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This device is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment 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. This is generally done using an oral scan data or a physical impression by a dental health professional (e.g. clinician). 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. 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 document is a 510(k) Pre-market Notification from the FDA for a device called "Clear Aligner." It describes the device, its intended use, and provides information on non-clinical studies performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaways:

• This submission focuses on establishing substantial equivalence to an existing predicate device rather than proving de novo clinical efficacy.
• The primary study described is a manufacturing validation to ensure the aligner adheres to dimensional and rotational precision during its creation, which is crucial for its intended function.
• No human-in-the-loop or standalone algorithm performance studies are described as this is a physical medical device (aligner) primarily manufactured using a digital process, not an AI or software algorithm that analyzes patient data to output a diagnosis or treatment plan recommendation. The software mentioned (3Shape Ortho System™ Software) is used for the manufacturing process, not for diagnostic interpretation.
• No clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify an exact numerical sample size for the manufacturing validation study. It states that "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 multiple measurements were taken across these aspects, but the specific number of units, models, or measurements is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study is a non-clinical manufacturing validation, meaning it would typically involve controlled laboratory testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This section is not applicable as the ground truth for this non-clinical manufacturing validation was not established by human experts. Instead, the ground truth was the "target input value" derived from the treatment planning software, and measurements were compared against this engineering specification.

4. Adjudication method for the test set

• Not applicable. There was no human adjudication process described for the manufacturing validation. The comparison was against objective numerical tolerances (0.3mm for translation, 3 degrees for rotation).

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. An MRMC comparative effectiveness study was not performed. The device is a physical aligner, and this submission focuses on its manufacturing precision and biocompatibility, not on an AI algorithm that assists human readers/diagnosticians.

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

• No. This is not an AI or software device that performs standalone interpretations or recommendations. The software (3Shape Ortho System™ Software) is used for the manufacturing process of the physical aligner, not for standalone diagnostic performance.

7. The type of ground truth used

• For the manufacturing validation, the ground truth was the predefined "target input value" (engineering specifications) for translational and rotational movements as determined by the treatment planning software. This is a form of engineering specification/design ground truth.
• For biocompatibility, the ground truth was compliance with international standards (ISO).

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." The manufacturing process validation does not involve machine learning model training.

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

• Not applicable. As there is no training set, this question is irrelevant.

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