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The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation under the supervision of a trained physical therapist for the following population with upper extremity motor function at least 4/5 in both arms:

· Individuals with spinal cord injuries at levels T4 to L5

• · Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D)
  The therapist must complete a training program prior to use of the device.

The device is not intended for sports or stair climbing.

The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation institutions, hospitals, or similar institutions under the supervision of a healthcare professional (HCP) such as a trained physical therapist. The ExoAtlet-II is indicated for individuals with spinal cord injuries at levels T4-L5 and individuals with spinal cord injuries at levels of C7-T3. All users must have upper extremity motor function of at least 4/5 in both arms. The ExoAtlet-II is intended for multiple users in a clinical setting (i.e., gait lab or rehabilitation center) under supervision. The ExoAtlet-II includes a battery powered exoskeleton, an ExoCrutch, and a Tablet PC.

ExoAtlet-II is designed to be operated with a trained physical therapist who has received preliminary training on the Exoskeleton operation. This therapist will be familiar with the rules of the use and operational documentation. Training is conducted in a designated medical facility that is representative of the indicated environments (e.g., hospital, outpatient physical therapy clinic or similar). The training identifies safe environments of device use and uses all of the safety features found in the subject device. The training manual will be provided with the user manual along with a trainee itinerary and a trainee certification exam. The trainee needs to pass 80% of the exam questions to obtain certification.

Here's a breakdown of the acceptance criteria and study information for the ExoAtlet-II device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes general performance characteristics and notes differences from the predicate device that were evaluated for safety and effectiveness through testing.

However, based on the "Comparison of Technological Characteristics" table and the "Summary of Clinical Testing" section, we can infer some key performance aspects and their reported outcomes:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Study): 20 subjects (n=20)
• Data Provenance: The study was described as an "open label, non-randomized clinical study." The document does not specify the country of origin but implies it was internal to ExoAtlet given "ExoAtlet conducted an... clinical study." The study is prospective as it was conducted to assess the safety and effectiveness of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for a test set in the traditional sense of diagnostic accuracy. Instead, the clinical study involved subjects using the device under the supervision of a "trained physical therapist." The therapist's role is to supervise, and their training and certification are mentioned as a requirement for device use. The study monitors objective performance (walk tests) and subjective feedback (comfort surveys, skin assessments) directly from the subjects and observations.

4. Adjudication Method for the Test Set

Not applicable. The clinical study described is a performance and safety study involving a device for rehabilitation, not a diagnostic study requiring adjudication of expert interpretations for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, but a powered exoskeleton for rehabilitation. Therefore, an MRMC study and effects on human reader performance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The ExoAtlet-II is a physical device intended to be used by individuals under the supervision of a trained physical therapist. It is inherently a "human-in-the-loop" device by design and intended use. There is no mention of a standalone algorithm performance test.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The clinical study assessed the device's safety and effectiveness directly through:

• Performance metrics: Successful completion of the 10 Meter Walk Test and 6-Minute Walk Test.
• User feedback: Comfort ratings via surveys.
• Medical observation: Skin assessments for adverse events.
• Overall safety and functionality: Absence of new safety issues or ineffectiveness compared to predicates.

These are direct measures of the device's functional performance and user impact, rather than a "ground truth" established through external pathological or expert consensus for a diagnostic task.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI. The training described is for the human therapist who uses the device.

• Training for Therapists: Not a "training set" for the device's algorithm, but a program for healthcare professionals. The therapist completes a training program and must pass 80% of an exam for certification.

9. How the Ground Truth for the Training Set Was Established

As noted above, there is no AI/ML training set mentioned. The "training set" for therapists involves instructions, operational documentation, and an exam, but this is human training, not algorithm training data.

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