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The intended use of the Invacare Topaz Bariatic Manual Wheelchair is to provide mobility to persons that may be restricted to a sitting position.

The Invacare Model 9000 Bariatric Manual Wheelchair (Topaz) is a manually operated, user propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons limited to a sitting position. The wheelchair consists primarily of a steel frame, large rear wheels with hand rims for propelling the wheelchair, and smaller front pivoting casters for steering and turning. It is a folding, or non-rigid type of wheelchair that is designed for use by patients weighing up to 1000 lbs.

The frame is constructed of round, steel tubing that is welded. The tubing is 1" outside diameter (O.D.) with a wall thickness of 1/8". The seat width ranges from a minimum of 28" wide to a maximum of 30" wide and seat to floor height ranges from 17½" to 19½". The modification to this device consists of a frame with a reinforced design to withstand the higher weight capacity of 1000 lbs. In particular, two extra gussets have been added to the frontal tube and thicker gussets have been added to the rear upright and head tube. Also, the armrests have been reinforced and a stronger tire is used on the front caster.

The Invacare Model 9000 Bariatric Manual Wheelchair (Topaz) underwent performance testing to demonstrate that modifications made to the device met predetermined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "Performance Testing conducted as a result of the modifications," implying that at least one modified wheelchair was tested to confirm the increased weight capacity and structural integrity.
• Data Provenance: The testing was conducted by Invacare Corporation and the results were submitted to the FDA as part of a 510(k) premarket notification. The text does not specify a country of origin for the data beyond Invacare's location in Elyria, Ohio, USA. The testing was likely prospective, performed specifically for the 510(k) submission to validate the design changes.

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

This type of information is generally not applicable to the performance testing of a mechanical device like a wheelchair. Ground truth for a device like this is established through engineering specifications, industry standards (like ISO 7176), and physical testing, rather than expert consensus on interpretive data.

4. Adjudication Method for the Test Set:

Not applicable. Device performance is determined by objective measurements against established engineering and safety standards, not by an adjudication process as might be used for subjective medical image interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., radiologists reading medical images) and evaluate the impact of AI assistance on their performance. For a mechanical device like a wheelchair, the performance is assessed through its physical attributes and mechanical testing.

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

Yes, the performance testing described for the wheelchair can be considered "standalone" in the sense that the device's mechanical integrity and functionality were evaluated in isolation against engineering standards, without a human "in the loop" for interpretive tasks. The wheelchair itself is not an algorithm, so this question may be interpreted differently in this context. The core testing was on the device's physical capabilities.

7. The Type of Ground Truth Used:

The ground truth used for the performance testing was based on:

• Engineering Specifications: The design parameters for the reinforced frame, armrests, and caster tires, specifically to achieve a 1000 lbs weight capacity.
• Industry Standards: The performance testing was conducted "in accordance with ISO 7176, parts 1 and 8." These international standards specify requirements and test methods for manual wheelchairs, establishing the benchmarks for safe and effective performance.

8. The Sample Size for the Training Set:

Not applicable. For a mechanical device like a wheelchair, there is no "training set" in the context of an AI/machine learning algorithm. The design and validation of the modified wheelchair are based on engineering principles and physical testing, not data-driven machine learning models.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for the device's design and performance validation is established by adherence to existing engineering principles and relevant ISO standards for manual wheelchairs.

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