(36 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The COMFORT POWERED WHEELCHAIR, LY-EB206 is an indoor / outdoor Electric 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 510(k) submission (K072711) describes a Powered Wheelchair (COMFORT POWERED WHEELCHAIR, LY-EB206). The submission focuses on demonstrating substantial equivalence to a predicate device (COMFORT Powered Wheelchair, LY-EB103, K030356), rather than establishing new performance criteria through a standalone study. Therefore, the information provided mainly pertains to the comparison with the predicate device and the standards met, rather than a traditional "acceptance criteria" and "study proving it meets acceptance criteria" as might be found for novel diagnostic AI devices.
However, I can extract the relevant information and present it in a structured way based on the provided text.
Here's an analysis of the provided information:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards)
Given that this is a 510(k) for a powered wheelchair, the "acceptance criteria" are implicitly defined by the safety and performance standards met by the device, as well as its substantial equivalence to a legally marketed predicate device. The "device performance" is primarily discussed in terms of meeting these standards and being comparable to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Standards & Predicate Comparison) | Reported Device Performance (COMFORT POWERED WHEELCHAIR, LY-EB206) |
|---|---|
| Intended Use (Mobility for persons restricted to a seated position) | Intended for medical purposes to provide mobility to persons restricted to a seated position. (Same as predicate) |
| Mainframe Strength & Fatigue | Mainframes meet strength and fatigue tests. (Similar to predicate) |
| Material Aspects | Similar mainframe materials to predicate. |
| Back Upholstery Ignition Resistance | Back upholstery passed resistance ignition test by SGS. (Same material as predicate) |
| Electronic Systems Safety (controller, batteries, motor, charger) | Electronic systems are the same as the predicate and all passed UL certification. (Same safety level assured) |
| EMC Compliance | Complies with EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995. |
| Maximum Speed (Under 6 mph limit) | Maximum speed is 4.75 mph. (Within the 6 mph limit, compared to predicate's 5.31 mph) |
| Maximum Range per Charge | Maximum range per charge is 23.8 miles. (Different from predicate's 20 miles, but considered substantially equivalent in real-life use) |
| Other Features (Suspension, footplates, incline degree 12°, armrest type, weight limit, warranty) | All are the same as the predicate device. |
| Overall Dimensions | Minor differences from the predicate, but not considered a safety aspect. |
| Tire Sizes | Differences in tire sizes from the predicate, but not considered a safety aspect. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a clinical test set for AI/diagnostic performance. The "test set" here refers to the device itself undergoing engineering and performance testing. The document describes the testing of the wheelchair as a single unit or representative units, not a patient-centric data set.
- Data Provenance: The referenced standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) are international and national technical specifications for power wheelchairs and electrical compatibility. The ignition resistance test was conducted by SGS, a global inspection, verification, testing, and certification company. The electronic components were UL certified. The manufacturing country is Taiwan, R.O.C. (Comfort Orthopedic Co., LTD.). This is a submission for a physical device, so "retrospective or prospective" data provenance regarding patient cohorts is not relevant.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For a physical device like a wheelchair, "ground truth" is established through engineering specifications, validated test methods (e.g., those specified in ANSI/RESNA, CISPR, EN, IEC standards), and certifications from recognized bodies (e.g., UL, SGS). There's no mention of human experts establishing a "ground truth" in the diagnostic sense.
- Qualifications of Experts: N/A. The "experts" are the engineers and technical specialists involved in the design, testing, and certification processes according to established industry standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is typically relevant for medical imaging or diagnostic AI where discordant expert opinions need resolution for ground truthing. For a physical device, compliance is determined by meeting predefined engineering specifications and passing standardized tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This submission does not include an MRMC study. MRMC studies are used to evaluate the diagnostic performance of a system (often AI-assisted) compared to human readers over a diverse set of cases. This is a submission for a physical medical device (powered wheelchair) where such studies are not typically performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: Not applicable. This device is a physical powered wheelchair, not an algorithm. Its performance is measured directly through mechanical, electrical, and safety tests, not through an AI algorithm operating in a standalone capacity. The "standalone performance" here would be the physical performance of the wheelchair itself as tested against the standards mentioned.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device is based on engineering specifications, compliance with recognized industry standards (e.g., ANSI/RESNA, CISPR, EN, IEC) for safety and performance, and certifications from accredited testing laboratories (e.g., UL, SGS). The primary "ground truth" for substantial equivalence is the performance and safety profile of the predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: N/A. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: N/A. There is no training set for this type of 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).