(39 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S Powered Wheelchair MAMBO F120 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter 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.
The provided text describes the 510(k) summary for the WU'S POWERED WHEELCHAIR, MAMBO F120. This documentation focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific device performance against a set of acceptance criteria for a novel medical AI/ML device. Therefore, much of the requested information regarding AI/ML study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this submission.
However, I can extract the relevant performance testing information that was included to support the claim of substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a quantitative, pass/fail table format with specific thresholds. Instead, it refers to compliance with recognized standards. The "reported device performance" is essentially that the device "passed" these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance) |
|---|---|
| EMC Report per CISPR 11: 1990 | Passed |
| EMC Report per EN61000-3-2: 1995 | Passed |
| EMC Report per IEC61000-3-3: 1995 | Passed |
| Performance Testing per ANSI / RESNA WC/Vol.2-1998 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods) | Passed |
| Electrical systems (controller, batteries, recharge) meeting UL certification | Passed (same suppliers, specifications) |
| Strength and fatigue tests (mainframes materials) | Met (similar to predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The performance testing refers to engineering and electrical safety standards for the device itself, not a clinical study involving a test set of data.
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 is not an AI/ML device requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical powered wheelchair, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The performance tests assess the standalone physical and electrical characteristics of the wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and electrical safety performance testing, the "ground truth" is defined by the technical specifications and limits set forth in the referenced international and national standards (e.g., CISPR 11, EN61000-3-2, IEC61000-3-3, ANSI / RESNA WC/Vol.2-1998, UL certification). Compliance with these standards is considered the "ground truth" for the device's acceptable performance in these areas.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
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).