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Its intended use is to provide mobility to persons restricted to a sitting position.

The Comed K-Series Manual Wheelchair is a user-propelled, manually operated folding wheelchair that is indicated for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 9 degrees. It consists of a mechanical steel frame and nylon upholstery. Designed to be lightweight and foldable, the model is approximately 18" wide, approximately 16" deep, has a weight capacity of 220lbs, and weighs approximately 42lbs.

The provided text describes a 510(k) premarket notification for a manual wheelchair and does not contain information about acceptance criteria or a study proving that a device (in the context of AI/medical imaging devices) meets acceptance criteria.

The document discusses the Comed K-Series Manual Wheelchair, which is a physical product, not a software or AI device. The "acceptance criteria" referred to in the document are conformance to non-clinical standards for wheelchairs (ISO 7176 series), which are mechanical and physical performance tests.

Therefore, I cannot extract the requested information about acceptance criteria and studies for an AI/software device from this text as it is not present.

However, I can provide the information as it relates to the physical wheelchair and the standards it met:

1. A 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):
This information is not applicable and not provided for a physical wheelchair tested against mechanical standards. The tests are typically conducted on a sample of the product itself by a testing laboratory.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. For mechanical standard testing, the "ground truth" is typically defined by the objective measurement procedures and criteria outlined in the ISO standards themselves, not by expert consensus in a clinical sense. Testing would be performed by qualified technicians/engineers in a certified lab.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for mechanical standard testing of a physical product.

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:
This information is not applicable. This is a physical wheelchair, not an AI or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is 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 adherence to the specifications and performance limits defined by the specific ISO standards (e.g., a certain amount of static stability, a specific braking efficiency, etc.). These are objective, measurable criteria.

8. The sample size for the training set:
This information is not applicable. The product is a physical device, and there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.

In summary, the provided document describes a 510(k) for a physical medical device (manual wheelchair) and not a software or AI-powered medical device. Therefore, the questions related to AI/software performance metrics (such as expert readers, training sets, ground truth for algorithms, MRMC studies) are not pertinent to this submission. The device's "acceptance criteria" were conformance to established international mechanical and safety standards for wheelchairs.

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