(57 days)
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.
The subject device, Electric Wheelchair, mainly powered by DC motor, driven by user controlling joystick controller and adjusting speed. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Rear wheels.
The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the loystick can control the wheelchair to travel in any direction, the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electic Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.
The Electric Wheelchair has 7 inch front wheels and 12 inch rear tires.
Max. distance of travel on the fully charged battery is 15 km and Max. speed forward is 6.5 km/h.
When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate to lock the motor, so as to brake.
This is a 510(k) summary for an Electric wheelchair (KR-8807), not an AI/ML powered device. As such, the requested information regarding AI/ML specific acceptance criteria, study methodologies, and ground truth establishment is not applicable to this document. The document describes the device's adherence to various engineering and safety standards for wheelchairs.
However, I can extract and present the information available in the document regarding the device's performance based on the provided engineering standards:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Electric wheelchair (KR-8807) are primarily defined by adherence and successful testing against a comprehensive set of ISO 7176 series standards, as well as ISO 16840-10 and ISO 10993 series for biocompatibility. The reported performance confirms compliance with these standards.
| Acceptance Criteria (Measured by Adherence to Standards) | Reported Device Performance (Compliance Status) |
|---|---|
| ISO 7176-1: 2014: Determination of static stability | Complies |
| ISO 7176-2: 2017: Determination of dynamic stability | Complies |
| ISO 7176-3: 2012: Determination of effectiveness of brakes | Complies |
| ISO 7176-4: 2008: Energy consumption / theoretical distance range | Complies (Max. distance of travel on fully charged battery is 15 km) |
| ISO 7176-5: 2008: Determination of overall dimensions, mass, maneuvering space | Complies |
| ISO 7176-6: 2018: Determination of maximum speed, acceleration | Complies (Max. speed forward is 6.5 km/h) |
| ISO 7176-7: Measurement of seating and wheel dimensions | Complies |
| ISO 7176-8: 2014: Requirements and test methods for static, impact and fatigue strengths | Complies |
| ISO 7176-9: 2009: Climatic tests | Complies |
| ISO 7176-10: 2008: Determination of obstacle-climbing ability | Complies |
| ISO 7176-11: 2012: Test dummies | Complies |
| ISO 7176-13: 1989: Determination of coefficient of friction of test surfaces | Complies |
| ISO 7176-14: 2008: Power and control systems for electrically powered wheelchairs | Complies |
| ISO 7176-15: 1996: Requirements for information disclosure, documentation and labeling | Complies |
| ISO 16840-10: 2021: Resistance to ignition of postural support devices | Complies |
| ISO 7176-19: 2022: Wheelchairs for use as seats in motor vehicles | Complies |
| ISO 7176-21: 2009: Requirements and test methods for electromagnetic compatibility | Complies |
| ISO 7176-25: 2022: Lead-acid batteries and chargers for powered wheelchairs | Complies |
| ISO 10993 series standards: Biocompatibility | Complies (Differences in materials in contact with user do not impact safety/effectiveness) |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of clinical studies for a human-in-the-loop or AI/ML evaluation. The evidence for compliance comes from non-clinical tests performed on the device itself (likely a prototype or production sample) to verify it meets the specifications outlined in the various ISO standards. The data provenance is implied to be from laboratory testing against established engineering standards. There is no information on the country of origin of this testing data beyond the applicant's location in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for this device's performance is established by engineering standards and their associated test methodologies, not by expert consensus in an AI/ML context. The tests are designed to objectively measure physical and electrical properties of the wheelchair against predefined limits or characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert interpretation is involved. For engineering specifications tested against ISO standards, the results are typically quantitative measurements that either meet or fail the specified criteria.
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 document describes an electric wheelchair, which is a physical device, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable for the reasons stated above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" is defined by international engineering and safety standards (ISO 7176 series, ISO 16840-10, ISO 10993 series). The device's performance is compared against the requirements and test methods stipulated within these standards.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/ML device.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).