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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.

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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:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. 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.

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