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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The MAXHEALTH Mechanical Wheelchair, K1 is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

The provided document describes the 510(k) summary for the MAXHEALTH Mechanical Wheelchair, K1. It states that the device's performance meets applicable requirements in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. However, the document does not provide specific acceptance criteria or detailed results of a study proving the device meets these criteria in the format requested.

Here's what information can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document only states that "Performance Testing" was conducted but doesn't mention the number of units tested.
• Data Provenance: Not specified. The country of origin of the data (where the testing was conducted) and whether it was retrospective or prospective testing are not mentioned.

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

• This information is not applicable and not provided. The testing relates to mechanical performance standards, not diagnostic or clinical interpretation requiring expert consensus on a "ground truth" for a test set of data. The "ground truth" in this context would be the pass/fail criteria defined by the engineering standards.

4. Adjudication method for the test set

• Not applicable and not provided. As per point 3, this type of mechanical performance testing typically relies on objective measurements against predefined thresholds, not on adjudication of subjective interpretations.

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 and not provided. This is a mechanical wheelchair and not an AI-assisted diagnostic device.

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

• Not applicable and not provided. See point 5.

7. The type of ground truth used

• The "ground truth" for this device would be defined by the technical specifications and performance thresholds outlined in the ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. These standards define acceptable levels of performance for various attributes of a wheelchair (e.g., strength, stability, braking, dimensions). The device's performance is measured against these established engineering standards.

8. The sample size for the training set

• Not applicable and not provided. This product is a mechanical device, not an AI model that requires a training set.

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

• Not applicable and not provided. See point 8.

Summary of what is known:

The MAXHEALTH Mechanical Wheelchair, K1 was tested for its performance against ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. The manufacturer claims the device "meets the applicable performance requirements" of these standards. The device's substantial equivalence was compared to the JAN MAO Wheelchair JMC612-FL318EPP (K062218).

Summary of what is missing from the provided document:

Detailed acceptance criteria (specific numerical thresholds), specific test results, sample size of tested units, testing methodology details, and any information related to AI or ground truth establishment in a clinical context are absent. The document focuses on regulatory approval through substantial equivalence rather than a detailed scientific study publication.

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