(74 days)
The intended use of the 888 WNLE powered wheelchair by Pihsiang Machinery Mfg. Co., LTD is to provide mobility solutions to individuals who are limited to a seated position.
The 888 WNLE is a Center-wheel Drive Powered Wheelchair with front and rear pivoting caster wheels. It is equipped with a pair of electronic 4 pole 24vdc motors, electronic solenoid brakes, and two 12V 60Ah Group M34 batteries. The 888 WNLE is controlled by a PG Drives VR2 controller and is configured for an Off-board Charger. The 888 WNLE has front and rear battery access, and the main frame is composed of a welded steel construction. The 888 WNLE is joystick controlled. which when deflected, informs the controller to release the electromagnetic parking brake and apply power to the motors. This enables the chair to travel in the direction selected by the user with the joystick. When the user releases the joystick, the controller employs regenerative braking to bring the chair to a stop before electromagnetic parking brakes are applied automatically. The 888 WNLE is intended to be driven on various dry outdoor surfaces such as blacktop, concrete, and asphalt.
The 888 WNLE is also equipped with a vinyl Captain's seat with adjustable reclining back. Optional accessories are adjustable height armrests and a center mount foot platform. which help to properly position and support the user.
This document describes the 888 WNLE Powered Wheelchair/ROVI X3 and its substantial equivalence to a predicate device, the Jazzy 600 (K042612). The information provided focuses on non-clinical testing to demonstrate safety and performance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard requirement) | Device Performance (888 WNLE) |
|---|---|
| Obstacle Height (minimum 60mm) | Capable of negotiating obstacles up to 80mm |
| Stability on Inclines (minimum 7.5°) | Stable on inclines up to 9° |
| Theoretical Range (minimum 12 miles) | Capable of theoretical range of 16.4 miles |
| Structural Soundness | Proven structurally sound (per Section 8 of RESNA WC Vol.1 2009 for static, impact, and fatigue strengths) |
| Electrical Standards Compliance | Compliant to all electrical standards (e.g., Section 2: Determination of dynamic stability, Section 4: Energy consumption, Section 9: Climatic tests, Section 14: Power and control systems, Section 21: Electromagnetic Compatibility of RESNA WC Vol. 2 2009) |
| Flammability Standards Compliance | Compliant to all flammability standards (e.g., Section 16: Resistance to Ignition of Upholstered Parts of RESNA WC Vol.1 2009) |
| Biocompatibility | Biocompatibility for polyurethane vinyl (seat) and polyurethane foam (armrests) previously evaluated and cleared under TE 888W (K983808) |
| Risk Management | Complies with ISO 14971: 2009 Medical devices -- Application of risk management to medical devices |
| Other Measured Parameters (Dimensions, Mass, etc.) | Determined per Section 5 and 7 of RESNA WC Vol.1 2009 (specific values not provided in the summary) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the number of devices (e.g., individual wheelchairs) used for testing. It refers to "the 888 WNLE" in the singular, implying one or more units were tested. Without specific numbers, it's impossible to determine the precise sample size.
- Data Provenance: The testing was non-clinical, performed in accordance with RESNA and ISO standards. The data provenance is from the manufacturer's internal testing as part of their 510(k) submission. The document is from Pihsiang Machinery Mfg. Co., Ltd (Taiwan).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable (N/A). The "ground truth" in this context is established by the defined performance requirements in the RESNA and ISO standards against which the device was tested. These are objective measures, not subjective expert assessments.
4. Adjudication method for the test set
This information is N/A. Adjudication methods (like 2+1, 3+1) typically refer to situations where multiple human readers or experts are involved in reviewing data to establish a consensus, often for medical imaging or clinical trial endpoints. Since this is non-clinical device performance testing against objective standards, such adjudication methods are not relevant.
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
This information is N/A. This is a 510(k) submission for a powered wheelchair, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is N/A. As stated above, this is a powered wheelchair, not an algorithm or AI system.
7. The type of ground truth used
The ground truth used for this study is objective performance requirements/specifications defined by established international standards (RESNA WC Vol. 1 2009, RESNA WC Vol. 2 2009, ISO 14971: 2009, and ISO 10993 for biocompatibility). The device's performance was measured against these predefined limits and criteria.
8. The sample size for the training set
This information is N/A. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
This information is N/A. As there is no training set, this question is not applicable.
§ 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).