(501 days)
The 3M Littmann™ Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by a Health Care Professional. It can be used for the amplification of faint heart, lung and other body sounds as well as normal auscultation and selective frequency filtering. The extended range mode amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode, where some lung and heart sounds may occur, as well as providing low frequency response at a slightly reduced level compared to the bell mode.
The 3M Littmann™ Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by a Health Care Professional. It can be used for the amplification of faint heart, lung and other body sounds as well as normal auscultation and selective frequency filtering. The extended range mode amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode, where some lung and heart sounds may occur, as well as providing low frequency response at a slightly reduced level compared to the bell mode.
This 510(k) submission for the 3M Littmann™ Electronic Stethoscope does not provide the detailed acceptance criteria and study data in the format requested. The document describes non-clinical testing for frequency response and gain to establish substantial equivalence to a predicate device, but it does not specify quantitative acceptance criteria or report performance against such criteria in a structured manner.
Here's an breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
No explicit table of acceptance criteria or quantitative performance metrics against these criteria is provided in the document. The submission focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical testing using a "computerized audio analysis system" and a "transducer." This indicates a laboratory setup, not a clinical test set with patient data. Therefore, there's no information about:
- Sample size: Not applicable as it's not a clinical test involving a "test set" of patient data.
- Data provenance: Not applicable. The testing is described as lab-based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since this was a non-clinical, lab-based test for frequency response and gain, there were no human "experts" establishing ground truth in the clinical sense (e.g., radiologists interpreting images). The ground truth for the frequency response test would be the known input frequencies and amplitudes generated by the swept frequency oscillator.
4. Adjudication Method for the Test Set:
Not applicable. There was no human interpretation or adjudication involved, as it was a non-clinical, instrumental test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The testing described is non-clinical, focusing on the device's physical properties (frequency response and gain) compared to a predicate device. It does not involve human readers using the device with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
The device itself is an electronic stethoscope, designed to be used by a human healthcare professional. The "non-clinical testing" described is effectively a standalone performance test of the device's technical specifications (frequency response and gain) in a controlled lab environment. However, the document doesn't present it as an "algorithm only" study in the modern sense of AI device evaluation. It's a characterization of the physical device.
7. Type of Ground Truth Used:
The ground truth for the non-clinical testing was the known, controlled audio frequencies and amplitudes generated by the "frequency oscillator" and presented to the stethoscope via a transducer. This is objective, physical measurement data, not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
Not applicable. This device is an electronic stethoscope, not an AI/ML algorithm that requires a "training set" in the context of machine learning model development. The document describes a physical product.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm.
Summary of what is available from the provided text:
The provided 510(k) summary focuses on demonstrating substantial equivalence of the 3M Littmann™ Electronic Stethoscope to a predicate electronic stethoscope through non-clinical testing of its physical characteristics (frequency response and gain).
- Acceptance Criteria (Implicit): The implicit acceptance criteria were that the frequency response and gain of the new device should be "substantially equivalent" to the predicate, with intentional differences designed for improvement (e.g., improved bell mode, reduced noise in diaphragm mode, reduced masking in extended range mode).
- Study: A non-clinical study using a computerized audio analysis system.
- A frequency oscillator swept frequencies from 10 to 5000 Hz.
- The stethoscope was placed on a transducer receiving these frequencies.
- A calibrated microphone in the eartip measured the stethoscope's response.
- The computer recorded and stored this response.
- This was performed for each of the three frequency response modes.
- Conclusion: The manufacturer concluded that the device performs "as well as, and in many cases substantially better than the predicate electronic stethoscope" based on these measurements, justifying the intentional design differences.
§ 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.