(26 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The JAN MAO Wheelchair, JMC611-F18EPP is an 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.
Here's a breakdown of the acceptance criteria and study information for the JAN MAO Wheelchair, JMC611-F18EPP, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required by Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC vol. 1 (Wheelchair Standards) | Meets applicable requirements |
| ISO 7176 (Wheelchair Standards) | Meets applicable requirements |
| California Technical Bulletin CAL 117 (Flame Retardant Standard for Upholstery Fabric) | Meets standard |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical data or patient-specific evaluation. The "testing" refers to performance testing of the device itself against established engineering and safety standards.
- No "sample size" of patients or users is mentioned for the performance testing. The wheelchair as a product is tested.
- Data Provenance: The testing was conducted by JAN MAO INDUSTRIES CO., LTD. in Taiwan. The summary does not provide details on specific labs or whether external, independent testing was performed, only that the company states the device "meets the applicable performance requirements."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This type of information is not applicable to the performance testing of a mechanical wheelchair against engineering standards. "Ground truth" in this context refers to the defined specifications within the ANSI/RESNA WC vol. 1 and ISO 7176 standards, and the flame retardancy criteria of CAL 117. These standards are established by technical committees and regulatory bodies, not by individual experts assessing a specific test set.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess a case to establish a consensus ground truth. For equipment performance testing against explicit standards, the results are objectively measured and compared to the standard's specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a type of clinical trial involving human readers evaluating medical images or data. This is not relevant to the regulatory submission for a mechanical wheelchair, which focuses on device safety and performance according to engineering standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. "Standalone" performance generally refers to the performance of an AI algorithm without human interaction. This concept is not applicable to a mechanical wheelchair.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on:
- Established Industry Standards: ANSI/RESNA WC vol. 1 and ISO 7176 are internationally recognized standards for wheelchair performance and safety.
- Regulatory/Technical Standards: California Technical Bulletin CAL 117 is a specific standard for flame retardancy of materials.
The device's performance is measured against the specifications, test methods, and acceptance criteria defined within these published standards.
8. The Sample Size for the Training Set
N/A. The concept of a "training set" applies to machine learning algorithms. This device is a mechanical wheelchair and does not utilize a training set in this context.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for a mechanical wheelchair, there is no ground truth established for it in this manner. The "ground truth" for verifying the product is the adherence to the published performance and safety 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).