(29 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The TEH LIN Powered Scooter, TL-560 is an indoor / outdoor Powered Scooter that It has a base with four-wheeled with a seat. is battery operated. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the The device can be disassembled for transport and is provided with steering column. an onboard battery charger.
The provided document is a 510(k) summary for the TEH LIN Power Scooter, TL-560. It focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving performance against those criteria. Therefore, much of the requested information cannot be extracted directly from this document.
However, I can provide the information that is available and explicitly state what is not.
Acceptance Criteria and Device Performance Study for TEH LIN Power Scooter, TL-560
This 510(k) submission primarily demonstrates substantial equivalence to a predicate device (TEH LIN POWER SCOOTER TL-821, K042011) rather than presenting a performance study against explicit acceptance criteria. The "Performance Testing" section refers to compliance with specific standards, which serve as the implicit acceptance criteria for safety and electrical compatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| EMC Report ANSI / RESNA WC/Vol.2-1998 | No specific performance data provided, but implied compliance for equivalence. |
| CISPR 11: 1990 | No specific performance data provided, but implied compliance for equivalence. |
| EN61000-3-2: 1995 | No specific performance data provided, but implied compliance for equivalence. |
| IEC61000-3-3: 1995 | No specific performance data provided, but implied compliance for equivalence. |
Note: The document states that the new device and the predicate device "have the same intended use, the same technological aspects and only minor differences exist. So the new device is substantially equivalent to the predicate devices in this aspect." This is the primary "performance" being demonstrated for regulatory purposes – equivalence to a device already deemed safe and effective. The safety level is assured because key components and characteristics (batteries, control systems, recharger, material resistance ignition tests) are the same or have passed relevant tests.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a performance study with a specific "test set" in the context of clinical or diagnostic performance. The "performance testing" mentioned refers to compliance with established engineering and electrical safety standards. Therefore:
- Sample size for the test set: Not applicable in the context of clinical/diagnostic performance. The tests would be performed on the device itself.
- Data provenance (country of origin, retrospective/prospective): Not applicable for the type of testing described (product standard compliance). The resistance ignition test was performed by "SGS," a global inspection, verification, testing, and certification company.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The document does not describe a study involving expert assessment or ground truth establishment for a clinical or diagnostic outcome.
4. Adjudication Method
This information is not applicable. No adjudication method is described as there is no clinical or diagnostic study involving multiple readers/assessors.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document does not describe any human-in-the-loop performance or comparison of human readers with vs. without AI assistance. The device is a powered scooter, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
No, a standalone performance study in the context of an algorithm or AI is not applicable or described. The performance testing refers to the device's compliance with engineering and electrical safety standards.
7. Type of Ground Truth Used
This information is not applicable in the typical sense for clinical/diagnostic devices. The "ground truth" for the performance testing mentioned (EMC, CISPR, EN, IEC standards) is the state-of-the-art engineering and safety requirements defined by those standards. For material properties, the ground truth is established by passing specific resistance ignition tests (by SGS).
8. Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI/machine learning device.
§ 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).