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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.

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