(202 days)
Indicated for use in alignment of teeth through orthodontic treatment of malocclusion.
The Proposed Device is indicated for use in the alignment or mixed dentition teeth through orthodontic treatment of misalignment and malocclusion, with 20 to 22 hours of daily wear for at least 10 days. The Proposed Device allows the option of forward repositioning of the mandible to a more optimal bite profile.
This premarket notification is submitted to notify the FDA of Wuxi EA Medical Technologies' intent of changes to the Clear Aligner (hereafter referred to as "Proposed Device") to the currently marketed reference device's, Clear Aligner (K203688, cleared October 8, 2021) (hereafter referred to as "Reference Device") indications for use to include mixed dentition, a wear time of at least 10 days, and mandibular repositioning features.
The Proposed Device consists of multiple stages of thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental move teeth by way of gentle continuous force and reposition the mandible to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for cleaning. Patients can be prescribed with more than one aligner of different materials within a single stage.
The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. The Proposed Device includes mandibular repositioning features known as "A6" on each upper and lower aligner. A6 is intended for use in patients with growing mandibles presenting with retrognathic Class II malocclusions in permanent dentition or stable late mixed dentition.
Once the treatment plan is reviewed and approved by a dental health professional, the 3D model of each stage from the treatment plan is manufactured by 3D printed models are then thermoformed over with a suitable dental thermoplastic sheet. The final manufactured aligner stages are then delivered to the patient. The patients' dental health professional then monitors their treatment from the placement of delivered initial aligner stage to the final aligner stage.
The provided text is a 510(k) summary for a medical device (Clear Aligner) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a rigorous test set evaluation usually seen with AI/ML-enabled devices.
This document describes a "special 510(k)" submission, which is typically used for modifications to a company's own already-cleared device where the modification does not raise new questions of safety and effectiveness. In this case, the modifications are to the indications for use (adding mixed dentition, shorter wear time, and mandibular repositioning features) and material options.
The "clinical performance testing" section states: "Retrospective clinical data has been provided the Proposed Device. The data collected for the study showed that successful alignment of teeth through orthodontic treatment of misalignment and malocclusion with at 20 to 22 hours of daily wear for at least 10 days was achieved when using the Proposed Device."
This statement is very general and does not provide the quantitative details needed to fill out the requested table or address most of the specific questions about acceptance criteria and study methodology. It mentions "retrospective clinical data" and "successful alignment," but lacks specific metrics, sample sizes for the test set, ground truth creation details, expert qualifications, or MRMC study information.
Therefore, I cannot provide the requested information from the given text. The document focuses on demonstrating substantial equivalence to a predicate device based on similarities in indications for use, technological characteristics, and non-clinical performance data, rather than presenting a detailed performance study against specific acceptance criteria for a novel AI/ML algorithm.
§ 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.