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GENIOVA Aligners are indicated for use in the alignment of permanent 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.

GENIOVA aligners are thermoformed plastic aligners designed to be used in sequence to facilitate the movement of teeth to the desired final position. Sequential aligners introduce incremental movements that move teeth by a gentle continuous force. Aligners should be worn 20 to 22 hours a day and should be removed for eating and cleaning.

GENIOVA aligners are designed based on traditional mold impression or digital scans of the patient's dentition submitted by a dental health professional (e.g., a dentist or orthodontist). From the scan, specialized orthodontic CAD/CAM software is used to develop the treatment plans, which consist of sequential dental models in which the teeth are gradually realigned at each step. For these 510(k) applications, the Ortho system from 3Shape A/S (K180941) will be used.

(K180941) from 3Shape A/S. Ortho System is approved for use in orthodontic model management, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has 510k clearance for 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 Essix thermoplastic material used for BRIUS Clear Aligners has 510(k) clearance (K062828) for use as an aligner material; the 510(k) holder (of the material) conducted the physical properties testing for the material.

The aligner trays are then delivered to the patient by the prescribing dental health professional. This dental health professional then monitors the patient's treatment from the first aligner to the delivery of the final aligner and completion of treatment. The aligners are held in place by pressure and can be removed by the patient at any time.

The provided text describes the 510(k) summary for GENIOVA Aligners, seeking substantial equivalence to predicate devices. It details non-clinical testing for dimensional accuracy and material properties but explicitly states that clinical testing was not conducted. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for clinical performance cannot be extracted as it is not present in the document.

However, based on the non-clinical testing performed, here's what can be inferred and reported:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Dimensional Accuracy/Manufacturing Validation: Not explicitly stated as a numerical sample size. The text mentions "The submitted intraoral scans, digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners were all assessed quantitatively or qualitatively in the validation." This suggests a test set encompassing various stages of the manufacturing process of the aligners.
• Data Provenance: The testing was an "internal manufacturing validation" performed by Geniova Technologies Sociedad Limitada. No country of origin is specified for the data itself, but the company is located in Madrid, Spain. The nature of the data is quantitative measurements and qualitative visual inspections from this internal validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable/Not provided. The ground truth for dimensional accuracy testing would be the "target input value" (the digitally designed dimensions), rather than a subjective expert assessment. The validation was a technical measurement against a predefined tolerance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. Adjudication methods are typically used for subjective assessments or when there's disagreement among human reviewers. This testing involved objective measurements.

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:

• Not applicable. No clinical testing, and no AI component involving human readers is described. The device is an orthodontic aligner, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. No standalone algorithm performance testing is described for the aligners themselves, as they are physical devices. The software used for design (3Shape A/S's Ortho System) is a cleared reference device, implying its own prior standalone validation, but this document does not detail performance of that software, only its use in the aligner manufacturing process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Dimensional Accuracy/Manufacturing Validation: The "ground truth" was the target input value (the predefined digital dimensions) against which the physical measurements were compared.

8. The sample size for the training set:

• Not applicable. This document describes the validation of a physical medical device and its manufacturing process, not the training of a machine learning model.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for a machine learning model is described.

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