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The Powered wheelchair (mobility robot) is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

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I'm sorry, but based on the provided FDA 510(k) Clearance Letter, there is no information available regarding acceptance criteria related to device performance or a study that proves the device meets such criteria.

The letter primarily covers:

• The FDA's decision of substantial equivalence for the "Powered wheelchair (mobility robot) (M4, M4U)" to predicate devices.
• Regulatory information such as regulation numbers, product codes, and class.
• General controls and additional regulations applicable to medical devices (e.g., Quality System regulation, UDI rule, MDR).
• Contact information for FDA resources.
• The device's Indications for Use.

The document does not contain details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. The number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Stand-alone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Training set sample sizes.
9. How ground truth for the training set was established.

This type of information, particularly regarding performance studies and acceptance criteria, is typically found in the 510(k) summary document or the full 510(k) submission, which are more detailed technical documents submitted by the manufacturer to the FDA. The clearance letter itself is a notice of the FDA's decision, not a detailed report of the studies performed.

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