(129 days)
The VCS S3Y 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 VCS S3Y 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 VCS S3Y scooter is with a 136 kg (300 lbs) weight capacity.
The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steef frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat.
It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21 AH which maximum speed upto 8.6 km/hr (5.4 mph).
Acceptance Criteria and Study for VCS S3Y scooter
The provided 510(k) summary for the VCS S3Y scooter describes a substantial equivalence determination based on compliance with established non-clinical performance standards. It does not involve a study of predictive performance using AI or clinical outcomes for diagnosis. The device is a motorized three-wheeled vehicle intended for transportation, not a diagnostic or therapeutic medical device in the typical sense that would necessitate such detailed performance metrics.
Therefore, many of the requested fields are not applicable in this context. Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999: Determination of static stability | Compliant |
| ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998: Static, impact and fatigue strengths-Requirements and test methods | Compliant |
| ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003: Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters | Compliant |
| CISPR 11-1990: Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics -- limits and methods of measurement | Compliant |
| IEC 61000-4-2-1995: EMC-Electrostatic discharge immunity test (ESD) | Compliant |
| IEC 61000-4-3-1995: EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test | Compliant |
| California Bureau of Home Furnishings 116 Flammability Standards | Compliant |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The testing would have been conducted on one or more units of the VCS S3Y scooter.
- Data provenance: Not explicitly stated, but the testing was performed against international and US standards (ANSI/RESNA, ISO, IEC, CISPR, California Bureau of Home Furnishings). The manufacturer is from Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device's performance is compliance with established engineering and safety standards, as verified by non-clinical testing. This does not involve expert consensus in a diagnostic sense.
4. Adjudication method for the test set
Not applicable. Compliance with engineering standards is typically determined by testing against predefined pass/fail criteria, not through adjudication by experts.
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 device is not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a motorized scooter, not an algorithm or software. It is a standalone physical product.
7. The type of ground truth used
The ground truth used is the defined performance specifications and safety requirements outlined in the referenced international and national standards (ANSI/RESNA, ISO, IEC, CISPR, California Bureau of Home Furnishings Flammability Standards).
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set involved.
§ 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).