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The Convaid Flyer models are manual wheelchairs; they are intended to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.

In addition the Flyer Transit models FL12T. FL14T. FL15T and FL16T comply with the requirements of RESNA WC4:2012 section 19 Wheelchairs used as seating in motor vehicles.

The Flyer series are attendant propelled manual wheelchairs constructed of the same materials and contain the same typical components and accessories found on most manual attendant propelled wheelchairs. The product consists of high strength powder coated tubular aluminum and steel plates that are welded, brazed, riveted or bolted. It comes standard with 5.5' front wheels attached to pivoting casters for steering and turning and 11.5" wheels in the rear. The product has a lightweight rigid base with a folding removable seating module, which is designed for everyday indoor or outdoor use on flat firm terrain. The Flyer offers its users a -5° to 40° range of continuously adjustable tilt-in-space achieved through the use of a single mechlok and hand lever to control the tilt action and 80° to 170°of seat to back adjustment (recline) that is controlled with a hand activated two plunger type pin system and plates on each side of the seating module with 10° incrementally located holes, the plungers pins engage to maintain the desired degree of recline. The chair comes standard with seat and back cushions that meet the requirements of WC1 section 16 for flammability and ISO 10993 biological evaluation of medical devices. However, the user also has the option of using a commercially available compatible seat and back cushion. The seat depth is set at the factory to one of four (4) depths and an adjustable back height of 17 to 23 inches. Positioning accessories include a two point belt or three point belt with crotch pad, foot positioners, H-harness with padded covers, adjustable footplate, head support and adjustable headwing, flip-up armrests and LTV bracket. The Flyer Transit models are WC4:2012 section 19 transit approved for use as a seating in motor vehicles.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them, structured to address your specific points:

This document is a 510(k) Summary for a manual wheelchair (Convaid Flyer). It focuses on demonstrating substantial equivalence to a predicate device (Convaid Trekker) rather than presenting a novel device's performance against pre-defined acceptance criteria in a clinical trial. Therefore, many of your requested points, particularly those related to clinical studies, expert-established ground truth, and reader studies, are not directly applicable or reported in this type of document.

However, I will extract all the relevant information present.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (manual wheelchair), performance targets are typically defined by compliance with established international and national standards rather than specific statistical metrics like sensitivity or specificity.

Reported Device Performance Summary: The Convaid Flyer series subjects were found to have “yielded similar results” to the predicate Convaid Trekker series for all listed RESNA and ISO standards. This "similar results" indicates that the Flyer meets the same performance and safety criteria as the legally marketed predicate.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified in terms of number of devices tested. The testing appears to be primarily type testing (i.e., testing representative samples of the device and its materials) rather than statistical sampling of many individual units for performance metrics.
• Data Provenance: Not explicitly stated as "country of origin," but given it's a US FDA submission for a US company (Torrance, CA), the testing was presumably conducted in adherence to standards recognized/required in the US, likely at a certified testing facility. The data is retrospective in the sense that the results were from tests already completed when the 510(k) was submitted.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable and not reported in this 510(k) summary. For a manual wheelchair, "ground truth" is established by direct measurement and physical/mechanical testing against engineering specifications and industry standards, not by expert medical interpretation or consensus.

4. Adjudication Method for the Test Set

This is not applicable and not reported. Adjudication methods are typically used in clinical studies where human interpretation or endpoint assessment is involved. Here, the "truth" is determined by objective physical tests and measurements.

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. This is a physical medical device (manual wheelchair), not an AI-powered diagnostic or assistive tool for human readers. There are no "human readers" or "AI assistance" involved in its primary function or testing for substantial equivalence.

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

This is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by the requirements and test methods specified in the referenced ASTM, RESNA, and ISO standards (e.g., specific weights for stability tests, defined impact forces for strength tests, material properties for biocompatibility). The device either passes these objective criteria, or it does not.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing are based on established engineering principles and standards.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as point 8.

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