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Manual transportation device for person who are unable to walk or have a . walking impediment, propulsion by an attendant.

Manual Wheelchair

This document is a 510(k) submission for a manual wheelchair and does not contain information about the acceptance criteria or a study proving device performance as it relates to AI or software.

The provided text is a 510(k) summary and the FDA's clearance letter for the "Sherpa Mobility System (Manual Wheelchair)." This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the context of advanced algorithms or AI.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document describes a traditional mechanical device (a manual wheelchair) and its regulatory clearance process, not a device involving complex performance metrics tied to AI or specific acceptance criteria for such algorithms.

Specifically, the document lacks the following information:

• A table of acceptance criteria and reported device performance: This is not typically part of a 510(k) summary for a mechanical device like a wheelchair, which focuses on safety and substantial equivalence to a predicate.
• Sample size used for the test set and data provenance: No "test set" in the context of an algorithm is mentioned.
• Number of experts used to establish ground truth: Not applicable to a manual wheelchair.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable as there is no algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: No "training set" in the context of an algorithm is mentioned.
• How the ground truth for the training set was established: Not applicable.

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