(90 days)
The SmileAlign® Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The SmileAlign Orthodontic Aligner System positions teeth by way of continuous gentle force.
The SmileAlign® Orthodontic Aligner System is a series of dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.
This document describes the 510(k) premarket notification for the SmileAlign® Orthodontic Aligner System (K191774). However, it does not contain any information about an AI/Algorithm-driven device that would require an evaluation against specific acceptance criteria for algorithm performance, a test set, expert ground truth establishment, or clinical performance data related to AI assistance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Byte Aligner System, K180346) based on material properties, indications for use, technological characteristics, and biocompatibility. It explicitly states: "Clinical data was not included in this submission."
Therefore, based on the provided text, I cannot fill in the requested table and information points regarding acceptance criteria and study data for an AI-driven device's performance, as this information is not present in the given FDA 510(k) summary.
The document describes the device as: "a series of dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner." The only mention of software is that "Both the subject and predicate devices use independent dental software to translate tooth movements in developing the model schemes and allow the dental practitioner to review and approve the model schemes before aligner fabrication." This refers to standard CAD/CAM software used in the dental industry, not an AI algorithm performing diagnostic or treatment planning functions.
If this was a request for an AI-driven device, the provided text does not contain the necessary 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.