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The Rodeo manual wheelchairs are a tilt in space mobile positioning system for everyday use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user. It is an attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position.
Convaid's Rodeo manual wheelchairs and Sunrise Medical Zippie TS are a tilt in space mobile positioning system for everyday indoor and outdoor use on flat firm terrain. They are available in a range of sizes to accommodate a particular fit to the user. The Convaid Rodeo is a attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position. It has a variety of options to control or support the users specific needs.
This device is indicated for individuals with the specific medical conditions Listed, but the indications are not necessarily limited to such conditions: Amputee; Arthritis: Arthrogriposis; Cerebral Palsy; Geriatric conditions; Head injury or trauma; Hemiplegics; Multiple Scierosis; Muscular Dystrophy; Paraplegic; Polio; Quadriplegic; Spina Bifida; StokeJCVA; Tetraplegic; and Other immobilizing or debilitating conditions, including spinal cord injuries and Other lower and upper extremity paralysis

The Rodeo model is constructed of the same materials and contains the same typical components found on most manual wheelchairs. The frame consists primarily of powder coated round tubular steel from 5/8" to 1" diameter, that is welded, bolted and riveted. With 6" front wheels attached to pivoting casters for steering and turning, and 8" wheels in the rear. The product is a lightweight folding or non-rigid type wheelchair, which is designed for everyday indoor or outdoor use on firm terrain. Also available with a transit option for use in approved transport vehicles. The Rodeo offers its users a 10°-45° of adjustable tilt and 90°-105° of seat to back angle adjustment and comes with a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy. Adjustable seat depth, footplate and height of push handle.

The Convaid Rodeo Manual Wheelchair is a Class 1 device that was cleared via the 510(k) pathway (K032402) on September 24, 2003. This submission focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study with performance metrics in the traditional sense of AI/diagnostic devices. Therefore, some of the requested information regarding AI study design is not applicable.

Here's an analysis of the provided information:

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. The "test set" here refers to the physical wheelchairs undergoing non-clinical performance and safety testing, not a dataset of patient data. The quantity of wheelchairs tested is not specified, but it would typically involve representative samples.
• Data Provenance: Not applicable in the context of patient data. The testing refers to engineering and mechanical assessments of the device itself.

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

• Number of Experts: Not applicable. The "ground truth" for mechanical performance is established through adherence to standardized testing protocols and measurements, not expert consensus on diagnostic images or patient outcomes.
• Qualifications of Experts: Not applicable. The personnel conducting the tests would be qualified engineers or technicians with expertise in wheelchair testing protocols, but they are not "experts establishing ground truth" in a medical diagnostic sense.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical data. For non-clinical device testing, results are typically determined by direct measurement against established objective criteria in the standards.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI/diagnostic imaging devices.

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

• Standalone Study: No, a standalone study (in the context of an algorithm) was not done. This device is a manual wheelchair, not an AI algorithm.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this device's performance is objective compliance with established engineering and safety standards (ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards, and California Technical Bulletin CAL 117 for flammability).

8. The sample size for the training set

• Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Ground Truth Establishment: Not applicable. There is no training set for this type of device.

Summary of the Study:

The provided information describes a substantial equivalence submission for a manual wheelchair. The core of the "study" demonstrating that the device meets acceptance criteria is non-clinical testing against relevant industry standards. Convaid Products Inc. states that their Rodeo manual wheelchairs meet the applicable performance requirements of ANSI/RESNA WC vol. 1 or ISO 7176 Wheelchair Standards for various aspects like dimensions, fatigue strength, documentation, labeling, and use as seating in motor vehicles (ANSI/RESNA W/C 19). Additionally, the upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.

The FDA's clearance (K032402) confirms that Convaid demonstrated substantial equivalence to predicate devices (Sunrise Medical's Quickie Model "Zippie TS Folding Model" and Quickie/Zippie Series) based on these non-clinical tests and a comparison of technological characteristics. The equivalence is based on shared performance features, technology, construction, and the absence of new safety and effectiveness issues.

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