(15 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The JAN MAO Wheelchair、JMC612-FL318EPP(& JMC612-FL418EPP)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 California Technical Bulletin CAL 117 standard for flame retardant.
The acceptance criteria pertain to the JAN MAO Wheelchair models JMC612-FL318EPP and JMC612-FL418EPP.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC Vol. 1 | Meets applicable performance requirements |
| ISO 7176 Wheelchair Standards | Meets applicable performance requirements |
| California Technical Bulletin CAL 117 (flame retardant for upholstery) | Meets standard for flame retardant |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "test set" sample size or data provenance in terms of country of origin or whether it was retrospective or prospective. It refers to general "Performance Testing" against standards. This suggests that the testing was likely done on physical samples of the manufactured wheelchairs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for a medical device like a wheelchair is established by its adherence to recognized engineering and safety standards (ANSI/RESNA WC Vol. 1, ISO 7176, CAL 117), not by expert consensus on clinical presentation or pathology.
4. Adjudication Method for the Test Set:
Not applicable. The evaluation relies on standardized testing protocols outlined in the referenced standards, not an adjudication process involving human reviewers for clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a diagnostic device where human reader performance would be enhanced by AI. The device is a mechanical wheelchair.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The device is a mechanical wheelchair, not an algorithm. Performance testing is purely standalone, meaning the device itself is tested against established engineering and safety benchmarks.
7. Type of Ground Truth Used:
The ground truth used for performance evaluation is based on recognized engineering and safety standards. Specifically:
- ANSI/RESNA WC Vol. 1 (Wheelchair standards for performance requirements)
- ISO 7176 Wheelchair Standards (International standards for wheelchairs)
- California Technical Bulletin CAL 117 (Standard for flame retardancy of upholstery fabric)
8. Sample Size for the Training Set:
Not applicable. The JAN MAO Wheelchair is a mechanical device, not an AI/ML algorithm or software that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
Study Proving Device Meets Acceptance Criteria:
The document states that "JAN MAO Wheelchair, JMC612-FL318EPP ( & JMC612-FL418EPP ) meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." Additionally, the upholstery fabric "meets the California Technical Bulletin CAL 117 standard for flame retardant."
This indicates that internal performance testing, likely conducted by the manufacturer or a third-party testing facility, was performed to verify compliance with these established standards. While the specific test reports are not included in this summary, the statement serves as the manufacturer's claim of compliance based on such studies. The FDA's 510(k) clearance implies that the FDA found sufficient evidence in the submission to support these claims, allowing the device to be marketed as substantially equivalent to a predicate device that also meets these standards.
§ 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).