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The UniSmile Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The UniSmile Clear Aligner System positions teeth by way of continuous gentle force.

The UniSmile Clear Aligner System is fabricated of clear thin thermoformed plastics in a sequential series to progressively reposition the teeth. Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner.

This FDA 510(k) summary for the UniSmile Clear Aligner System does not contain details of an acceptance criteria study, nor a study proving the device meets specific performance criteria through clinical data or statistical analysis.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ClearCorrect System, K113618) and a reference device (Orchestrate 3D, K181112) primarily through a comparison of:

• Intended Use/Indications for Use: The UniSmile system is indicated for "treatment of tooth malocclusion in patients with permanent dentition" to "position teeth by way of continuous gentle force," which is stated to be "Same" as the predicate.
• Technological Characteristics, Design, and Device Features: This includes comparisons of regulation number, common name, product code, device description, mode of action, anatomy location, size/dimension, method of manufacturing, material, material hardness, material tensile modulus, material tensile strength, and biocompatibility.

Here's a breakdown of the specific information requested, based on the provided document:

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

The document does not provide a table of acceptance criteria in terms of clinical outcomes (e.g., specific tooth movement percentages, treatment success rates, patient satisfaction scores) or quantitative engineering performance thresholds (beyond material properties).

Instead, the "acceptance criteria" appear to be implicit in the demonstration of substantial equivalence, where the UniSmile system's characteristics are deemed "Same" or "Similar" to the predicate device.

However, the document does provide information on material properties which can be considered "reported device performance" in a technical sense:

Note: The "acceptance criteria" for tensile modulus and strength are vaguely stated as "acceptable for as an orthodontic base material," rather than specific numerical thresholds.

Regarding the study that proves the device meets acceptance criteria:

The document does not describe a specific clinical study or an engineering performance study designed to prove the device meets pre-defined acceptance criteria for efficacy or overall clinical performance (e.g., ability to correct malocclusion in a patient population).

Instead, it relies on:

• Material Testing: "Performance properties have been tested and approved for clear aligner applications." (pg 3)
• Biocompatibility Testing: "Biocompatibility testing has been provided according to ISO-10993." (pg 3) This is further detailed in the comparison table (pg 5) as "Passed ISO 10993-1 assessment" including cytotoxicity, intracutaneous intradermal reactivity, and sensitivity.

These tests demonstrate the mechanical and biological safety of the materials used, but not the overall clinical effectiveness of the system in treating malocclusion.

Additional requested information (based on the provided text):

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

• Not provided. The document does not describe a clinical "test set" in the context of human patients or clinical outcomes for the UniSmile system. The "test set" for material and biocompatibility testing is not specified in terms of sample size or provenance.

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. No clinical "test set" requiring expert ground truth establishment for performance evaluation is described. The "ground truth" for material properties and biocompatibility would be based on validated laboratory standards and measurements, not expert consensus on clinical cases.

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

• Not applicable/Not provided. No clinical "test set" requiring adjudication or consensus among experts is described.

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/Not provided. This document describes a physical medical device (clear aligners) and a software (Orchestrate 3D) used for treatment planning, not an AI-assisted diagnostic or interpretative system where human reader performance would be a relevant metric. The software is used to design treatment plans, not to interpret cases or assist human readers in a diagnostic capacity.

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

• Not applicable/Not provided. The UniSmile Clear Aligner System involves a series of physical clear aligners and a software for treatment planning. The aligners are worn by patients, and the treatment plan is designed by software but approved by a dental practitioner (human-in-the-loop). There is no "standalone algorithm" performance assessed in the context of interpretation or diagnosis in this document.

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

• For material performance and biocompatibility, the "ground truth" is based on established ISO standards and laboratory testing protocols.
• For the software (Orchestrate 3D), the "ground truth" for its function (treatment plan design) is implicitly tied to its equivalence to the predicate software and its established regulatory clearance (K181112), and ultimately the practitioner's approval. No independent "ground truth" for treatment plan accuracy from clinical outcomes is mentioned for this 510(k).

8. The sample size for the training set

• Not applicable/Not provided. The document does not describe a "training set" in the context of machine learning or AI algorithm development for the UniSmile system or its associated software.

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

• Not applicable/Not provided. As no training set is mentioned, the method for establishing its ground truth is not relevant here.

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