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The ReWalk® 7 Personal Exoskeleton 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 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 accordance with the User assessment and training certification program. The ReWalk 7 is intended for including standing and walking on level surfaces and mild slopes, and ascending and descending stairs and curbs.

The ReWalk® 7 Personal Exoskeleton is a wearable, battery-powered prescription device intended for use by certified individuals at least 18 years old with lower limb disability to perform routine ambulatory functions at home and in the community.

Control of the exoskeleton is achieved through a user-worn wireless, web connected wrist control unit (WCU), a wireless crutch-mounted control unit (CCU), and specific body movements as measured through a tilt sensor. The powered device movements are performed by a set of gears and motors at the knee and the hip joints.

The ReWalk 7 Personal Exoskeleton includes the exoskeleton (incl. rigid frames, waist pack, and straps), battery power supply, crutches with integrated powered crutch control add-on unit (CCU), and the Wrist Control Unit (WCU). The wireless, web connected therapist handheld device (THD) is used by certified therapists for device configuration and control.

All ReWalk 7 Personal Exoskeleton components are suitable for indoor and outdoor use.

The ReWalk use includes standing, walking on level surfaces, mild slopes, ascending and descending stairs and curbs.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for performance outcomes like gait speed, distance, or specific functional improvements. Instead, it focuses on demonstrating that the ReWalk® 7 Personal Exoskeleton:

• Performs safely and effectively according to its intended use.
• Is substantially equivalent to the predicate device (ReWalk® P6.0) regarding intended use, indications, contraindications, and basic principles of operation.
• Meets recognized consensus standards and regulatory requirements related to electrical safety, electromagnetic compatibility, usability, software lifecycle, biological compatibility, risk management, and shipping.

Therefore, a table of acceptance criteria and reported device performance in the typical sense of a clinical trial cannot be created from this document. The "performance" being demonstrated is primarily compliance with safety standards and functional equivalence to the previously cleared device.

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

• Sample Size for Test Set: Not mentioned. The document primarily refers to non-clinical tests based on standards and analyses, rather than a clinical user study with a specific test set of patients.
• Data Provenance: Not mentioned. The tests were likely conducted by the manufacturer or contracted labs in accordance with the specified standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This section does not describe a study where ground truth was established by experts in the context of clinical performance data. The "ground truth" here is compliance with technical standards and validated design changes.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. The device is an exoskeleton, not an imaging or diagnostic device that would typically involve a multi-reader multi-case study.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. The ReWalk 7 is a physical powered exoskeleton, not a standalone algorithm. Its performance is intrinsically tied to human interaction and the physical device.

7. Type of Ground Truth Used

• Compliance with Recognized Consensus Standards and Technical Analyses: The "ground truth" for the device's safety and effectiveness in this submission is established through rigorous testing against a wide array of international standards (e.g., IEC 60601 series, ISO 10993 series, ISO 14971), internal technical analyses (e.g., assessing weight change impact), and demonstration of substantial equivalence to a legally marketed predicate device.

8. Sample Size for the Training Set

• Not applicable. The document does not describe a "training set" in the context of machine learning or AI. The design and validation process followed traditional engineering and regulatory pathways, focusing on design controls, testing, and compliance.

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

• Not applicable. As there is no training set mentioned, this question is not relevant to the provided text.

Summary of the Study (as described in the document):

The document details a non-clinical study approach to demonstrate the safety and effectiveness of the ReWalk® 7 Personal Exoskeleton. The core of this demonstration relies on:

• Technical Bench Testing and Analysis: Evaluation of the device's electrical safety, electromagnetic compatibility, usability, software functionality, biological compatibility (for materials in contact with skin), and risk management processes against a comprehensive list of recognized international consensus standards.
• Comparison to a Predicate Device: The ReWalk 7 is presented as an enhanced version of the previously cleared ReWalk® P6.0. The submission argues for substantial equivalence based on identical intended use, indications for use, contraindications, environment of use, intended users, and basic principles of operation. The enhancements (battery change, new control units, updated modes, cloud connectivity) were individually assessed through testing and analysis to ensure they did not introduce new safety or effectiveness concerns.
• Conclusion: The study concludes that the ReWalk 7 performs safely and effectively according to its intended use and is substantially equivalent to the predicate device, thus not raising different questions of safety and effectiveness. Clinical tests were not required because the device's indications and contraindications are identical to the predicate device, and the changes were primarily technical refinements verified through non-clinical means.

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