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The Mechanical Wheelchair is intended to provide mobility to persons restricted to a sitting position.

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This document is an FDA 510(k) clearance letter for a Mechanical Wheelchair. It does not contain information about acceptance criteria or a study proving device performance in the context of AI or machine learning. The letter confirms substantial equivalence to a predicate device, which is a regulatory pathway for Class I and II medical devices that typically relies on the device meeting established performance standards rather than requiring extensive clinical trials or AI-specific performance metrics.

Therefore, I cannot provide the requested information from the provided text, as it describes a traditional mechanical medical device and not an AI-enabled one.

Here's why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not available. This is a clearance letter, not a performance report for an AI device.
2. Sample size used for the test set and the data provenance: Not applicable. There's no AI test set mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no AI ground truth establishment described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for a mechanical wheelchair, not an AI-assisted device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses regulatory clearance for a physical product (a mechanical wheelchair) and does not involve AI/ML performance evaluation.

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