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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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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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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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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: R-100) 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 rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a rechargeable 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.

The provided document is a 510(k) premarket notification from the FDA for a scooter (motorized three-wheeled vehicle). It is not an AI/ML medical device submission. Therefore, the information required to address the acceptance criteria for an AI/ML device, such as acceptance criteria in terms of performance metrics (sensitivity, specificity, AUC), sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies, is not present in this document.

The document discusses the regulatory process for clearing a non-AI medical device and demonstrates its substantial equivalence to a predicate device based on non-clinical performance testing against established international standards for wheelchairs and scooters.

Here's a breakdown of why I cannot fulfill the request with the provided text:

• Device Type: The device is a "Scooter, Model: R-100," a motor-driven transportation vehicle, not an AI/ML-driven diagnostic or analytical tool.
• Study Type: The "study" refers to non-clinical performance tests conducted to verify compliance with standards and demonstrate substantial equivalence to a predicate device. There is no mention of clinical studies, AI algorithm performance evaluation, or human reader studies.
• Acceptance Criteria for AI: The concept of sensitivity, specificity, AUC, or other AI performance metrics, as well as the methodology for evaluating AI (e.g., test/training sets, ground truth, expert adjudication, MRMC) are completely absent because they are irrelevant to this type of device.
• Ground Truth: The "ground truth" for a physical device like a scooter is its physical performance and safety characteristics as measured against engineering standards (e.g., static stability, dynamic stability, brake effectiveness, speed, range, weight capacity). It's not a diagnostic "truth" established by experts.
• Sample Size: "Sample size" in this context would likely refer to the number of scooters tested, not data samples for an AI algorithm. This information is not explicitly provided, only that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

To reiterate, the document contains no information that would allow me to populate the requested table or answer the questions related to AI/ML device acceptance criteria and study methodology.

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

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a motorized three-wheeled vehicle (Scooter Mars Series, Model TL-588). It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The letter explicitly states that the device is a "Motorized three-wheeled vehicle" and is regulated under "890.3800," which corresponds to "Motorized three-wheeled vehicle" in the FDA's classification database. This is a physical device, not a software-based AI/ML device.

Therefore, I cannot provide the requested information. The concepts of acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and standalone performance are relevant to AI/ML device evaluations, not to the traditional medical device approval process for a motorized scooter described in this document.

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