(19 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The A&I Scooter SC-301 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 steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided document is a 510(k) premarket notification for a medical device called the "A&I Scooter, SC-301," which is a motorized three-wheeled vehicle. This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its effectiveness through clinical trials with specific acceptance criteria as you've outlined for AI/ML devices.
Therefore, the information regarding acceptance criteria, study design elements (sample sizes, ground truth, experts, adjudication, MRMC studies, standalone performance, training data), is not applicable to this document.
Instead, the "performance testing" section of this 510(k) document refers to engineering and safety standards, and the "study" is a comparison to a predicate device.
Here's an analysis based on the information provided, tailored to a 510(k) submission for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
For this device, "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the device is deemed acceptable if it meets established safety and electromagnetic compatibility (EMC) standards and is substantially equivalent to a legally marketed predicate device.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| EMC Report ANSI / RESNA WC/Vol.2-1998 | Device aligns with these standards. |
| CISPR 11: 1990 | Device aligns with these standards. |
| EN61000-3-2: 1995 | Device aligns with these standards. |
| IEC61000-3-3: 1995 | Device aligns with these standards. |
| Substantial Equivalence to Predicate Device (WU's 3-Wheeled Neo Scooter, WT-T3D (K032488)) | The new device has the same intended uses, back upholstery, maximum speed, warranty, and electronic systems (suppliers, UL certified batteries/recharge, electronic controllers). Minor differences are in overall dimension, size of tires, and weight, which are deemed not to affect safety. |
| UL certification for electronic systems (batteries, recharge, controllers) | Electronic systems are UL certified. |
| Resistance ignition test for back upholstery (by SGS) | Back upholstery passed the resistance ignition test. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This type of information is not relevant for the 510(k) submission of this medical device. The "test set" here refers to the actual scooter undergoing engineering and safety tests, not a dataset for an AI model. There is no data provenance in the context of clinical or image data.
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: This information is not relevant as there is no "ground truth" established by human experts in the context of an AI/ML model for this device. The standards compliance is assessed by testing facilities (e.g., SGS for ignition test) and regulatory bodies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: There is no adjudication method described as there's no "ground truth" for an AI/ML model being assessed. Compliance with standards is evaluated through specified test procedures.
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 not an AI/ML device, so no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI/ML device, so no standalone algorithm performance was assessed. The device itself is a standalone product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: There is no ground truth in the context of clinical outcomes or diagnostic accuracy for this device. "Ground truth" for this product would be adherence to engineering specifications and safety standards defined by organizations like ANSI/RESNA, CISPR, EN, and IEC.
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI/ML device, so there is no training set ground truth to establish.
§ 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).