(121 days)
To provide an optional means of mobility for physically challenged people.
Coach 888W
The provided document is a 510(k) clearance letter from the FDA for a powered wheelchair (Coach 888W). It's a regulatory document confirming substantial equivalence to a predicate device, not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, and expert qualifications is not available in this document.
Companies must conduct testing and provide data to the FDA to demonstrate substantial equivalence, but this particular letter is the result of that process, not the detailed report of the studies themselves.
To answer your request, here's what can be inferred or stated about the information that is not present:
Information Not Found in the Document:
- 1. A table of acceptance criteria and the reported device performance: This document does not contain a table of acceptance criteria or performance data for the Coach 888W. Regulatory letters like this generally summarize the FDA's decision, not the underlying test results.
- 2. Sample size used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as this device is a powered wheelchair and likely evaluated based on engineering and safety standards, not interpretation by medical experts to establish a "ground truth" in the way an AI diagnostic tool might.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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. MRMC studies are relevant for diagnostic AI devices where human readers interpret images or data. This is a powered wheelchair, not a diagnostic AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a powered wheelchair.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a diagnostic "ground truth" for this type of device. The "ground truth" for a powered wheelchair would relate to its ability to meet performance and safety standards, not a diagnostic outcome.
- 8. The sample size for the training set: Not applicable; powered wheelchairs are not typically "trained" in the machine learning sense.
- 9. How the ground truth for the training set was established: Not applicable.
What the document DOES tell us:
- Device Name: Coach 888W
- Regulation Number: 890.3860 (Powered wheelchair)
- Regulatory Class: II
- Product Code: ITI
- Indications for Use: To provide an optional means of mobility for physically challenged people.
- FDA Finding: Substantially equivalent to legally marketed predicate devices.
- Date of Clearance: July 10, 2003
In summary, this document is a regulatory approval notice and does not contain the detailed technical study information you've requested. That kind of information would typically be found in the 510(k) submission itself, not the clearance letter.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).