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The Feelix Stethoscope is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. It can be used on any person undergoing a physical examination.

Sonavi Labs, in collaboration with Johns Hopkins University, has developed a next generation stethoscope with pristine digital audio to help clinicians and healthcare workers detect, amplify, and record sounds during physical examination. The Feelix Stethoscope (Feelix) re-engineers the classic stethoscope and offers three major improvements: (1) more uniform sensitivity over its entire face so that sound quality is less dependent on placement on the body (2) leading noise suppression and sound volume control, and (3) onboard real-time algorithms so the device can operate as a stand-alone rather than requiring connection to a computer.

The provided text does not contain specific acceptance criteria or an explicit study that uses precise quantitative metrics to prove the device meets those criteria. Instead, it details a 510(k) submission for the Feelix Stethoscope, asserting substantial equivalence to a predicate device (M3DICINE's Stethee Pro 1) based on functional and technological similarities, and general performance testing.

Therefore, many of the requested sections regarding specific acceptance criteria, reported performance, sample sizes for test/training sets, expert details, adjudication methods, or MRMC studies cannot be extracted directly from this document.

However, based on the information provided, here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific numerical acceptance criteria for performance metrics (e.g., decibel gain, signal-to-noise ratio thresholds) nor direct reported performance against such criteria. The "Performance Testing" section states: "Acoustic Performance...demonstrated that the device was as effective as other legally marketed electronic stethoscopes." This is a qualitative statement of effectiveness rather than a quantitative performance metric.

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

• Sample Size for Test Set: Not specified. The document mentions "Bench performance data were collected," but does not provide details on the number of subjects, recordings, or specific test cases used for acoustic performance, noise suppression, or usability testing.
• Data Provenance: Not explicitly stated. The testing was conducted as "Bench performance data," implying lab-based testing. There is no information about country of origin, retrospective or prospective nature of the data, or if patient data was even used since it mentions "Animal and clinical testing were not necessary."

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

Not applicable. The document does not describe a process involving human experts to establish ground truth for the performance testing. The "acoustic performance" and "noise suppression" would likely be evaluated against objective engineering specifications or benchmarks, not expert consensus on physiological sounds.

4. Adjudication Method for the Test Set

Not applicable, as expert-based ground truth establishment is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states: "Animal and clinical testing were not necessary," and an MRMC study typically involves human readers (clinicians) interpreting cases, often with and without AI assistance, which falls under clinical testing.

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

The document mentions "onboard real-time algorithms so the device can operate as a stand-alone rather than requiring connection to a computer." This implies the device has standalone processing capabilities, but it does not describe a standalone performance study (e.g., comparing algorithm output to ground truth without human intervention). The performance data cited is for the overall device's function (signal acquisition, noise suppression).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document implies objective, engineering-based ground truth for acoustic performance, signal acquisition, and noise suppression. It would likely involve known sound inputs and measurements of the device's output and processing capabilities (e.g., signal-to-noise ratio measurements, frequency response analysis). It explicitly states that "Animal and clinical testing were not necessary," which means no pathology, outcomes data, or expert clinical consensus on patient cases were used as ground truth for this submission.

8. The Sample Size for the Training Set

Not specified. The document describes the device's features and performance testing for regulatory submission, but it does not detail the development or training of any internal algorithms (e.g., for noise suppression or sound processing).

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

Not specified. As the document does not detail algorithmic training, it does not describe how ground truth for such a training set would be established.

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