(167 days)
Sunrise scooters empower physically challenged persons by providing a means of mobility.
The Three Wheeled mid Range Scooter is a medium duty, conventional, rear whech drive, rigid frame power Vehicle. The armrests of the sear are adjustable. The seat may be repositioned from from to back and chair height can be adjusted up and down. There are many kinds of accessories that are commonly sold after market. These accessories include canopies, crutch holders, cup holders, baskers etc.
Like most scooters, the tiller and throttle controls are the user interface. They transfer the rider's intentions to command the device. When the control is activated, or moved out of neutral position, the motor brake is energized and released, allowing the scooter to move in the appropriate direction. When the activation device is released, the scooter slows to a stop and the motor brake is automatically reengaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device.
If the scooter looses power, the motor brake is automatically engaged and the scooter comes to a stop. To prevent the rider from becoming stranded, the scooter may be pushed. The design incorporates a "free wheel" device motor lock disengagement device. This device allows the drive train to be manually disengaged, enabling the scooter to be pushed. It should be noted that the scooter would not have electronic brakes when in the "free wheel" mode.
The controller is microprocessor based and program-able. It is pro-programmed at the manufacturer to meet Sunrise specifications. This controller is currently used on selected models of the Sunrise scooters under K880425. Drive characteristics that are pre set are:
forward/reverse acceleration forward speed
forward/reverse deceleration reverse speed
The controller also has manual reset circuit breakers. These adjustments and features are similar to all standard scooter controllers.
The provided text describes a 510(k) submission for a medical device, specifically a mobility scooter. However, it does not include the typical information one would expect for demonstrating the acceptance criteria and performance of an AI/ML device in a clinical study.
The document is a K981885 submission for a "Sunrise 3 Wheel Scooter" in 1998, which is a physical device, not an AI/ML software device. The "testing" section refers to engineering standards like ISO 7176 and RESNA for wheelchairs, covering aspects like stability, brakes, energy consumption, and EMC. The "efficacy" section refers to articles about power wheelchairs in general, not specific studies on this particular device's clinical efficacy in a statistical sense.
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria, as the provided input does not contain information relevant to an AI/ML device's clinical performance assessment.
Here's a breakdown of why each requested point cannot be addressed with the given document:
- A table of acceptance criteria and the reported device performance: The document lists engineering tests (e.g., Static Stability, Dynamic Stability, Effectiveness of Brakes) and states that the device was tested to these standards. It doesn't present specific acceptance criteria values (e.g., "must stop within X feet at Y speed") and then reported performance values against them in a table format. These are design and safety standards, not clinical performance metrics for an AI/ML diagnosis/prediction.
- Sample sized used for the test set and the data provenance: Not applicable. This refers to engineering tests, not a clinical study on patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth is established for patient data.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory submission for a physical medical device (a scooter) and focuses on engineering safety standards and comparisons to predicate devices, not on the clinical performance validation of an AI/ML algorithm.
§ 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).