(140 days)
The ReWalk™ P6.0 orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.
The ReWalk™ P6.0 is a prescription device which enables individuals with spinal cord injuries to perform ambulatory functions and composed of an external, powered, motorized frame fits to the lower limbs and part of the upper body. Control of the device is achieved through a wrist-worn user-operated wireless remote controller (RC), tilt sensor and specific body movements. The gait movements are performed by a set of gears and motors at the knee and the hip joints. The ReWalk™ P6.0 system includes Remote control (RC) Communicator, Exoskeleton (Inc. Rigid Frames, Waistpack and Straps), Battery charger and Laptop (GUI).
The provided text is a 510(k) summary for the ReWalk P6.0 exoskeleton. It establishes substantial equivalence to a predicate device (also a ReWalk P6.0, K160987). However, the document does not contain specific acceptance criteria or the details of a study with performance data that proves the device meets those criteria.
The document primarily focuses on establishing substantial equivalence based on comparisons of indications for use, technological characteristics, and conformity to recognized standards, rather than presenting original performance data against specific acceptance criteria.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving this performance, as that information is not present in the provided text.
Specifically, the document states:
- "The only differences between the ReWalk™ and its predicate are two (2) minor software modifications for sit-to-stand transition, and the addition of one (1) new software feature for stand-to-sit transition. These minor differences do not present any new or different questions of safety or effectiveness as confirmed by completed testing also discussed in further detail below."
- "Review of non-clinical performance testing as well as comparison of the device classification, indication for use, operating principles, technological characteristics demonstrate that the subject device is substantially equivalent to the predicate. Any differences between the subject and the predicate device do not raise new questions of safety or effectiveness."
These statements imply that testing was done to confirm safety and effectiveness related to the software changes, but the document does not detail the acceptance criteria for those tests or the results of those tests. It refers to "completed testing also discussed in further detail below," but this "further detail" is not present in the provided excerpts.
The document mainly lists standards that the device is designed to fulfill (e.g., IEC 60601-1-11:2015, IEC 60601-1-2, ANSI AAMI ES 60601-1:2005, ISO 14971, IEC 62304) and asserts that "Performance data are available to assess the effects of the new characteristics" and "Performance data (along with descriptive characteristics) demonstrate substantial equivalence," but these data are not included.
§ 890.3480 Powered lower extremity exoskeleton.
(a)
Identification. A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) Design characteristics must ensure geometry and materials composition are consistent with intended use.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
(ii) Simulated use testing (
i.e., cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present;
(iv) The accuracy of device features and safeguards; and
(v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
(6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (
e.g., indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use.
(8) Labeling for the Physician and User must include the following:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
(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 properly maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
(iv) Pertinent non-clinical testing information (
e.g., EMC, battery longevity).(v) A detailed summary of the clinical testing including:
(A) Adverse events encountered under use conditions,
(B) Summary of study outcomes and endpoints, and
(C) Information pertinent to use of the device including the conditions under which the device was studied (
e.g., level of supervision or assistance, and environment of use (e.g., indoors and/or outdoors) including obstacles and terrain).