(168 days)
The Power Wheelchair, W5521, 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 Power wheelchair, W5521, 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 10Ah, 240Wh) with 10 Km (6.2 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 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) summary for the Power Wheelchair, W5521 (K231508) focuses on demonstrating "substantial equivalence" to a predicate device (Power Wheelchair, N5515B, K220747) through non-clinical testing. It does not involve AI/ML components or clinical effectiveness studies in the typical sense of a comparative effectiveness study with human readers for image-based diagnostics.
Therefore, many of the requested elements pertaining to AI/ML device performance (like acceptance criteria for accuracy, recall, F1-score, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance, etc.) are not applicable to this specific device submission.
The "acceptance criteria" in this context refer to compliance with various ISO and IEC standards for wheelchairs, which are physical and electrical performance benchmarks, not AI model metrics.
Here's a breakdown of the information provided in relation to your questions, noting where information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are the successful compliance with the listed ISO and IEC standards. The "performance" is stated as meeting these standards.
| Acceptance Criteria (Relevant Standards) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7176-1:2014 (Static stability) | Complied with requirements |
| ISO 7176-2:2017 (Dynamic stability of electric wheelchairs) | Complied with requirements |
| ISO 7176-3:2012 (Effectiveness of brakes) | Complied with requirements |
| ISO 7176-4:2008 (Energy consumption for theoretical distance range) | Complied with requirements |
| ISO 7176-5:2008 (Dimensions, mass, maneuvering space) | Complied with requirements |
| ISO 7176-6:2018 (Max speed, acceleration, deceleration) | Complied with requirements |
| ISO 7176-7:1998 (Seating and wheel dimensions) | Complied with requirements |
| ISO 7176-8:2014 (Static, impact, fatigue strength) | Complied with requirements |
| ISO 7176-9:2009 (Climatic tests) | Complied with requirements |
| ISO 7176-10:2008 (Obstacle-climbing ability) | Complied with requirements |
| ISO 7176-11:2012 (Test dummies) | Complied with requirements |
| ISO 7176-13:1989 (Coefficient of friction of test surfaces) | Complied with requirements |
| ISO 7176-14:2008 (Power and control systems) | Complied with requirements; Software validated |
| ISO 7176-15:1996 (Information disclosure, documentation, labeling) | Complied with requirements |
| ISO 16840-10:2021 (Resistance to ignition of postural support devices) | Complied with requirements |
| ISO 7176-21:2009 (Electromagnetic compatibility) | Complied with requirements |
| ISO 7176-22:2014 (Set-up procedures) | Complied with requirements |
| ISO 7176-25:2013 (Batteries and chargers) | Complied with requirements |
| IEC 60601-1-2:2014 (Electromagnetic Compatibility Testing) | Complied with requirements |
| AIM 7351731 (Electromagnetic Immunity Test) | Complied with requirements |
| ISO 10993-5:2009 & ISO 10993-10:2010 (Biocompatibility) | Complied via identical materials to predicate |
2. Sample Size Used for the Test Set and Data Provenance
- This device is a physical product (power wheelchair), not an AI/ML diagnostic software. The "tests" are performance and safety evaluations against engineering standards, typically involving a limited number of physical units, not a large data set in the usual sense. The document does not specify the number of units tested.
- Data Provenance: Not applicable in the context of clinical data sets (e.g., country of origin, retrospective/prospective). The tests are engineering bench tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. "Ground truth" in this context is defined by engineering standards (e.g., a specific static stability angle, braking distance, maximum speed). No human experts are establishing "ground truth" for a test set in the way a radiologist would for medical images. Compliance is measured instrumentally against predefined criteria in the standards.
4. Adjudication Method for the Test Set
- Not applicable. Since there are no human interpretations or "readings" to adjudicate, this concept does not apply.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a power wheelchair, not a diagnostic device involving human readers or AI assistance in interpretation. Thus, MRMC studies and effect sizes related to human reader improvement with AI are not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. There is no AI algorithm in the diagnostic sense that performs "standalone." The device itself is a standalone product. It has a control system with software, and the document states "Software validation" was performed, which refers to validating the functional correctness and safety of the embedded software controlling the wheelchair's operations as per ISO 7176-14:2008.
7. The Type of Ground Truth Used
- For physical performance and safety (e.g., stability, braking, speed, obstacle climbing, EMC): The "ground truth" is defined by the technical specifications and limits established in the various ISO and IEC performance standards (e.g., "Maximum safe operational incline degree: 6°", "Braking distance: ≤1 m").
- For material safety (biocompatibility): Ground truth is established by declaration of identical materials to a previously cleared predicate device, which had already demonstrated biocompatibility per ISO 10993 standards.
8. The Sample Size for the Training Set
- Not applicable. This device does not use an AI/ML model trained on a data set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML training set, this question is not relevant.
In summary, this 510(k) submission is for a conventional medical device (a power wheelchair) and relies on compliance with established international performance and safety standards, as well as substantial equivalence to a previously cleared predicate device. It does not involve the type of AI/ML performance evaluation studies that your questions are designed to address.
§ 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).