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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 Electric Wheelchair (JLE-W01A-2023), is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box, charger and anti-tip wheels.

The device is powered by Li-ion Battery pack with 27.5 Km range, which can be recharged by an offboard battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

Anti-tip wheel is a safety device to prevent the wheelchair from turning over when driving on the slope. When the operator needs to use the subject electric wheelchair, he must pull down the anti-tip wheels.

This document is a 510(k) summary for an Electric Wheelchair (JLE-W01A-2023). It describes the device, its intended use, and substantial equivalence to a predicate device (K220747).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Electric Wheelchair are primarily based on compliance with various ISO standards for wheelchairs and related components, as well as biocompatibility and EMC standards. The reported device performance is that the device "meets its design specification" or "meets the requirements" of these standards.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample size used for the test set in the non-clinical tests. It indicates that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and mentions "test records" and "test results" without quantifying the number of devices or components tested.

The data provenance is from China, as the applicant (Zhejiang Jianrui Technology Company Limited) is located in Jinhua City, Zhejiang Province, China, and the tests were conducted to support their 510(k) submission to the FDA. The tests are prospective in nature, as they were conducted on the specific device to demonstrate its performance against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for these types of device performance tests is established by adherence to globally recognized engineering and medical device safety standards (like the ISO 7176 series and ISO 10993 series). The standards themselves define the test methodologies and acceptance criteria. The execution and interpretation of these tests are typically performed by qualified test engineers and technicians at accredited testing laboratories, rather than by medical "experts" in the clinical sense to establish a "ground truth."

4. Adjudication Method for the Test Set

This is not applicable for the type of non-clinical, standards-based testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation studies where expert consensus is needed to establish a definitive diagnosis or assessment for a complicated case. Here, the "adjudication" is implicitly covered by the adherence to the published test methodologies and criteria of the ISO/IEC standards.

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

An MRMC study was not done. This submission is for an Electric Wheelchair, a physical medical device. It does not involve AI or human readers for diagnostic interpretation, so an MRMC comparative effectiveness study is not relevant.

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

This is not applicable. The device is an Electric Wheelchair and does not feature an AI algorithm that would have standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance and safety tests is based on compliance with established international standards (ISO 7176 series, ISO 10993 series, IEC 62133-2). These standards define objective, measurable parameters and acceptable limits for various aspects of the device's function, stability, safety, and biocompatibility.

8. The Sample Size for the Training Set

This is not applicable. The Electric Wheelchair is a physical device and not a machine learning or AI model, so there is no "training set" in the context of data.

9. How the Ground Truth for the Training Set was Established

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

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