(60 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The TEH LIN Power Scooter, TL-822 is an indoor / outdoor Power Scooter that is It has a base with four-wheeled with a seat. battery operated. 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 a 510(k) submission for the TEH LIN Power Scooter, TL-822. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than full clinical efficacy studies with acceptance criteria based on patient outcomes.
Therefore, the input document does not contain the information requested in the prompt regarding acceptance criteria for device performance in a clinical or diagnostic context, nor does it detail a study that proves the device meets such criteria.
Specifically, the document discusses:
- Device Description: The TEH LIN Power Scooter, TL-822, is an indoor/outdoor, four-wheeled, battery-operated scooter for mobility.
- Intended Use: To provide mobility to persons restricted to a seated position.
- Performance Testing: It mentions "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995" which are standards related to electromagnetic compatibility and wheelchair/scooter requirements. These are engineering and safety standards, not clinical performance acceptance criteria.
- Substantial Equivalence: The primary focus is on establishing substantial equivalence to a predicate device (TEH LIN POWERED SCOOTER TL-588, K022698) based on having the same intended use, technological aspects, and only minor differences in appearance, dimensions, wheel size, maximum speed, and weight limit. The document explicitly states that "these differences for the two devices do not lead to any performance differences."
Based on the provided text, I cannot complete the table or answer the specific questions as they pertain to clinical or diagnostic performance criteria and studies, which are not detailed in this 510(k) summary.
Here's a breakdown of why each specific point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: The document only mentions adherence to safety/engineering standards (EMC/RESNA) and asserts that the differences from the predicate device do not lead to performance differences. There are no measurable "acceptance criteria" for clinical performance (e.g., accuracy, sensitivity, specificity) and no reported device performance against such criteria.
- Sample size used for the test set and the data provenance: No test set (in a clinical sense) is described. The "performance testing" mentioned refers to engineering standards, not typical clinical study data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set or ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for diagnostic devices, not mobility scooters.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI/software performance.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- 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).