(19 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The A&I Scooter SC-402 is an indoor / outdoor Powered Scooter that 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 stecring column. The device can be disassembled for transport and is provided with an onboard battery charger.
This submission is for a motorized scooter, not an AI/ML powered device. Therefore, many of the requested categories for describing an AI study are not applicable. I will extract the relevant information from the provided text regarding the scooter's performance and testing.
Device: A&I Scooter, SC-402
The regulatory submission describes the A&I Scooter, SC-402, as an indoor/outdoor battery-operated powered scooter with four wheels and a seat. It is controlled by hand controls on the steering column, can be disassembled for transport, and includes an onboard battery charger.
The study presented here is a 510(k) submission for substantial equivalence to a predicate device, focusing on safety and functional similarities rather than a performance study with acceptance criteria in the typical sense for an AI/ML device. The "performance testing" referenced is related to electrical and mechanical safety standards rather than clinical efficacy or accuracy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a 510(k) for substantial equivalence of a medical device, specifically a motorized scooter), "acceptance criteria" and "device performance" are framed in terms of compliance with safety standards and similarity to a predicate device, rather than specific numerical efficacy metrics.
| Acceptance Criteria (Implied from comparison and testing) | Reported Device Performance |
|---|---|
| Intended Use: Device provides mobility to persons restricted to a seated position. | Met. "The device is intended for medical purposes to provide mobility to persons restricted to a seated position." (Same as predicate device) |
| Compliance with Safety Standards: EMC, Electrical Scooter standards. | Met. "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995. IEC61000-3-3: 1995 (Electrically Powered Scooters, controller, and their chargers requirements and test methods)" |
| "Electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries, recharge, and the electronic controllers. Thus the same safety level for the two devices is assured." | |
| Maximum Speed: Below 6 mph limit. | Met. "The maximum speed is 5.6 mph for the new device and 6.0 mph for the predicate device that are also under the 6 miles maximum speed limited." |
| Material Safety (Back Upholstery): Resistance ignition test. | Met. "back upholstery is the same material, and also passed the resistance ignition test by SGS." |
| Technological Characteristics: Similar electronic systems, battery, charger, controller. | Met. "Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries, recharge, and the electronic controllers." |
| Overall Dimensions/Weight: Differences are not safety-critical. | Met. "The major differences existing of the two Powered Scooters are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety aspect." |
2. Sample size used for the test set and the data provenance
This section is not applicable as this is a medical device approval for a physical product (electric scooter) based on substantial equivalence to a predicate device and compliance with safety standards, not an AI/ML software device requiring a test set of data. The "testing" involves physical product testing against specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. Ground truth, in the context of expert consensus, is typically used for AI/ML diagnostic or prognostic devices. For this physical product, regulatory bodies (e.g., UL, SGS) or internal engineering teams would verify compliance with standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically employed in clinical studies or for establishing ground truth in AI/ML performance evaluations.
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
This section is not applicable. MRMC studies are designed for evaluating diagnostic AI systems, not physical medical devices like a scooter.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a physical device, an electric scooter, with no AI algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is implied by the established engineering and electrical safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, UL certification, SGS resistance ignition test). Compliance with these standards serves as the "ground truth" for the device's safety and foundational functionality. Substantial equivalence to a legally marketed predicate device (WU's 3-Wheeled Neo Scooter, WT-L4Jr (K032617)) also forms a key part of the "ground truth" for regulatory approval.
8. The sample size for the training set
This section is not applicable. The device is a physical product and does not involve AI/ML requiring a training set.
9. How the ground truth for the training set was established
This section is not applicable due to the absence of an AI/ML component and training set.
§ 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).