(24 days)
The intended use of the Pride Mobility Products Corporation Maxima V, Three and Four Wheel Scooters is to provide mobility to disabled persons having limited walking capabilities.
The Maxima V, Three and Four Wheel Scooters are heavy duty battery-operated scooters with programmable controllers. Features include various size removable seats, a foldable tiller, and an off board charger. The Scooter can be disassembled into four parts: the rear section, the front section, batteries, and seat; this allows for ease of use when travelling or storing the scooter. Safety features include electronic speed control, rear anti-tip wheels, and front anti-tip wheels on the three wheel model.
The provided document is a 510(k) summary for the Pride Mobility Products Corporation's Maxima V, Three and Four Wheel Scooter. It is a premarket notification for a medical device that claims substantial equivalence to previously cleared devices.
Based on the content, this device is a power scooter, and the "acceptance criteria" are related to its compliance with established testing standards for wheelchairs and scooters, rather than performance metrics from a diagnostic or screening study. There is no "study" in the traditional sense of a clinical trial proving diagnostic accuracy or treatment efficacy. Instead, the "study" is a series of non-clinical tests to demonstrate compliance with safety and performance standards.
Here's the information extracted and formatted as requested, with "N/A" where the information is not present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria | Standard | Acceptance (Pass/Fail) / Reported Performance |
|---|---|---|
| Durability and Performance | RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters) | Passed all necessary testing |
| Electrical System Safety | RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems | Passed all necessary testing |
| Electromagnetic Compatibility | ANSI/RESNA WC Vol. 2-1998 Section 21 – Requirements and Test Methods for Electromagnetic Compatibility | Passed all necessary testing |
| General Safety | IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety | Passed all necessary testing |
| Flammability | CAL 117 – Flammability Testing | Passed all necessary testing |
| Comparison to Predicate Devices | Substantially equivalent to Pride Mobility Sunrunner SC 400 (K926296) and Sunrunner SC440 (K930953) in performance, maneuverability, stability, and structure. | The non-clinical testing and predicate comparisons demonstrate that any differences do not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. This typically refers to the number of units tested.
- Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. Given the nature of medical device testing for regulatory clearance, these would be prospective, controlled tests conducted in a laboratory or test facility according to the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is not applicable as this is a non-clinical device safety and performance evaluation, not a study involving human subjects or expert assessment for ground truth in a diagnostic context. "Ground truth" here is defined by the technical specifications of the standards.
4. Adjudication method for the test set
N/A. Not applicable to non-clinical device testing against established standards.
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
N/A. This is a non-clinical device and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a mobility scooter, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the non-clinical testing is defined by the requirements and test methods outlined in the cited industry standards (RESNA WC Vol.1, RESNA WC Vol. 2, ANSI/RESNA WC Vol. 2-1998 Section 21, IEC 601-1-1, CAL 117). Compliance with these standards indicates the device meets the accepted safety and performance criteria.
8. The sample size for the training set
N/A. This is a physical device, and the concept of a "training set" is not applicable in the context of its non-clinical testing for regulatory clearance, as it's not a machine learning model.
9. How the ground truth for the training set was established
N/A. As above, the concept of a "training set" and its "ground truth" is not relevant to this type of device and its regulatory submission.
§ 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).