(152 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Not Found
The provided document is an FDA 510(k) clearance letter for a "Mobility Scooter". It is a regulatory document confirming substantial equivalence to a predicate device, which allows the manufacturer to market the product.
This type of document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or a detailed technical report would. It is not a performance study report.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and the reported device performance: This is not included in an FDA clearance letter.
- Sample size used for the test set and the data provenance: Not applicable for this type of document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparativeeffectiveness study: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The FDA clearance letter primarily focuses on:
- The device's trade name and regulatory classification.
- The determination of substantial equivalence to a legally marketed predicate device.
- The applicable regulatory requirements (e.g., general controls, quality system regulations, UDI rule).
- The stated Indications for Use: "It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position."
To get the kind of information you are asking for, one would typically need to review the 510(k) summary or the full 510(k) submission (if publicly available and containing such details), which would include details of the design verification and validation testing, risk analyses, and performance data submitted by the manufacturer to demonstrate substantial equivalence and safety/effectiveness. This clearance letter is the result of that review, not the review itself.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).