(a) Identification. A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision making.

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

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance testing must be conducted:

(i) Mechanical testing to evaluate the effect of the device on the mechanical performance of the implant and to characterize the mechanical limits of the components used with the implant; and

(ii) Accuracy and repeatability testing of strain measurements.

(2) Usability testing must evaluate the effect of the device on the performance of the surgical procedure.

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

(4) Performance testing must support the sterility and shelf life of the patient-contacting components of the device.

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

(6) Performance data must validate the reprocessing instructions for reusable components of the device.

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

(8) Labeling must include the following:

(i) A shelf life;

(ii) Instructions for use;

(iii) Reprocessing instructions for any reusable components; and

(iv) A statement that the device is not intended to provide diagnostic information or influence clinical decision making.

[86 FR 68405, Dec. 2, 2021]