(37 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The TEH LIN Powered Scooter, TL-688 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 describes a 510(k) premarket notification for the TEH LIN Power Scooter, TL-688. It focuses on demonstrating substantial equivalence to a predicate device (TEH LIN POWER SCOOTER TL-588) rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical or performance study for AI/diagnostic devices would.
Therefore, many of the requested fields (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or cannot be extracted from this document, as they pertain to a different type of device evaluation process.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of quantitative acceptance criteria and performance metrics for a diagnostic or AI device, this submission relies on demonstrating similarity to a predicate device. The "acceptance criteria" here is effectively meeting the standards of the predicate and relevant industry performance tests.
| Acceptance Criterion (Demonstrated by Equivalence/Testing) | Reported Device Performance (as demonstrated by similarity to predicate or testing) |
|---|---|
| Intended Use (to provide mobility to persons restricted to a seated position) | Same as predicate device (TEH LIN POWER SCOOTER TL-588). |
| Battery Safety/Performance | Uses the same brand and type of batteries as the predicate, certified by UL. |
| Control System Performance/Safety | Uses the same brand (Penny & Giles) control systems as the predicate device. |
| Recharger Safety/Performance | Uses the same recharger resource (HP8204A) as the predicate, certified by UL. |
| Structural Integrity & Material Safety (e.g., Foldable Frame, Removable Arm Type) | Foldable frame, removable arm type, same seat size, same climbing angle, same warranty on component and frame, weight limit, maximum range per charge, and back upholstery are the same material as the predicate. Back upholstery passed the resistance ignition test by SGS. |
| EMC (Electromagnetic Compatibility) | Tested according to: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995. (Specific results are not provided in this summary, but adherence to these standards implies satisfactory performance.) |
| Overall Safety Level (Based on components, materials, controls, and battery system) | "Thus the same safety level for the two devices is assured" based on the shared components, materials, and control systems with the predicate device. Minor differences in overall dimension, weight capabilities, and maximum speed are deemed "not safety aspect" and do not preclude substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a 510(k) for a powered scooter where "testing" primarily involves engineering standards and comparison to a predicate, not a "test set" of patient data.
- Data Provenance: The document refers to engineering and safety standards (e.g., UL certification, SGS resistance ignition test, EMC standards) and the comparison to an existing device (TEH LIN POWER SCOOTER TL-588). The manufacturing origin is Taipei County, Taiwan R.O.C. The data is prospective in the sense that the testing was performed on the TL-688 model for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is not a diagnostic device relying on expert interpretation of data for ground truth. "Ground truth" here is established by engineering specifications, safety standards, and performance test results.
4. Adjudication Method for the Test Set
- Not applicable. (See #3)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This type of study is not relevant for the regulatory approval of a powered scooter.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Ground truth is established through:
- Compliance with recognized industry performance standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 for EMC).
- Certifications from recognized testing bodies (e.g., UL for batteries and recharger, SGS for material resistance ignition).
- Direct comparison to a legally marketed predicate device (TEH LIN POWER SCOOTER TL-588) regarding components, materials, and design features.
8. The Sample Size for the Training Set
- Not applicable. (See #2) This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See #2 and #8)
§ 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).