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The RNK PPA/BT-RB Stethoscope is intended for use in detecting and amplifying heart, lung and other body sounds for diagnostic or monitoring purposes on a patient.

The RNK PPA/BT-RB Stethoscope is comprised of a PCP Chest Piece assembly, an Amplifier Module containing an amplifier which amplifies the signal from the PCP Chest Piece and a Bluetooth wireless transmitter, and a standard audio Headset, plus an optional Bluetooth Headset.

The PCP Chest Piece assembly includes an attached cable terminated in a standard 3.5 mm audio stereo plug, which plugs into the Chest Piece port of the Amplifier Module. A standard, off-theshelf Headset with a 3.5 mm stereo audio plug can plug into the Headset port of the Amplifier Module to enable a listener to hear the amplified sounds from the PCP Chest Piece. Optionally, an off-the-shelf Bluetooth Headset can be used to listen to the signal from the PCP Chest Piece over a Bluetooth connection to the Bluetooth transmitter in the Amplifier Module.

The RNK Amplifier is powered by x2 AAA NiMH batteries, which can be recharged from a wall mount 5vdc power supply with a micro-USB connector. The Ampifier Module is not functional as a stethoscope while the batteries are being charged.

The RNK PPA/BT-RB Stethoscope provides up to about 20 times greater amplitude signal than a typical acoustic stethoscope. The overall auscultation frequency response of the RNK PPA/BT-RB Stethoscope is 20 Hz - 1,500 Hz.

Here's an analysis of the provided text regarding the RNK PPA/BT-RB Stethoscope, focusing on acceptance criteria and supporting studies.

It's important to note that the provided documents (510(k) summary and FDA letter) are a regulatory submission and approval, not a detailed scientific study report. Therefore, much of the requested information about specific study designs (sample sizes, expert qualifications, ground truth establishment, MRMC studies) is not present in the given text. The information below is extracted and inferred only from what is provided.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a table with numerical targets in the provided document. Instead, the document relies on demonstrating "substantial equivalence" to a predicate device (RNK Electronic Stethoscope, K072026). The "acceptance criteria" are thus implicitly met by demonstrating similar performance and safety characteristics to the predicate device.

Study Details (Based on Provided Text)

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not specified. The document states "passed the same auscultation performance tests as the predicate device both in bench testing and by clinicians," implying some level of clinical evaluation, but details like the number of patients or sounds are not provided.
   • Data Provenance: Not specified. Given the regulatory submission context for a US market, it's generally assumed internal testing, but no country of origin for specific data is mentioned. The document doesn't indicate if it was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified. The document mentions "by clinicians" but does not quantify them or detail their roles in establishing ground truth.
   • Qualifications of Experts: Not specified.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified. The methodology for how clinicians "passed" the performance tests is not detailed.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or detailed. The submission emphasizes "substantial equivalence" to a predicate device, which usually involves demonstrating similar performance rather than a direct comparison of human reader effectiveness with and without the new device. The phrase "passed the same auscultation performance tests as the predicate device both in bench testing and by clinicians" suggests direct comparison of the device's output/performance to the predicate, rather than human reader improvement with the device.
   • Effect size of human readers improve with AI vs without AI assistance: Not applicable, as this device is an electronic stethoscope (an amplification and transmission tool) and not an AI-powered diagnostic system.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in part. The document states the device "passed the same auscultation performance tests as the predicate device both in bench testing and by clinicians." "Bench testing" would fall under standalone performance for the device's technical specifications (e.g., amplitude, frequency response, electrical safety, EMC). The "clinicians" part suggests a human-in-the-loop component, but the pure technical measurement (e.g., of frequency response) is standalone.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly defined. For auscultation performance, the "ground truth" for "passing" tests would likely be based on established audiological standards for stethoscopes and potentially subjective clinical assessment by the "clinicians" mentioned, comparing the sounds heard and their diagnostic utility to those from the predicate device. It is not mentioned to be pathology or outcomes data.

7. The sample size for the training set:

   • Not applicable. This device is an electronic stethoscope that amplifies and transmits sound; it does not involve machine learning or AI that would require a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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The RNK PCP-USB 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 the IP network with the signal carried on an IP connection between the two locations.

The PCP-USB Stethoscope consists of a hardware element, the PCP-Chest Piece, and software elements consisting of some audio signal processing in the Streaming Stethoscope Over IP (sSOIP) Anywhere software on the end station PCs, communications software on the end station PCs (sSOIP Anywhere), and communications networking software on the Telemedicine Communications Server (TMCS), Relay Server and Stethoscope User Data (SUD) Server. It provides remote auscultation between a patient at one location and a clinician at another location.

The PCP-USB Chest Piece contains an embedded piezo sensor, audio amplifier Analog to Digital Converter (ADC) and Encoder to create a digitized stream, plus a USB interface to send that data to the PC. The PCP-USB Chest Piece derives its operating voltage from the 5v lead of the USB interface to the PC.

Under direction of the sSOIP Anywhere program in the PC, the digitized signal is formatted in the PC into IP packets for transmit end station (i.e. patient end) and the receive end station (i.e. clinician end) log into the TMCS, which indicates their availability for a connection.

In the sSOIP Anywhere program, the clinician at the receive end, selects a patient from a list of available patients and initiates a connection request to the TMCS, which passes on the request to the patient station. When the patient accepts the incoming connection request in the sSOIP Anywhere program, the TMCS facilitates a direct (peer-to-peer) connection between the two parties. If a direct connection is not possible, the TMCS facilitates a relay connection between the two parties through a Relay Server. No patient stethoscope data passes through the TMCS.

At the receive end PC, the sSOIP Anywhere program directs the acceptance of the IP packets, conversion of the digitized signal back to analog and presentation of the analog signal to the Headset port of the PC.

The TMCS receives information on users that are permitted to use the TMCS services from a SUD Server. That information would be entered into the SUD Server by the health care provider responsible for those users.

The provided text is a 510(k) summary for the RNK PCP-USB Stethoscope, focusing on its substantial equivalence to a predicate device. It details the device's function, technical characteristics, and the testing conducted to support its claims. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics in a way that allows for a direct population of the requested table and comprehensive answers to all questions.

The device is an electronic stethoscope intended for remote auscultation. The submission asserts substantial equivalence to a previous device (RNK Products PCP/PC Stethoscope, K102893) based on similar intended use, principles of operation, and technological characteristics.

Here's a breakdown of what can be extracted and what is missing, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and a detailed table of reported device performance are NOT available. The document states:

• "The PCP-USB Stethoscope passed the same auscultation performance tests as the predicate device both in bench testing and by clinicians."
• "Both the PCP-USB Stethoscope and the predicate device successfully demonstrated conformance to IEC60601-1:2005 3rd Edition Medical Electrical Equipment Part 1: General Requirement for Safety and to EN60601-1-2, 2007/03, EMC Immunity Requirements for Medical Electrical Equipment Part 1: General Requirements for Safety, 2."

This indicates that the acceptance criteria were likely based on successful demonstration of conformance to these standards and equivalence in performance to the predicate device, but the specific metrics are not quantified in this summary.

2. Sample size used for the test set and the data provenance

The text mentions "bench testing and clinical testing" were performed. However, it does not specify the sample size for the test set (number of subjects, number of recordings, etc.) or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The text mentions "clinicians" were involved in testing: "The PCP-USB Stethoscope passed the same auscultation performance tests as the predicate device both in bench testing and by clinicians." However, it does not specify the number of clinicians/experts or their qualifications used to establish ground truth or evaluate performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The text does not describe any adjudication method used for the test set.

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

This device is an electronic stethoscope for transmitting auscultation sounds. There is no indication of a MRMC comparative effectiveness study involving AI assistance in the provided text. The device itself is a tool for remote auscultation, not an AI-powered diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable. The device is a hardware and software system for transmitting sound; it's inherently a human-in-the-loop device (a clinician listens to the transmitted sounds). There is no standalone "algorithm only" performance reported, as the primary function is to enable remote listening by a human.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The text implies "auscultation performance tests" conducted by "clinicians." This suggests a form of expert evaluation or comparison to the predicate device's performance as the basis for "ground truth" (or, more accurately, basis for equivalence), but the specific method (e.g., expert consensus on specific sound characteristics, comparison of diagnoses made using the device vs. predicate) is not detailed.

8. The sample size for the training set

The concept of a "training set" typically applies to machine learning algorithms. While the device involves "audio signal processing" in its software, the document presents it as an enhancement of an existing system (sSOIP software) for connection purposes, not as an AI-powered diagnostic tool requiring a distinct training phase in the context of typical AI/ML development. Thus, a "training set" in this context is not explicitly mentioned or applicable based on the provided information.

9. How the ground truth for the training set was established

As there is no explicit mention of a training set in the context of AI/ML, there is no information on how its "ground truth" was established.

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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.

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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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The RNK Electronic Stethoscope is intended for use in detecting and amplifying heart, lung and other body sounds for diagnostic or monitoring purposes on any patient undergoing a physical assessment.

The RNK Electronic Stethoscope is comprised of a Chest Piece assembly, an Amplifier module containing an amplifier, and a standard audio Headset. The Chest Piece assembly and Headset are detachable and can plug into the Amplifier module. The Amplifier module amplifies and filters the signal from the Chest Piece and presents it to the attached Headset. A standard 3.5 mm audio cable is used to connect the RNK Chest Piece Assembly to the RNK Amplifier. A standard, off-the-shelf Headset with a 3.5 mm plug can plug into the RNK Amplifier to enable a listener to hear the sounds from the RNK Chest Piece. The RNK Amplifier is powered by x2 AAA batteries, which can be easily accessed for replacement. Unplugging the RNK Chest Piece puts the Amplifier into low power mode. The RNK Electronic Stethoscope provides up to about 20 times greater amplitude signal than a typical acoustic stethoscope. The overall auscultation frequency response of the RNK Electronic Stethoscope is 20 Hz - 1,500 Hz.

The provided text is a 510(k) summary for the RNK Electronic Stethoscope. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics. Therefore, many of the requested details about acceptance criteria, detailed study design, and performance metrics are not explicitly available in this document.

However, I can extract information related to the device description, intended use, and the nature of the evaluation for substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

This document does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a table format. The primary demonstration of effectiveness is through user testing to show substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "user testing with clinicians" but does not specify the sample size of this test set, the data provenance (country of origin), or whether it 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)

This information is not provided. The user testing is described generally as being with "clinicians," without specifying their number or qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for the user testing.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described. The device is an electronic stethoscope intended to amplify and filter body sounds for human clinicians.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is an electronic stethoscope, designed to be used by a human listener. It's not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document implies that the ground truth for "effectiveness" in the user testing was based on clinicians' assessment during the user testing, likely comparing the device's performance to predicate devices in identifying and hearing body sounds. No explicit "ground truth" method (like pathology or outcomes data) is described.

8. The sample size for the training set

This is not applicable. The device is a hardware electronic stethoscope and not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. The device is a hardware electronic stethoscope and not an AI/ML algorithm that requires a training set and established ground truth for it.

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