(19 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The LERADO, AVANTICARE Power Wheelchair, PW-1800 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
This document describes the 510(k) submission for the LERADO, AVANTICARE Power Wheelchair, PW-1800. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the SINON Power Wheelchair, SN-W401.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from demonstrating substantial equivalence to the predicate device. The performance of the subject device (PW-1800) is considered to meet these criteria by being "SAME" as the predicate device (SN-W401) across various parameters, or having minor differences that are argued not to lead to performance differences.
| ITEMS | Acceptance Criteria (Predicate Device SN-W401 Performance) | Reported Device Performance (Subject Device PW-1800) | Meets Criteria? |
|---|---|---|---|
| General | |||
| Intended Use | "The device is intended for medical purposes to provide mobility to persons restricted to a sitting position." | SAME | Yes |
| Frame | FOLDABLE | SAME (foldable) | Yes |
| Removable Arm Type | Not explicitly detailed for predicate, but implied by "SAME" | SAME | Yes |
| Back Upholstery | Material passed resistance ignition test by SGS | SAME material, passed resistance ignition test by SGS | Yes |
| Dimensions | |||
| Overall length | 102 cm / 40-1/8" | SAME | Yes |
| Overall width | 61 cm / 24" | SAME | Yes |
| Overall height | 99cm / 39" | SAME | Yes |
| Overall dimensions | Implied to be specific values | SAME | Yes |
| Wheel size | Not explicitly detailed for predicate | SAME | Yes |
| Seat dimensions | Not explicitly detailed for predicate | SAME | Yes |
| Performance | |||
| Weight Limit | 115 kgs / 250 lbs | SAME | Yes |
| Maximum Speed | 4 mph / 6.4 km | SAME | Yes |
| Incline Degree | Not explicitly detailed for predicate | SAME | Yes |
| Crusing Range | 20 miles / 32 km | SAME | Yes |
| Electronics/Power | |||
| Electronics (Controller) | Dynamic DL controller | SAME (Dynamic DL 50 series type) | Yes |
| Batteries Quantity | Two | Two | Yes |
| Batteries Type | U1, 38Ah 12VDC* 2 | U1, 34Ah 12VDC* 2 | Minor Difference |
| Charger | HP8204B, certified by UL | SAME resource, HP8204B, certified by UL | Yes |
Note regarding Battery Type: The subject device uses 34Ah batteries while the predicate uses 38Ah. The submission states that "The two type batteries are from the same supplier, and also certified by UL. The differences for the two devices do not lead to any performance differences, thus they are substantially equivalent." This is the only explicit "difference" acknowledged and justified.
Performance Testing:
The submission mentions "Performance Testing:" EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods). This indicates that the device was tested against these industry standards. However, specific results from these tests are not provided in this excerpt, but rather the implication is that the device passed these tests to demonstrate safety and performance.
2. Sample Size Used for the Test Set and Data Provenance
This is a 510(k) submission for a power wheelchair, a medical device, not a diagnostic AI/ML system. Therefore, the concept of "test set" in the context of a dataset for an algorithm does not directly apply. The "test set" for this device would refer to the physical units produced for compliance testing. The document doesn't specify the number of individual devices tested, but rather the standards against which a device (or representative samples) were tested.
- Sample Size: Not explicitly stated for specific tests, but generally refers to physical prototypes or production samples.
- Data Provenance: Not applicable in the context of a data-driven system. The "provenance" here refers to the manufacturing location (Taiwan, ROC) and the standards applied.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as this is a physical medical device (power wheelchair), not an AI/ML diagnostic system requiring expert annotated ground truth on a dataset. The "ground truth" for a power wheelchair is its physical performance and safety characteristics as measured against established engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable for a physical device. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth. For this device, compliance is determined by testing against predefined engineering and safety standards.
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 not an AI/ML diagnostic device that would involve human "readers" or an "AI assistance" component to improve their performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone physical power wheelchair, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance and safety is established through:
- Engineering Specifications: The design parameters and declared specifications of the device (e.g., weight limit, maximum speed, dimensions).
- Safety Standards: Compliance with recognized international and national standards such as ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 for EMC and other wheelchair-specific requirements.
- UL Certification: Mentioned for the charger and batteries, indicating adherence to UL safety standards.
- Ignition Resistance Test: For back upholstery, performed by SGS.
These standards and certifications serve as the objective benchmarks against which the device's performance and safety are assessed.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML system requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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).