(200 days)
This device is indicated for use in the alignment of all permanent dentition through orthodontic treatment and malocclusion.
The Clear Aligner is intraoral thermoformed plastic aligner that worn 20 to 22 hours per day and is designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligner is to be removed for eating and for cleaning.
Clear Aligner is fabricated using a three-step process.
The first step is to obtain the dimensions and details of the patient's baseline dentition from the prescribing clinician who takes impressions or scans of the patient's teeth and sends them to the lab. The scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.
The second step is to sent the treatment plan to the dentist for review and approval, then print the 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, we utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.
The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. And the thermoformed aligners are sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the treatment from the first aligner until treatment is completed.
Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation is this submission is the 3Shape Ortho System ™ Software which have 510(k) (K152086).
The provided text is a 510(k) Summary for a medical device (Clear Aligners). While it details non-clinical studies and testing, it explicitly states that no clinical studies or tests were conducted (Section 11). This means the information requested regarding a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or the establishment of ground truth for training/test sets based on expert consensus or pathology data is not applicable and not present in this document.
The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical performance testing related to manufacturing validation and biocompatibility.
Here's a breakdown of the available information based on your request:
1. Table of acceptance criteria and reported device performance
The document contains a table comparing the subject device to a predicate device, but it's not a table of acceptance criteria and reported performance in the traditional sense of a clinical or AI study. Instead, the "acceptance criteria" for the manufacturing validation are described in the text.
Manufacturing Validation Acceptance Criteria & Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All translational measurements within 0.3mm of target input value | All translational measurements were within 0.3mm of the target input value. |
| All rotational measurements within 3 degrees of target input value | All rotational measurements were within 3 degrees of the target input value. |
| No statistical differences in the intended and measured values observed from any of the groups | There were no statistical differences in the intended and measured values observed from any of the groups. (Implicitly met based on the above) |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated as a numerical count of aligners or patients. The text mentions "Three critical aspects of the manufacturing process were assessed: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner." This implies a set of these items were tested, but no specific quantity is given.
- Data provenance: Not specified. It's implied this was internal testing performed by the manufacturer. The location of the test (if external) is not mentioned beyond the manufacturer's address in Shenzhen, China. The document does not specify if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the manufacturing validation was established by measurements against target input values using "an independent 3rd party software and digital calipers," not by human expert assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the ground truth was based on physical measurements, not human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done. The document explicitly states: "Clinical studies and tests were not conducted." (Section 11)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device (Clear Aligner) is a physical medical device, not an AI algorithm. The 3Shape Ortho System™ Software is mentioned as a reference device used in the manufacturing process (for treatment planning and generating 3D printer files), but no performance study of this software itself (standalone or otherwise) is presented in this 510(k) summary for the Clear Aligner. The manufacturing validation assessed the output of the process that uses the software, not the software's performance as an AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the manufacturing validation was target input values from the treatment plan, against which physical measurements of the produced aligners/molds were compared. These are physical measurement standards.
8. The sample size for the training set
Not applicable. This document describes the validation of a manufactured medical device, not the training of an AI model.
9. How the ground truth for the training set was established
Not applicable, as there was no AI model training set.
§ 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.