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The SmileSeries™ is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in adult and adolescent patients with permanent dentition (i.e. all second molars). The SmileSeries™ positions teeth by way of continuous gentle force.

The SmileSeries™ is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. SmileSeries™ aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to SmileSeries™. A digital setup of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

This document is a 510(k) Premarket Notification from the FDA for the device "SmileSeries™" by Ordont Orthodontic Laboratories, Inc. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, not to prove that the device meets specific acceptance criteria through a clinical study in the way one might for a novel diagnostic AI algorithm.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of performance metrics that would be applicable to an AI device (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) is not present in this document.

Instead, this document describes a comparison to a predicate device based on intended use, technological characteristics, materials, and manufacturing processes, supported by bench testing for manufacturing accuracy and biocompatibility testing of the plastic material.

Here's how to address your points based on the provided document:

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

The document does not present quantitative performance acceptance criteria or reported performance results in the typical sense for a diagnostic device. Since SmileSeries™ is an orthodontic appliance (a physical device), the "acceptance criteria" revolve around demonstrating that it is substantially equivalent to a predicate device, meaning it is as safe and effective as a legally marketed device.

The "performance" is primarily shown through:

• Identical Indications for Use: The SmileSeries™ is used for the same purpose as the predicate.
• Similar Technological Characteristics: Same material (thermoformed plastic), similar manufacturing process (forming plastic sheets on models), and the same software used for planning.
• Successful Bench Testing: To validate the manufacturing process and ensure accuracy of the final aligner compared to the digital scan. No specific numerical results or benchmarks from this bench testing are provided in this summary, only that a "final report was part of the 510(k) package."
• Biocompatibility: The material meets requirements, referencing prior 510(k) submissions.

Table based on the document's comparison of characteristics:

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

This document describes bench testing for manufacturing accuracy, not clinical performance testing with a "test set" of patients or data, as would be common for an AI device. Therefore, a "sample size" in that context is not applicable or provided. The document states:

• "Bench testing was performed to validate the manufacturing process, to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan."
• "A final report was part of the 510(k) package."

No details on the sample size of items tested, data provenance, or retrospective/prospective nature are provided for this bench testing in this summary.

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. This device is an orthodontic appliance, not a diagnostic AI system requiring expert-derived ground truth for a test set. The validation focuses on manufacturing accuracy and material safety, not diagnostic performance.

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

Not applicable. As above, this is not a diagnostic study requiring adjudication of expert readings.

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. This is not an AI-assisted diagnostic device. The study performed was bench testing of the physical aligner and its manufacturing process, and biocompatibility testing of the material. The document explicitly states: "In vivo Animal and Human Clinical performance testing are not required for this device category."

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

Not applicable. This is not an algorithm-only device. The reference to software (Ortho Analyzer) is for treatment planning and 3D printing of models for the creation of the aligners, not for standalone diagnostic performance.

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

For the bench testing, the "ground truth" would implicitly be the initial digital scan or design specifications of the aligner, against which the accuracy of the final thermoformed aligner was compared. It's a comparison to a precise digital model, not a biological or clinical ground truth in the sense of disease presence.

8. The sample size for the training set

Not applicable. This refers to an AI training set, which is not relevant to this physical device submission.

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

Not applicable. As per point 8.

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