(90 days)
The Power 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.
This Power wheelchair, W5538, is a motor driven, indoor 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 and drive devices, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.
The device is powered by a Li-ion Battery pack (24V 12Ah, 288Wh) with 15 Km (9.3 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 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 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.
Here's a breakdown of the acceptance criteria and study information for the Power Wheelchair (W5538), based on the provided text:
Important Note: This device is a power wheelchair, a physical product, not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test/training set, training set sample size, how ground truth for training set was established) are not applicable to this type of medical device submission. The submission focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized performance standards and comparative analysis of physical and technical specifications.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (W5538) | Discussion/Conclusion (relative to Predicate Device W5521) |
|---|---|---|
| General | ||
| Manufacturer | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | Same |
| Device classification | Class II | Same |
| Regulation name | Powered Wheelchair (21 CFR 890.3860) | Same |
| Product code | ITI | Same |
| Indication for use | Mobility to disabled/elderly person limited to a seated position (indoor & outdoor) | Same |
| Intended user | Disabled people with mobility difficulties and elderly people | Same |
| Use condition | Indoor and outdoor use | Same |
| Number of wheels | 6 (two front, two rear, two anti-tip) | Same |
| Function of wheels | Front: driven; Rear: driving; Anti-tip: preventing tipping | Same |
| Movement control method | By Joystick control | Same |
| Driving system | Direct drive on rear wheels | Same |
| Brake system | Automatic electromagnetic brake system | Same |
| Back cushion material | Polyester fabric | Same |
| Seat cushion material | Rubber patch cloth and Oxford fabric | Same |
| Armrest material | Polyurethane (PU) | Same |
| Specific Performance/Design | ||
| Main frame material | Magnesium alloy material | Different material, but performance tests (ISO 7176 series) confirm safety/effectiveness. |
| Total mass | 19 kg | Different weight due to frame material, no new safety/effectiveness concerns. |
| Overall Dimension (LWH) | 1030mm X 605mm X 940mm | Minor difference, validated with max rated weight dummy. |
| Stowage Dimension (LWH) | 360mm X 605mm X 790mm | Minor difference, validated with max rated weight dummy. |
| Front wheel size/type | 6.8" x 1.3" / PU Solid tire | Minor difference, no impact on performance. |
| Rear wheel size/type | 10.5" x 1.4" / PU Solid tire | Minor difference, no impact on performance. |
| Max speed forward | Up to 6.1 km/h (1.7 m/s), adjustable | Minor difference, validated with max rated weight dummy. |
| Max Speed backward | Less than 3 km/h (0.6 m/s) | Minor difference, no impact on performance. |
| Maximum safe operational incline degree | 10° | Minor difference, evaluated per ISO 7176 series for static/dynamic stability. |
| Braking distance | ≤1.2 m | Minor difference, no impact on performance. |
| Battery | Li-ion battery pack; rechargeable, 24 VDC 12Ah | Minor difference in capacity, no new safety/effectiveness concerns. |
| Battery charger | Off-board charger Input: 100-240V, 50/60Hz, 1.1A, Output: 24 Vdc, 2A | Minor difference in input current, no new safety/effectiveness concerns. |
| Max loading weight | 120 kg | Minor difference, validated per ISO 7176 series. |
| Maximum distance of travel on fully charged battery | 15 km | Minor difference, no new safety/effectiveness concerns. |
| Motor | Brushless DC motor; 24VDC; 250W; 2pcs | Minor difference in power, evaluated per ISO 7176-14, no new safety/effectiveness concerns. |
| Electronic controller | DZWN2435-BWL Controller | Similar to predicate, control system, joystick, brakes, user interface etc. evaluated per ISO 7176-14 and software validation. No new safety/effectiveness concerns. |
| Turning Radius | 900 mm | Minor difference due to size, may cause minor inconvenience but no new safety/effectiveness concerns. |
| Maximum obstacle climbing | 25 mm | Minor difference, no impact on safety/effectiveness. |
Study Details
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Sample size used for the test set and the data provenance:
- This information is not directly applicable to a physical power wheelchair submission based on recognized standards. The "test set" here refers to the physical device itself being subjected to various ISO standard tests. The ISO standards specify test methodologies, but typically do not define a "sample size" in the context of clinical trials or data-driven AI systems.
- The provenance is that the tests were conducted by the manufacturer (or a testing lab on their behalf) to demonstrate compliance with the specified ISO standards for the Power Wheelchair (W5538).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A). This is a hardware device. "Ground truth" in this context would refer to the physical and functional parameters of the wheelchair, which are measured and compared against established engineering standards (ISO 7176 series). There are no "experts" establishing a diagnostic "ground truth" as there would be for an AI-driven diagnostic tool.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert-labeled datasets, typically for AI/software evaluations. In hardware testing, the device's performance is measured against objective, quantifiable criteria defined by the ISO standards. There is no subjective interpretation requiring adjudication.
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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:
- No. This is a power wheelchair, a physical mobility device. An MRMC study is designed for evaluating the impact of AI assistance on human diagnostic performance (e.g., radiologists reading images). It is not relevant to this device.
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- N/A. This is not an algorithm or AI system. It's a complete physical device (power wheelchair). However, the "standalone performance" could be viewed as the wheelchair's ability to perform safely and effectively on its own (e.g., maintaining stability, braking distance) when operated by a user, which is what the ISO standards verify.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- International Standards and Engineering Specifications. The "ground truth" for this device's performance is established by widely recognized international standards for wheelchairs (ISO 7176 series) and general medical device standards (ISO 14971 for risk management, IEC 60601-1-2 for electromagnetic compatibility, ISO 10993 series for biocompatibility). These standards define acceptable performance ranges and test methodologies.
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The sample size for the training set:
- N/A. This refers to machine learning models. For a physical device, there is no "training set."
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How the ground truth for the training set was established:
- N/A. As there is no training set for a physical device, this question is not applicable.
§ 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).