(15 days)
Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages such as : Arthritis, Amputee, Paraplegic, Cerebral Palsy, Hemiplegic, Tetraplegic, Quadriplegic, Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric conditions, And other immobilizing or debilitating condition
The tool-less wheel chair is a light weight manual chair. Which is intended to provide mobility based on an individual users' needs and capabilities. It is available in a range of sizes (dimensions) to allow fit to a particular user, and is adjustable in various ways, including: The key change covered by this submission is the ability to make several routine adjustments quickly, and without the need for additional parts or the use of tools. These typical routine adjustments include: CHAIR STANCE (Camber, Forward / aft wheel position, Toe in/ toe out, Track Width, Caster height) and RIDER POSITION (Back Rest Angle, Squeeze). Tool less wheelchairs consists of typical components found on most wheelchairs, such as backrest, seat frame, cushion, footrest and casters. Accessories include items such as armrests, positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc.
The provided text describes the "Tool-less Wheel Chair" and its 510(k) submission. Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The device's performance is demonstrated through testing against established wheelchair standards. The acceptance criteria essentially reflect compliance with these standards, with the reported performance indicating that the device "passed" each criterion.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Determination of Static Stability (ISO7176 and ANSI/RESNA) | Pass |
| Overall Dimensions, Mass and Turning Space (ISO7176 and ANSI/RESNA) | Pass |
| Seating Dimensions (ISO7176 and ANSI/RESNA) | Pass |
| Static Impact and Fatigue Strength (ISO7176 and ANSI/RESNA) | Pass |
| General Requirements for Safety (ISO7176 and ANSI/RESNA) | Pass |
Study Information
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Sample size used for the test set and the data provenance:
The document does not specify the sample size used for the tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. The testing was conducted against ISO7176 and ANSI/RESNA Wheelchair Standards, which are international and American standards, respectively. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for the test set in the context of device performance testing. The "Pass" results are based on compliance with the objective parameters of the specified standards. -
Adjudication method for the test set:
Not applicable, as the performance testing against standards doesn't typically involve adjudication in the conventional sense (e.g., of expert opinions). The results are objective measurements/evaluations against predefined limits within the standards. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The submission focuses on the technical performance of the wheelchair itself against safety and performance standards. The efficacy section briefly mentions general articles on power wheelchairs but not a study comparing human readers or users with and without AI assistance (which is not relevant for this device type). -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The concept of "standalone" performance (algorithm only) is not applicable to a physical medical device like a wheelchair. The performance is inherently tied to the physical design and construction. -
The type of ground truth used:
The ground truth for the device's performance is defined by the objective specifications and quantifiable limits within the ISO7176 and ANSI/RESNA Wheelchair Standards. The device must meet these predefined criteria to achieve a "Pass" status. -
The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set." -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of 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).