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Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages such as: Arthritis, Amputee, Paraplegia, Cerebral Palsy, Hemiplegia, Tetraplegia, Quadriplegia, Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric conditions And other immobilizing or debilitating condition. A wheelchair with Bus Transport Option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J2249

The Breezy series wheelchairs are light weight manual chairs. These chairs are intended to provide mobility based on an individual users' needs and capabilities. They are available in a range of sizes (dimensions) to allow fit to a particular user, and is adjustable in various ways, including: The key change covered by this submission is the addition of a reclining back model to the Breezy product line. Chairs are configured to customer orders when sold. Configuration to order allows flexibility. Features such as width, depth, and back height are specified. Specific configuration includes chair accessories and desired safety features. Any combination of features from the approved matrix may be configured to create the chair features needed by a given rider It is the rider and the health care professional that determine the appropriate configuration for the users needs. As the individuals condition or size change, other components or accessories may be ordered and the chair reconfigured to meet the evolving needs of its user. Breezy wheelchairs with or without the reclining back option, consists of typical components found on most wheelchairs, such as backrest, seat frame, cushion, footrest and casters. Accessories include items such as armrests, positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. Many of these components may become available in a range of sizes, shapes, angles, forms, materials or coverings. These variations allow the chairs to be configured to meet the specific desires and needs of the user.

The provided text is a 510(k) summary for the Breezy Series of wheelchairs. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data a medical device that rely on AI or complex algorithms might require. Therefore, much of the information requested in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or typically found in this type of submission for a manual wheelchair.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Breezy Series manual wheelchairs does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way a clinical study would for an AI/algorithmic device. Instead, the "performance" is implicitly demonstrated through the device's description and its substantial equivalence to predicate devices, which are already accepted as safe and effective.

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

Not applicable. This 510(k) submission for a manual wheelchair does not describe a "test set" in the context of an algorithm or AI model development. The evaluation is based on engineering design, materials, and comparison to existing devices.

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

Not applicable. Ground truth establishment with experts is typical for image analysis or diagnostic AI, not for a manual wheelchair 510(k) submission.

4. Adjudication method for the test set

Not applicable. There is no mention of a "test set" with 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. MRMC studies are relevant for diagnostic or AI-assisted medical devices. This document is for a manual wheelchair.

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

Not applicable. This is not an algorithmic or AI device.

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

Not applicable. For a manual wheelchair, "ground truth" would relate to its physical performance and safety features meeting design specifications and user needs, which is assessed through engineering tests and adherence to standards, not expert consensus on medical images or pathology.

8. The sample size for the training set

Not applicable. There is no AI/algorithm training set for a manual wheelchair.

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

Not applicable.

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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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