Chest Piece Assembly and Headset are detachable and can plug into the electronics 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 communication interface to the RNK Telephonic Stethoscope is a standard USB data interface to a PC with a data communication channel.

This submission is a 510(k) premarket notification for the RNK Telephonic Stethoscope Model TR-USB. It claims substantial equivalence to a predicate device (RNK Products Telephonic Stethoscope Model TR-1).

The provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document details the device description, its intended use, and states that it is substantially equivalent to a predicate device because it has the "same intended use, principles of operation and technological characteristics." It explicitly states, "There are no new questions of safety or effectiveness."

Therefore, based on the provided text, I cannot complete the table or answer most of the questions regarding acceptance criteria and study details.

Here's an overview of what can be extracted based on the input:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in the document. The basis for clearance is "substantial equivalence" to a predicate device, implying that its performance is considered equivalent to the predicate.
   • Reported Device Performance: Not explicitly stated with specific metrics or values. The device's performance is implicitly assumed to be acceptable due to its substantial equivalence to the predicate device.

   Acceptance Criteria	Reported Device Performance
   Not explicitly stated. Implicitly, functional equivalence to the predicate device leading to no new questions of safety or effectiveness.	Not explicitly stated. Assumed to be functionally equivalent to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No specific performance testing with a "test set" is described in this 510(k) summary. The submission relies on substantial equivalence.

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. No specific performance testing requiring expert-established ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No specific performance testing is described.

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. This device is a telephonic 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. This device is a telephonic stethoscope, not an algorithm. Its function is to transmit sounds for a human clinician to interpret.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No specific performance testing requiring ground truth is described.

8. The sample size for the training set: Not applicable. This device is a hardware product, not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established: Not applicable. As there is no training set, there is no ground truth for it.

In summary, this 510(k) submission establishes substantial equivalence purely based on the device's intended use, principles of operation, and technological characteristics being the same as the predicate device, without presenting new performance study data.

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