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The intended use of the device is as a wheelchair. The wheelchair and drive system empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

The MyCycle Handmaster Light wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Breezy Wheelchair (K880280). The measurements of each dimension, as well as the construction materials, and the type of welding techniques utilized are substantially identical, based on the documentation available to applicant regarding this wheelchair. The only difference is that in place of a single wheel carrier, the MyCycle Handmaster Light wheelchair instead utilizes two vertical carriers in parallel to better distribute the load. Accordingly, the maximum weight bearing capacity, the tiltover testing, the dimensions and the weight of the device are identical.

The provided text doesn't contain information about acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial or performance study with quantified metrics.

Instead, the submission for the MyCycle Handmaster Light Wheelchair relies on demonstrating substantial equivalence to a predicate device, the Breezy Wheelchair. This means the acceptance criteria are implicitly met by showing the new device is functionally and structurally the same as an already approved device.

Here's how the information aligns with your request:

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)

• Sample Size: Not applicable in the context of a dedicated performance study for the MyCycle Handmaster Light Wheelchair itself. The "testing" referred to is a reliance on the existing test results and approvals for the Breezy Wheelchair (K880280).
• Data Provenance: The provenance of the Breezy Wheelchair's data is not provided in this document.

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)

• Not applicable. Ground truth, in this context, refers to the established safety and effectiveness of the existing predicate device, the Breezy Wheelchair, as determined by previous regulatory processes. No new expert panel was convened for the MyCycle Handmaster Light Wheelchair's equivalence determination.

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

• Not applicable. No new test set for the MyCycle Handmaster Light Wheelchair required adjudication. The "adjudication" was the FDA's regulatory review of the substantial equivalence claim.

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 device is a physical wheelchair, not an AI-powered diagnostic or assistive tool that would involve human readers or AI assistance.

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

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

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

• The "ground truth" is the previously established safety and effectiveness of the Breezy Wheelchair (K880280) and the Wijit manual power attachment through their respective regulatory approvals and subsequent market performance. This implicitly includes any testing and expert evaluations undertaken for those predicate devices.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. This is not a machine learning or AI device.

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