(63 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.
This Electric Wheelchair, model: YFWB-63, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped 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 25 Km range, which can be recharged by an offboard 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.
The provided FDA 510(k) clearance letter and summary for the "Electric Wheelchair (YFWB-63)" detail a non-clinical study to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria for an AI/Software as a Medical Device (SaMD).
Therefore, I cannot provide information on acceptance criteria and study details related to AI/SaMD, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details. This document focuses on the mechanical and electrical safety and performance of a physical device (electric wheelchair) as per relevant ISO standards.
However, I can extract the acceptance criteria and reported device performance from the provided document as they pertain to the Electric Wheelchair (YFWB-63) and its comparison to the predicate device.
Acceptance Criteria and Reported Device Performance for Electric Wheelchair (YFWB-63)
The study conducted was a non-clinical test to verify that the proposed device met design specifications and was substantially equivalent (SE) to the predicate device (K220747). The acceptance criteria were primarily based on compliance with various ISO 7176 series standards related to wheelchairs and ISO 10993 series for biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Item / Test (Acceptance Criteria) | Reported Device Performance and Compliance |
|---|---|
| Biocompatibility | All user directly contacting materials are compliant with ISO10993-5 (In Vitro Cytotoxicity), ISO10993-10 (Irritation and Skin Sensitization), and ISO 10993-23 (Irritation) requirements. |
| Electromagnetic Compatibility (EMC) | Conforms to ISO7176-21 (EMC of electrically powered wheelchairs) and IEC 60601-1-2. |
| Safety and Performance (ISO 7176 Series) | |
| ISO 7176-1: Static Stability | Static stability determined, test results meet design specification. |
| ISO 7176-2: Dynamic Stability of Powered Wheelchairs | Dynamic stability determined, test results meet design specification. |
| ISO 7176-3: Effectiveness of Brakes | Effectiveness of brakes determined, test results meet design specification. |
| ISO 7176-4: Energy Consumption & Theoretical Distance Range | Theoretical distance range determined, test results meet design specification. |
| ISO 7176-5: Overall Dimensions, Mass and Manoeuvring Space | Dimensions and mass determined. |
| ISO 7176-6: Maximum Speed, Acceleration and Deceleration | Dimensions and mass determined (likely referring to parameters defined for these tests). Max speed forward: 6.3 ± 0.5km/h. Max speed backward: Less than 3.8 km/h. |
| ISO 7176-7: Measurement of Seating and Wheel Dimensions | Seating and wheel dimensions determined. Front wheel size/type: 8" x 2.2"/ TU75+TPU Solid tire. Rear wheel size/type: 10"x 2"/ PU Solid tire. |
| ISO 7176-8: Static, Impact and Fatigue Strengths | All test results meet the requirements in Clause 4 of ISO 7176-8. |
| ISO 7176-9: Climatic Tests | Device continued to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9. |
| ISO 7176-10: Obstacle-Climbing Ability | Obstacle-climbing ability determined. Maximum obstacle climbing: 15 mm. |
| ISO 7176-11: Test Dummies | Test dummies used in the ISO 7176 series testing meet the requirements of ISO 7176-11. |
| ISO 7176-13: Coefficient of Friction of Test Surfaces | Coefficient of friction of test surfaces determined. |
| ISO 7176-14: Power and Control Systems | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. |
| ISO 7176-15: Information Disclosure, Documentation and Labeling | Information disclosure, documentation, and labeling of the device meet the requirements of ISO 7176-15. |
| ISO 16840-10 (formerly ISO 7176-16): Resistance to Ignition | Performance of resistance to ignition meets the requirements of ISO 16840-10. |
| ISO 7176-19: Wheelchairs for Use as Seats in Motor Vehicles | (Standard listed, compliance implied by "Non-Clinical Test Conclusion"). |
| ISO 7176-25: Lead-acid Batteries and Chargers | Performance of batteries and charger meet the requirements of ISO 7176-25. |
| General Performance Parameters | |
| Braking distance | ≤1.5 m |
| Maximum safe operational incline degree | 6° |
| Max loading weight | 100 kg |
| Maximum distance of travel on fully charged battery | 25 km |
| Turning radius | $1000 \pm 20$ mm |
| Battery type | Li-ion battery pack; rechargeable, 24 VDC 25Ah. |
| Motor type | Brushless DC motor; 24VDC; 250W; 2pcs. |
| Controller type | Brushless dual-drive rocker controller. |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a dataset for software evaluation. Instead, it refers to physical testing of the device itself. The tests were conducted according to various ISO standards. The data provenance would be the test reports generated from these physical tests of the Electric Wheelchair (YFWB-63) device. No information on country of origin of the data or retrospective/prospective status as it pertains to a dataset is applicable here.
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 to the non-clinical testing of a physical medical device like an electric wheelchair. "Ground truth" in this context refers to established engineering standards (like ISO 7176) and directly measured physical performance, not expert consensus on medical images or patient outcomes. The testing would be performed by qualified engineers at a testing facility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically associated with human-in-the-loop medical image review or similar subjective evaluations requiring multiple experts.
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 not an AI/SaMD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD device. No algorithm is being evaluated in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the performance requirements and test methods defined by the referenced International Standards (ISO 7176 series, ISO 10993 series, etc.). The device's physical performance (e.g., speed, stability, braking distance, biocompatibility) was measured and compared against these objective, established standards.
8. The sample size for the training set
Not applicable. This is not an AI/SaMD device. There is no training set for a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD 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).