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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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The Manual Wheelchair is to provide mobility to persons limited to a sitting position.

MW18 manual wheelchair is a mechanical which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a foldable frame, a seat, two footrests and four wheels. The larger rear wheels have push-rims of slightly smaller diameter projecting just beyond the user to manoeuvre the chair by pushing them on without requiring them to grasp the tyres. The manual wheelchairs have brakes that bear on the tyres of there are two push handles at the upper rear of the frame to allow for manual propulsion by a second person, e.g. caregiver. The wheelchair can support users of up to 120kg.

Main Components:

Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, hand rim, crossbar, footrest, skirt guard, brake, anti-tipper (optional)

The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

The provided FDA 510(k) summary is for a Manual Wheelchair (MW18), a Class I, reserved medical device. This type of device does not typically involve AI components or require the complex statistical studies, multi-reader multi-case studies, and expert ground truth establishment that are common for AI/ML-driven diagnostic devices.

Instead, the acceptance criteria for a manual wheelchair primarily focus on functional performance, safety, and compliance with established industry standards. The study proving the device meets these criteria is a series of non-clinical performance tests conducted in accordance with international standards for wheelchairs.

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

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

The document lists the ISO standards that the device complies with, which effectively serve as the acceptance criteria. The "reported device performance" is the statement of compliance with these standards.

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

The document does not specify a "test set" in the context of patient data, as this is a mechanical device. The "test set" refers to the physical units of the Manual Wheelchair (MW18) that were subjected to the non-clinical tests. The document does not explicitly state the number of sample units used for these tests. Data provenance is not applicable in the context of patient data as it's not an AI/ML device.

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

This information is not applicable to this device. "Ground truth" in the context of AI/ML performance is not relevant for a mechanical manual wheelchair. The "truth" is established by the ability of the device to meet the defined performance specifications and safety standards through physical testing.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image interpretation, not for mechanical device testing. Compliance with standards is typically assessed by conformity to predefined pass/fail criteria for each test.

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 is not applicable. An MRMC study is designed for evaluating the performance of diagnostic algorithms, often with human readers in the loop. This device is a manual wheelchair, not a diagnostic AI tool.

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

This is not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device is the compliance with established international performance and safety standards (ISO standards) for manual wheelchairs. This is determined through objective, quantifiable physical tests, rather than expert consensus, pathology, or outcomes data in the way it's understood for diagnostic devices.

8. The sample size for the training set

This is not applicable. There is no "training set" for a mechanical device like a manual wheelchair.

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

This is not applicable. There is no "training set" or "ground truth for a training set" for this type of device.

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