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The ProTron Technologies, Electronic Stethoscope, Model Stethotron is intended for medical diagnostic purpose only. Stethotron has two modes of operation, amplification with filtering (Mode 1) and amplification only (Mode 2). Mode 1 filters out sounds below 350 Hz and above 1,000 Hz and used to listen specifically for vascular pathology. Mode 2 is used to listen for heart, lung, arteries, and other body sounds from 20 Hz to 20,000 Hz during routine physical examinations. Stethotron can be used on adult or paediatric patients undergoing physical examination.

The ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron is a battery powered analog device with two user selectable modes of operation for detecting, amplifying and filtering various body sounds of the heart, lungs, arteries, and internal organs: Mode 1 filters out sounds below 350 Hz and above 1,000 Hz. Mode 2 provides amplification only, 20 Hz to 20,000 Hz. Stethotron has volume controls on both modes enabling the user to adjust the sound to the level desired. The chestpiece of the device is sized for use with adult or pediatric patients and is a bell and diaphragm design incorporating a microphone. All of the electronics are contained in a plastic casing positioned below the bifurcation of the stethoscope yoke that connects to the headset that terminates at the eartips. The electronic casing includes the ON/OFF switch, volume control, and mode of operation selection control on the face. It is powered by two AAA alkaline batteries.

The provided document K082771 describes the ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron, and its substantial equivalence to a predicate device. The information details the device's technical characteristics and the non-clinical testing performed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron are based on demonstrating substantial equivalence to the predicate device, the 3M Littman Electronic Stethoscope, Model 2000 (K961848). This means the ProTron device's performance characteristics needed to be equivalent or not raise new questions of safety or effectiveness compared to the predicate.

The primary performance aspect evaluated was the audio response and gain, ensuring it functioned similarly to an electronic stethoscope.

2. Sample Size Used for the Test Set and Data Provenance

The documentation does not specify a "test set" in the traditional sense of a clinical trial with human subjects. Instead, the testing described is non-clinical electrical and acoustic testing.

• Sample Size: Not applicable in the human subject sense. The testing involved the ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron devices themselves. The specific number of devices tested is not mentioned, but it refers to the device's inherent characteristics.
• Data Provenance: The testing was electrical and acoustic performance evaluation, not data collected from patients. The document does not specify the country of origin for the testing itself, but given the submission to the FDA, it is presumed to be conducted according to US regulatory standards. It is retrospective in the sense that the test results already existed at the time of the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. The "ground truth" for the non-clinical testing of audio response and gain was established by objective measurements using a computerized audio analysis system and a calibrated microphone.
• Qualifications of Experts: Not applicable for establishing ground truth for this type of test.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. There was no human adjudication process described for the non-clinical performance tests. The system relied on direct measurement and comparison to the predicate's known performance characteristics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC study done? No. The document does not mention any MRMC comparative effectiveness study involving human readers. The device is a diagnostic tool (electronic stethoscope) that amplifies sounds, and the focus of the submission is on its technical performance characteristics rather than reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone study done? Yes, in a sense. The described "Test Data" refers to the standalone performance of the device's electrical and acoustic properties. The device's ability to amplify and filter sounds was evaluated purely based on its technical specifications, independent of human interaction or interpretation for the purpose of establishing substantial equivalence. The computerized audio analysis system measured the device's output compared to a known input, which is a standalone performance assessment of the device itself.

7. Type of Ground Truth Used

• Type of Ground Truth: For the electrical and acoustic performance, the ground truth was based on objective physical measurements (frequency sweeps, gain measurements) against established engineering standards and comparison to the known performance of the legally marketed predicate device.
  • For biocompatibility, the ground truth was established by adherence to ISO 10993-Part 1 standards and safety evaluations of material components.
  • For electrical safety, the ground truth was based on electrical testing standards and safety compliance.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a hardware electronic stethoscope, not an AI or machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

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