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510(k) Data Aggregation
(253 days)
Smylic Invisible Clear Aligners
The Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
The Smylio Invisible Clear Aligners are intraoral thermoformed plastic aligners that are worn 20 to 22 hours per day and are 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 aligners are to be removed for eating and for cleaning.
Smylio Invisible Clear Aligners are fabricated using a three-step process.
The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.
The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor 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.
Here's an analysis of the provided text regarding the Smylio Invisible Clear Aligners' acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Measure | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Accuracy | All translational measurements within 0.3 mm of the target input value. | All translational measurements were within 0.3 mm of the target input value. |
| All rotational measurements within 3° of the target input value. | All rotational measurements were within 3° of the target input value. | |
| Biocompatibility | Compliant with ISO 7405:2008 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry). | Tested and shown to be compliant with ISO 7405:2008. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes a "manufacturing validation" study. While it states that "three critical aspects of the manufacturing process were assessed," it does not explicitly state the sample size (e.g., number of aligners, number of 3D models tested).
The data provenance is not specified regarding country of origin, nor whether it was retrospective or prospective. Given it's a manufacturing validation, it's inherently prospective in the sense of testing newly manufactured prototypes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the manufacturing validation. The ground truth was established by "target input values" or "predefined tolerance of the manufacturing process." An "independent 3rd party software and digital calipers" were used for measurements.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as experts were not used to establish ground truth. Measurements were taken using instrumentation and compared against predefined tolerances.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing was not conducted."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The manufacturing validation study appears to be a standalone performance assessment of the manufacturing process and resulting product (aligners). While software (3Shape®) is involved in the design and planning, the validation focuses on the physical accuracy of the manufactured components (digital models, 3D printed molds, thermoformed aligners) against their intended values, not on the performance of the software as a standalone diagnostic or treatment planning tool in comparison to a human. The independent 3rd party software and digital calipers act as the measurement tools, not as the AI algorithm itself being evaluated.
7. The Type of Ground Truth Used
The ground truth used for the manufacturing validation was based on pre-defined target input values for translational and rotational measurements. These targets represent the intended or desired dimensions and angles planned during the treatment design.
8. The Sample Size for the Training Set
No training set is mentioned or applicable here. The study described is a manufacturing validation, not an AI algorithm development study that would involve training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set.
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