(290 days)
The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner is intended to position teeth by way of continuous gentle force.
ClearPath Orthodontics uses clear, thin, thermoformed plastic material for the manufacture of its ClearPath Aligner. The aligners are provided non-sterile and are customized for each patient according to the molds provided by the treating dentist or orthodontist. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each aligner is 14 days and it is to be worn except during meals.
This document is a 510(k) premarket notification for the ClearPath Aligner. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.
Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria, especially concerning artificial intelligence (AI) or an algorithm's performance. The document explicitly states:
- No in vitro or animal testing were required for this product.
- The reason for this 510(k) was to expand the indication from "minor anterior tooth movement" to "realignment of all permanent teeth."
- Clinical case reports were submitted to demonstrate that the aligners can effectively realign all permanent teeth as indicated. These are not described as a formal clinical study with acceptance criteria, sample sizes, or ground truth establishment in the way one would evaluate an AI/algorithm's performance. They appear to be observational case reports supporting the broader indication by showing positive outcomes.
- The focus of the submission is on substantial equivalence to an existing predicate device based on "the same intended use, the same design, identical materials, identical methods used for fabricating the aligners, and submission of clinical reports that demonstrate the device performs as intended."
Therefore, it is not possible to provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or an MRMC study for AI performance, as this document does not describe such a study. The device itself (ClearPath Aligner) is a physical, thermoformed plastic appliance, not an AI or algorithm.
The request details are relevant to the evaluation of AI/ML-driven medical devices, but the provided text describes a traditional medical device submission.
§ 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.