(14 days)
The Jumao Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Jumao Manual Wheelchair is an indoor/outdoor wheelchair that has a base with four-wheels with a seat. The device can be disassembled for transport and it is foldable easily. Both the back and seat upholstery material is the same resistance-ignitability fabric.
The provided text describes a 510(k) Premarket Notification for the Jumao Manual Wheelchair. The submission aims to demonstrate "Substantial Equivalence" to a predicate device, which is a common regulatory pathway for Class I medical devices in the United States. In such cases, the acceptance criteria and study data are primarily focused on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against novel, independently established criteria through extensive clinical trials.
The document states that the Jumao Manual Wheelchair's design, materials, physical and performance characteristics, technological, and safety characteristics are identical to the predicate device, the Universal Wheelchair by Graham-Field Health Products, Inc. (510(k) K930411).
Therefore, the "study" proving the device meets acceptance criteria is a demonstration of substantial equivalence to this predicate device.
Here's an breakdown based on your request, with the understanding that for a 510(k) for a Class I device based on substantial equivalence, many of the typical "AI/algorithm study" questions are not directly applicable:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Jumao Manual Wheelchair) |
|---|---|
| Intended Use: Provide mobility to persons restricted to a seated position. | Identical: Intended for medical purposes to provide mobility to persons restricted to a seated position. |
| Material Characteristics: Equivalent materials to predicate device. | Identical: Materials (e.g., back and seat upholstery resistance-ignitability fabric) are identical to the predicate device. |
| Physical Characteristics: Equivalent design and physical properties to predicate device. | Identical: Device design, physical properties are identical to the predicate device. Foldable, disassemblable for transport. |
| Performance Characteristics: Equivalent functional performance to predicate device. | Identical: All device functions, scientific concepts, and performance characteristics are identical to the predicate device. |
| Technological Characteristics: Equivalent technology to predicate device. | Identical: Technological characteristics are identical to the predicate device. |
| Safety Characteristics: Equivalent safety profile to predicate device. | Identical: Safety characteristics are identical to the predicate device. Complies with relevant ISO 7176 standards. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of this 510(k). There was no "test set" of subjects or data to evaluate algorithm performance in a clinical study. The evaluation was based on a comparison of engineering, material, and design specifications to the predicate device.
- Data Provenance: Not applicable. The data primarily consists of engineering specifications, material lists, and design descriptions, compared directly to a predicate device's documented characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable for this type of 510(k) submission. "Ground truth" in this context would be the established safety and effectiveness of the predicate device, which FDA has already cleared based on its own review. The current submission relies on the manufacturer's engineering and design expertise to demonstrate the new device's identity to the predicate.
4. Adjudication method for the test set
- Not applicable. There was no test set requiring adjudication in the context of a clinical performance study. The FDA's review process itself involves adjudication by regulatory experts evaluating the submitted technical documentation against regulatory requirements and the predicate device's information.
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 device (manual wheelchair), not an AI-powered diagnostic or interpretive system. Therefore, MRMC studies and "human readers" interpreting data with or without AI are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the Jumao Manual Wheelchair's performance claims is the established safety and effectiveness of the legally marketed predicate device (Universal Wheelchair by Graham-Field Health Products, Inc., 510(k) K930411). The manufacturer asserts that all relevant characteristics are identical, thus implying identical safety and effectiveness. The performance is also shown to comply with relevant ISO 7176 standards, which are another form of established "ground truth" for wheelchair performance.
8. The sample size for the training set
- Not applicable. There is no training set for an AI/algorithm as this is a mechanical device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for an AI/algorithm.
§ 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).