(31 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The AVANTICARE Transport Wheelchair, MT-3000 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 Transport Wheelchair, MT-3000. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study proving that the device meets those criteria in the way typically expected for an AI-powered diagnostic device.
The "Performance Testing" section states: "AVANTICARE Transport Wheelchair, MT-3000 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards."
This indicates that compliance with these established industry standards serves as the "acceptance criteria" and the "study" is the testing performed against these standards. Unfortunately, the document does not provide the specific numerical acceptance criteria, the detailed results, or the methodology of this performance testing.
Therefore, I cannot fully complete the requested table and answer all questions in the requested format for an AI/diagnostic device, as the provided content pertains to a mechanical wheelchair and not a software or AI-based medical device.
However, I can extract what is provided related to performance and create a table based on the type of information that would be in an acceptance criteria table, even if specific numerical values are not given in this document.
Here's an attempt to answer based only on the provided text, acknowledging its limitations for an AI/diagnostic context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Wheelchair Standards Compliance | Meet applicable requirements of ANSI/RESNA WC vol. 1 | "Meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1" |
| Wheelchair Standards Compliance | Meet applicable requirements of ISO 7176 | "Meets the applicable performance requirements as specified in ISO 7176" |
| Material Flame Retardancy | Upholstery fabric meets California Technical Bulletin CAL 117 standard | "Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. It refers to the testing of "the device" (singular), implying a representative unit or units.
- Data Provenance: Not specified. The device manufacturer is in Taiwan, ROC, so testing would likely have occurred there or with a certified lab. The study type (e.g., retrospective or prospective) is not applicable or specified for this type of mechanical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the performance testing of a mechanical wheelchair against engineering standards. "Ground truth" in this context would be the objective measurements and adherence to the specified technical parameters of the standards, not expert interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert opinions related to diagnostic interpretation. The wheelchair testing would involve objective measurements and pass/fail criteria based on engineering specifications.
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 for AI-assisted diagnostic devices, not mechanical wheelchairs.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is for AI algorithms, not mechanical wheelchairs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing of the wheelchair would be the objective measurements of the device's characteristics and performance parameters (e.g., strength, stability, dimensions, durability, flame retardancy of materials) as defined and evaluated against the specific, quantifiable criteria within the ANSI/RESNA WC vol. 1 and ISO 7176 standards, and California Technical Bulletin CAL 117.
8. The sample size for the training set
Not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is used for this 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).