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

Illusion Aligners are intraoral thermoformed plastic aligners that are worn at least 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. Illusion Aligners are fabricated using a ten-step process.

The Step 1 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. Step 3, the scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. In the Step 3, Laxmi Dental Exports Pvt Ltd, Inc. utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. Step 4, the treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. Step 5 is the printing of 3D models of the treatment plan for use in Step 7 thermoforming. The thermoforming process is accomplished using a standard thermoforming equipment and the appropriate material as outlined in this submission.

The provided document, K211010, describes a 510(k) premarket notification for "Illusion Aligners." This document primarily focuses on establishing substantial equivalence to a predicate device (Smylio Invisible Clear Aligner, K173784) rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the manner of a clinical trial for a novel AI/software medical device.

Therefore, the information required for a comprehensive answer regarding acceptance criteria and a study proving device performance (especially for an AI/ML device) is largely not present in this document.

However, I can extract the information that is available and explain why other requested information is missing.

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

This document does not present quantitative acceptance criteria or reported device performance for a software-driven clinical outcome in the format typically seen for AI/ML devices. Instead, it focuses on demonstrating equivalence through material properties and manufacturing processes.

• Part 5 (Cytotoxicity Elution - MEM)
• Part 10 (Skin Irritation)
• Part 10 (Guinea Pig Maximization Test) | - PETG (Polyethylene terephthalate glycol) material tested according to Good Laboratory Practices.
• Tests performed as per ISO 10993 Parts 5 and 10.
• "No effect on biocompatibility. ISO 7405 directly references the same test as conducted using ISO 10993 et.al." (referring to the predicate device's biocompatibility summary). |
  | Non-Clinical Physical Properties | Adherence to ASTM standards:
• Elongation @ Yield (%) ASTM D638
• Elongation @ Break (%) ASTM D638
• Tensile @ Yield (PSI) ASTM D638
• Tensile Strength (PSI) ASTM D638
• Tensile Modulus (PSI) ASTM D638
• Water Absorption (%) 24 hours @ 23°C ASTM D570 | - Device material tested to the listed ASTM standards.
• Stated that the material "meet the acceptance criteria" (specific values not provided in this summary). |
  | Intended Use | "Alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion." | The "Illusion Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion." This matches the predicate device's intended use. |
  | Technological Principle (Mode of Action) | "Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays." | "In the same manner as the predicate device, each aligner exerts gentle force to achieve progressive realignment of the teeth until the final correction has been attained. This is based on the treatment plan and proceeds over time." |
  | Manufacturing Process / Software | Use of FDA 510(k) cleared software for treatment planning. | Utilizes "3Shape Software K180491 and K152086," which are "FDA 510K cleared."
  "The use/manufacturing process has been validated by Laxmi."
  "Laxmi Dental Exports Pvt Ltd. prepares the treatment plan in Step 2... for subsequent approval by a doctor," which is considered "No effect, both treatment plans are doctor approved" when compared to the predicate. |
  | Material (Equivalence to Predicate) | Material properties suitable for clear aligners, showing no safety or effectiveness differences when compared to the predicate. | Illusion Aligners use PETG (Polyethylene terephthalate glycol) material versus the predicate's "Thin thermoformed polyurethane" (Smylio Uses Zendura polyurethane).
  "No effect, PETG (Polyethylene terephthalate glycol) material is manufacturing validated and biocompatible." |

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. The document describes non-clinical physical and biocompatibility testing of the material itself, not a clinical study on patient outcomes with a "test set" of patient data. The "testing" referred to is laboratory testing of the material. There is no mention of a test set for assessing algorithmic performance on patient data.

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 applicable/not provided. There is no "test set" with ground truth established by experts described in this 510(k) summary relating to clinical performance or AI/ML algorithm output. The document focuses on material properties and manufacturing process equivalence.

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

This information is not applicable/not provided. No adjudication method for a test set is mentioned.

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

This information is not applicable/not provided. This device is a physical orthodontic aligner. While its manufacturing process involves software for treatment planning, the document does not describe it as an AI-assisted diagnostic or decision-support tool that would undergo an MRMC study comparing human performance with and without AI assistance. The software mentioned (3Shape) is for designing the aligners, not for interpreting medical images or providing clinical diagnoses.

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

This information is not applicable/not provided. This device is not an algorithm-only standalone diagnostic or treatment device. It is a physical aligner whose design process uses software. The software, 3Shape, is referred to as "FDA 510K cleared," indicating it has its own clearance. The current submission is for the physical aligners.

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

This information is not applicable/not provided in the context of an AI/ML device performance study. The "ground truth" here would relate to the physical and biocompatibility properties of the material, which are measured directly by laboratory tests (e.g., precise measurements for ASTM standards, cellular responses for ISO 10993).

8. The sample size for the training set

This information is not applicable/not provided. Since this is a submission for a physical medical device (aligners) and not a de novo AI/ML algorithm, there is no mention of a "training set" in the context of machine learning. The "training" here would refer to the historical data and experience used to develop the manufacturing process and material selection.

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

This information is not applicable/not provided for the same reasons as #8.

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