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The TAILWIND power assist wheelchair empowers physically challenged persons by providing a means of enhanced mobility.

The TAILWIND power assist wheelchair is a light duty, conventional, rear wheel drive, rigid wheelchair. The TAILWIND wheelchair incorporates power assist components with a typical manual wheelchair. As a motorized wheelchair, it contains motors, drive wheels, and batteries. The wheelchair is propelled using a mix of human power to manually turn the chair wheels; this action activates the power assist electric motors to provide a short burst of supplementary power.

The provided document is a 510(k) summary for the TAILWIND power assist wheelchair and the FDA's clearance letter. It describes the device, its intended use, and its comparison to a predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or AI model validation study would.

The "Non-Clinical Tests Performed" section refers to a suite of ISO 7176 standards. These standards define various tests for wheelchairs, but the document does not present specific acceptance criteria (e.g., "must achieve X speed", "must climb Y degree incline") or the TAILWIND's reported performance against those criteria. Instead, it makes a general statement: "All applicable tests were voluntarily conducted in accordance with ISO 7176, including Parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 16, and 21. Where applicable a 100 kg dummy (plus 13.4 kg) as specified in ISO 7176 - 11 was used." The summary then concludes that "any differences between the TAILWIND power assist wheelchair and the predicate device do not raise any questions of safety or effectiveness," implying that the TAILWIND met the necessary performance as demonstrated by these tests, but without explicitly detailing the results.

Therefore, many of the requested details, especially those related to AI algorithm validation (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance), are not applicable or cannot be extracted from this document, as it describes a physical medical device (a wheelchair) and its regulatory clearance process, not a software or AI device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified in terms of units tested. The document mentions "a 100 kg dummy (plus 13.4 kg) as specified in ISO 7176 - 11 was used" for applicable tests, but not the number of wheelchairs tested or iterations.
• Data provenance: Not specified. The tests are "Non-Clinical Tests," implying laboratory or engineering testing rather than human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device, and "ground truth" as typically understood in AI/clinical studies (e.g., expert consensus on medical images) is not relevant here. The tests are against engineering standards (ISO 7176).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used for expert review of data/cases, not for physical product testing against engineering standards.

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 a physical power assist wheelchair, not an AI software or imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical power assist wheelchair, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is adherence to the specifications and performance requirements outlined in the ISO 7176 standards. This could be considered a form of "engineering ground truth" or "standards compliance."

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical device, not an AI model that requires a training set.

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