(46 days)
Zip'r4 and Zip'r4 Xtra scooter are intended for the indoor/outdoor electrical scooter that provide transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.
The Zip'r4 and Zip'r4 Xtra scooter are the indoor/outdoor electrical scooter. The design of the scooters is basically similar to other electrical scooters that are already on the market. By providing the electrical scooter that breaks down into three manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
The Zip'r4 and Zip'r4 Xtra scooters are with a 113 kg (250 Ibs) weight capacity. They are basic conventional rear wheel drive, rigid frame vehicle that are battery powered. They consist primarily of a welded steel frame, lighting system, a sealed powered. Incor (155W, DC24V) drive system, electromagnetic braking system, electric motor controller (PG S-Drive 45A) and two batteries with an off-board battery charger (2A). They are powered by two 12 volt lead-acid DC batteries with 16 km (10 miles) with 12 AH which maximum speed upto 6.8 km/hr (4.25 mph).
The provided text describes the regulatory submission for the Zip'r4 and Zip'r4 Xtra scooters and their substantial equivalence to a predicate device. It primarily focuses on compliance with existing standards for motorized wheelchairs and the administrative process of 510(k) clearance.
Unfortunately, the document does not contain the detailed information necessary to answer all the questions regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way one might describe for a software or AI/ML-based medical device.
The context of this document is a 510(k) submission for a physical medical device (electrical scooter), not an AI/ML diagnostic tool. Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable or not provided.
However, I can extract the information related to the device's compliance with established standards, which serve as its "acceptance criteria" in this context.
Here's the breakdown of what is available from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999 | Complied |
| ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001 | Complied |
| ANSVRESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 | Complied |
| IEC 61000-4-2-2001 | Complied |
| IEC 61000-4-3-2008 | Complied |
| CISPR 11: 2004+A2: 2006 | Complied |
| California Bureau of Home Furnishings 117 Flammability Standards | Complied |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. Testing likely involved a representative number of units to demonstrate compliance with the listed standards, but the exact count is not detailed.
- Data Provenance: Not specified, but Global FabTech Wheelchair (Shanghai) Co., Ltd. is based in Shanghai, China, and Taichung, China (Taiwan). The testing was for international (ISO/IEC), US (ANSI/RESNA), and California standards, implying testing was conducted to meet these specific regulations. The nature of the testing for physical device standards implies prospective testing of manufactured units rather than retrospective data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable to this type of device. "Ground truth" in the context of physical medical devices typically refers to measured performance against established engineering and safety standards, usually conducted by certified testing laboratories, not medical experts establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is relevant for expert review of medical images or data, not for testing the mechanical and electrical specifications of a mobility scooter.
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 AI/ML diagnostic tools, not for a motorized scooter.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this device, the "ground truth" for the test results (compliance with standards) is based on objective measurements and assessments against the specifications outlined in the referenced ANSI/RESNA, ISO, IEC, CISPR, and California Flammability standards, performed by qualified testing methods and equipment.
8. The sample size for the training set
- Not applicable; this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).