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The purpose of The Gunnell Rehab Series Wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. The Kidster is the only device in the GRSW that is solely intended for pediatric users.

The intended use of all of the GRSW's is to provide mobility to individuals restricted to a sitting position.

The Gunnell Rehab Series of Wheelchairs (GRSW) are manually operated, mechanical wheelchairs. The GRSW are fabricated from materials common to many other wheelchairs in the industry. In addition, the GRSW offer the same options and exhibit the same features as many other mechanical wheelchairs in the market. The entire GRSW feature a recline function. The TNT. MAC, and Kidster include a tilt in space feature, which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt feature can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access. The TNT, RAM, and Kidster also have an optional lateral tilt feature allowing for 20° lateral tilt to the right and left. The lateral tilt feature is helpful in positioning individuals with a number of different conditions. For example, this feature allows for the seat to be on a lateral angle in response to the angle or degree of scoliosis exhibited by the user thereby providing better positioning for long term usage. The TNT and the RAM are available in bariatric sizes, featuring the same options and construction as that of their respective standard models.

The acceptance criteria for the Gunnell Rehab Series Wheelchairs (GRSW) are based on successful testing in accordance with applicable parts of ISO 7176. This international standard for wheelchairs includes evaluations for various aspects of performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes used for each test under ISO 7176 or the data provenance (e.g., country of origin, retrospective/prospective). However, the phrase "The GRSW successfully tested" implies that a representative sample of the devices underwent the required tests. Given that ISO standards are internationally recognized, it's highly probable that the testing was conducted in a controlled, prospective manner to meet the standard's rigorous requirements.

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

This information is not applicable as the device is a mechanical wheelchair, and its performance is evaluated through objective, standardized physical testing (ISO 7176), not through expert interpretation of data or images. The "ground truth" is defined by the objective pass/fail criteria outlined in the ISO standards.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3. Performance is determined by objective measurements and standardized test procedures, not subjective adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. An MRMC study is relevant for diagnostic or screening devices where human readers interpret medical images or data. The GRSW is a mechanical medical device, and its effectiveness is determined through physical performance tests against engineering standards, not through human reader interpretation of clinical cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable. This concept applies to AI/software algorithms. The GRSW is a physical, mechanical device, and its performance is inherently standalone in the sense that it performs its function without an AI algorithm controlling its core operation.

7. Type of Ground Truth Used:

The ground truth used for proving the device meets the acceptance criteria is based on objective, standardized measurements and pass/fail criteria defined within the various parts of the ISO 7176 standards. For example, a stability test in ISO 7176-1 would have a defined angle or force application that the wheelchair must withstand without tipping to pass the test.

8. Sample Size for the Training Set:

This information is not applicable. The GRSW is a mechanical device, not an AI or machine learning system. Therefore, there is no "training set" in the context of data-driven model development. The design and manufacturing processes are informed by engineering principles and extensive experience, as stated in the document: "The Gunnell Rehab Series of Wheelchairs have been developed based on extensive knowledge and experience gained by providing mobility for individuals requiring assistive technology since the introduction of Gunnell Inc. in the late 1950's."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

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