(24 days)
The device is intended for medical purposes to provide mobility to person restricted to a sitting position.
BIOTECH B900 SUPER LIGHT WHEELCHAIR
This document is a 510(k) premarket notification letter from the FDA regarding the Biotech B900 Super Light Wheelchair. It focuses on the regulatory approval and substantial equivalence to a predicate device, rather than detailed performance studies or AI-driven diagnostic tools. Therefore, information related to AI acceptance criteria, study methodologies, and expert involvement is not present in this document.
Here's an analysis based on the provided text, recognizing the limitations for the requested AI-centric information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed performance results for the Biotech B900 Super Light Wheelchair in a format applicable to AI device evaluation (e.g., sensitivity, specificity, AUC). The approval is based on "substantial equivalence" to a legally marketed predicate device, meaning its safety and effectiveness are considered comparable.
| Acceptance Criteria (Not explicitly stated for AI performance) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Safe for intended use | Considered safe for medical purposes |
| Effective for intended use | Considered effective for providing mobility |
| Comparable to predicate device in terms of safety and effectiveness | Substantially equivalent to legally marketed predicate devices |
Information Not Available in the Document:
- Details on specific mechanical or functional performance metrics used to establish equivalence.
- Any quantitative data on device performance, as this is an FDA approval letter, not a study report.
The following points are pertinent to AI device evaluation but are not present in the provided document because it pertains to a mechanical wheelchair and not an AI-driven medical device:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable/Not present. This document is for a mechanical wheelchair, not an AI device.
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/Not present. Ground truth establishment with experts is not relevant for a mechanical wheelchair approval.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not present. Adjudication methods are used in studies involving human interpretation or consensus, not for mechanical device approval.
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/Not present. This is relevant for AI-assisted diagnostic devices, not for a mechanical wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not present. This concept applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not present. The "ground truth" for a mechanical wheelchair would be its physical properties and functional performance under testing, which are not detailed here.
8. The sample size for the training set:
- Not applicable/Not present. Training sets are for machine learning models, not mechanical devices.
9. How the ground truth for the training set was established:
- Not applicable/Not present. Again, this is for AI model development.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for a mechanical wheelchair. It indicates that the device has been found substantially equivalent to legally marketed predicate devices for its intended use: "to provide mobility to person restricted to a sitting position." The letter confirms regulatory compliance and allows marketing but does not contain information on detailed performance studies, clinical trials, or any aspects related to AI device evaluation as requested in the prompt.
§ 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).