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BRIUS Clear Aligners are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

The BRIUS Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 2 0 to 22 hours a day and are to be removed for eating and for cleaning.

BRIUS Clear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, specialized orthodontic CAD/CAM software will be used to develop the treatment plans that consist of sequential dental models wherein the teeth are gradually realigned with each step. For this 510(k), 3Shape A/S's Ortho System (K180941) will be used for this application. Ortho System is approved for use in the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligner trays are then delivered to the prescribing dental health professional. This dental health professional then monitors treatment from the placement of the first aligner to the delivery of the final aligner and completion of treatment.

The provided text from the FDA 510(k) summary for BRIUS Clear Aligners (K202792) primarily focuses on establishing substantial equivalence to a predicate device through comparison of specifications and non-clinical performance testing. It does not describe a study involving expert readers or AI performance in the typical sense of diagnostic or prognostic devices.

Instead, the non-clinical performance testing described is related to the manufacturing process and material properties of the aligners themselves. Therefore, the requested information elements related to AI performance, expert consensus, sample sizes for test/training sets in an AI context, MRMC studies, or standalone performance are not applicable based on the provided document.

Here's a breakdown of the applicable information based on the provided text, adapted to the context of the device's manufacturing and material validation:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported performance relate to the manufacturing validation of the BRIUS Clear Aligners.

2. Sample Size for the Test Set and Data Provenance

The document mentions an "internal manufacturing validation" but does not specify a numerical sample size for the aligners tested for dimensional accuracy and qualitative assessment.

• Test Set Sample Size: Not explicitly stated as a numerical value. The study refers to "the submitted intraoral scans, digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners" being assessed, implying a collection of these components.
• Data Provenance: The validation was an "internal manufacturing validation," indicating it was conducted by BRIUS Technologies, Inc. or their associated entities. The origin country is not specified, but the company is based in Carrollton, TX, USA. It is a retrospective assessment of manufactured products against internal specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the validation was for manufacturing accuracy and material properties, not for diagnostic or prognostic AI performance requiring expert review of medical images or data. The "ground truth" was the target input values for measurements and predefined specifications for qualitative attributes.

4. Adjudication Method for the Test Set

This information is not applicable. The assessment involved objective measurements (digital calipers and 3rd party software) and qualitative visual inspections against predefined specifications, rather than an adjudication process typically used for subjective expert panel reviews.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this device is a clear aligner, not an AI software intended to assist human readers in a diagnostic task.

6. Standalone Performance Study (Algorithm Only)

A standalone algorithm performance study was not performed in the context of AI. The "manufacturing validation" described is a standalone assessment of the physical product's adherence to specifications.

7. Type of Ground Truth Used

• For Dimensional Accuracy: The ground truth was the "target input value" (digital design specifications) from the orthodontic CAD/CAM software (3Shape A/S's Ortho System).
• For Qualitative Assessment: The ground truth was predefined performance, cosmetic, and other detectable issue specifications.
• For Biocompatibility: The ground truth was adherence to international standards (ISO 10993-1 and ISO 10993-5).

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device (clear aligner) whose manufacturing process was validated, not an AI algorithm that requires a training set. The orthodontic CAD/CAM software used (3Shape A/S's Ortho System) would have its own development and validation, but that is not the subject of this 510(k) for the BRIUS Clear Aligners.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8.

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