(29 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The TEH LIN Powered Scooter, TL-360 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.
The provided text is a 510(k) Pre-Market Notification for a powered scooter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document, as it describes a comparison to a predicate device and not a standalone performance study with specific acceptance criteria and ground truth establishment.
Here's what can be inferred or stated as not available based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as pass/fail criteria for specific performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device (TEH LIN POWER SCOOTER TL-821 (K042011)). | The summary for substantial equivalence comparison states:Intended Use: Same as predicate.Batteries: Same brand (UL certified) as predicate.Control Systems: Same brand (Penny & Giles EGIS type) as predicate.Recharge: Same resource (UL certified) as predicate.Other Shared Features: Foldable frame, maximum speed, safe climbing angle, removable arm type, same warranty on component and frame, and back upholstery material (passed resistance ignition test by SGS) are the same as predicate.Major Differences: Different overall dimension, tires, seat size, weight limit, weight capabilities, and cruising range. |
Study Details
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Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing performance on a "test set" of data in the context of AI or diagnostic devices. It's a comparison of physical product specifications and certifications.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not relevant in this type of submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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. This is a medical device, but not an AI/diagnostic device that would involve human readers or AI assistance in interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is the established safety and performance characteristics of the predicate device, demonstrated through adherence to standards (EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995). The new device is deemed substantially equivalent based on matching key technical specifications and certifications.
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The sample size for the training set: Not applicable. This document does not describe an AI/ML algorithm or a "training set."
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How the ground truth for the training set was established: Not applicable.
§ 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).