(61 days)
To provide an optional means of mobility for physically challenged people.
PHFW-10 Folding Power Chair
The provided documents are a 510(k) premarket notification letter from the FDA for a powered wheelchair (PHFW-10) and an "Indications for Use" statement.
This documentation does not contain any information regarding:
- Acceptance criteria table and reported device performance
- Details of a study proving the device meets acceptance criteria
- Sample size used for test set or data provenance
- Number of experts or their qualifications for ground truth establishment
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance study
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study results with specific acceptance criteria in the manner often seen for AI/ML-based medical devices. The letter states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" for the stated indications for use.
Therefore, I cannot fulfill your request for the acceptance criteria and study details based on the provided text.
§ 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).