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lt is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Solax Electric Scooter (Models: S302121, S302131, S302141, S302151) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has a base with aluminum alloy frame, two front wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a remote for folding/unfolding the device and a Lithium battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the control panel. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually.

This document is a 510(k) premarket notification for a medical device called the "Solax Electric Scooter." It describes the device, its intended use, a comparison to a predicate device, and a summary of performance and safety tests.

Here's the breakdown of the information requested, based on the provided text:

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

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the format typically associated with an AI/ML device study. Instead, it lists various ISO and IEC standards that the device was tested against to demonstrate safety and effectiveness. The "reported device performance" is implicitly that the device met the requirements of these standards.

Here's a table based on the provided information, interpreting the standards as acceptance criteria for the respective performance aspects:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "performance and safety tests" but does not specify the sample size for these tests. It is implied that tests were performed on the device itself (Solax Electric Scooter models S302121, S302131, S302141, S302151). This is a physical device, not an AI/ML algorithm processing data.

The data provenance is industrial testing of a physical product. The submitter is Dongguan Prestige Sporting Goods Co., Ltd. from China. The types of tests (ISO standards) are generally standardized laboratory or field tests.

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)

This information is not applicable. The device is a physical electric scooter, not an AI/ML diagnostic or predictive tool that requires expert consensus for ground truth on a test set. The "ground truth" for its performance is determined by adherence to the engineering and safety standards listed.

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

This information is not applicable. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies involving multiple readers for diagnostic tasks (e.g., radiologists interpreting images) to establish a consensus ground truth. This document describes the testing of a physical medical device against established engineering standards.

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 information is not applicable. A MRMC comparative effectiveness study is relevant for AI/ML diagnostic or imaging devices where human performance with and without AI assistance is being evaluated. The Solax Electric Scooter is a physical mobility device and does not involve human readers interpreting data.

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

This information is not applicable. The Solax Electric Scooter is a physical device, not a standalone algorithm.

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

The "ground truth" for the Solax Electric Scooter's performance is compliance with established international engineering and safety standards (ISO and IEC standards). These standards define performance limits and test methodologies, and the device is evaluated against these predefined criteria rather than a subjective "expert consensus" or biological "pathology" data set.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI/ML model that requires a "training set."

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

This information is not applicable. As stated above, the device is not an AI/ML model requiring a training set with established ground truth.

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