(63 days)
The intended use of the Model M powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The WHILL Model M is an indoor/outdoor battery-operated 4 wheel drive powered wheelchair. It is powered by two 12 VDC 50Ah batteries and controlled by the R-net 120 amp motor controller. As with all commerciallyavailable powered wheelchairs, the user sits in the wheelchair seat and uses controls positioned on the arms to turn the chair on, control the speed, and direct the movement. The directional controller can be mounted on the left or right arm. When the user activates the directional controller the brakes are released and the motors rotate to move the device in the desired direction. When the user releases the directional controller the device is brought to a controlled stop. The chair frame is a welded nut and steel construction and includes two rear wheels with drive units (motor, gear and brake) connected by belts to the front all directional wheels. Adjustments can be made to the two arm supports, foot support, and seat height and depth to position the user correctly in the device. The device supports a maximum weight of 220 lb, and has an approximate driving range of 12 miles. The device can be operated on carpet, tile, wood, vinyl, concrete, blacktop, dirt, gravel, grass, and wet (
This document is a 510(k) Premarket Notification for the WHILL Model M Powered Wheelchair. It describes the device, its intended use, and compares it to a predicate device (Permobil F3 Corpus) to demonstrate substantial equivalence, primarily through technical specifications and adherence to relevant standards.
Here's an analysis of the acceptance criteria and study information provided, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the sense of specific numerical thresholds that are then met by the device's performance data. Instead, the "acceptance criteria" are implied by the adherence to various national and international standards for powered wheelchairs. The "reported device performance" is the successful completion of testing against these standards.
| Acceptance Criteria (Implied by Standard Adherence) | Reported Device Performance (Successful Completion of Testing) |
|---|---|
| Static Stability defined by ANSI/RESNA WC-1:2009 Section 1 | Performance testing conducted and compliant |
| Dynamic Stability defined by ANSI/RESNA WC-2:2009 Section 2 | Performance testing conducted and compliant |
| Effectiveness of Brakes defined by ANSI/RESNA WC-2:2009 Section 3 | Performance testing conducted and compliant |
| Energy Consumption for Theoretical Distance defined by ANSI/RESNA WC-2:2009 Section 4 | Performance testing conducted and compliant |
| Maneuvering Space defined by ANSI/RESNA WC-1:2009 Section 5 | Performance testing conducted and compliant |
| Maximum Speed, Acceleration, Deceleration defined by ANSI/RESNA WC-2:2009 Section 6 | Performance testing conducted and compliant |
| Seating and Wheel Dimensions defined by ANSI/RESNA WC-1:2009 Section 7 | Performance testing conducted and compliant |
| Static, Impact, Fatigue Strengths defined by ANSI/RESNA WC-1:2009 Section 8 | Performance testing conducted and compliant |
| Climatic Tests defined by ANSI/RESNA WC-2:2009 Section 9 | Performance testing conducted and compliant |
| Obstacle Climbing defined by ANSI/RESNA WC-2:2009 Section 10 | Performance testing conducted and compliant |
| Test Dummies defined by ANSI/RESNA WC-1:2009 Section 11 | Performance testing conducted and compliant |
| Coefficient of Friction of Test Surfaces defined by ANSI/RESNA WC-1:2009 Section 13 | Performance testing conducted and compliant |
| Power and Control Systems for Electrically Powered Wheelchairs defined by ANSI/RESNA WC-2:2009 Section 14 | Performance testing conducted and compliant |
| Information Disclosure, Documentation, Labeling defined by ANSI/RESNA WC-1:2009 Section 15 | Performance testing conducted and compliant |
| Resistance to Ignition of Upholstered Parts defined by ANSI/RESNA WC-1:2009 Section 16 (tests to ISO 8191-1 and ISO 8191-2) | Performance testing conducted and compliant |
| Wheelchairs used as seats in motor vehicles defined by ANSI/RESNA WC-4:2012 Section 19 | Performance testing conducted and compliant |
| Electromagnetic Compatibility defined by ANSI/RESNA WC-2:2009 Section 21 | Performance testing conducted and compliant |
| Performance Testing of Shipping Containers and Systems defined by ASTM D4169 | Performance testing conducted and compliant |
| Resistance to ignition of postural support devices defined by ISO 7176-16:2012 | Performance testing conducted and compliant |
| Assessment of ignitability of upholstered furniture (smouldering cigarette) defined by ISO 8191-1:1987 | Performance testing conducted and compliant |
| Assessment of ignitability of upholstered furniture (match-flame equivalent) defined by ISO 8191-2:1988 | Performance testing conducted and compliant |
| Tests for Flammability of Plastic Materials defined by UL 94 | Performance testing conducted and compliant |
| Biological evaluation of medical devices (risk management) defined by ISO 10993-1 | Performance testing conducted and compliant |
| Biological evaluation of medical devices (in vitro cytotoxicity) defined by ISO 10993-5 | Performance testing conducted and compliant |
| Biological evaluation of medical devices (irritation and skin sensitization) defined by ISO 10993-10 | Performance testing conducted and compliant |
| Power and control systems for electrically powered wheelchairs (R-Net Power Module) defined by ISO 7176-14:2008 | Performance testing conducted and compliant |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes performance testing of the device, not a clinical study on human subjects with a "test set" of patient data. Therefore, the concept of sample size for a test set and data provenance (country of origin, retrospective/prospective) related to patient data is not applicable in this context. The "test set" would refer to the physical WHILL Model M device itself being subjected to various engineering and safety tests as defined by the standards listed. The provenance of the device testing would be from WHILL, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the type of device and study described. This document pertains to the regulatory clearance of a physical medical device (powered wheelchair) based on engineering performance and safety standards, not an AI or diagnostic device that requires expert-established ground truth from medical images or clinical data. The "ground truth" for these tests are the objective performance criteria set by the ISO, ANSI/RESNA, ASTM, and UL standards.
4. Adjudication Method for the Test Set
This question is not applicable. The performance testing of a physical device against engineering standards typically involves objective measurements and adherence to specified test protocols, not subjective adjudication methods like those used for expert consensus in clinical data analysis. The "adjudication" is implicitly the objective pass/fail determination based on the standard's criteria.
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 question is not applicable. The WHILL Model M is a powered wheelchair; it is not an AI diagnostic or assistance system that would involve human readers or affect their performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The WHILL Model M is a physical powered wheelchair, not an algorithm. Its performance is inherent to its design and functional capabilities, not an algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for this regulatory submission is adherence to established international and national engineering, safety, and performance standards for powered wheelchairs. These standards (e.g., ANSI/RESNA WC-1, WC-2, WC-4; ISO 7176, ISO 8191, ISO 10993; ASTM D4169; UL 94) define objective metrics, test methodologies, and acceptable performance limits. The "ground truth" is the successful demonstration that the device's physical and functional attributes meet these predefined requirements.
8. The Sample Size for the Training Set
This question is not applicable. The WHILL Model M is a physical medical device, not an AI model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set."
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).