(90 days)
The Mechanical Wheelchairs are intended to provide mobility to persons restricted to a sitting position.
Not Found
This document is a 510(k) clearance letter from the FDA for several models of mechanical wheelchairs. It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced medical devices involving AI or image analysis. This type of clearance (510(k)) is based on substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to answer based on the available information, noting what cannot be found:
1. A table of acceptance criteria and the reported device performance
The document does not specify performance-based acceptance criteria in terms of numerical metrics (e.g., sensitivity, specificity, accuracy) like those found in studies for diagnostic devices. The acceptance is based on "substantial equivalence" to predicate devices. The device performance is implicitly considered to be equivalent to safely and effectively marketed predicate mechanical wheelchairs.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to legally marketed predicate devices for the stated Indications for Use (providing mobility to persons restricted to a sitting position). | Reviewed and determined to be substantially equivalent to predicate devices marketed interstate prior to May 28, 1976, or to lawfully reclassified devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) clearance for mechanical wheelchairs, not a study involving a "test set" of data for performance evaluation in the context of AI or diagnostic algorithms. The clearance is based on design and safety characteristics compared to existing devices.
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)
Not applicable. There is no mention of "experts" establishing ground truth for a test set in this document. The FDA's review involves assessing the device's design, materials, and intended use against regulatory requirements and predicate devices, which is performed by FDA reviewers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described in this document.
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 document pertains to mechanical wheelchairs, not AI-assisted reading or diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" in the context of performance studies for diagnostic or AI devices does not apply here. The "truth" in this context is whether the wheelchairs meet safety and performance standards equivalent to predicate devices.
8. The sample size for the training set
Not applicable. There is no training set for an algorithm mentioned in this document.
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).