(67 days)
The Marvél Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
The Marvél Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position. It can be operated on most indoor and outdoor surfaces, with the exception of stairs.
The frame is constructed primarily of aluminium but with titanium elements in specific areas to reduce vibration and weight. Large rear wheels with handrims propel the chair and smaller front pivoting casters provide stability. The wheelchair is a lightweight manual chair designed for everyday use, both indoors and outdoors. The wheelchair is a rigid, non-folding type wheelchair.
The Marvel wheelchair consists of three major components or sections in addition to the large rear whecls: the caster wing assembly, the main frame assembly and the seating assembly.
The Marvel Wheelchair offers modularity and a number of adjustability features. The seat height, width, angle, rear seat-to-floor height, and front seat-to-floor height may be adiusted easily for the comfort of the user. Modularity allows replacement of worn components and allows the user to continually customize their own chair to ensure optimal functionality for their lifestyle.
The provided text is for a 510(k) premarket notification for a mechanical wheelchair, not a software device or an AI algorithm. Therefore, the questions related to AI/software performance, ground truth establishment, expert adjudication, or MRMC studies are not applicable.
The acceptance criteria for the Marvél Wheelchair are based on recognized industry standards for mechanical wheelchairs.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet applicable performance standards specified in Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs". | The Marvél Wheelchair will meet the applicable performance standards specified in RESNA Standard ANSI/RESNA WC/Vol. 1-1998. |
Study Proving Device Meets Acceptance Criteria:
The submission states that the Marvél Wheelchair "will meet" the applicable performance standards from the RESNA standard. This phrasing suggests that testing was either planned, underway, or completed, and the manufacturer asserts compliance. However, the document does not provide specific test results or a detailed study report demonstrating this compliance. Instead, this 510(k) relies on a claim of substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a "test set" in the context of data for an AI/software device. The performance data refers to physical testing of the wheelchair against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a mechanical wheelchair, not an AI/software device requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/software device with expert adjudication of test results.
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/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this mechanical device, the "ground truth" for performance is defined by the technical specifications and test methods outlined in the ANSI/RESNA WC/Vol. 1-1998 standard.
8. The sample size for the training set
Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).