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Stethophone Pro is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone Pro is intended for use on adult patients. Stethophone Pro is not intended for self-diagnosis and not intended to be used as a sole means of diagnosis. Stethophone Pro can be used in clinical and nonclinical environments.

For Rx-only: Stethophone Pro is intended to provide decision support to clinicians in their evaluation of patients' heart sounds. The software analyzes heart sounds and phonocardiograms and can automatically detect murmurs that may be present, sound timing and character, including S1, S2, and the absence of a heart murmur. The interpretations of heart sounds offered by the software are not diagnoses and are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment.

For OTC: When used without access to the automatic analysis feature or under supervision of healthcare professional, Stethophone Pro is also intended to be used by lay users.

Stethophone Pro is an electronic stethoscope software application that operates on smartphones. Stethophone enables the capture and amplification of chest sounds for real-time or recorded listening. Cloud storage with sound record sending capabilities, filtering for selected frequency ranges, and visualization all assist with sound analysis.

Stethophone is designed to assist healthcare professionals in both hearing and visualizing heart and lung sounds during a physical examination of a patient and in storing recorded sounds in the cloud for later analysis. It also enables home users to record and send chest sounds to their physicians.

Stethophone can be used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Assessment should be performed by healthcare professionals, while sound capturing can be performed by both healthcare professionals and home users.

While all functions described above are available to both prescription and OTC users, the following analysis features and the associated report are accessible exclusively with a prescription: Stethophone Pro performs basic analysis of heart sounds, including detection of murmurs, identification of S1 and S2 heartbeats on the timeline, and calculation of timing intervals between them.

Key Product Features Available for both prescription and OTC users

• Capturing chest sounds using the smartphone microphone:
  • Real-time listening to chest sounds
  • Recording of chest sounds
• Sending examinations to specialists for assessment
• Two modes of sound visualization: oscillogram and spectrogram
• Selecting from three audio filters for listening:
  • Bell Traditional filter used in stethoscopes for low frequency sounds
  • Diaphragm Traditional filter used for higher frequency sounds of heart and lungs
  • Starling Filter for listening to the full frequency of chest sounds

All of these features are present in both the primary predicate, Stethophone Pro (K240901), and the reference device, Stethophone (K231551), and are now available for OTC use.

Product Features For prescription users only

• Detecting murmurs, timing for S1 and S2 sounds, and calculating heart rate

These features are derived from the Stethophone Pro (K240901, Rx-only).

Collectively, these features enable home users to acquire their own sounds, share them with healthcare professionals, and control their health, as well as allow healthcare professionals to examine and monitor patients on site and remotely, seek out second opinions from specialists, and use the device in a telemedicine context.

Based on the provided FDA 510(k) clearance letter for Stethophone Pro (K252595), here's an analysis of the acceptance criteria and study information:

The document explicitly states that no new performance data was required for this submission. This is because the device is a modified version of previously cleared devices (Stethophone Pro K240901 and Stethophone K231551), and the modifications were solely to the indications for use, not to the underlying acoustics algorithms or automated sound analysis capabilities.

Therefore, the following information is not available in the provided document, as no new studies were conducted for this specific clearance (K252595):

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set
• Data provenance for the test set
• Number of experts used to establish ground truth for the test set
• Qualifications of experts
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done
• Effect size of human reader improvement with AI vs. without AI assistance
• If a standalone performance (algorithm only without human-in-the-loop performance) was done
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How the ground truth for the training set was established

However, we can infer that acceptance criteria and performance data were established and met in the previous clearances (K240901 and K231551) for the functionalities that remain unchanged.

Summary of Device Performance and Acceptance Criteria (Based on Previous Clearances - Not explicitly detailed in this document):

The document states:

• "The acoustics algorithms for sound filtering (that are used for both OTC and Rx parts of the software) capabilities remain entirely unchanged from those validated and cleared in both K240901 and K231551."
• "Automated sound analysis capabilities (that are available for Rx use only) remain entirely unchanged from those validated and cleared in K240901."

This implies that for the features that do have performance claims (specifically, automated sound analysis for murmur detection and heart sound timing in the Rx-only version), acceptance criteria were met during the clearance of K240901. Similarly, for the basic functions of sound capture, amplification, filtering, and transmission, acceptance criteria were met during the clearance of K231551 and K240901.

To obtain the specific details regarding the acceptance criteria, study designs, sample sizes, and ground truth methodologies for these functionalities, one would need to refer to the original 510(k) submissions for K240901 and K231551. This current document (K252595) serves as a modification that leverages the previously established substantial equivalence and performance data.

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