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

Clear Moves Aligners are 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. They are made of biocompatible thermoformable plastics, either from a copolyester or a composite of copolyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides physical or scanned impressions of the patient's teeth to Clear Moves Aligners. A treatment plan using commercially available treatment planning software 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 with patient identifying information and treatment step. 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 a dental device called "Clear Moves Aligners." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials. Therefore, the information provided focuses on comparisons to existing devices and bench testing, rather than detailed human clinical study data with specific acceptance criteria, expert ground truth, or MRMC studies that would be typical for more novel or higher-risk medical devices.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device itself (e.g., accuracy of tooth movement in millimeters). Instead, the "performance" described is about demonstrating that the manufacturing process is valid and the materials are biocompatible, and that the device is "substantially equivalent" to predicate devices.

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

The document explicitly states: "In vivo Animal and Human Clinical performance testing are not required for this device category." Therefore, there is no test set of clinical patient data in the traditional sense, for which sample sizes or data provenance (country, retrospective/prospective) would be applicable concerning the device's clinical performance. The "test sets" mentioned would be for biocompatibility testing (material samples) and mechanical bench testing (prototype aligners/molds). These details are not provided in terms of specific sample numbers or origins within this document.

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

Not applicable. As no human clinical performance testing was required or conducted for this 510(k) submission, there was no "ground truth" derived from expert consensus on patient outcomes/diagnoses related to the device's effectiveness. Ground truth for bench testing would typically involve engineering specifications or physical measurements.

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

Not applicable. No clinical test set requiring adjudication was used.

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 device is a physical orthodontic aligner, not an AI-powered diagnostic or assistive tool. While software is used for treatment planning, the submission focuses on the aligner itself and does not include an MRMC study comparing human performance with and without AI assistance.

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

Not applicable. This is not an AI algorithm being submitted for standalone performance. The software mentioned (Ortho Analyzer) is a pre-existing, referenced device used for treatment planning, not for autonomous diagnosis or treatment execution.

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

For the compliance requirements:

• Biocompatibility: Ground truth would be established by validated test methods (e.g., ISO standards) and comparison to known safe materials.
• Manufacturing Process Validation: Ground truth would be established by engineering specifications, CAD models, and precise measurements comparing the manufactured parts to the digital design.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set" for an algorithm to learn from data.

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

Not applicable, as no training set for an AI algorithm was used.

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The Clear Moves Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Clear Moves Aligners position teeth by way of continuous gentle force.

The Clear Moves Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of the teeth to the final desired position. The sequential aligners introduce increments that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning. Generally the typical wear time for each aligner is a two weeks duration prior to being replaced by the next aligner in sequence.

A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition, a specialized orthodontic CAD/CAM software is used to develop treatment plan. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health profession's prescription.

The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.

Once approved. the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Space Maintainers Laboratories produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.

Based on the provided text, the device in question is the "Clear Moves Aligners," which is an orthodontic device. The FDA document K240038 is a 510(k) premarket notification, indicating that the manufacturer is seeking substantial equivalence to a legally marketed predicate device rather than outright approval based on a clinical efficacy study.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence to a predicate device, rather than a clinical trial demonstrating efficacy of the aligners themselves beyond what is already established for this class of device.

The document states multiple times that "there was no clinical testing necessary to support this device" due to the well-established clinical performance of sequential aligners and the device's equivalence to its predicate.

Here's an analysis of the provided information concerning the acceptance criteria for substantial equivalence and the "study" (non-clinical testing and comparison) proving this:

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

The "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a predicate device (K223141 STR8 Clear Aligners and another reference predicate). This means showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

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

• Test Set (Non-Clinical Performance Data):
  • Manufacturing Validation: The document states "An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing for Clear Moves Aligner." and "all the aligners including in the study passed and were deemed an excellent fit." However, it does not specify the sample size (number of aligners or manufacturing runs) used for this internal validation.
  • Biocompatibility & Physical Properties: The data provenance for these tests is the "material manufacture." This implies the tests were conducted by the supplier of the Zendura FLX material, not SML. No country of origin is specified for these tests. These are presumably prospective tests performed on the material and (for cytotoxicity) the final product.
  • Clinical Performance Data: The document explicitly states: "The clinical performance of sequential aligners (product code NXC) has been well established since the first device of this category was cleared by the FDA in 1998. The Clear Moves aligners have equivalent indication and method of use to its predicate, therefore there was no clinical testing necessary to support this device." Thus, there is no clinical "test set" in the context of a new human clinical study performed for this specific device.

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)

• Manufacturing Validation: "A trained physician" evaluated the final aligner fitness. The exact number of physicians or their specific qualifications (e.g., years of experience) are not specified, beyond being "trained."
• Other Data: Given that no new clinical study was conducted for this device, the concept of "experts establishing ground truth for a test set" involving human patients does not directly apply to this 510(k) submission's safety and effectiveness demonstration beyond the general scientific and regulatory consensus on the predicate.

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

• Manufacturing Validation: The document mentions "a trained physician" evaluated the fit. It does not mention any adjudication method (e.g., multiple readers, consensus, etc.). If only one physician was involved, the adjudication method would implicitly be "none" in terms of multiple expert reviews.
• Other Data: Not applicable as no multi-reader evaluation was performed for the device's performance given the nature of the submission.

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 MRMC Study: The document explicitly states "there was no clinical testing necessary to support this device." Therefore, no MRMC comparative effectiveness study was done.
• No AI Assistance Element: This device (aligners) is a physical medical device, not an AI software intended to assist human readers (e.g., radiologists interpreting images). The software mentioned is for treatment planning, not for image interpretation by clinicians requiring AI assistance.

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

• Manufacturing Validation: An "internal manufacturing validation" was done, assessing dimensional accuracy and fit. This is a standalone performance test of the manufacturing process and aligner product, but not an "algorithm" in the sense of AI.
• Software: The Guidenia Ortho+ software is mentioned as FDA-cleared (K162850), implying it has its own standalone performance characteristics for the purpose of treatment planning, but this submission isn't validating that software itself, only confirming its cleared status.

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

• Manufacturing Validation: The "ground truth" for the manufacturing validation implicitly involved predefined engineering tolerances (0.150mm) for dimensional accuracy and a trained physician's assessment of "excellent fit" as an acceptance criterion.
• Substantial Equivalence: The primary "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate device (STR8 Clear Aligners, K223141) and the established clinical practice for sequential aligners in general.

8. The sample size for the training set

• No new training set data: Since no new clinical study was performed for this 510(k), there is no "training set" of patient data in the typical sense of an efficacy trial.
• Manufacturing Process/Software: The software used (Guidemia Ortho+) and the manufacturing processes would have their own internal validation/training data, but these details are not provided in this 510(k) summary as SML is not validating the software itself, only using a cleared one, and the manufacturing process details are proprietary.

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

• Not applicable for this 510(k) context: As explained above, no new clinical training set was established. The ground truth for the predicate device's initial clearance and the general understanding of orthodontic aligners is based on historical clinical data and expert consensus over many years in the field of dentistry and orthodontics.

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