(23 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S 3-WHEELED NEO SCOOTER WT-T3E is an indoor / outdoor electric scooter that is battery operated. It has a base with three-wheeled with a seat, 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 document provided describes a 510(k) premarket notification for a medical device, the WU'S 3-WHEELED NEO SCOOTER WT-T3E. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria as you might see for novel medical devices. Therefore, much of the requested information regarding detailed performance studies, sample sizes, expert ground truth, MRMC studies, and training set information is not typically found or required in a 510(k) filing that relies on substantial equivalence.
Based on the provided information, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (WU'S WT-T3E) |
|---|---|---|
| Safety - Electrical | EMC Compliance (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, IEC61000-4-3: 1995) | Passed EMC Report; Electronic systems are UL certified (controller, batteries, recharge). |
| Safety - Fire Resistance | Resistance ignition test for back upholstery | Passed resistance ignition test by SGS for back upholstery. |
| Performance - Intended Use | Provides mobility to persons restricted to a seated position. | Same intended use as predicate device WT-T3D. |
| Performance - Weight Limit | Specific weight limit (details not provided) | Same weight limit as predicate device WT-T3D. |
| Performance - Cruising Range | Specific cruising range (details not provided) | Same cruising range as predicate device WT-T3D. |
| Performance - Maximum Speed | Specific maximum speed (details not provided) | Same maximum speed as predicate device WT-T3D. |
| Stability/Structure - Safety Climbing Angle | Specific safety climbing angle (details not provided) | Same safety climbing angle as predicate device WT-T3D. |
| Durability - Warranty Period | Specific warranty period (details not provided) | Same warranty period as predicate device WT-T3D. |
Study that Proves Device Meets Acceptance Criteria:
The primary study approach described is a comparison to a legally marketed predicate device (WU'S 3-WHEELED NEO SCOOTER WT-T3D, K032488) to establish "substantial equivalence." The sponsor performed performance testing for EMC and fire resistance, but the overall demonstration of equivalence relies on the known safety and performance profile of the predicate.
Missing Information (Not typically provided in a 510(k) for substantial equivalence):
The following information is generally not provided or required for a 510(k) where substantial equivalence is demonstrated primarily through comparison to a predicate device, especially one involving a physical product like a scooter rather than an AI/software device.
2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was conducted for EMC and fire resistance, but these are typically engineering tests on the device itself, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept is relevant for AI devices where diagnostic accuracy is assessed against expert consensus. For a physical device like a scooter, "ground truth" would be objective measurements of physical properties and safety standards.
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 type of study is for AI-assisted diagnostic tools.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing, the ground truth would be the objective measurements and adherence to the specified technical standards (e.g., EMC standards, fire resistance standards). For the comparison to the predicate, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device.
8. The sample size for the training set: Not applicable. This concept is for AI/machine learning models.
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).