Search Results

The Y207 Electric Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. This product is suitabled people with mobility difficulties and elderly people people.

This electric wheelchair is a motor driven, indoor and outdoor transportation vehicle, which is a device for assisting elderly and disabled people to be mobile. It is suitable for disabled people with mobility difficulties and elderly people.

The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, battery box, controller and charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back upholstery.

The device is powered by Li-ion Battery pack (24V 20Ah, 480Wh) with 20 Km (12.5 miles) 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 intelligent electromagnetic brake system starts to work. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

The provided document is a 510(k) Pre-market Notification for a medical device (Y207 Electric Wheelchair). It details a comparison between the subject device and a predicate device (PL00I power wheelchair). However, it does not contain information about a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance study with defined acceptance criteria for metrics like sensitivity, specificity, accuracy, etc. that would be applicable to an AI/ML powered device.

Instead, the provided text describes the device's adherence to various international standards for wheelchairs (ISO, IEC) and biocompatibility standards, and validates substantial equivalence to a predicate device.

Therefore, the following points address the questions based on the information available in the document, acknowledging that typical "acceptance criteria" and "study" as implied by the prompt (which often refers to AI/ML device performance) are not directly applicable here for this type of device submission.

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

The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, etc.) for the overall device. Instead, it refers to compliance with numerous international standards for electric wheelchairs and biocompatibility. The reported "performance" is the device's compliance with these standards, ensuring it functions safely and effectively as a powered wheelchair.

Here's a summary of the standards cited for compliance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical (bench) testing against international performance standards for wheelchairs. There is no "test set" in the context of patient data or algorithm performance. The testing would involve physical units of the device.

• Sample size: Not specified, but typically this would involve a limited number of physical devices (e.g., one or more production units) undergoing the tests outlined in each standard.
• Data provenance: Not explicitly stated, but the testing would have been conducted by the manufacturer (Jiangsu Intco Medical Products Co., Ltd.) or a contracted testing facility in China, as the manufacturer is based in China. The testing is prospective in the sense that the device was specifically manufactured and then subjected to these standard tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The approval is for a physical medical device (electric wheelchair), not an AI/ML algorithm that requires expert ground truth labeling. Compliance with engineering and safety standards is assessed through objective measurements and validated test procedures defined within those standards.

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

This question is not applicable. There is no "adjudication method" in the context of expert review for a physical device's compliance with engineering and safety standards. The results of the tests are objective measurements against specified thresholds in the 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

This question is not applicable. The device is an electric wheelchair, not an AI/ML diagnostic or assistive tool for human readers.

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

This question is not applicable. The device is an electric wheelchair, not an algorithm. Its "standalone performance" refers to its ability to meet the physical and electrical safety standards as designed.

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

The "ground truth" used for this device approval is the adherence to established international engineering, safety, electrical, and biocompatibility standards (e.g., ISO 7176 series, IEC 60601 series, ISO 10993 series). Success is determined by meeting the specified thresholds and methodologies within these recognized standards.

8. The sample size for the training set

This question is not applicable. There is no "training set" for physical medical devices like an electric wheelchair. The design and manufacturing process involves engineering principles and material selection rather than machine learning training.

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

This question is not applicable for the reasons stated above.

Ask a specific question about this device