(58 days)
The AVANTICARE SA4021 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The AVANTICARE SA4021 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided text K060068 is a 510(k) summary for a medical device called AVANTICARE SA4021 scooter. It outlines the device description, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with performance evaluations for AI/software-based medical devices.
The document is for a physical medical device (an electric scooter) and the provided information focuses on regulatory classification and substantial equivalence to legally marketed devices based on inherent technical specifications and intended use, rather than performance metrics from a clinical study or benchmark testing.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because the provided text does not contain this information.
Specifically, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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).