(157 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 Electrically powered wheelchair 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.
It is mainly composed of front wheel, drive wheel, frame, controller (joystick), motor and drive devices, armrest, backrest, seat belt, footrest, battery box and charger.
The device is powered by Li-ion Battery pack (25V 10Ah) with 11.8 Km 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. When the user releases the joystick will automatically go 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.
This document is a 510(k) summary for an electrically powered wheelchair (HP202). It focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (K230964) rather than proving the device meets specific acceptance criteria through a clinical study of an AI/software component.
Therefore, the request for details related to AI/software performance evaluation (like acceptance criteria for an AI model, sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) cannot be fully answered from the provided text.
The document states: "No clinical study is included in this submission." and primarily relies on non-clinical testing against established ISO standards and direct comparison of specifications to the predicate device to argue for substantial equivalence.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent for AI-specific criteria:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by conformity to specific ISO standards and the performance metrics of the predicate device. The document presents a comparison table (Table 1: General Comparison, and implicitly Table 3: Performance Comparison) rather than a formal acceptance criteria table with a "Pass/Fail" or "Meets" column. The "Remark" or "Results" columns in these tables serve a similar purpose by indicating "S.E." (Substantially Equivalent) or explaining minor differences that do not raise new safety or effectiveness concerns.
| Feature/Test | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Subject Device) | Result/Remark |
|---|---|---|---|
| Biocompatibility | Compliance with ISO 10993-5, -10, -23 | Compliance with ISO 10993-5, -10, -23 | S.E. |
| EMC | Compliance with ISO 7176-21 | Compliance with ISO 7176-21 & IEC 60601-2-1 | S.E. |
| Braking distance | ≤ 1.5 m (as per predicate) | ≤ 1 m | Minor difference, shorter distance is safer. |
| Max. safe operational incline | 9° (as per predicate) | 10° | Minor difference, doesn't raise new safety/effectiveness concerns as stability evaluated per ISO 7176 series. |
| Max loading weight | 110kg (as per predicate) | 120kg | Difference on loading weight will not cause different performance; validated with max loading weight. |
| Max distance of travel | 10 km (as per predicate) | 11.8 km | Caused by wheel size; farther is better. |
| Turning Radius | 900 mm (as per predicate) | 1000 mm | Minor difference due to size, doesn't raise new safety/effectiveness concerns. |
| Maximum obstacle climbing | 40 mm (as per predicate) | 20 mm | Minor difference, doesn't raise new safety/effectiveness concerns. |
| Static stability | Meets ISO 7176-1 requirements | Meets ISO 7176-1 requirements | S.E. |
| Dynamic stability | Meets ISO 7176-2 requirements | Meets ISO 7176-2 requirements | S.E. |
| Brake effectiveness | Meets ISO 7176-3 requirements | Meets ISO 7176-3 requirements | S.E. |
| Energy consumption/Distance range | Meets ISO 7176-4 requirements | Meets ISO 7176-4 requirements | S.E. |
| Overall dimensions, mass | Meets ISO 7176-5 requirements | Meets ISO 7176-5 requirements | S.E. |
| Max speed, acceleration, deceleration | Meets ISO 7176-6 requirements | Meets ISO 7176-6 requirements | S.E. |
| Seating and wheel dimensions | Meets ISO 7176-7 requirements | Meets ISO 7176-7 requirements | S.E. |
| Static, impact, fatigue strengths | Meets ISO 7176-8 requirements | Meets ISO 7176-8 requirements | S.E. |
| Climatic tests | Meets ISO 7176-9 requirements | Meets ISO 7176-9 requirements | S.E. |
| Obstacle-climbing ability | Meets ISO 7176-10 requirements | Meets ISO 7176-10 requirements | S.E. |
| Test dummies requirements | Meets ISO 7176-11 requirements | Meets ISO 7176-11 requirements | S.E. |
| Coefficient of friction of test surfaces | Meets ISO 7176-13 requirements | Meets ISO 7176-13 requirements | S.E. |
| Power and control systems | Meets ISO 7176-14 requirements | Meets ISO 7176-14 requirements | S.E. |
| Information disclosure, documentation, labeling | Meets ISO 7176-15 requirements | Meets ISO 7176-15 requirements | S.E. |
| Resistance to ignition of postural support devices | Meets ISO 16840-10 requirements | Meets ISO 16840-10 requirements | S.E. |
| Batteries and chargers | Meets ISO 7176-25 requirements | Meets ISO 7176-25 requirements | S.E. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided as no clinical study was conducted. The testing described is primarily physical device testing against engineering standards. The manufacturer is based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided as no clinical study or expert-based ground truth establishment (relevant for AI/image analysis) was performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as no clinical study or expert-based ground truth establishment was performed.
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
No MRMC study was done. The device is an electrically powered wheelchair, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance test for an AI algorithm was not performed because the device itself is an electrically powered wheelchair and the submission does not describe an AI algorithm component requiring such testing. The "software validation" mentioned relates to the wheelchair's control system, not an AI for interpretation or diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by conformance to internationally recognized engineering standards (ISO 7176 series, ISO 10993 series) and direct comparison of technical specifications and safety features to a legally marketed predicate device. This is a non-clinical "ground truth."
8. The sample size for the training set
This information is not provided as no AI training set was described or used in this submission.
9. How the ground truth for the training set was established
This information is not provided as no AI training set was described or used in this submission.
In summary: The provided FDA 510(k) summary for the "Electrically powered wheelchair (HP202)" demonstrates substantial equivalence through non-clinical testing against ISO standards and direct comparison to a predicate device. It does not involve a clinical study or the evaluation of an artificial intelligence/software component where the requested details about acceptance criteria, sample sizes, expert ground truth, or human-AI interaction would be relevant.
§ 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).