(52 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S SCOOTER WT-M3A is an indoor / outdoor electric scooter that is battery operated. It has a base with three-wheeled, a seat, two armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided text describes a 510(k) submission for a medical device, the WU'S 4-WHEELED NEO SCOOTER, WT-M3A (rebranded as WU'S NEO SCOOTER, WT-M3A in the K082963 FDA letter). This document demonstrates the device's substantial equivalence to a predicate device (WU'S SCOOTER WT-M4A, K072337) rather than providing a detailed study proving performance against acceptance criteria in the typical sense of a clinical trial or algorithm performance study.
Therefore, the requested information elements related to clinical studies, sample sizes, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI/algorithm devices are not applicable to this document.
The "Performance Testing" section listed in the document refers to compliance with established industry standards for electrically powered wheelchairs, scooters, and their chargers. These are engineering and safety standards, not clinical performance metrics in the way usually discussed for advanced medical devices or algorithms.
Here's an attempt to answer the questions based on the available information, noting the inapplicability of many points:
1. A table of acceptance criteria and the reported device performance
Based on the document, "acceptance criteria" are not explicitly defined as numerical thresholds for specific performance metrics in a clinical study. Instead, the focus is on demonstrating substantial equivalence to a predicate device by meeting common design specifications and regulatory standards. The reported "performance" is primarily a comparison of features and compliance with engineering standards.
| Acceptance Criteria (Implied by Substantial Equivalence Comparison) | Reported Device Performance (WU'S NEO SCOOTER, WT-M3A) |
|---|---|
| Intended Use | Same |
| Mainframes (material, strength, fatigue) | Fixed (same), materials meet tests (similar) |
| Weight Limit | Same |
| Maximum Speed | Same |
| Incline Angle | Same |
| Korb Climbing Ability | Same |
| Groove Crossing | Same |
| Suspension of Cross Brace | Same |
| Size of Wheels | Same |
| Type of Armrest | Same |
| Footplate | Same |
| Wheel Lock | Same |
| Warranty | Same |
| Back Upholstery Materials (fabric, ignition resistance) | Same fabric, passed resistance ignition test |
| Electronic Systems (suppliers, UL certification) | Same suppliers, all UL certificated (electronic controller, batteries, motors, recharge) |
| Cruising Range (Predicate: 10~15 miles) | 10~20 miles (improved) |
| Turn Radius (Predicate: 53.1") | 37.8" (improved) |
| Overall Weight (Predicate: 100kgs) | 91kgs (lighter) |
| EMC Report Compliance | ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 |
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 applicable. This document describes a 510(k) submission for substantial equivalence based on design comparison and engineering test compliance, not a clinical study involving a "test set" of patients or data.
- Data Provenance: Not applicable.
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. There was no clinical "test set" requiring expert ground truth establishment for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 a mobility scooter, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical mobility scooter; it does not contain an algorithm in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. The "ground truth" for this submission is established through adherence to recognized performance standards (e.g., ANSI/RESNA, CISPR, EN, IEC for EMC) and direct comparison of specifications with a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. There is no AI/algorithm training set for this device.
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).