Search Results

The Electric 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 Electric wheelchair, YE200, is a powered wheelchair that is designed to fold when not in use so it can be more easily transported in a car trunk or similar space. It uses rechargeable lithium batteries, and is controlled by a joystick and a few other simple controls which are located on the end of the armrest. The joystick assembly may be installed on either side of the chair to accommodate both right-handed and left-handed users. The Electric wheelchair consists of two armrests, a back rest, a seat cushion, a foldable frame, two rear drive wheels with hub motor and electromagnetic brake assemblies, two pivoting casters, two Li-ion battery pack, an off-board battery charger, a control panel (joystick) with connect cables and an electric motor controller. The device is powered by Li-ion battery pack, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet when the device is not in use. The user 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.

The provided text is a 510(k) summary for an electric wheelchair (Model YE200). It details the device, its intended use, a comparison to a predicate device, and a summary of non-clinical testing performed to demonstrate substantial equivalence.

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

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

The document does not present a formal "acceptance criteria" table with specific pass/fail values. Instead, it provides a comparison table between the subject device (YE200) and the predicate device (DC01), highlighting similarities and differences. The "Discussion/Conclusion" column in this table serves as the performance assessment against the predicate. The underlying "acceptance criteria" appear to be the successful execution and passing of specific ISO standards relevant to electric wheelchairs.

Here's a re-imagined table focusing on key performance attributes where differences exist, and the stated conclusion regarding compliance with standards. It's important to note that the document states "all passed" or "will not affect safety/performance," implying that the measured performance met the unseen criteria of the referenced standards.

Study Proving Device Meets Acceptance Criteria:

The study to prove the device meets the acceptance criteria is primarily a non-clinical performance evaluation through testing against recognized international standards (ISO and IEC), and a comparison to a legally marketed predicate device.

2. Sample sized used for the test set and the data provenance:

• Sample Size: The document does not specify a numerical "sample size" in terms of number of devices tested. It refers to "the subject device" (singular), implying that at least one physical unit of the YE200 electric wheelchair was subjected to the various performance, strength, climatic, and EMC tests. For biocompatibility, individual material samples would have been tested.
• Data Provenance: The document does not explicitly state the country of origin of the data collection or whether it was retrospective or prospective. However, given that Shenzhen Yattll Industry Co., Ltd is based in China and the submission is to the FDA, it is highly likely that the testing was performed by a certified lab, possibly in China or a mutually recognized testing facility. Since it's for a 510(k) submission for a new device model, the testing data would be prospective relative to the submission date, generated specifically for this application.

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

This information is not applicable in the context of this 510(k) summary. The "ground truth" for an electric wheelchair's performance is established by objective, measurable outputs against defined engineering and safety standards (e.g., maximum speed, braking distance, stability angles, EMC limits, biocompatibility results), not by expert consensus or interpretation of complex medical images. The testing labs would have qualified technicians and engineers performing these measurements according to ISO/IEC protocols.

4. Adjudication method for the test set:

This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in medical imaging studies where there's subjective interpretation by multiple readers/experts that needs to be reconciled to establish a "ground truth" for diagnosis. For engineering performance tests like those for an electric wheelchair, the tests yield objective, quantifiable results, not subjective interpretations requiring adjudication.

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 is not applicable. This document is for an electric wheelchair, which is a physical mobility device, not an AI-powered diagnostic or assistive tool for human readers/clinicians interpreting data. Therefore, an MRMC study is not relevant to demonstrating its safety and effectiveness.

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

This is not applicable. This device is an electric wheelchair, which does not have an AI algorithm that functions in a standalone capacity. It is a user-controlled device with embedded electronic controls. While software validation was performed, it's for the control system of the wheelchair, not for an AI algorithm for diagnostic purposes.

7. The type of ground truth used:

The "ground truth" for the performance of the electric wheelchair is objective, measurable performance criteria defined by internationally recognized standards (ISO 7176 series, ISO 10993 series, IEC 60601-1-2) and engineering specifications. For example:

• Static stability: Measured in degrees.
• Braking distance: Measured in meters.
• EMC: Measured against specific radiated/conducted emission and immunity limits.
• Biocompatibility: Results of specific biological tests (cytotoxicity, sensitization, irritation) against defined pass/fail criteria.
• Strength/Fatigue: Ability to withstand specified forces for a given number of cycles.

The predicate device's performance also serves as a crucial point of comparison, establishing substantial equivalence rather than a medical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a "training set" of data. The device's functionality is based on established engineering principles and pre-programmed controls, not learned patterns from data.

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

This is not applicable as there is no "training set" for this type of device.

Ask a specific question about this device