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The Merits Model R series Positioning System for Powered Wheelchair is intended for people using a powered wheelchair and requiring positional change. Its intended function and use is to aid in the pressure relief to persons confined to a powered wheelchair, by way of tilt and reclining seat back.

The R Series Positioning System for Powered Wheelchair is designed for use with power wheelchairs. The R Series Positioning System for Powered Wheelchair use the Merits Model P323 Power Wheelchair as the base unit for the tilting and reclining System. The Positioning System and base unit is to be sold together. Model P323 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 60amp controller. The user interface is a joystick. P323 is powered by two 12 VDC 64ah batteries. The batteries are charged by 5A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 38km (24mi). The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (including motor, gear, brake), batteries and front and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick. The intended function of the R Series Positioning System for Powered Wheelchair is to aid in the pressure relief of persons confined to a wheelchair, by providing a method of tilting the seat and reclining the seat back. The R series Positioning System consists of tilt, recline and shear reduction power seat modules. The tilting and reclining systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline system, or as a separate tilt system or reclining system depending upon the user' needs. The tilting and reclining systems are actuated by 24V DC motorized linear actuator. The tilt system include one motorized linear actuator (Manufacturer: Moteck / Model: FD-24-A4-323) causes the seat frame to shift forward. This enhances stability since the center of gravity is kept substantially in plane while the user is tiliting. The recline system include one motorized linear actuator (Manufacturer: Moteck / Model: FD-24-A4-278) change the position of the backrest with respect to the seat pan. The shear reduction module works with recline function to reduce the shear movement between the user and the backress The reclining system also includes a movable leg rest feature. There two basic models included in the R Series Positioning System. They are Model R153(tilt) and R154(tilt +reclining). The upholstery of the device complies with EN 1021-1/-2:2006: Furniture: Assessment of the ignitability of upholstered furniture: Ignition annuce: Smouldering cigarette/ Match flame equivalent. The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

The provided text describes a 510(k) premarket notification for a medical device, the Merits Model R Series Positioning System for Powered Wheelchair. This submission focuses on establishing substantial equivalence to a predicate device through non-clinical testing, rather than a clinical study evaluating the device's performance against specific clinical acceptance criteria in a human population.

Therefore, many of the requested categories related to clinical study design, such as "sample size used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set details," are not applicable in this context. The information provided pertains to engineering and safety performance testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the number of units tested. This type of non-clinical testing typically involves a limited number of production units or prototypes.
• Data Provenance: The testing was conducted by Merits Health Products Co., LTD. (Taiwan) according to international standards (ISO, IEC, EN). The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance.

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

• This question is not applicable. For non-clinical performance and safety testing against international standards, "ground truth" is not established by clinical experts but by adherence to the specific test methodologies and criteria outlined in each standard. The expertise lies in the engineers and technicians performing and verifying the tests in accordance with these standards.

4. Adjudication method for the test set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or symptoms. For this type of device testing, the results are objectively measured against the quantitative or qualitative pass/fail criteria of each standard.

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 question is not applicable. The device is a powered wheelchair positioning system, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is not relevant.

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

• This question is not applicable. The device is a mechanical and electrical system, not an algorithm, and is designed for human interaction (the user and caregivers).

7. The type of ground truth used

• The "ground truth" in this context is the established performance and safety requirements defined by the international ISO, IEC, and EN standards listed in the document. These standards specify objective test methods and acceptance criteria for various aspects of wheelchair performance, safety, and functionality (e.g., static stability, brake effectiveness, electromagnetic compatibility, material ignitability).

8. The sample size for the training set

• This question is not applicable. The device is not based on machine learning or AI that would require a "training set."

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

• This question is not applicable for the reasons mentioned in point 8.

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