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The DenMat Orthodontic Aligners are in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

The DenMat Orthodontic Aligner consists of a series of clear plastic trays, which fit over a patient's teeth, and move the teeth by external force a small amount daily. This material is the only patient contacting material, there are no lubricants, coatings, or colorants. The dental professional determines the ultimate movement needed, and an FDA-cleared software design tool is used to produce a treatment series of aligners to achieve this goal. The trays are produced when the software design tool outputs a file to a 3-D printer, which produces a resin model. The resin used to manufacture the model has been tested for cytotoxicity and has been shown to be non-cytotoxic. The positive mold is cleaned with isopropyl alcohol prior to vacuum forming the aligner. The resin model is then used with the FDA-cleared plastic material to thermoform the plastic aligner. The aligners, once formed, are rinsed with distilled water only, and air dried. Depending on the prescription, 10 to 15 aligners are produced for a single patient set. Each aligner is worn for 2 weeks, and the dental professional checks progress during treatment.

This FDA 510(k) summary does not contain the detailed study information to complete the table for Acceptance Criteria and Reported Device Performance, nor does it provide other specific details such as sample sizes for test and training sets, data provenance, expert qualifications, or adjudication methods for a diagnostic device.

The document is a declaration of substantial equivalence for a medical device (DenMat Orthodontic Aligners) to a previously cleared predicate device (Clear Image Aligners). For such devices, the primary demonstration of safety and effectiveness is often through comparisons to existing, legally marketed devices, rather than conducting new clinical trials with detailed performance metrics.

Here's what can be extracted and inferred:

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

The document does not explicitly list acceptance criteria or reported device performance metrics in the way one might expect for a diagnostic or algorithmic device that produces quantitative outputs. Instead, the "performance" is demonstrated through substantial equivalence to a predicate device.

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

This information is not provided in the document because this is not a study reporting specific performance data from a test set. The submission focuses on demonstrating equivalency to an already cleared device, not on presenting novel performance study results.

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)

This information is not provided. This type of detail is typically associated with studies evaluating diagnostic accuracy, which is not the focus of this 510(k) submission for an orthodontic aligner.

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

This information is not provided. Similar to the above, adjudication methods are relevant for studies establishing ground truth, which is not documented here.

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

An MRMC study was not conducted as part of this submission, nor is it mentioned. This device is a physical orthodontic aligner for tooth movement, not an AI-assisted diagnostic tool for human readers.

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

A standalone performance study of an algorithm was not conducted or reported here. While the manufacturing process includes "FDA-cleared software design tool," the performance being assessed is of the physical aligner itself through substantial equivalence. The software's performance would have been assessed in its own 510(k) submission (K171634/K152086 for 3Shape Ortho System).

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

The "ground truth" in this context is the safety and effectiveness established for the predicate device, Clear Image Aligners (K183643). The DenMat Orthodontic Aligner claims substantial equivalence based on sharing identical design, manufacturing materials, intended use, principles of operation, and technical characteristics. Therefore, the "ground truth" for the current submission is the established regulatory clearance of the predicate device, implying its safety and effectiveness.

8. The sample size for the training set

This information is not provided. This is not a study that involved machine learning model training.

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

This information is not provided. This is not a study that involved machine learning model training.

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