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This Electric Wheelchair 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 product is intended only carry one person and used as a means of transportation for the old and infirm who have difficulty in moving.

The maximum occupant mass is 100kg.

The Electric Wheelchair is a battery powered four wheeled vehicle. It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, Battery charger socket), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices.

The wheelchair can easily fold and unfold for transportation or storage.

The provided text describes the FDA 510(k) clearance for an Electric Wheelchair. However, it does not include information about acceptance criteria for a device performance study in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or accuracy.

Instead, the "acceptance criteria" for this device are demonstrated through adherence to a comprehensive set of international standards for wheelchairs. The study that proves the device meets these criteria is a series of non-clinical tests conducted against these standards.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Electric Wheelchair are largely defined by compliance with a comprehensive set of ISO and IEC standards related to wheelchairs. The reported device performance is demonstrated by its successful adherence to these standards.

Study Details:

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

   • The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." This typically implies testing of a representative sample of the manufactured device models. Specific numbers for each test (e.g., how many units were tested for static stability) are not provided.
   • Data provenance: The tests were performed by the manufacturer, Ningbo Baichen Medical Devices Co., Ltd., which is located in China. The data would be considered retrospective in the sense that the testing was completed prior to the 510(k) submission, but it's prospective in relation to the design validation process.

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

   • This question is not applicable in the context of this device and study type. The "ground truth" for non-clinical performance (e.g., static stability, brake effectiveness) is defined by the technical specifications and limits set forth in the international standards (ISO, IEC). The testing involves objective measurements rather than expert interpretation of data like in an image-based diagnostic study.

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations (e.g., 2+1 means 2 out of 3 experts agree, 3+1 means 3 out of 4 agree, with a fourth to resolve ties). Since these are objective physical performance tests against established numerical standards, there is no expert adjudication process. The results are either within the standard's limits or they are not.

4. 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. This is an Electric Wheelchair, a physical medical device, not an AI software intended for interpretation by human readers. Therefore, an MRMC study is not relevant.

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

   • This is not applicable. This is a physical medical device. While it contains an "Electronic controller" (SYC-PM30), the performance described (e.g., speeds, stability, braking) is a property of the integrated physical device, not a standalone algorithm. Software validation was performed for the control system, as mentioned under the difference D#11, but this is part of the overall device's non-clinical testing, not a standalone algorithm performance study in the context of diagnostic AI.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is established by international consensus standards (ISO and IEC). These standards define the acceptable performance parameters and test methods for electric wheelchairs to ensure their safety and effectiveness.

7. The sample size for the training set:

   • This question is not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms for this type of device. The design and validation are based on engineering principles and compliance with established standards.

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

   • This question is not applicable, as there is no training set for this device.

In summary, the provided document details a non-clinical performance study demonstrating substantial equivalence through rigorous adherence to internationally recognized safety and performance standards for electric wheelchairs. The specific metrics are defined by these standards, and the device's performance met these criteria through objective physical testing.

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