(260 days)
The Electric wheelchair is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.
The Electric wheelchair (Model S7012) is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair. The device and accessories (remote controller, AC power wire, charger, and battery) are reusable. The Electric wheelchair (Model S7012) is about 125 kg weight capacity and size is about 840mm x 640mm x 930mm if unfold and about 700mm x 640mm x 370mm if fold. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable welded-aluminum frames, sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and Li-ion batteries with an off-board battery charger. It has some components as two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, and has a remote for folding/unfolding the device. Its basic function is powered by rechargeable batteries with 15 km which has a maximum speed up to 6 km/h. The controller with a joystick attaches to either armrest and velocity of the powered wheelchair. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop. The joystick can move up and down, left and right. There is a speed button to adjust the speed, and the speed indicator can display the speed. In addition, there is a remote control to control the folding and unfolding of the device. And no any new features of the device.
The provided text is a 510(k) Summary for an Electric Wheelchair (Model: S7012). It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical studies against acceptance criteria in the manner one might expect for a novel AI/software as a medical device.
Therefore, the requested information regarding detailed acceptance criteria, study design for proving those criteria, sample size for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment does not apply in the context of this traditional medical device submission. The submission relies on adherence to established international standards for wheelchairs and a comparison of technical specifications to a predicate device.
However, I can extract the closest analogous information from the document:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are generally implied by conformity to the listed ISO and IEC standards and demonstrating substantial equivalence to the predicate device in terms of specifications. The "reported device performance" is given by the subject device's specifications.
| Element of Comparison | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Subject Device) | Notes for Equivalence |
|---|---|---|---|
| General | Conformity to ISO 7176 series, IEC 62304, IEC 60601-1-6, IEC 62366, ISO 10993 series | Complies with all listed standards | Explicitly stated that the device complies with these standards. |
| Intended Use | Provide mobility to a disabled or elderly person limited to a seated position. | Provide mobility to a disabled or elderly limited to a seated position. | Substantially Equivalent (SE). The intent is the same. |
| Dimensions (e.g., Unfold Size) | Similar to predicate (e.g., 890 mm *603 mm *670 mm approx) | 840mm x 640mm x 930mm | SE: "subtle changes of the physical characteristics will not affect the critical functions or the normal use." (Note 1) |
| Total Mass | Similar to predicate (e.g., 28 kg) | 25.84 kg | SE: "subtle changes of the physical characteristics will not affect the critical functions or the normal use." (Note 1) |
| Speed | Similar to predicate (e.g., 7 km/h) | 6 km/h | SE: "very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use." (Note 2) |
| Safe Gradient | Similar to predicate (e.g., 0-12°) | 0-8° | SE: "very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use." (Note 2) |
| Range | Similar to predicate (e.g., 20 km) | 16 km | SE: "very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use." (Note 2) |
| Maximum Capacity | Similar to predicate (e.g., 100 kg) | 125 kg | SE: "very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use." (Note 2) |
| Obstacle Climbing Ability | Similar to predicate (e.g., 25 mm) | 40 mm | SE: "very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use." (Note 2) |
| Battery | Similar to predicate (e.g., Lithium 24V/20AH) | Lithium battery 24V/10Ah | SE: "both of them are comply with the standards IEC 62133 and ISO 7176, it will not raise any safety or effectiveness issue." (Note 3) |
| Motor | Similar to predicate (e.g., 24V 250W) | 24V 137W | SE: "both of them are comply with the standards IEC 62133 and ISO 7176, it will not raise any safety or effectiveness issue." (Note 3) |
| Brake | Electromagnetic | Electromagnetic | SE |
| Biocompatibility | Compliance with ISO10993-5 and ISO10993-10 | Compliance with ISO10993-5 and ISO10993-10 | SE. |
| Electrical Safety / EMC | Compliance with ISO 7176 series / ISO 7176-21 | Compliance with ISO 7176 series / ISO 7176-21 | SE. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The "tests" mentioned are conformity to international standards (e.g., ISO 7176 series, IEC 62304) for a physical device, not statistical performance evaluations against a test set of data. These standards typically involve testing a single or a small number of physical units to verify specifications and safety features.
- Data Provenance: Not applicable in the context of data used for statistical evaluation of a test set. The provenance of the tested device itself is Dongguan Prestige Sporting Goods Co., Ltd., 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):
Not applicable. This device is an electric wheelchair, not an AI/diagnostic device that generates an output needing expert "ground truth." The "truth" is established by direct physical measurement, engineering tests, and adherence to performance specifications outlined in the international standards cited (e.g., measuring speed, stability, brake effectiveness).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for this type of device submission. Adjudication methods are typically used in clinical studies where expert consensus is needed to define a ground truth for a diagnostic outcome.
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. MRMC studies are specific to evaluating the effectiveness of AI-assisted diagnostic tools on human reader performance. This device is a physical mobility aid.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product (electric wheelchair), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance relies on:
- Direct Physical Measurements: E.g., dimensions, weight, speed, range, turning radius.
- Engineered Safety Standards: Compliance with ISO 7176 series (static stability, dynamic stability, brakes, strength, climatic tests, EMC, etc.), IEC 62304 (software life-cycle), IEC 60601-1-6 (usability), IEC 62366 (usability engineering), and ISO 10993 series (biocompatibility).
- Comparison to a Predicate Device: Demonstrating that any differences in specifications do not raise new questions of safety or effectiveness.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning 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).