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The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.

The Model XW-LY001 Electric wheelchair is powered by Li-ion battery, driven by DC motor. Users control direction and adjust speed by controller. It is suitable to be used in low speed, good road condition and small slope. The electric wheelchair consists of two foldable armrests, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The subject device has 8 inch front wheel and 12.5 inch rear wheel. The motor of electric wheelchair is DC24V 200W; the battery is 25.2V 10.4Ah Li-ion battery; the charger is DC 24V, 2A. Max. loading can not be over than 125Kgs, and its maximum speed is 6km/h. The braking time is about 2-3s,and the braking distance is ≤1.5m

The provided FDA 510(k) summary (K200423) for the Electric Wheelchair (XW-LY001) details non-clinical tests to demonstrate substantial equivalence to a predicate device (K170787). This document does not describe a study involving an AI device or a comparative effectiveness study with human readers. Therefore, several aspects of your request related to AI performance, human reader improvement, and ground truth establishment for AI models cannot be addressed from the given text.

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are its compliance with various ISO and IEC standards for wheelchairs and the demonstration of substantial equivalence to a predicate device. The reported device performance is presented as compliance with these standards and a comparison of its characteristics to the predicate device.

The "study that proves the device meets the acceptance criteria" is described as "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." (page 5, "7.0 _Non-Clinical Test Conclusion"). These tests demonstrated compliance with the listed ISO and IEC 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 data or AI model evaluation. The tests conducted were non-clinical performance and safety tests of the physical wheelchair device. The provenance of the data is not applicable in this context as it refers to physical testing results against engineering standards.

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

Not applicable. This is not an AI device or a diagnostic device where expert ground truth would be established for image or data interpretation. The "ground truth" here is the pass/fail criteria defined by the ISO and IEC standards.

4. Adjudication method for the test set

Not applicable, as there is no human adjudication of a test set in the context of this device's non-clinical safety and performance testing.

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 is not an AI-assisted diagnostic or interpretation device. No MRMC study was performed or is relevant to this submission.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for the device's performance is adherence to the specifications and performance metrics outlined in the various international standards (ISO and IEC) for wheelchairs and medical devices. These standards define the acceptable range or criteria for parameters like static stability, dynamic stability, braking effectiveness, energy consumption, dimensions, maximum speed, strength, climatic performance, obstacle climbing, power/control systems, electromagnetic compatibility, battery safety, and biocompatibility.

8. The sample size for the training set

Not applicable, as this is not an AI device that requires a training set.

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

Not applicable, as this is not an AI device that requires a training set or ground truth establishment for AI models.

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