(268 days)
The Merits Transformer Power Scooter, S941, is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
The Merits Transformer Power Scooter, S941, is battery powered, rear transaxle driven and is controlled by the Dynamic Rhino-2 120amp controller. The user interface is a throttle lever and control buttons on the control panel. S941 is powered by two 12 VDC 50ah (22NF) batteries. The batteries are charged by 5A off-board charger connect with 3-pin Microphone Connector to charging socket on Tiller. The approximate driving range on fully charged batteries is up to 40km (25mi). The scooter frame is a welded steel construction and includes 2 rear wheels with drive units (including motor, gear box, and brake), batteries, 2 front wheels and a tiller to control its turning direction. When the user activates the throttle lever, the controller receives a signal to release the brakes. With the brakes released, the scooter is allowed to move forwards or backwards. When the user releases the throttle lever, the scooter slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the throttle lever. The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices.
The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
This document describes a 510(k) premarket notification for the Merits Transformer Power Scooter, S941, and its substantial equivalence to a predicate device. This is a notification for a physical product, not a software device, and therefore the requested information regarding AI/algorithm performance and study details is not applicable.
Here's a breakdown of the provided information, focusing on the device, not an algorithm:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by a series of ISO standards for wheelchairs and scooters. The document states that the device was tested against these standards and "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device."
| Acceptance Criteria (ISO Standard) | Reported Device Performance |
|---|---|
| ISO 7176-1:1999 Determination of Static Stability | Meets specifications |
| ISO 7176-2:2001 Determination of Dynamic Stability of electric wheelchairs | Meets specifications |
| ISO 7176-3:2012 Determination of effectiveness of brakes | Meets specifications |
| ISO 7176-4:2008 Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Meets specifications |
| ISO 7176-5:2008 Determination of overall dimensions, mass and maneuvering space | Meets specifications |
| ISO 7176-6:2001 Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Meets specifications |
| ISO 7176-7:1998 Method of Measurement of Seating and Wheel Dimensions | Meets specifications |
| ISO 7176-8:1998 Requirements and test methods for static, impact and fatigue strengths | Meets specifications |
| ISO 7176-9:2009 Climatic tests for wheelchairs | Meets specifications |
| ISO 7176-10:2008 Determination of obstacle-climbing ability of electrically power wheelchairs | Meets specifications |
| ISO 7176-11:2012 Test dummies | Meets specifications |
| ISO 7176-13:1989 Determination of coefficient of friction of test surfaces | Meets specifications |
| ISO 7176-14:2008 Power and control systems for electrically powered wheelchairs and scooter- Requirements and test methods. | Meets specifications |
| ISO 7176-15:1996 Requirements for Information Disclosure, Documentation and Labeling | Meets specifications |
| ISO 7176-16:2012 Resistance to ignition of postural support devices | Meets specifications |
| ISO 7176-21:2009 Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers. | Meets specifications |
| ISO 14971:2007 Medical devices -- Application of risk management to medical devices | Meets specifications |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of an algorithm's test set. The tests were performed on the physical device itself. The provenance of the testing data would be from the manufacturing facility or a contracted testing lab. The study is a non-clinical performance evaluation of the physical device, not an analysis of a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as there is no "ground truth" to be established by experts for a physical device's performance against engineering standards. The ground truth here is derived from the objective measurements and pass/fail criteria of the ISO standards.
4. Adjudication method for the test set
Not applicable. The tests against ISO standards have predefined criteria for pass/fail, not human adjudication.
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. This is for a physical medical device (a scooter), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is adherence to the specified ISO standards. These standards define objective test methods and acceptable performance limits (e.g., stability angles, braking distances, speed ranges).
8. The sample size for the training set
Not applicable. This submission is for a physical device, not an algorithm trained on data.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical device.
§ 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).