(222 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 Power Wheelchair, model: JJW-6001, is a motor driven, indoor and outdoor 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, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger. The device is powered by Li-ion Battery pack with 16 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 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 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 text is a 510(k) Premarket Notification from the U.S. FDA for a Power Wheelchair (JJW-6001). It outlines the device's characteristics, comparison to a predicate device, and the non-clinical tests performed.
This document pertains to the physical performance and safety of a medical device (a power wheelchair), not the performance of an AI/ML algorithm or software. Therefore, the questions related to AI/ML specific criteria (such as MRMC studies, ground truth for AI, training/test set sample sizes for AI, number of experts for AI ground truth, or adjudication methods for AI performance) are not applicable to the information contained in this document.
The document describes non-clinical tests conducted to confirm the device's safety and effectiveness compared to a predicate device, adhering to various ISO standards relevant to wheelchairs and electrical medical equipment.
Here's the relevant information based on the provided text, addressing the applicable questions:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by demonstrating compliance with various ISO standards. The reported device performance is that it met the design specifications by passing these tests. Specific numerical acceptance criteria and reported values for each performance metric are not explicitly presented in a single table as distinct "acceptance criteria" vs. "reported performance" for each individual test, but rather as statements of compliance.
However, a comparison table (Table 1) provides some performance specifications for both the subject device and the predicate device.
Table of Device Performance (from Table 1, "General Comparison")
| Element of Comparison | Predicate Device (K220747) | Subject Device (JJW-6001) | Remark / Compliance |
|---|---|---|---|
| Max Speed forward | Up to 6 km/h (1.6 m/s), adjustable | Up to 6 km/h (1.6 m/s), adjustable | S.E. (Substantially Equivalent) |
| Max Speed backward | Less than 3 km/h (0.5 m/s) | Less than 3 km/h (0.5 m/s) | S.E. |
| Braking distance | $\leq$ 1.5 m | $\leq$ 1.5 m | S.E. |
| Maximum safe operational incline degree | 9° | 10° | Analysis (presumably found acceptable after testing) |
| Maximum distance of travel on the fully charged battery | 15 km | 16km | Analysis (presumably found acceptable after testing) |
| Maximum obstacle climbing | 40 mm | 25mm | Analysis (presumably found acceptable after testing) |
Implied Acceptance Criteria for Safety and Performance:
The document states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:" followed by a list of ISO and IEC standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, IEC 60601-1-2 for electromagnetic compatibility). The acceptance criteria for these tests are the requirements specified within these standards. The device's reported performance is that it met these standards.
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in terms of number of patients or data records, as it refers to engineering and non-clinical performance testing of a physical medical device. The "test set" would be the physical JJW-6001 device itself. The data provenance is from non-clinical laboratory testing performed to demonstrate compliance with international standards. The origin of the testing data is implied to be in China, as the manufacturer and submission correspondent are based there. The tests are "non-clinical," meaning they are not performed on human subjects and thus do not have retrospective or prospective patient data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device submission, not an AI/ML or diagnostic imaging submission. Ground truth for device performance is established by standardized test procedures (e.g., ISO 7176, ISO 10993).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a physical device and not an AI/ML algorithm requiring human expert adjudication of output. Performance is determined by compliance with standard measurements and specifications.
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 a physical device, not an AI-assisted diagnostic tool. No human reader study information is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical non-AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is compliance with established international standards (e.g., ISO 7176 series for wheelchair performance, ISO 10993 series for biocompatibility). These standards define the test procedures and acceptance criteria for various physical and safety aspects of the device.
8. The sample size for the training set
Not applicable. This is a non-AI physical device. No training set is described.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth establishment is described for this physical 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).