(70 days)
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.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (RNK PPA/BT-RB Stethoscope) |
|---|---|
| Intended Use: Detection and amplification of heart, lung, and other body sounds for diagnostic/monitoring. | Intended for use in detecting and amplifying heart, lung and other body sounds for diagnostic or monitoring purposes on a patient. (Matches predicate) |
| Technological Characteristics: Similar principles of operation. | Uses the same amplifier circuit and enclosure as the predicate device (RNK Electronic Stethoscope). |
| Amplitude Signal: Capable of sufficient amplification. | Provides up to about 20 times greater amplitude signal than a typical acoustic stethoscope. |
| Frequency Response: Appropriate range for auscultation. | Overall auscultation frequency response of 20 Hz - 1,500 Hz. |
| Electrical Safety: Conformance to relevant standards. | Successfully demonstrated conformance to IEC60601-1:2005 3rd Edition Medical Electrical Equipment Part 1: General Requirement for Safety. |
| EMC Immunity: Conformance to relevant standards. | Successfully demonstrated conformance to EN60601-1-2, 2007/03, EMC Immunity Requirements for Medical Electrical Equipment Part 1: General Requirements for Safety, 2. Collateral Standard - Electromagnetic Compatibility Requirements and Tests. |
| Biocompatibility: Safe for patient/clinician contact. | Uses the same materials that a patient or clinician might touch; Biocompatibility Analysis is the same as the predicate. |
| Auscultation Performance: Clinically equivalent performance. | Passed the same auscultation performance tests as the predicate device both in bench testing and by clinicians. |
Study Details (Based on Provided Text)
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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.
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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.
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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.
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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.
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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.
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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.
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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."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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.