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The intended use of the Model Top End Terminator Titanium Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The Invacare Corporation Model Top End Terminator Titanium is a manually operated, self-propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons who may be restricted to a sitting position.

The product consists of a titanium frame, large rear wheels with handrims for propelling the chair, and smaller front pivoting casters for steering and turning. The product is designed to be a lightweight, user adaptable, everyday wheelchair, for both indoor and outdoor use. It is a rigid or non-folding type wheelchair, which has a more sporty appearance than the traditional type of manual wheelchairs.

The Top End Terminator Titanium Wheelchair incorporates a one-piece frame. The frame is constructed from 1" diameter, 3-2.5 seamless titanium tubing that is brazed together. The wheelchair adjustable tension back upholstery consists of U850 ballistic material with fiber batting and the wheelchair adjustable tension seat upholstery consists of U240 nylon and webbing. Both upholstery types meet a minimum of the California Bureau of Home Furnishings 116 and 117 Flammability Standards.

This document is a 510(k) summary for a manual wheelchair, not a study describing the acceptance criteria and performance of a device using AI, imaging, or pathology data. Therefore, the requested information elements such as sample sizes, expert qualifications, and ground truth methods are not applicable to this submission.

However, I can provide information based on the performance data section of the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document pertains to a physical medical device (manual wheelchair) and its compliance with established performance standards for such devices, not a study involving a test set of data samples in the context of AI or imaging.

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

• Not Applicable. Ground truth in the context of this document refers to the established performance requirements of the RESNA standard, not expert consensus on data interpretation.

4. Adjudication method for the test set:

• Not Applicable. This is not a study involving adjudication of interpretations. Compliance with the RESNA standard is determined through defined test methods rather than adjudication.

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 document is for a manual wheelchair and does not involve AI or human readers.

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

• Not Applicable. This document is for a manual wheelchair and does not involve an algorithm.

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

• The "ground truth" in this context is the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs (Including Scooters)." This standard defines the performance criteria and test methods that wheelchairs must meet.

8. The sample size for the training set:

• Not Applicable. This document refers to a physical device and its compliance with a standard, not machine learning model training.

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

• Not Applicable. No training set as this is not a machine learning study.

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