(203 days)
The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.
The Zhenjiang Assure Mechanical Wheelchair, model:A227 is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device can be disassembled for transport and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, the upholstery fabric meets the flame retardant test. The maximum weight bearing capacity of the device is 250 1bs/113.5 kgs.
This submission describes the Zhenjiang Assure Mechanical Wheelchair, model: A227, a Class 1 device intended to provide mobility to persons restricted to a sitting position. Since this is a mechanical wheelchair, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to compliance with recognized performance standards rather than typical AI/algorithm performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ISO/ANSI/RESNA Standards) | Reported Device Performance (Model: A227) |
|---|---|
| Static Stability (ISO7176-1:1999) | Meets applicable performance requirements. |
| Brake Effectiveness (ISO7176-3:2003) | Meets applicable performance requirements. |
| Overall Dimensions, Mass, and Maneuvering Space (ISO7176-5:2008) | Meets applicable performance requirements. |
| Test Dummies (ISO7176-11:1992) | Meets applicable performance requirements. |
| Coefficient of Friction of Test Surfaces (ISO7176-13:1989) | Meets applicable performance requirements. |
| Information Disclosure, Documentation, and Labelling (ISO7176-15:1996) | Meets applicable performance requirements. |
| Resistance to Ignition of Upholstered Parts (ISO7176-16:1997) | Meets applicable performance requirements (fabric meets flame retardant test and California Technical standard). |
| General Performance Requirements (ANSI/RESNA WC Vol. 1) | Meets applicable performance requirements. |
| Maximum Weight Bearing Capacity | 250 lbs / 113.5 kgs |
| Ground Clearance | 60 mm / 2.3" |
| Curb Climbing Ability | 20 mm / 0.8" |
| Maximum Incline for Operation | Not to exceed 10 degrees (avoid too steep incline over 10 degrees). |
2. Sample Size Used for the Test Set and Data Provenance:
This submission does not involve a software algorithm or AI, so there is no "test set" in the traditional sense of a dataset. The performance testing involves physical testing of the wheelchair device against established international standards. The sample size would refer to the number of physical units of the Zhenjiang Assure Mechanical Wheelchair (model: A227) that were subjected to these tests. The document does not specify the exact number of units tested.
The data provenance is from physical performance testing conducted on the device, specifically mentioned as being performed by the manufacturer, Zhenjiang Assure Medical Equipment Co., Ltd., to comply with ISO and ANSI/RESNA standards. The location of the company is Zhenjiang, China. The testing would be prospective in nature, as it's directly assessing the performance of the manufactured wheelchair model against specified criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. For a mechanical device like a wheelchair, "ground truth" is established by adherence to universally accepted engineering and safety standards (e.g., ISO, ANSI/RESNA). There are no human experts establishing a subjective ground truth for a test set in the way there would be for an AI diagnostic algorithm. Compliance is determined by objective measurements and tests. The experts involved would be engineers and technicians specialized in medical device testing and quality assurance, trained in applying these specific standards.
4. Adjudication Method for the Test Set:
Not applicable. Compliance with mechanical standards is typically determined by objective measurements and passing/failing predefined test protocols, not by expert adjudication.
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 mechanical wheelchair, not an AI-powered diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this mechanical device is defined by international consensus standards for wheelchair performance and safety, specifically the ISO 7176 series and ANSI/RESNA WC Vol. 1 standards. These standards prescribe specific test methods and acceptable limits for various performance parameters (e.g., static stability, brake effectiveness, ignition resistance).
8. The Sample Size for the Training Set:
Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for a mechanical device, there is no ground truth to be established for it.
§ 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).