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The A011 Manual Wheelchair is to provide mobility to persons limited to a sitting position.

A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. Manual Wheelchair A011 is a mechanical wheelchair including four wheels, a Aluminum alloy frame and a textilene upholstery that is flame resistant. A011 has a physical dimension of 1100mm × 660mm × width × height) with the seat itself has a dimension of 480mm × 430mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 16 kilograms. The color is yellow and black.

This document describes the premarket notification for the Manual Wheelchair, Model A011. The information provided is for a physical medical device (a manual wheelchair) and not a software/AI-based medical device. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and details about training/test sets for an algorithm, are not applicable to this submission.

The acceptance criteria for this device are based on performance standards for manual wheelchairs and comparisons to a predicate device, focusing on physical characteristics and safety.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not applicable:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally "Meets [ISO Standard]" or "Comply with [ISO Standard]," implying that the device's performance reached the thresholds defined by these international standards. The reported device performance is explicitly stated as meeting these standards.

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

• Sample Size: Not explicitly stated as a numerical count of individual wheelchairs tested. For physical devices, testing often involves a small number of units (e.g., a few prototypes or production samples) subjected to stress tests, rather than large "test sets" in the AI/software sense. The document states "Tests were conducted following the recommended procedures outlined in the respective consensus standards." These standards specify the number of units and repetitions needed for testing, but the exact number used by the manufacturer is not disclosed in this summary.
• Data Provenance: The manufacturer is Ningbo Shenyu Medical Equipment Co., Ltd. in China. The testing was "non-clinical" testing, meaning it was performed in a lab environment (not on human subjects). The data is presumably prospective from these tests, as they were conducted to support the 510(k) submission.

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" for its performance is established by objective measurements based on engineering and safety standards (the ISO standards listed), not by expert interpretation of data points or images. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the defined standards.

4. Adjudication method for the test set

• Not Applicable. See point 3. Testing against physical standards does not typically involve an adjudication method in the context of human interpretation of data.

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 wheelchair, not an AI-assisted diagnostic or therapeutic device. No human-in-the-loop performance or MRMC study was conducted or relevant.

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

• Not Applicable. This is a physical wheelchair, not an algorithm.

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

• The "ground truth" for this device's performance is defined by adherence to international consensus standards (ISO 7176 series for wheelchairs and ISO 10993 series for biocompatibility). These standards define the acceptable range of physical properties, durability, stability, brake effectiveness, and biological safety. The "outcomes" are whether the device successfully passes these standardized tests, demonstrating compliance.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/ML model that requires a "training set."

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

• Not Applicable. See point 8.

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