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The Clear Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

The Clear Aligners are intraoral thermoformed plastic aligners that are worn 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. The 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 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.

The provided text describes the 510(k) submission for the Shenzhen Meiming Dentistry Technology Co., Ltd Clear Aligner. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria related to clinical performance or an AI component.

The document primarily details non-clinical tests for manufacturing validation and biocompatibility. There is no mention of an AI algorithm or an AI-powered device, nor is there any AI-specific study described. The software mentioned (3Shape®) is for treatment planning and producing 3D printer files, which is a common CAD/CAM software used in dentistry, not an AI for diagnosis or treatment recommendation.

Therefore, many of the requested sections regarding AI-specific criteria, such as "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," "adjudication method," and "sample size for the training set" cannot be answered from the provided text, as these are not relevant to this device's submission.

Here's a breakdown of the information that is available based on your request:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Manufacturing Validation Accuracy: The document states that "digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner" were assessed, but it does not specify the sample size (e.g., number of models, molds, or aligners) used for this testing.
• Biocompatibility: The text indicates that these tests were conducted on the "material," but the sample size for these tests is not specified.
• Data Provenance: Not specified, but implied to be internal testing by the manufacturer or a contracted lab.

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 as this is not an AI device submission requiring expert human adjudication for a test set. The manufacturing validation used "an independent 3rd party software and digital calipers" for measurement, which implies objective measurement, not expert opinion for ground truth.

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

• Not applicable. The manufacturing validation relied on objective measurements rather than expert 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. This is not an AI device, and no MRMC study was conducted or described.

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

• Not applicable. This is not an AI device.

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

• Manufacturing Validation Accuracy: The ground truth for translational measurements was the "target input value" from the digital treatment plan. The actual measurements were then compared against this target.
• Biocompatibility: The ground truth for biocompatibility tests is based on established scientific standards and protocols for cytotoxicity, irritation, and sensitization, with results compared against these defined requirements.

8. The sample size for the training set

• Not applicable. This device does not involve an AI algorithm with a training set. The 3Shape® software mentioned is a commercial CAD/CAM treatment planning software, not a custom-trained AI model.

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

• Not applicable. This device does not involve an AI algorithm with a training set.

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