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510(k) Data Aggregation
(52 days)
SIGMA DISTRIBUTION & SUPPLY, INC.
For transportation of disabled persons.
The device consists of a chromed steel frame with cross bars, slung fabric seat and back, fixed or removable armrests, fixed or removable foot/legrests. Front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.
The provided text describes a 510(k) summary for a manual wheelchair and the FDA's clearance letter. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The device described is a physical manual wheelchair, and the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design features and compliance with a flammability test for its fabric, not performance metrics common to AI/ML devices.
Therefore, I cannot provide the requested information for an AI/ML device based on the given input.
If the request was intended for a medical device in general, the provided text includes some information relevant to product specifications and a single test:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance / Predicate Value (Invacare Tracer Wheelchair - K935398) | Reported Device Performance (Sigma Manual Wheelchair) |
|---|---|---|
| Seat Height | 20" | 20" |
| Widths | 14"-22" | 14"-22" |
| Rear Wheels | 24" | 24" |
| Front Casters | 8" | 8" |
| Product Weight | 44 lbs | 43 lbs |
| Weight Limit | 250 lbs. | 250 lbs. |
| Fabric Flammability | NFPA 701-89 Flame Resistant Textile and Films test (implied by predicate, explicitly stated for the submitted device) | Meets NFPA 701-89 Flame Resistant Textile and Films test |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" consists of comparing the specifications of one submitted device model to a predicate device and a single fabric flammability test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Specifications like dimensions and weight limits are objective measurements. Fabric flammability is determined by standardized tests, not expert consensus in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is based on direct measurement and standardized testing.
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 a physical wheelchair, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical wheelchair, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* For physical dimensions and weight: Direct measurement/specification.
* For fabric flammability: Results from a standardized ignitability test (NFPA 701-89).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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