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The intended use is to provide mobility to persons limited to a seated position

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This document is a 510(k) premarket notification decision letter from the FDA for a powered wheelchair, the Hoveround Teknique HD6 MKII. It confirms that the device is substantially equivalent to legally marketed predicate devices.

This type of document is not relevant for providing the requested information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/ML-based medical devices. The letter primarily focuses on regulatory approval based on equivalence to existing devices, not on detailed performance studies for novel algorithmic features.

Therefore, I cannot extract the information requested in the prompt from the provided text.

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The intended use is to provide mobility to persons limited to a seated position.

Hoveround Teknique HD-6 Power Wheelchair

This document is a 510(k) premarket notification letter from the FDA for a power wheelchair, the Hoveround Teknique HD-6 Power Wheelchair. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It refers to regulations governing manufacturing practices, labeling, and adverse event reporting, but there is no mention of an algorithm or AI component, nor any performance study details as typically found for AI/ML devices.

Therefore, I cannot provide the requested information based on the provided document.

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The intended use is to provide mobility to persons limited to a seated position.

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This document is a 510(k) clearance letter from the FDA for the Hoveround Teknique GT Powered Wheelchair. It does not contain the acceptance criteria, study details, or performance data of the device.

Therefore, I cannot answer your request based on the provided text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not include the technical performance specifications or study results you are asking for.

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The intended use is to provide mobility to persons limited to a seated position.

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The provided text is a U.S. FDA 510(k) clearance letter for a Hoveround Teknique FWD mk4 power wheelchair. This document is a regulatory approval for a physical medical device and does not contain information about an AI/ML device or its performance study.

Therefore, I cannot extract any details regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, or multi-reader multi-case studies as these concepts are not relevant to this type of medical device approval.

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