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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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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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The ReWalk ReStore is intended to be used to assist ambulatory functions in rehabilitation under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke who can ambulate at least 1.5m (5ft) with no more than minimal to moderate levels of assistance. The trained therapist must successfully complete a training program prior to operating the device. The device is not intended for sports or stair climbing.

The ReWalk ReStore™ ("ReStore™") device is a lightweight, wearable, battery-powered soft orthotic exosuit is intended to be used to assist ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.

The ReStore™ device is designed to provide plantarflexion (PF) and dorsiflexion (DF) assistance to the paretic ankle during walking by transferring mechanical forces from two motors mounted on a Waistpack through Bowden cables to attachment points worn on the calf and insole. Through a set of gears, the motors actuate the Bowden cables to provide plantarflexion and dorsiflexion forces. Forces are transferred through the Bowden cables by pulling an inner cable within an outer sheath. The distal end of the outer sheath is fixed at an attachment point worn on the Calf Wrap, and the distal end of the inner cable is fixed at an attachment point worn on an insole made of flexible plastic that is worn within the shoe on the paretic foot. The relative motion that occurs between these two points when the inner cable is moved results in torques being applied across the ankle joint. The placement of the attachment points anterior and posterior to the ankle joint result in corresponding torques to provide assistance during dorsiflexion and plantarflexion, respectively. Load cells attached to the cables provide force feedback allowing control of the level of assistance provided to the patient. Sensors attached to the shoes are used to detect gait events during walking to inform timing of the assistance from the ReStore™ device. Specifically, inertial measurement units (IMUs) are attached to shoes on both legs to provide signals corresponding to events within the gait cycle, such as heel-strike or toeoff, in order to determine the appropriate timing of assistance from ReStore™.

The ReStore™ is designed to provide adjustable levels of assistance to the patient's paretic leg. It does not constrain or provide assistance to the patient's non-paretic leg. The device enables the therapist to individually modify the level of assistance provided during plantarand dorsiflexion as appropriate for each individual patient. The timing of assistance is based on data collected from the motion sensors on both the paretic and non-paretic feet, which determines the patient's orientation within their gait cycle.

Plantarflexion assistance occurs during the late stance and toe-off portion of the paretic leg gait cycle. This level of assistance targets a desired cable force, which can be adjusted from 0% to 25% of the patient's body weight. Dorsiflexion assistance occurs during the swing and heel-strike phase of the paretic gait cycle. This level of assistance targets a desired cable travel, which can be adjusted from 0 cm to 5 cm. Plantarflexion and dorsiflexion assistance levels are determined by the therapist based on visual evaluation of the patient's gait symmetry, the therapeutic goals of the walking session or the ability of the patient to achieve consistent ground clearance or heel-strike landing patterns with their paretic foot. The ReStore™ device includes apparel-like components, mechanical components, electrical components, cables, sensors and a handheld controller.

The ReWalk Restore device is a soft orthotic exosuit intended to assist ambulatory functions in rehabilitation for individuals with hemiplegia/hemiparesis due to stroke.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating the safety and effectiveness of the ReWalk Restore device against a predicate device (Indego®) through clinical and non-clinical studies. While explicit "acceptance criteria" in a quantitative sense for performance metrics are not clearly defined as pass/fail thresholds in the provided text, the successful completion of the clinical trial demonstrating safety and efficacy, alongside meeting all design requirements and compliance with standards, serves as the basis for acceptance. The performance is reported in terms of safety outcomes and improvements in walking parameters.

2. Sample Size and Data Provenance for Test Set:

• Sample Size for Clinical Trial: 44 subjects for the multi-site clinical trial.
• Sample Size for Engineering Studies: 35 unique participants across two ongoing engineering studies (with 10 participants enrolled in both).
• Sample Size for Clinical Validation Substudy: 9 participants.
• Total Unique Participants: 79 individuals.
• Data Provenance: The multi-site clinical trial was conducted across 5 study sites, and the engineering studies were conducted at the Wyss Institute at Harvard University (Cambridge, MA). The country of origin is the USA for the engineering and clinical validation studies, and likely includes multiple sites/countries for the "multi-site clinical trial" but specific country details are not provided beyond the Wyss Institute location for some studies. All studies were prospective as they were IRB-approved and conducted according to Good Clinical Practice (GCP) principles.

3. Number of Experts and Qualifications for Ground Truth:

The document does not detail the number of experts used to establish the ground truth for specific performance metrics in the way one might see in an image classification study. Instead, the "ground truth" for the device's safety and effectiveness is established through a clinical trial involving trained therapists supervising patients. Their observations and assessments during the trials, along with objective measurements of walking parameters, form the basis of evaluating the device's performance. The document states, "The trained therapist must successfully complete a training program prior to operating the device," indicating a level of qualification for the individuals involved in using and assessing the device. Specific qualifications like "radiologist with 10 years of experience" are not applicable to this type of device and study.

4. Adjudication Method for the Test Set:

The document does not describe "adjudication methods" in the context of expert consensus (e.g., 2+1, 3+1). The primary endpoints for the clinical trial are device safety (frequency and severity of device-related adverse events, falls) and exploratory endpoints for efficacy (walking speed, distance). These are assessed through direct observation and measurement during the study, rather than through expert consensus on qualitative events. Adverse event reporting and management would involve a clinical team review rather than an adjudication panel for "ground truth."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is more relevant to diagnostic imaging interpretation (where multiple readers interpret cases). The ReWalk Restore is a therapeutic and assistive device, and its effectiveness is measured by direct patient outcomes and performance improvements in ambulation, not by human reader interpretation.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. The ReWalk Restore device is inherently human-in-the-loop, designed to provide assistance to a person with hemiparesis/hemiplegia during ambulation. Its function is to augment human movement, not to perform independently. The performance is always assessed with the human user.

7. Type of Ground Truth Used:

The ground truth for device safety was based on the occurrence and severity of device-related adverse events and falls as reported and managed during the clinical trials. For efficacy, the ground truth was based on objective physiological and functional outcome measures such as 10-meter walk tests (comfortable and maximal speeds) and 2-minute walk distances, directly measured from the subjects during their walking assessments.

8. Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning. The studies described are for clinical validation and engineering development. If any machine learning components are part of the device's control system, the data used for their development/training is not detailed in this summary. The 79 individuals who participated in the various studies represent the subjects on whom the device was tested and refined, rather than a distinct "training set" for an AI algorithm in the traditional sense of a diagnostic or predictive model.

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

As there is no clearly defined "training set" for an AI algorithm in the provided text, the method for establishing ground truth for such a set is not described. The studies focused on validating the device's safety and effectiveness through direct clinical assessment and objective measures in human participants.

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