(41 days)
The device is intended for medical purposes to provide mobility to persons restrict to a seated position.
The ESG 4-WHEEL SCOOTER, ESG-03 is an indoor / outdoor electric scooter tl is battery operated. It has a base with four-wheeled with a seat. 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) premarket notification for the "ESG 4-WHEEL SCOOTER, ESG-03". This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating the device meets specific acceptance criteria through clinical trials or detailed performance metrics.
Therefore, many of the requested sections regarding acceptance criteria, study design, ground truth, and expert evaluation cannot be extracted from this document, as they are not applicable to this type of regulatory submission for a simple mobility device.
However, I can extract information related to the device description and the comparison to the predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance reports in a clinical or analytical study context. Instead, it relies on regulatory standards for performance testing to demonstrate safety and substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (as per document) |
|---|---|
| Electrical Safety & Performance Standards | EMC Report: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods) |
| Electronic Systems Safety | "The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured." |
| Substantial Equivalence to Predicate Device | The device is deemed substantially equivalent to the predicate device (WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763)) in terms of intended use, electronic systems safety, and overall safety aspects, despite differences in controller, agility, dimensions, tire size, and weight. Overall appearance differences are not considered safety aspects. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a mobility device, not a study involving a test set of data. Performance testing appears to be on a device prototype/model and adherence to standards.
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. Ground truth for a test set is not relevant for this type of device and 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. The device is an electrical scooter and does not involve AI or human "readers".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an electrical scooter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is compliance with established electrical and performance standards for wheelchairs/scooters and demonstrating substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/algorithm-based product.
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).