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Quickie manual wheelchairs empower physically chailenged persons by Quickle manual whicelonano chaptires includes temporary and permanent conditions in all ages such as : Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy Multiple Sclerosis Polio Geriatric condition and other Immobil- ing or debilitating condition

Claim being added: A wheelchair with the Bus Transport option, may be used for motor vehicle transportation, with the use of Wheelchair tiedown and occupant restraint systems (WTORS) that meet the requirements of SAE J2249.

For people with disabilities who are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as the vehicle seat. Therefore, the wheelchair must be secured to the vehicle so that it does not impose forces on its occupant and/or become a hazard to other vehicle occupants in a collision or sudden vehicle maneuver. Providing occupant protection for the wheelchair-seated occupant, therefore, requires that equipment be installed to secure the wheelchair and restrain the user. The bus transport models of the Zippie, Quickie, and Breezy Series manual wheelchairs are chairs that can be used in motor vehicle transport. The key change covered by this submission is the addition of securement hardware to the wheelchairs so that they can be used in motor vehicle transport. Each bus transport model includes securement hardware that is bolted to the wheelchair or installed at the factory. The securement hardware is identified by proper labeling. The labeling identifies the locations to which the wheelchair tiedown and occupant restraint systems or WTORS secure to the vehicle. WTORS are complete restraint systems for wheelchair-seated occupants. They are comprised of a system or device for wheelchair tiedown as well as a separate system for restraining the occupant. WTORS include all anchorage hardware and anchorage fasteners (or specifications for anchorage fasteners) required for installing and using the system in a vehicle. These WTORS secure the wheelchair and the occupant to the vehicle; they do not secure the occupant to the chair. WTORS will not be supplied by Sunrise Medical.

The provided text describes specific details about a wheelchair product rather than an AI/ML powered device. As such, information regarding AI/ML-specific criteria like multi-reader multi-case studies, standalone performance, training set details, or expert consensus for ground truth establishment is not present. Therefore, I can only extract information relevant to the device described.

Here's an analysis of the provided text:

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)

The text does not specify a distinct "test set" sample size in terms of the number of wheelchairs tested or the number of crash tests performed. It states "The wheelchairs made by Sunrise Medical have been throughly tested," but provides no quantitative details on the number of units or tests. The data provenance is not mentioned.

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)

No information is provided regarding experts or ground truth establishment in this context. The acceptance criteria are based on the SAE J2249 standard, which dictates test methods and performance requirements.

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

No adjudication method is mentioned. The testing performance is evaluated against the SAE J2249 standard.

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 is not applicable as the submission is for a physical medical device (wheelchairs) and not an AI/ML-powered device or a diagnostic tool involving human readers.

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

This is not applicable as the submission is for a physical medical device (wheelchairs) and not an AI/ML algorithm.

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

The "ground truth" for the device's performance is compliance with the SAE J2249 Recommended Practice for "Wheelchair Tiedown and Occupant Restraint Systems for Use in Motor Vehicles," specifically its requirements for dynamic performance in a frontal impact crash test. This standard-based performance is the benchmark.

8. The sample size for the training set

This is not applicable as the submission is for a physical medical device and not an AI/ML model that requires a "training set."

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

This is not applicable as the submission is for a physical medical device and not an AI/ML model.

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