(29 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
WU'S Power Wheelchair, MAMBO 5
This document is a 510(k) clearance letter from the FDA for the WU'S Power Wheelchair, MAMBO 5. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the detailed acceptance criteria or a study proving that the device meets those criteria, as typically found for AI/ML medical devices.
Medical devices like power wheelchairs are regulated differently from AI/ML software. Their "acceptance criteria" primarily relate to performance standards, safety, and functional requirements, which are typically established through engineering tests, usability assessments, and predicate device comparison, rather than clinical studies with ground truth established by experts.
Therefore, most of the requested information regarding AI/ML device studies, ground truth, expert consensus, and sample sizes for training/test sets is not applicable to this document. The document confirms market clearance based on substantial equivalence to a predicate device.
Here's what can be extracted based on the nature of the device and the document provided:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided in this document. For a power wheelchair, acceptance criteria would typically involve:
- Safety standards: e.g., electrical safety, mechanical stability, braking effectiveness.
- Performance standards: e.g., maximum speed, range per charge, weight capacity, obstacle climbing ability, turning radius, durability.
- Usability: ease of operation, comfort.
- The document states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device meets the same performance and safety standards as those predicates. Therefore, the "reported device performance" is essentially congruent with that of existing compliant power wheelchairs.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This information is relevant for clinical studies or AI/ML model validation, not for the regulatory clearance of a physical medical device like a power wheelchair. Testing for a wheelchair would involve engineering and performance tests on the device itself, not a "test set" of patient data.
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 / Not provided. "Ground truth" established by experts is a concept for evaluation of diagnostic or AI/ML tools. For a power wheelchair, ground truth is established by physical measurement, engineering standards, and user testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are used in clinical trials or expert reviews, not typically for the direct testing of a physical device like a wheelchair.
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
- No, this was not done and is not applicable. MRMC studies are specifically for evaluating AI/ML-assisted diagnostic tools where "human readers" (e.g., radiologists, pathologists) interpret data. This device is a power wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this was not done and is not applicable. This concept pertains to AI/ML software performance. The "algorithm" of a power wheelchair is its mechanical and electrical design, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a power wheelchair, ground truth would be based on:
- Engineering standards: e.g., ANSI/RESNA standards for wheelchairs and scooters.
- Physical measurements and tests: e.g., measuring speed, stability, battery life, weight capacity.
- Usability assessments: observing users operating the device.
- Safety compliance: ensuring adherence to electrical, mechanical, and fire safety regulations.
- The document implies that these types of "ground truth" (i.e., compliance with relevant standards and predicate performance) were met implicitly through the substantial equivalence determination.
8. The sample size for the training set
- Not applicable / Not provided. This is irrelevant for a physical mechanical/electrical device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is irrelevant for a physical mechanical/electrical device.
In summary, this FDA clearance letter for a power wheelchair does not contain the information requested because the device type and regulatory pathway are fundamentally different from those applicable to AI/ML medical devices where such detailed study and ground truth information would be available. The clearance is based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, meaning it performs as safely and effectively as similar devices already on the market, meeting established safety and performance standards.
§ 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).