(15 days)
The intended use of the Model Top End Terminator SS Manual Wheelchair is to provide mobility to persons limited to a sitting position.
The Invacare Corporation Model Top End Terminator SS is a manually operated, self propelled, manual, mechanical wheelchair. It's intended function and use is to provide mobility to persons who may be restricted to a sitting position. The product consists basically of a metal frame, larger rear wheels with handrims for propelling the chair, and smaller front pivoting casters for steering and turning. The product is designed to be a lightweight, user adaptable, everyday wheelchair, for both indoor and outdoor use. It is a rigid, or, non-folding type wheelchair, which has a more sporty appearance than the traditional type of manual wheelchairs. The Top End Terminator SS Wheelchair incorporates a one piece frame. The frame is constructed from 1'' and 1 1/8 " diameter chrome-moly steel tubing, that is brazed together. The wheelchair upholstery is a vinyl material which meets the requirements of EN 1021:1 standard for flame retardancy. The Top End Terminator SS also includes a front and rear suspension feature. This feature which mounts to the front and rear of the wheelchair, is designed to absorb minor bumps and shocks encountered during everyday use, thus providing added comfort to the wheelchair user.
The provided text describes a 510(k) submission for the Invacare Corporation's Model Top End Terminator SS Manual Wheelchair. The primary purpose of this submission is to demonstrate substantial equivalence to predicate devices, rather than to present a de novo study with acceptance criteria and performance data for a novel device.
Therefore, the text does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a new device.
The only relevant performance information provided is:
- Acceptance Criteria/Performance Standard: The device "meets the applicable performance requirements specified in: Rehabilitation Engineering Society of North America (RESNA) Standard . ANSI/RESNA WC/Vol.1-1998 'Requirements and Test Methods for Wheelchairs (Including Scooters)'."
Essentially, the "study" demonstrating this involves testing the wheelchair against the parameters outlined in the RESNA standard. However, the document does not provide the specific numerical acceptance criteria from the RESNA standard itself, nor does it present the detailed results of the Invacare device's performance against those criteria. It merely states that the device meets them.
Without this specific information from the RESNA standard and the detailed test results, a table of acceptance criteria and reported device performance cannot be fully constructed as requested.
Here's what can be extracted and inferred from the provided text, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from RESNA ANSI/RESNA WC/Vol.1-1998) | Reported Device Performance |
|---|---|
| Specific parameters of the RESNA standard (e.g., static stability, dynamic stability, braking efficiency, structural integrity, durability, etc.) | Meets the applicable requirements of the RESNA standard. |
Note: The specific numerical thresholds and performance metrics are not detailed in the provided document, only the general statement that the device meets the standard.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. Typically, performance testing for devices like wheelchairs involves a limited number of units (often a few prototypes or production samples) subjected to standardized tests rather than a large "test set" in the sense of patient data.
- Data Provenance: Not explicitly stated, but the testing would be conducted in a laboratory or testing facility to comply with the RESNA standard. It is prospective testing of the device itself, not retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of device performance testing against an engineering standard. The "ground truth" here is the standard itself, developed by a professional society (RESNA). The experts involved would be the engineers and technicians conducting the tests and interpreting the RESNA standard. Their qualifications are not mentioned.
4. Adjudication method for the test set:
- Not applicable. Performance against an engineering standard is typically objectively measured and assessed against defined pass/fail criteria, not adjudicated through multi-expert consensus.
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:
- Not applicable. This is a manual wheelchair, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself (the wheelchair) is the "standalone" entity being tested for its mechanical performance. There is no AI algorithm involved.
7. The type of ground truth used:
- Engineering Standard: The ground truth for performance is established by the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs (Including Scooters)." This standard defines the objective, measurable criteria a wheelchair must meet.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device. There is no "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).