(106 days)
The EksoNR™ is intended to perform ambulatory functions in rehabilitations under the supervision of a trained physical therapist for the following populations:
- · Individuals with acquired brain injury, including traumatic brain injury and stroke (upper extremity motor function of at least 4/5 in at least one arm).
- · Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms).
- · Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).
The therapist must complete a training program prior to use of the devices are not intended for sports or star climbing.
The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
The provided text is a 510(k) Summary for the EksoNR™ exoskeleton, a medical device for rehabilitation. It details the device's indications for use, its technical characteristics, and non-clinical and clinical performance data to support its substantial equivalence to a predicate device.
However, the information provided does not contain details about an AI/algorithm-driven device, nor does it specify acceptance criteria in terms of quantitative performance metrics (like sensitivity, specificity, or AUC) that would be typically found for such a device. The document focuses on showing the device's safety and effectiveness for an expanded patient population in rehabilitation based on clinical studies, rather than the performance of an algorithm.
Therefore, I cannot extract the information required to populate the requested table or answer questions related to AI/algorithm performance, ground truth establishment for a test set, expert adjudication, or MRMC studies.
The document indicates "Software - Verification, Validation, and hazard analysis" was performed, but it does not describe a study involving a test set, ground truth experts, or performance metrics relevant to an AI/algorithm's diagnostic or predictive capabilities. It primarily discusses the exoskeleton's performance in facilitating gait ambulation and safety for patients, not an AI's performance in, for example, image analysis or diagnostic prediction.
To answer your request thoroughly, I would need a document describing an AI/algorithm-driven medical device and its performance evaluation against defined acceptance criteria.
§ 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).