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To provide an optional means of mobility for physically challenged people.

F-11 Folding Power Chair

The provided document is a 510(k) clearance letter from the FDA for the F-11 Folding Power Chair. This type of document establishes substantial equivalence to a predicate device and permits marketing. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way you've outlined for an AI/CADe device.

The questions you've asked are typically relevant for the regulatory review of a diagnostic or AI-powered medical device, where performance metrics like sensitivity, specificity, or AUC are evaluated against pre-defined acceptance criteria based on clinical studies.

For a physical device like a powered wheelchair, the "acceptance criteria" and "proof" would be satisfied through different types of testing and documentation, such as compliance with recognized standards (e.g., ISO, ANSI/RESNA for wheelchairs), mechanical stress tests, battery life tests, electromagnetic compatibility (EMC) tests, and documented risk management. These details are usually found in the full 510(k) submission, not in the public-facing clearance letter.

Therefore, I cannot extract the information requested from the provided text because it does not exist within the scope of this FDA clearance letter.

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