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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The KING I Powered Scooter, CTL-11 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-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.

This document describes the regulatory submission for the KING I Powered Scooter, CTL-11, where substantial equivalence to a predicate device (WU'S 3-WHEELED NEO SCOOTER WT-T3D) is claimed rather than presenting a performance study with defined acceptance criteria and device performance metrics. Therefore, many of the requested elements are not applicable in this context.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission claiming substantial equivalence, explicit performance acceptance criteria and reported device performance metrics in the way one would see for a novel device or a clinical trial are not presented. Instead, the submission focuses on demonstrating that the new device has "the same safety level" and similar characteristics to the legally marketed predicate device.

The "Performance Testing" section lists standards it meets, which could be interpreted as implicit acceptance criteria for safety and electrical compatibility:

The narrative also states: "the electronic systems between two devices are the same suppliers and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured."

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 submission does not describe a clinical study with a test set of data. The performance testing refers to engineering and safety standards applied to the device itself.

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 is not a study involving expert assessment or ground truth establishment in a medical imaging or diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set requiring adjudication is described.

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 an electric scooter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This refers to an electric scooter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. Ground truth, in the context of device performance, typically refers to a gold standard for a diagnostic task. For this device, the "ground truth" for safety and performance is adherence to established engineering and safety standards (e.g., ANSI/RESNA, CISPR, IEC) and certifications (UL, SGS).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

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