(39 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The AVANTICARE Mechanical Wheelchair, MR-9000 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.
The provided text is a 510(k) summary for the LERADO AVANTICARE Mechanical Wheelchair, MR-9000. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria and a study proving the device meets those criteria in the format requested.
Here's an analysis based on the information provided, and what is missing:
Information Provided:
- Acceptance Criteria: The document states, "Mechanical Wheelchair, MR-9000 meets the applicable AVANTICARE performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." These standards contain detailed performance and safety requirements, which serve as the acceptance criteria. However, the specific individual criteria (e.g., maximum weight capacity, braking effectiveness, durability cycles) from these standards are not listed in the provided text, nor are the specific results for each criterion.
- Study That Proves the Device Meets Acceptance Criteria: The document simply states that the device "meets the applicable performance requirements." It does not provide details of the study conducted to demonstrate this. There is no mention of a testing report, the methodology, or the results against each specific requirement.
- Device Performance: No specific performance metrics (e.g., weight capacity, speed, range) are reported, beyond the general statement of meeting the standards.
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (country of origin, retrospective/prospective).
- Number of Experts/Qualifications: Not applicable for this type of mechanical device testing.
- Adjudication Method: Not applicable.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating diagnostic or screening systems where human readers are involved.
- Standalone Performance: The core assertion is that the device (algorithm equivalent) meets the standards, but the details of the standalone testing are not provided.
- Type of Ground Truth: For mechanical devices, "ground truth" often refers to objective measurements against established technical standards. The ground truth here would be the specified requirements within ANSI/RESNA WC vol. 1 and ISO 7176.
- Sample Size for Training Set: Not applicable for a mechanical device.
- How Ground Truth for Training Set was Established: Not applicable.
Based on the provided text, I cannot complete the requested tables and sections with specific values and details. The document only offers a high-level statement that the device meets relevant standards.
Here's how I would present the information, highlighting what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/RESNA WC vol. 1 and ISO 7176) | Reported Device Performance |
|---|---|
| Specific criteria not detailed in the provided text. | Specific performance metrics not detailed in the provided text. |
| Examples of applicable criteria would include: | The document generally states: |
| * • Static, impact, and fatigue strength tests* | • Meets applicable AVANTICARE performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. |
| * • Braking stability and effectiveness* | |
| * • User weight capacity* | |
| * • Dimensions and maneuverability* | |
| * • Flammability of upholstery* | • Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant. |
Note: The provided text indicates that the device meets the California Technical Bulletin CAL 117 standard for flame retardant upholstery, and the general performance requirements of ANSI/RESNA WC vol. 1 and ISO 7176. However, it does not enumerate the specific criteria from these standards nor the quantitative results of the device against each criterion.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified, but generally, testing for such devices would occur at a certified testing facility, likely in Taiwan (where the manufacturer is located) or a recognized international lab. The document does not specify if the tests were performed retrospectively or prospectively relative to the filing date, but regulatory testing is typically conducted prior to submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to the performance testing of a mechanical wheelchair. Ground truth for such devices is established by objective measurements and tests against industry standards by qualified technicians/engineers at testing facilities, not by medical experts forming a consensus on an image or medical condition.
4. Adjudication method for the test set
- Not applicable for the performance testing of a mechanical wheelchair.
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-assisted diagnostic or screening tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance testing described ("Mechanical Wheelchair, MR-9000 meets the applicable AVANTICARE performance requirements...") implicitly refers to standalone testing of the device itself, against various physical stress, durability, and safety parameters stipulated in the ANSI/RESNA and ISO standards. The results of these tests, while not detailed, are the basis for the claim of meeting the standards.
7. The type of ground truth used
- The ground truth for this mechanical device testing would be the objective, predefined technical specifications and performance limits outlined in the ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards, as well as the California Technical Bulletin CAL 117 standard. Test equipment and methodologies are designed to objectively measure if the device's performance meets these numerical and qualitative criteria.
8. The sample size for the training set
- Not applicable. Mechanical device design and testing do not typically involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).