(61 days)
The LuxCreo Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force.
Dental health professionals achieve orthodontic tooth movement through prescription of aligners which apply force to the patient's teeth so that each tooth follows a prescribed, predetermined displacement. LuxCreo Clear Aligner System is custom plastic aligner system which are a series of doctor prescribed clear removable aligners that are used as alternative treatment for the alignment of maloccluded or misaligned teeth. This series of aligners gently move the patient's teeth in small increments from their original state to a treated state.
A 3D printer, based on a 3D stereolithographic drawing, prints the predetermined shape of each aligner. Final polymerization is achieved by placing the printed aligner in a UV-light curing box. 3D printing uses specialty liquid resins, which help the aligners achieve mechanical properties similar to thermoplastics, and increased processability.
The aligners are packaged and labeled according to the sequence in which they are intended for use, determined by the prescribing dental health professional. The finished set of aligners is shipped with twelve-month-shelf-life to the prescribing physician, who is accountable for ensuring the patient uses the device properly and safely.
The LuxCreo Clear Aligner System mechanism of operation, and software usage, are identical to the predicate devices, and support a determination of substantial equality. Both the LuxCreo Clear Aligner System and the predicate devices are manufactured from a biocompatible, non-sterile polyurethane materials that supports a determination of substantial equality.
This FDA 510(k) clearance letter and supporting Special 510(k) Summary for the LuxCreo Clear Aligner System (K250343) does not describe an AI medical device or a study involving AI.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K212680) by comparing:
- Intended Use/Indications for Use: Identical for both devices.
- Mode of Action: Identical (application of continuous gentle force for teeth alignment).
- Method of Use: Identical (sequential use of preformed plastic trays).
- Manufacturing Process: Identical (light-cured 3D printing).
- Material: Different, but the new material's mechanical and chemical properties were tested against pre-determined acceptance criteria and found to be equivalent or better.
- Biocompatibility: Extensive ISO 10993 testing was performed to demonstrate biocompatibility of the new material, with all results meeting requirements.
- Shelf Life: Increased from 6 months to 12 months, supported by stability and packaging integrity testing.
The document does not mention any software that performs medical functions requiring AI/ML performance evaluation, nor does it refer to terms like "algorithm performance," "diagnostic accuracy," "human-in-the-loop," "ground truth," or "expert readers" in the context of an AI study. The "software usage" mentioned (Section H, page 7) refers to ordering workflow, not a medical function.
Therefore, I cannot extract the requested information (acceptance criteria, study details for AI performance, sample sizes, expert qualifications, etc.) because the provided text describes a medical device clearance based on material and shelf-life changes, not an AI/ML component.
If the LuxCreo Clear Aligner System had an AI component (e.g., AI-powered treatment planning, AI for predicting tooth movement, or AI for assessing aligner fit from scans), that information would typically be detailed in a separate section addressing the software's performance, validation, and clinical results. This document does not contain such information.
§ 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.