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The INDEPENDENCE™ iGlide™ Manual Assist Wheelchair is intended to provide mobility to persons limited to a seated position that are capable of operating a manual or power wheelchair.

The INDEPENDENCE/TM) iGLIDE(TM) Manual Assist Wheelchair is the TAILWIND Power Assist Wheelchair. With each push on the handrims, sensors and controllers calculate the difference between the effort on the handrims and the force needed to propel the chair. Electric motors supply the auxillary power needed to negotiate varying surfaces with virtually no change in effort.

The device drive consists of a gearbox with a motor controller for each side of the chair and a battery mounted underneath the chair. An on/off switch, located on the underside of the seat turns the unit on/off.

This document describes a 510(k) submission for the INDEPENDENCE™ iGLIDE™ Manual Assist Wheelchair. The key aspect of this submission is that the device is identical to a previously cleared predicate device, the TAILWIND Power Assist Wheelchair, with the only difference being the removal of a "Prescription Device Statement."

Therefore, the submission does not contain a study or data proving the device meets acceptance criteria in the traditional sense of a performance evaluation for a new or modified device. Instead, the justification for clearance relies solely on substantial equivalence to the predicate device because they are the same product.

Here's the breakdown based on your requested information, highlighting the unique nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. No new test set data was collected as the device is identical to the predicate.
• Data Provenance: Not applicable. The submission leverages the prior clearance and existing data/design of the predicate device.

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

• Not applicable. No new ground truth establishment was required for a test set. The substantial equivalence relies on the predicate device's prior clearance.

4. Adjudication method for the test set

• Not applicable. No test set was generated or adjudicated.

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 manual assist wheelchair, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

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

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

7. The type of ground truth used

• Ground Truth: The "ground truth" in this context is the prior regulatory clearance and established safety and effectiveness of the TAILWIND Power Assist Wheelchair through its original 510(k) process. The current submission argues that since the INDEPENDENCE™ iGLIDE™ is physically the same device, its "ground truth" (safety and effectiveness) is already established.

8. The sample size for the training set

• Not applicable. There is no AI component requiring a training set for this device.

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

• Not applicable. There is no AI component requiring a training set for this device.

Summary of the Study (or lack thereof):

The "study" in this submission is the claim of identity between the new device (INDEPENDENCE™ iGLIDE™ Manual Assist Wheelchair) and a predicate device (TAILWIND Power Assist Wheelchair). The acceptance criteria is solely based on demonstrating that these two devices are the same product. No new performance studies or clinical data are presented because the submitter argues that "Because the new and predicate devices are the same device, no new testing is needed." The FDA concurred with this assessment, granting 510(k) clearance based on substantial equivalence.

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