(55 days)
The intended use of the Invacare ZX2 Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
The Invacare Model Xterra GT power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or "non- folding" type power wheelchair, with front wheel drive capability.
The wheelchair frame is of rigid or non-folding type design. The frame consists of a combination both 2" diameter and 1 ¼ " diameter x . 109 wall, steel tubing. The frame is of one piece, welded construction.
The wheelchair is designed with front wheel, beam type suspension. That is, the front swivel casters are mounted to two separate front extension frame members, and are thus, independent of each other. Each extension frame member pivots independently about its' This allows the chair to better negotiate small obstacles such as curbs, or own axis. ramps, from a complete stop. The rear casters pivot as well, and also serve as wheelchair anti-tippers.
The Invacare Xterra GT wheelchair incorporates a direct, front wheel drive train, which includes two separate right angle gear motors. Because it is a direct drive system, there are no belts, pulleys, chains, sprockets or the like, to periodically adjust or maintain. Both gearboxes are sealed and maintenance free. The upholstery is fabricated from either U240 Nylon, or reinforced vinyl, depending upon the user's preference. Both of these materials meet California 116 and 117 and Boston Fire Department BFD-1 specifications for fire retardancy.
The Invacare Xterra GT wheelchair is powered by two 22NF 12 VDC batteries. Access to the batteries is gained from underneath the chair. The chairs will travel approximately 15 to 21 miles between charges, depending on use.
Here's a breakdown of the acceptance criteria and the study information based on the provided document for the Invacare Model Xterra GT Power Wheelchair:
Acceptance Criteria and Device Performance
The document does not explicitly list quantitative acceptance criteria for the power wheelchair's performance. Instead, it refers to compliance with a specific draft standard.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Compliance with ISO EMC Draft Standard 7176-14 ("Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" dated April 3, 1995) | "In all instances, the Invacare Xterra GT Power Wheelchair met the required performance criteria and functioned as intended." |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "the Invacare Xterra GT Power Wheelchair" as being tested, suggesting at least one unit of the final device was tested to the standard. It doesn't specify if multiple units were tested or if specific components were tested separately.
- Data Provenance: Not explicitly stated further than being conducted for the 510(k) submission. Likely conducted internally by Invacare or a contracted testing facility. No country of origin for the data is provided, nor is it specified as retrospective or prospective (standard testing for compliance is typically prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is the performance criteria defined by ISO EMC Draft Standard 7176-14. The testing process confirms the device's adherence to these predefined criteria, not an expert-established ground truth.
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Adjudication method for the test set:
- Not applicable. The testing is against a standardized set of procedures and criteria. There is no multi-reader or adjudication process mentioned for interpreting test results, rather a pass/fail determination based on the standard.
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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. This document describes a medical device (power wheelchair), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. The "performance" refers to the physical and electrical functioning of the power wheelchair.
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The type of ground truth used:
- Regulatory/Standard Compliance: The "ground truth" is defined by the performance criteria outlined in the referenced ISO EMC Draft Standard 7176-14. The device is expected to meet these engineering and safety specifications.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).