(34 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Lightweight Power Mobility Scooter, S34 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 does not contain information about acceptance criteria for a device's performance that would typically be described in a study, such as diagnostic accuracy metrics (sensitivity, specificity, AUC). Instead, it describes a medical device called the "HEARTWAY Lightweight Power Mobility Scooter, S34" and its substantial equivalence to a predicate device.
The "Performance Testing" section refers to compliance with established safety and engineering standards for electrically powered wheelchairs and scooters, rather than specific performance metrics for a diagnostic or AI device.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This information is not present in the provided document.
The document primarily focuses on:
- Device Description: A lightweight electric mobility scooter.
- Intended Use: To provide mobility to persons restricted to a seated position.
- Substantial Equivalence: Comparison to a predicate device (HEARTWAY Lightweight Power Mobility Scooter, S33 (K071007)) based on materials, strength, fatigue, suspension, back upholstery, electronic systems (which passed UL certification), and safety levels.
- Differences noted: 4-wheels vs. 3-wheels, "free-wheel" manual feature, cruising range, overall appearance, weight capabilities, and maximum speed. These differences were deemed not to affect safety significantly.
- Performance Testing Mentioned:
- EMC Report
- ANSI / RESNA WC/Vol.2-1998
- CISPR 11: 1990
- EN61000-3-2: 1995
- IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
These are compliance standards, not performance metrics related to diagnostic accuracy or AI.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).