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(a) Identification. A upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components, is a prescription device intended for medical purposes, and is intended to replace a partially or fully amputated or congenitally absent upper extremity. It uses electronic inputs (other than simple, manually controlled electrical components such as switches) to provide greater than two independent and simultaneously powered degrees of freedom and includes a simultaneously powered elbow and/or shoulder. Prosthetic arm components that are intended to be used as a system with other arm components must include all degrees of freedom of the total upper extremity prosthesis system.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Appropriate analysis/testing must validate electronic compatibility, electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(2) Appropriate software verification, validation, and hazard analysis must be performed.
(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench data, including durability testing, to demonstrate that the device will withstand forces, conditions, and environments encountered during use.
(ii) Simulated use testing to demonstrate performance of arm commands and available safeguard(s) under worst case conditions and after durability testing.
(iii) Verification and validation of force sensors and hand release button, if applicable, are necessary.
(iv) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor and brake performance.
(v) The accuracy of the device features and safeguards.
(4) Non-clinical and clinical performance testing must demonstrate the accuracy of device features and safeguards.
(5) Elements of the device that may contact the patient must be demonstrated to be biocompatible.
(6) Documented clinical experience and human factors testing must demonstrate safe and effective use, capture any adverse events observed during clinical use and demonstrate the accuracy of device features and safeguards.
(7) Labeling for the Prosthetist and User Guide must include:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities that may put the user at greater risk (e.g., driving).
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations,
(B) Instructions on fitting the patient,
(C) Instructions and explanations of all available programs and how to program the device,
(D) Instructions and explanation of all controls, input, and outputs,
(E) Instructions on all available modes or states of the device,
(F) Instructions on all safety features of the device, and
(G) Instructions for maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to be effective.
(iv) A detailed summary of the non-clinical and clinical testing pertinent to use of the device.
[81 FR 71612, Oct. 18, 2016]
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