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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: FDB01) 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, 2 rechargeable Lithium-Ion 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 Scooter only can be operated on the flat road.

The provided document describes a 510(k) premarket notification for a Scooter (Model: FDB01). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than efficacy or clinical performance in terms of disease detection or diagnostic accuracy. Therefore, many of the typical acceptance criteria and study elements associated with AI/ML-driven diagnostics will not be present.

Based on the information provided, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are compliance with various international standards for wheelchairs and scooters, and the "reported device performance" is the statement that the device meets these standards. The device is not an AI/ML diagnostic and therefore does not have acceptance criteria in terms of sensitivity, specificity, or similar metrics.

Study Information:

The study described is a non-clinical test program designed to demonstrate that the Scooter (Model: FDB01) meets established performance and safety standards, and is substantially equivalent to predicate devices. There are no clinical studies mentioned in this submission.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as "sample size" in the context of patients or cases, as this is a non-clinical device performance study. The testing refers to one Scooter (Model: FDB01) being subjected to various tests.
• Data Provenance: The tests were conducted to verify compliance with international standards (ISO series). The manufacturer is Nanjing Jin Bai He Medical Apparatus Co., Ltd, located in China. The testing itself is non-clinical, implying laboratory or controlled environment testing of the device specimen(s).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Experts: Not applicable. For non-clinical device performance testing against established standards, "ground truth" is determined by whether the device's physical and functional properties meet the numerical or qualitative requirements of the standard, as measured by calibrated equipment and documented test protocols. This isn't based on expert judgment in the way a diagnostic imaging study would be.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Device performance against ISO standards is typically assessed via objective measurements and adherence to specified test procedures, not through expert adjudication in the traditional sense of consensus reading or arbitration.

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:

• MRMC Study: No. This is a non-clinical submission for a medical device (scooter), not an AI/ML diagnostic or imaging device used by human readers for interpretation.

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

• Standalone Performance: Not applicable. This device is a motorized scooter, not a standalone AI algorithm. It is a physical device operated by a human user.

7. The Type of Ground Truth Used:

• Ground Truth: The "ground truth" for this device's performance is defined by the requirements and test methods outlined in the cited ISO 7176 series standards and ISO 10993 series standards. These standards specify how to measure various performance characteristics (e.g., static stability, brake effectiveness, dimensions, EMC) and the acceptable limits or conditions for those characteristics. The tests verify that the device's measured performance falls within these specified "ground truth" parameters.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Training Set Ground Truth: Not applicable. This is not an AI/ML device.

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