(11 days)
To assist the mobility of the elderly, sick, injured and disabled persons at an affordable price.
Mechanical Wheelchair
This document is a 510(k) premarket notification decision letter from the FDA for a mechanical wheelchair, specifically models TX312 and TX368, manufactured by Texin Industrial (International) Limited.
Based on the provided document, the following information can be extracted regarding acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance:
The document is an FDA clearance letter based on substantial equivalence. It does not contain a table of acceptance criteria or reported device performance metrics. The FDA determined the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This typically means the device has the same intended use, technological characteristics, and safety and effectiveness as a legally marketed device. Performance data, if submitted, would have been reviewed during the substantial equivalence determination but are not detailed in this type of letter.
2. Sample size used for the test set and the data provenance:
The document does not specify any sample size for a test set, nor does it mention data provenance (country of origin, retrospective/prospective). This letter is a regulatory decision, not a scientific study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention any experts used to establish ground truth or their qualifications. Ground truth establishment is typically part of a performance study, which is not described here.
4. Adjudication method for the test set:
The document does not describe any adjudication method.
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:
The document does not mention any MRMC comparative effectiveness study or AI assistance. The device is a mechanical wheelchair.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document does not describe any standalone algorithm performance. The device is a mechanical wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document does not specify any type of ground truth used.
8. The sample size for the training set:
The document does not specify any sample size for a training set.
9. How the ground truth for the training set was established:
The document does not describe how ground truth was established for a training set.
In summary:
This document is a regulatory clearance letter, not a detailed study report. It states that the device (mechanical wheelchair) was found substantially equivalent to a predicate device. Information regarding specific performance criteria, study methodologies, sample sizes, expert involvement, or any form of AI evaluation is not present in this document. The FDA's determination of substantial equivalence implies that the device is as safe and effective as a legally marketed predicate device, but the specifics of how that equivalence was demonstrated (through testing and data) are not detailed here.
§ 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).