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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 proposed device, Electrically Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.

The Electrically Powered Wheelchair consists of two foldable armrests, a backrest, a cushion, a foldable frame, two rear driving wheels with hub seat 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 electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.

Folding design: This foldable electric wheelchair has main frame, rear frame, backrest frame, seat frame, front wheel frame and battery frame. Release the locking device of the backrest frame and the rear frame, push the backrest frame downward, drive the seat frame to rotate toward the backrest frame with the rotating mechanism, the two armrest frames rotate towards the direction of the seat frame. At the same time two front wheel frames move to the direction of the seat frame. When the back cushion is in contact with the seat cushion, the folding is completed.

Joystick: This controls the speed and direction of the wheelchair. Push the joystick in the direction you wish to go. The further you push it, the faster the speed. Releasing the joystick stops the wheelchair and automatically applies the brakes.

Controller: The controller includes a power switch, a speed adjustment button, a horn button and a direction joystick. The operation interface controller receives the operation signal and transmits it to the main board of the controller body, and sends a control signal to the electric wheelchair to adjust and operate the electric wheelchair.

Wheel and frame connection method: First, the left and right frames are connected to the motor respectively, and then the motor shaft is connected to the wheel. The motor rotates to drive the wheels to rotate to drive the wheelchair.

Frame design: 1. The frame tube of this product is mostly is aluminum tube.

2. The operation mode of the folding mechanism is to remove the locking device by someone else and manually push the backrest frame to complete the folding operation under non-riding state.

The subject device has 6 inch front wheel and 10 inch rear tire.

The motor of electric wheelchair is DC24V 120W; the battery is 25.2V 10.4AH, Li-ion battery; the charger is 24V/2A.

Max. loading can not be over than 120Kgs.

The following surfaces are re commended NOT to operate on:

Sand surface

Wet or icy surface

Road maintenance hole metal cover

Do not use on stairs Do not use escalators. Use the elevator. Too steep incline over 6 degrees. Obstacle climbing ability: 1.97" Do not use outdoors

This document is a 510(k) Premarket Notification for an Electrically Powered Wheelchair (Model: HP458E). It focuses on demonstrating substantial equivalence to a predicate device (Powered Wheelchair DYW30A(D09), K170787) rather than providing detailed acceptance criteria and a study proving device performance in the context of an AI/ML-driven medical device.

Therefore, the requested information regarding acceptance criteria, sample sizes for test and training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document, as it pertains to a different type of medical device submission (electrically powered wheelchair) and does not involve AI/ML.

The document primarily relies on non-clinical testing against established ISO standards for wheelchairs and a comparison of technological characteristics to assert substantial equivalence.

However, I can extract information related to the device's technical specifications and the standards it meets, which serve as its "acceptance criteria" in the context of mechanical and electrical performance.

Here's an interpretation based on the provided document, assuming "acceptance criteria" generally refers to the performance specifications and safety standards the device is required to meet:

1. Table of Acceptance Criteria and Reported Device Performance

For an electrically powered wheelchair, "acceptance criteria" are defined by compliance with relevant international standards and performance specifications that demonstrate safety and effectiveness. The reported device performance is demonstrated through testing against these standards and by comparing its technical specifications to a predicate device.

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

• Test Set: Not applicable in the biological/imaging data sense, as this is a mechanical/electrical device. The "test set" here refers to the actual physical device model (HP458E) that underwent non-clinical performance and safety testing.
• Data Provenance: The tests were conducted according to international standards (ISO, IEC). The document does not specify the country of origin for the testing data or whether it was retrospective or prospective, beyond stating "non clinical tests were conducted to verify that the proposed device met all design specifications."

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/ML device relying on expert interpretation for ground truth. Ground truth for a wheelchair's performance is established by objective measurements and standardized testing procedures (e.g., measuring speed, stability angles, braking distance according to ISO standards).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No human interpretation 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 is not an AI-assisted diagnostic device.

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device's performance and safety is defined by international consensus standards (ISO, IEC) that specify test methods and acceptable performance limits for wheelchairs. This includes objective measurements of physical properties (e.g., dimensions, weight), dynamic performance (speed, braking, climbing), stability, and material properties (biocompatibility, flame retardancy).

8. The sample size for the training set

• 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

• Not applicable.

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