(60 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The TEH LIN Powered Scooter, TL-821 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. 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.
This document is a 510(k) premarket notification for a powered scooter (TEH LIN Power Scooter, TL-821), not a study evaluating an AI/ML device. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML validation cannot be extracted or inferred from this document.
The document focuses on demonstrating substantial equivalence to a predicate device (TEH LIN POWER SCOOTER TL-588 (K022698)) based on:
- Intended Use: Both devices are for "medical purposes to provide mobility to persons restricted to a seated position."
- Technological Characteristics: Comparison of components like batteries (same brand/type, UL certified), control systems (Penny & Giles), rechargers (HP8204A, UL certified), frame, arm type, tires, seat size, warranty, and upholstery (same material, passed ignition test).
- Performance Testing: References to EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 for electrically powered scooters.
Minor Differences Noted and Justified:
- Overall Dimensions, Weight Limit, Weight Capabilities: "Small" differences, with the new device being larger.
- Cruising Range: TL-821 is 37 km, predicate is 40 km, attributed to smaller batteries, and deemed substantially equivalent in real-life use.
- Safety Climbing Abilities: TL-821 is 12°, predicate is 15°. The manual for TL-821 will state a maximum of 12°.
- Maximum Speed: TL-821 is 5.6 mph, predicate is 5 mph. Justified by continuous speed adjustment for user control.
The substantial equivalence argument implies that by meeting relevant performance standards for powered scooters and demonstrating comparable (or slightly different but safe) specifications to a legally marketed predicate device, the TL-821 meets the "acceptance criteria" for market clearance under 510(k). However, these are not the detailed AI/ML-specific acceptance criteria and study designs you've asked for.
§ 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).