(110 days)
To provide an optional means of mobility for physically challenged people.
PHFW-10 Folding Power Chair
The provided text is an FDA 510(k) clearance letter for a powered wheelchair, the PHFW-10 Folding Power Chair. This document does not contain any information about acceptance criteria for a medical device's performance, nor does it describe a study proving the device meets such criteria.
The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than rigorous clinical performance studies with specific acceptance criteria that would typically be associated with AI or diagnostic algorithm submissions.
Therefore, I cannot provide the requested information from the given text. The text does not include details on:
- Acceptance criteria and reported device performance: This document is about regulatory clearance, not performance metrics like sensitivity, specificity, accuracy, or similar measures that would imply acceptance criteria.
- Sample size, data provenance: No study is described, so no sample size or data origin is mentioned.
- Number/qualifications of experts, adjudication method: These pertain to ground truth establishment for a performance study, which is not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable here, as it's not an AI or diagnostic device being evaluated in a clinical context in this document.
- Standalone performance study: No such study is mentioned.
- Type of ground truth used: Not applicable.
- Training set sample size: No training data or AI algorithm is discussed.
- Ground truth for training set: Not applicable.
§ 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).