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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.

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

The PS30 Scooter has a base with aluminum allov frame, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable lithium 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 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 Scooter only can be operated on the flat road.

The scooter is provided in four colors - cherry Red, Neptune Blue, Sunburst Orange, Frozen Grey Mat, for the outer shell of wheels and consoler panel.

The provided document is a 510(k) summary for the Scooter (PS30) and does not describe acceptance criteria or a study that proves a device meets acceptance criteria in the manner requested (i.e., for a medical device involving AI/machine learning, expert consensus, or complex clinical endpoints).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (K182471) for a motorized three-wheeled vehicle. The "acceptance criteria" here are essentially compliance with a comprehensive set of ISO and IEC standards relevant to wheelchairs and scooters, and the "study" is a series of non-clinical tests verifying that the device meets these standards and its design specifications.

Therefore, many of the specific details requested (like number of experts, adjudication methods, MRMC study, sample size for training set, ground truth establishment) are not applicable to this type of submission.

Below is an attempt to structure the available information into the requested format, clearly indicating when a category is not applicable based on the provided text.

Acceptance Criteria and Performance Study for Lichtmega Technology Co., Ltd.'s Scooter (PS30)

The "acceptance criteria" for the Scooter (PS30) are based on demonstrating compliance with a comprehensive set of ISO and IEC standards that address various aspects of electric wheelchairs and scooters, including stability, braking, energy consumption, dimensions, speed, strength, climatic performance, obstacle climbing, power/control systems, and electromagnetic compatibility. The "study" consisted of non-clinical tests to verify that the device met these standards and its design specifications.

1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance

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

• Sample Size: Not specified in terms of a "test set" as would be for clinical data. The tests are non-clinical, implying destructive/non-destructive testing of the device itself or its components. The document implies that at least one unit of the Scooter (PS30) and its components were subjected to these tests.
• Data Provenance: The tests were conducted to specific international standards (ISO, IEC), likely in a testing laboratory. The country of origin for the testing data is not explicitly stated, but the applicant and correspondent are based in Shanghai, China. The data is retrospective in the sense that the tests were completed before the submission.

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

• Not Applicable. This is a non-clinical device that does not involve expert interpretation or ground truth establishment in the diagnostic sense. Compliance with engineering standards is determined by test results against predefined limits, not expert consensus.

4. Adjudication method for the test set:

• Not Applicable. See point 3. The verification primarily involves physical and electrical measurements compared to standard specifications.

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 a mobility scooter and does not incorporate AI or involve human interpretation of medical images/data.

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

• Not Applicable. This device is a mechanical and electrical product, not an algorithm.

7. The type of ground truth used:

• Engineering Standards and Design Specifications. The "ground truth" for this submission is established by the requirements outlined in the cited ISO and IEC performance and safety standards, as well as the device's own design specifications. The non-clinical tests verify that the device's performance aligns with these objective, measurable standards.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device; therefore, there is no concept of a "training set."

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

• Not Applicable. See point 8.

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