Search Results

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 product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design.The wheelchair can easily fold and unfold for transportation or storage.The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.

The QDWP-A01 uses lithium batteries as its power source, The QDWP-B02 uses lead acid batteries as its power source.The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.

The frame of QDWP-A01 is aluminum,the frame of QDWP-B02 is steel. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.

The motor and brake system are fixed on the rear wheels.

The max loading of the device is 120KG. Only for one person sit.

This document is a 510(k) clearance letter for an electric wheelchair, not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria and study designs for AI/ML devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not available or applicable in this context.

The 510(k) letter focuses on demonstrating substantial equivalence to a predicate device based on:

1. Indications for Use: The current device has the same intended use as the predicate (to provide mobility to disabled or elderly individuals).
2. Technological Characteristics: Comparison of physical and operational specifications (e.g., motor, battery, dimensions, speed, braking).
3. Performance Benchmarking: Validation through adherence to widely accepted international standards for wheelchairs (ISO 7176 series) and biocompatibility (ISO 10993 series), rather than a clinical study comparing human performance with and without AI assistance.

Here's an attempt to structure the available information, acknowledging that many requested fields are not relevant for this type of device clearance:

Device: Electric Wheelchair (QDWP-A01, QDWP-B02)

Study Purpose (Implied from 510(k) clearance): To demonstrate substantial equivalence of the proposed device to legally marketed predicate devices, ensuring it meets established safety and performance standards for powered wheelchairs.

1. Table of Acceptance Criteria and Reported Device Performance

For an electric wheelchair, acceptance criteria are typically compliance with relevant ISO standards and specific performance thresholds based on comparative data with predicate devices. The document highlights "Analysis" remarks for minor differences and states that numerous ISO standards were met.

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

• Test Set Sample Size: Not specified in terms of a "sample size" of individual devices, as this is typically based on testing a representative number of units to demonstrate compliance with standards. Testing would involve a few prototypes/production units.
• Data Provenance: The device manufacturer is Jinhua Qidian Vehicle Co. Ltd. in China. The testing would have been conducted by the manufacturer or accredited testing laboratories, likely in China, to the specified ISO standards. The data is prospective in the sense that it's generated for the clearance submission.

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

• Not applicable. For a physical medical device like an electric wheelchair, "ground truth" is established by direct physical measurements, engineering tests, and adherence to objective performance standards (e.g., braking distance, speed, stability under load). It does not involve expert interpretation of medical images or clinical outcomes that require medical experts to establish a "ground truth."

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, particularly in image interpretation or clinical diagnosis. This device's performance is objectively measured against engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an electric wheelchair, not an AI-assisted diagnostic or therapeutic device. No human-in-the-loop clinical study comparing human performance with and without AI assistance would be conducted for this product.

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

• Not applicable. There is no "algorithm only" performance for an electric wheelchair in the sense of an AI/ML model. The device operates mechanically and electronically, with its "performance" being its ability to move, brake, and maintain stability.

7. The Type of Ground Truth Used

• Engineering Standards and Objective Measurements: The "ground truth" for this device's performance is established by recognized international engineering, safety, and quality standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility). Performance is measured directly against these benchmarks and compared to a predicate device. This includes physical measurements (dimensions, speed), mechanical tests (strength, stability, braking), electrical tests (battery, motor, EMC), and material tests (biocompatibility, flammability).

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML system that requires training data. The "training" for the device would be its design and manufacturing processes.

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

• Not applicable. As above, there is no AI/ML training set for this device. The design specifications and performance objectives are based on engineering principles and regulatory requirements for powered wheelchairs.

Ask a specific question about this device