(39 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Genemax Power Wheelchair, PW4 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.
The provided text describes a 510(k) submission for the "GENEMAX Power Wheelchair, PW4." This is a medical device, but not one that relies on complex algorithms or AI for its function. The "Performance Testing" section refers to engineering standards validation, not clinical studies with acceptance criteria in the manner you've described for AI/algorithm-based devices.
Therefore, many of the requested elements for describing acceptance criteria and study details (like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of device submission.
Here's a breakdown of what can be extracted and why other parts are inapplicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ANSI / RESNA WC/Vol.2-1998 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods) | Compliant (Implied by submission and clearance) |
| CISPR 11: 1990 (EMC) | Compliant (Implied by submission and clearance, "EMC Report") |
| EN61000-3-2: 1995 (EMC) | Compliant (Implied by submission and clearance) |
| IEC61000-3-3: 1995 (EMC) | Compliant (Implied by submission and clearance) |
| UL Certification (Electronic systems, batteries, recharger, switches, power supplies) | Compliant (Explicitly stated: "all passed by the UL certificated") |
| Resistance Ignition Test (Back upholstery material) | Compliant (Explicitly stated: "material that also be passed the resistance ignition test by SGS") |
| Equivalence to Predicate Device (TEH LIN Power Wheelchair, TL-320 (K022697) on safety aspects) | Met (Explicitly stated: "The electronic systems between two devices are the same and all passed by the UL certificated... Thus the same safety level for the two devices is assured. ... The overall appearance and weight differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.") |
Explanation for Inapplicability of other sections:
This 510(k) submission establishes substantial equivalence primarily through comparison to a legally marketed predicate device and adherence to recognized performance standards for electrical and mechanical safety/functionality. It does not involve a clinical study in the sense of evaluating diagnostic or treatment accuracy based on data interpretation by an algorithm.
- Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, how training ground truth was established: These concepts are relevant for AI/Machine Learning algorithms or devices that require human interpretation of data for clinical decision-making. The Genemax Power Wheelchair is a mechanical device with electrical components, and its validation revolves around engineering specifications and safety standards, not statistical performance metrics on datasets. Its "performance testing" refers to meeting the requirements of recognized industry standards (EMC, functional wheelchair standards), not a clinical trial.
§ 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).