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It 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 Scooter (Models: KPL001) 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 metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, rechargeable lead-acid battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. 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.

The parts of Scooter, such as seat, rear, basket, batteries cover, could be disassembled easily. No tools will need in installation or uninstallation.

The Scooter could be detached as following steps:

• Before operating, the knob is in the horizontal direction, then Push the lock konb forward and a. point to the key hole ,turn it 90 degree clockwise, the tiller will be locked in a straight ahead position.
• Separating the seat from the scooter by lifting up the seat. If the seat is blocked while you are b. removing it, please loosen the seat while lifting and turn the seat back.
• Separating the batteries from the scooter by lifting up the battery pack. C.

And, the scooter could be installed as following steps:

• Firstly, use the quick release handle to lift the frame. a.
• b. Then, put the motor support forward, the frame hook is correctly attached to the tube.
• Turn the tiller to a high position and tighten the tiller button. C.
• d. The re installation of the batteries.
• Reinstalling the seat, and turning it until it is fixed in right place. e.
• f. The counterclockwise rotation of a knob, unlock the tiller.

The document provided is a 510(k) Premarket Notification for a medical device (a scooter) and focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific clinical study for the device's performance against predefined acceptance criteria using AI. Therefore, much of the requested information (e.g., sample sizes for test sets, number of experts for ground truth, MRMC study details, training set information) is not available in this document as it pertains to AI/algorithm performance studies, which are not relevant to this type of device submission.

However, the document does contain "Non-Clinical Test Conclusion" and "Table 4 Test results of ISO 7176 series comparison" which can be interpreted as acceptance criteria and their fulfillment through testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are generally implied by adherence to various ISO 7176 series standards, which define test methods and requirements for wheelchairs and scooters. The "Remarks" column in Table 4 (Safety Comparison) indicates "SE" (Substantially Equivalent), meaning the proposed device's performance meets or is comparable to the predicate devices in these aspects, and thus implicitly meets the requirements of the standards.

2. Sample size used for the test set and the data provenance:

• Sample size used for the test set: Not explicitly stated. The tests refer to the device itself, implying a small number of physical units (likely one or a few prototypes) were subjected to the tests described in the ISO standards. This is typical for physical device testing, not statistical sampling of data.
• Data provenance: The tests were non-clinical, conducted to verify the device met design specifications and was substantially equivalent to predicate devices. The data originates from the manufacturer's own testing as part of the 510(k) submission process. There is no information on country of origin of the data beyond the manufacturer being in China. The testing would be considered "prospective" in the sense of being performed specifically for this submission, rather than retrospective analysis of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a physical scooter, not an AI or diagnostic tool requiring expert ground truth for interpretation. The ground truth for these tests is defined by the objective measurement criteria and performance limits described in the ISO standards themselves.

4. Adjudication method for the test set:

• Not applicable. The tests are objective measurements against defined standards, not subjective interpretations requiring adjudication.

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 document is for a physical medical device (scooter), not an AI-assisted diagnostic or therapeutic tool.

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

• Not applicable. This document is for a physical medical device (scooter).

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

• For the non-clinical tests, the "ground truth" is the established requirements and test methods defined by the referenced ISO standards (e.g., ISO 7176 series, ISO 10993 series). Device performance is measured against these objective criteria.

8. The sample size for the training set:

• Not applicable. This is not an AI/algorithm-based device, so there is no training set.

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

• Not applicable.

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