(66 days)
The TRIOCLEAR System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of increment, it sequentially positions teeth by way of continuous gentle force.
The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
The provided text describes the TRIOCLEAR System, an orthodontic device. However, it does not include the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven device.
The document is a 510(k) summary for the TRIOCLEAR System, which is a series of clear plastic aligners. The submission aims to establish substantial equivalence to a predicate device, primarily due to changes in raw material and thickness types. The performance testing section focuses on material properties of the thermoforming sheet, not the performance of an AI/ML component.
Therefore, I cannot provide the requested information from the given text. The text does not discuss:
- Acceptance criteria for an AI/ML device's performance.
- A study proving an AI/ML device meets acceptance criteria.
- Sample size for test sets or data provenance for AI/ML validation.
- Details about experts for ground truth establishment.
- Adjudication methods.
- MRMC studies or effect sizes for AI assistance.
- Standalone AI algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes) in the context of AI.
- Training set sample size or ground truth establishment for a training set for an AI/ML model.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.