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 Electric Wheelchair, model: LW01301A07, 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 and charger.

The device is powered by Li-ion Battery pack with 17.6 Km range, which can be recharged by an off-board 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.

This document is an FDA 510(k) clearance letter for an Electric Wheelchair, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and study proving the device meets the criteria in the context of AI/ML performance (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this document.

The acceptance criteria mentioned in this document refer to the device's compliance with established performance standards for electric wheelchairs, such as various ISO 7176 series standards, ISO 10993 series for biocompatibility, and IEC 60601-1-2 for EMC. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted against these standards.

Here's a breakdown of what can be extracted from the provided document, framed as close as possible to your request, but acknowledging the difference in device type:

Device: Electric Wheelchair (LW01301A07)

1. A table of acceptance criteria and the reported device performance

The document doesn't provide specific numerical acceptance criteria alongside reported performance values in a direct table format for all parameters. Instead, it states that the device "complies with" or "meets the requirements of" various ISO standards. Where numerical comparisons are made to the predicate, it highlights differences and then asserts that these differences do not cause new safety concerns because the device still meets the relevant standards.

Here's an attempt to synthesize the information into a table, focusing on the comparisons and the implicit acceptance of compliance with the listed ISO standards:

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

• Sample Size: The document does not specify a numerical sample size for the devices tested. Typically, for non-AI/ML devices undergoing performance testing against standards, a small number of devices (e.g., 1-5 units) are tested, often following specific sampling plans outlined in the test standards themselves.
• Data Provenance: The testing was "non-clinical laboratory data," implying the tests were conducted in a controlled lab environment. The manufacturer is Anhui Longway Medical Technology Co., LTD in China. The data would therefore be prospective, generated specifically for this submission.

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

• This is not applicable to a non-AI/ML device. "Ground truth" in this context is established by the performance standards themselves (e.g., a wheelchair must not tip at a certain angle) and measured by calibrated equipment and documented test procedures, not expert interpretation of outputs.

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

• Not applicable. Adjudication methods are typically relevant for human interpretation tasks in AI/ML studies where there might be inter-reader variability. For engineering performance tests, the results are objectively measured.

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 for an electric wheelchair, not an AI-assisted diagnostic or therapeutic device.

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

• Not applicable. This device is not an algorithm. Its "performance" is its physical function.

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

• The "ground truth" used for this device is compliance with established international engineering standards (ISO 7176 series, ISO 10993 series), electrical safety standards (IEC 60601 series), and FDA regulatory guidance. This is determined through physical testing, measurement, and validation against the specified requirements of these standards.

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML model that requires a training set.

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

• Not applicable. As above, there is no AI/ML model or training set.

Ask a specific question about this device