(43 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Electric Wheelchair (HC820N)" does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly not in the context of an AI/ML-based medical device.
The document is a standard FDA clearance letter for a Class II medical device (powered wheelchair), confirming its substantial equivalence to a legally marketed predicate device. It discusses regulatory requirements, such as general controls, quality system regulations, UDI rules, and adverse event reporting.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Training set sample size.
- Ground truth establishment for the training set.
This information is typically found in a "Device Description" or "Performance Studies" section of a 510(k) submission, which is not part of this clearance letter. The letter itself only confirms that the FDA has reviewed the submission and determined substantial equivalence.
§ 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).