(100 days)
The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These are for self-use by patient with monitoring of improvement by orthodontists.
The Clear Dental Aligners are thermoformed, orthodontic wearable & removable dental appliances that, when worn in the prescribed sequence and duration, progressively reposition the permanent malocclusion teeth. These aligners could be soft, medium, or hard as per prescription set by an orthodontist, and to exert the desired & continuous gentle force to progressively position the teeth. Each aligner is made of thermoforming BPA free material sheets.
The provided text, K223338, details the 510(k) premarket notification for the "Toothsi&SmileAligners" device. The document primarily focuses on demonstrating substantial equivalence to a predicate device ("ClearCorrect System, K113618") through comparison of specifications and bench testing.
Based on the provided text, there is no acceptance criteria or study that proves device performance against specific metrics relevant to AI/algorithm-driven medical devices (e.g., sensitivity, specificity, accuracy). The document outlines acceptance criteria and performance for non-clinical bench testing related to the physical properties and manufacturing of the aligners, not for an AI algorithm's diagnostic or predictive performance.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about AI-specific studies (sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) because the provided FDA submission document pertains to a physical medical device (orthodontic aligners) and not a software/AI-driven device requiring such performance metrics.
The "K223338" submission is for "Orthodontic Plastic Bracket" (Product Code NXC), which is a physical device that repositions teeth using continuous gentle force. The performance testing outlined (Table 2 on page 5) is for the physical aligners' properties:
- Surface finishing after polishing by two methods: Accepted
- Thickness of aligners after thermoforming with reference to aligner sheets: Accepted
- Aligner shape accuracy after mimicked use for 15 days: Accepted
- 3D Model shape accuracy for effectiveness of aligner punching as per treatment plan: Accepted
These are all physical engineering characteristic tests, not performance metrics for an AI or algorithm. The document explicitly states: "No comparative testing with predicate device was possible since clear dental aligners are patient specific devices made after treatment plan." and "The above four tests relate to safety (Sr. No 1 & 4) and performance (Sr. No 2, 3 and 4) of the clear aligners."
In summary, the provided document does not contain the information required to answer questions about acceptance criteria and study data for an AI/algorithm-driven device, as the submission is for a physical medical device.
§ 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.