(176 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Jiangsu Healthy Way Aluminum Mechanical Wheelchair 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 uses a standard sling type back and seat, the upholstery fabric meets the resistant to ignition source smouldering cigarette, and match flame equivalent.
This document describes the performance testing for the Jiangsu Healthy Way Aluminum Mechanical Wheelchair.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Device Performance
The device meets the applicable performance requirements specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series standards. The document lists the specific standards and their respective years.
Table of Acceptance Criteria and Reported Device Performance
| Standard | Description of Acceptance Criteria (Implied by standard title) | Reported Device Performance |
|---|---|---|
| EN 1021-1 /-2 (2006) | Assessment of the ignition of upholstered furniture (smouldering cigarette equivalent, match flame equivalent) | Meets the standard (upholstery fabric meets resistance to ignition source smouldering cigarette, and match flame equivalent) |
| ISO 7176-1 (1999) | Determination of Static Stability | Meets the standard |
| ISO 7176-3 (2003) | Determination of effectiveness of brakes | Meets the standard |
| ISO 7176-5 (2008) | Determination of overall dimensions, mass and maneuvering space | Meets the standard |
| ISO 7176-7 (1998) | Measurement of seating and wheel dimensions | Meets the standard |
| ISO 7176-8 (1998) | Requirements and test methods for static, impact and fatigue strengths | Meets the standard |
| ISO 7176-11 (1992) | Test dummies | Meets the standard |
| ISO 7176-13 (1989) | Determination of coefficient of friction of test surfaces | Meets the standard |
| ISO 7176-15 (1996) | Requirements for information disclosure, documentation and labeling | Meets the standard |
| ISO 7176-16 (1997) | Resistance to ignition of upholstered parts --Requirements and test methods | Meets the standard (back upholstery material also meets California Technical standard for flame retardant) |
| ISO 7176-22 (2000) | Set-up procedures | Meets the standard |
Note: The document states "Jiangsu Healthy Way Aluminum Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series standards". This implies successful adherence to all criteria within these standards.
Here's a breakdown of the other requested information based on the provided text:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify a sample size for the test set. These are likely engineering and material tests performed on a selection of devices rather than a statistically sampled patient population.
- Data provenance: Not explicitly stated, but the manufacturer is based in China (Jiangsu Healthy Way Medical Equipment Co., Ltd., China). The testing likely occurred in a validated laboratory, possibly in China or another region. The standards are international (ISO, EN) and US (ANSI/RESNA). The testing itself is prospective in the sense that the device was manufactured and then tested against these established standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" here is the adherence to engineering performance standards, not expert consensus on medical images or diagnoses. The "experts" would be the engineers and technicians performing the tests and comparing results against the specified standard values. Their qualifications would be in mechanical engineering, materials science, and knowledge of relevant ISO/EN/ANSI standards. The document does not provide details on the number or qualifications of these testing personnel.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None in the context of expert medical adjudication. Performance testing against engineering standards typically involves direct measurement and comparison to predefined thresholds, which does not require a human adjudication process in the same way clinical studies or image interpretations do.
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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:
- No. This type of study is completely irrelevant for a mechanical wheelchair. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation of medical images (e.g., radiologists reading mammograms).
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This study design refers to the performance of artificial intelligence algorithms. The device in question is a mechanical wheelchair, which does not utilize AI. Its performance is purely mechanical and material-based.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing of the mechanical wheelchair is the predefined thresholds and methodologies established within the listed international and national engineering standards (ISO, EN, ANSI/RESNA). These standards define what constitutes acceptable performance (e.g., minimum stability angles, maximum brake force, fatigue life cycles, resistance to ignition).
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The sample size for the training set:
- Not applicable. This device does not use a training set as it is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable. As stated above, there is no training set for this mechanical device.
§ 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).