(a) Identification. A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must fulfill the following:

(i) Testing must include a discussion of the patient population and any statistical techniques used for analyzing the data; and

(ii) Testing must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.

(2) Acoustic performance testing must evaluate microphone sensitivity, sound acquisition bandwidth, and amplitude accuracy. The acoustic sensor specifications and mechanism used to capture heart sounds must be described.

(3) A scientific justification for the validity of the algorithm(s) must be provided. This justification must fulfill the following:

(i) All inputs and outputs of the algorithm must be fully described;

(ii) The procedure for segmenting, characterizing, and classifying the acoustic signal must be fully described; and

(iii) This justification must include verification of the algorithm calculations and validation using an independent data set.

(4) The patient-contacting components of the device must be demonstrated to be biocompatible.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Human factors/usability testing must demonstrate that the user can correctly use the device, including device placement, based solely on reading the directions for use.

(7) Performance data must demonstrate the electromagnetic compatibility and electrical safety of the device.

(8) Labeling must include the following:

(i) A description of what the device measures and outputs to the user;

(ii) Instructions for proper placement of the device;

(iii) Instructions on care and cleaning of the device;

(iv) Warnings identifying sensor acquisition factors that may impact measurement results and instructions for mitigating these factors; and

(v) The expected performance of the device for all intended use populations and environments.