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The power 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 power wheelchair, model name:D26, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.

The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.

The power wheelchair, model name: D26, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.

The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.

This document is a 510(k) clearance letter for a Power Wheelchair (D26), not a software or AI-enabled medical device. Therefore, the provided information does not contain the details typically sought in an acceptance criteria and study report for AI/ML devices.

The 510(k) process for a physical device like a power wheelchair focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through engineering and performance testing against recognized standards, rather than clinical studies with human subjects in the same way an AI-driven diagnostic tool would be evaluated.

Here's why the AI/ML-specific questions cannot be answered from this document:

• No AI/ML Component: The device description clearly indicates it's a "motor driven, indoor and outdoor transportation vehicle" with components like motors, brakes, joystick control, and Bluetooth remote control. There is no mention of artificial intelligence, machine learning, or algorithms that perform diagnostic or interpretative functions.
• Performance Evaluation Type: The "study that proves the device meets the acceptance criteria" in this context refers to various engineering and safety tests outlined in the ISO 7176 series and IEC 60601-1-2 standards (e.g., static ability, dynamic stability, brake performance, biocompatibility, EMC). These are objective, quantitative tests of the device's physical properties and functionality.

Therefore, it is not possible to fill out the table and answer the questions about AI/ML device performance, ground truth, expert adjudication, or MRMC studies based on the provided FDA 510(k) document.

This document demonstrates substantial equivalence for a physical medical device by comparing its technical specifications and performance against international standards for wheelchairs.

However, if you're looking for an example of how a 510(k) for a non-AI/ML device does define acceptance criteria and demonstrates compliance, here's an interpretation based on the provided text:

Acceptance Criteria and Study for Power Wheelchair (D26)

The device, a Power Wheelchair (D26), is primarily evaluated based on its adherence to established international standards for wheelchairs and its substantial equivalence to a predicate device (K242448, Power Wheelchair, D26 from the same manufacturer). The "acceptance criteria" are derived from these standards and the comparative analysis with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of an "AI/ML test set." For a physical device, the "test set" refers to the specific physical unit(s) of the Power Wheelchair D26 that underwent engineering and performance testing. The document implies a sufficient number of units were tested to demonstrate compliance with the referenced ISO standards. The exact number of units tested is not specified in the public 510(k) summary, but typically, testing would be performed on representative production units.
• Data Provenance: The testing was conducted by Anhui JBH Medical Apparatus Co., Ltd. (manufacturer) in China, as indicated by the company's address. The data is prospective in the sense that it's generated specifically for this premarket notification as part of device design verification and validation.

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

• Not Applicable. For a physical device like a power wheelchair, "ground truth" is established by objective engineering measurements against defined performance specifications in international standards (e.g., maximum speed, braking distance, incline stability). These are not subjective interpretations requiring human experts for "ground truth" establishment in the way medical image analysis or clinical diagnosis would. The compliance is evaluated by qualified test engineers and regulatory professionals against the standard requirements.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication" necessary as the tests are objective, quantitative measurements against predefined criteria in the relevant standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is specifically relevant for AI/ML diagnostic or interpretive devices where human reader performance (e.g., radiologists, pathologists) is being compared with and without AI assistance. This is a physical, mobility device, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. There is no standalone algorithm being evaluated. The device functions as a complete physical system controlled by a human user with a joystick or remote.

7. The Type of Ground Truth Used

• Objective Engineering Specifications and International Standards: The "ground truth" for the device's performance is defined by the objective, measurable parameters and performance requirements outlined in the cited ISO 7176 series standards, IEC 60601-1-2, and biocompatibility standards (ISO 10993 series). For example, the braking distance being less than 1m or the maximum incline being 8 degrees are the "ground truth" metrics.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device. There is no AI/ML model or "training set" in the context of machine learning. The device's design and manufacturing process are based on established engineering principles and prior experience, not data-driven AI training.

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

• Not Applicable. As there is no AI/ML training set, this question is not relevant. The "ground truth" for the device's design and manufacturing are the universally accepted principles of mechanical, electrical, and materials engineering, combined with industry best practices and regulatory standards for safety and performance.

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