Kneevoice Cartilage Evaluation System (750-3600-001)

The KneeVoice Cartilage Evaluation System is a noninvasive diagnostic device that captures and amplifies sounds and vibrations from the patellofemoral joint during knee motion. It consists of an audio and position sensor assembly attached to the patient's patella with adhesive patches, connected via cable to a digital console that performs noise reduction, filtering, and pattern recognition to support clinical diagnostic decision-making by physicians.

The device uses an audio and position sensor assembly cabled to a digital console with a touch screen display, processor, and memory mounted on a desktop stand. It performs noise reduction, band-pass filtering, and pattern recognition on sound and motion data collected during eight knee flexion cycles from 0 to 90 degrees. Acoustic performance testing demonstrates equivalence to the Littmann 3200 electronic stethoscope reference device.

Not stated in this summary.

The predicate devices (Biomet 3-Channel Knee Electronic Amplified Stethoscope and 3M Littman 3200 Electronic Stethoscope) are also electronic stethoscopes designed to amplify and record bodily sounds for diagnostic support. The subject device has equivalent acoustic performance and intended use, and nonclinical testing including design verification, frequency response testing, and human factors validation demonstrates it does not raise new questions of safety or effectiveness compared to the predicates.