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The ReWalk® P6.0 fits to the lower limbs and part ofthe upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions in home and community settings with supervision of a specially certified 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 P6.0 is intended for indoor and outdoor use: including standing and walking on level surfaces and mild slopes and ascending and descending stairs and curbs.

The ReWalk® P6.0 Exoskeleton is a prescription device which enables individuals with spinal cord injuries to perform ambulatory functions and composed of an external, powered, motorized frame that fits to the lower limbs and part of the upper body.

The ReWalk is intended to enable certified users with spinal cord injuries at levels T7 to L5 to perform ambulatory functions in in home and community setting accompanied by a certified companion. Additionally, the ReWalk Personal Exoskeleton 6.0 is intended to enable certified users with spinal cord injuries at levels T4 to T6 to perform ambulatory functions in rehabilitation centers accompanied by a certified therapist.

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 system includes Remote control (RC) Communicator, Exoskeleton (Inc. Rigid Frames, Waistpack and Straps), Battery charger and Laptop (GUI), and off the shelf crutches. All of the ReWalk components are mandatory, suitable for indoor and outdoor usage. The device is intended for indoor use: including standing and walking on level surfaces and mild slopes, and ascending and descending stairs and curbs for users who are at least 18 years old.

The ReWalk® P6.0 device, an exoskeleton for individuals with spinal cord injury, had its stairs ascend and descend functionality reviewed. The acceptance criteria and the study proving its performance are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Clinical Performance Test Set (ReWalk P6.0 Active Users Field Survey Study-Stairs Usage):
  • Sample Size: 47 users who used the device to climb stairs (out of 85 recruited subjects).
  • Data Provenance: Retrospective, collected through a survey of actual users in Europe. Data monitored over a period of six (6) years (2015 to May 2022).
• Human Factors Engineering Study Test Set:
  • Sample Size: 11 ReWalk patient subjects and 11 companion subjects.
  • Data Provenance: Prospective, conducted under IRB Approved protocol, according to principles of Good Clinical Practice (GCP).

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

This information is not explicitly provided in the document. The studies rely on user performance and self-reported data (field survey), and observed performance (human factors study), rather than expert adjudication of a "ground truth" derived from patient data like in diagnostic device studies.

4. Adjudication Method for the Test Set:

• Clinical Performance Test Set (Field Survey): Adverse events were monitored through ReWalk's Customer Relation Management (CRM) database and reviewed by the company to determine if they were device-related. The "adjudication" was internal to the company, concluding AEs were not device-related but associated with user error or instruction non-compliance.
• Human Factors Engineering Study Test Set: Performance was observed during actual use scenarios and comprehension questions were evaluated. The document doesn't specify an external adjudication panel; the evaluation of successful task completion and correct answers likely involved researchers from the study lead by the company.

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:

This is not applicable. The ReWalk P6.0 is an exoskeleton device, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This is not applicable. The ReWalk P6.0 is a physical device that requires a human user and a certified companion/therapist for operation. Its performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used:

• For Clinical Performance (Field Survey): The "ground truth" was established by real-world usage data and objective tracking of adverse events. Successful use was measured by the number of stairs climbed, and safety by the incidence and nature of adverse events.
• For Human Factors Study: The "ground truth" was successful completion of predefined tasks (ascending/descending stairs and curbs) by the user/companion, as observed by study personnel, and correct answers to comprehension questions.
• For Bench Testing: The "ground truth" was the physical and functional outcomes meeting predetermined engineering specifications (e.g., mechanical integrity, walking speed verification).

8. The Sample Size for the Training Set:

This information is not provided. The document highlights that the ReWalk P6.0 with stairs functionality is identical in design, materials, and components to a previously cleared version (K200032), except for the enabled stairs function. The prior versions underwent extensive testing, and this submission focuses on validating the added stairs functionality. The "training" for the device itself would be implicitly derived from its design and engineering processes, as well as prior product generations.

9. How the Ground Truth for the Training Set was Established:

Not explicitly detailed for a "training set" in the context of machine learning. For medical devices, the "training set" would relate to the iterative design, development, and testing phases where engineers and designers establish the functional specifications and design goals. Ground truth in this context is established through engineering principles, relevant standards (e.g., IEC 60601 series), and established clinical understanding of safe and effective ambulation assistance.

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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.

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