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The LuxCreo Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force.

LuxCreo Clear Aligner System is custom plastic aligner system which are a series of doctor prescribed clear removable aligners that are used as alternative treatment for the alignment of maloccluded or misaligned teeth. This series of aligners gently move the patient's teeth in small increments from their original state to a treated state. A 3D printer, based on a 3D stereolithographic drawing, prints the predetermined shape of each aligner. Final polymerization is achieved by placing the printed aligner in a UV-light curing box. 3D printing uses specialty liquid resins, which help the aligners achieve mechanical properties similar to thermoplastics, and increased processability. The aligners are packaged and labeled according to the sequence in which they are intended for use, determined by the prescribing dental health professional. The finished set of aligners is shipped with six-month-shelf-life to the prescribing physician, who is accountable for ensuring the patient uses the device properly and safely.

This document is a 510(k) premarket notification for the LuxCreo Clear Aligner System and describes its substantial equivalence to predicate and reference devices. It details the device's indications for use, technological characteristics, and performance data from various tests. However, the document does not contain an acceptance criteria table with reported device performance in the context of device accuracy or clinical performance. Instead, it focuses on demonstrating substantial equivalence through comparisons of:

• Biocompatibility: The document lists several ISO 10993 tests performed (genotoxicity, cytotoxicity, subcutaneous implantation, oral mucosa irritation, pyrogenicity, skin irritation, skin sensitization, acute systemic toxicity, and sub-chronic systemic toxicity). It generally states that these tests indicated the light-cured polyurethane resin is safe to use and that the biocompatibility risks were considered.
• Physical and Mechanical Properties: The document provides values for flexural strength, flexural modulus, Shore D hardness, stress relaxation, water solubility, and water sorption for the proposed device and compares them to reference devices. The comparison often notes "Different" or "Similar" but does not explicitly state acceptance criteria or whether the new device met specific thresholds for these properties.
• Manufacturing Process and Materials: The document highlights the light-cured 3D printing process and light-cured polyurethane resin used for the LuxCreo system, comparing it to the thermoforming process and different materials of predicate devices. It states that "The difference in manufacturing process and base materials did not raise other safety and efficacy concerns" and that these differences "have been tested and validated."
• Design Verification, Validation, and Manufacturing Validation: The document broadly states that these were "completed" and "All the results meet the product specification requirements." However, specific acceptance criteria and detailed results are not provided in this summary.
• Transportation and Accelerated Aging Tests: These were validated and completed.

Based on the provided text, the following information can be extracted:

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

The document does not explicitly provide a table of acceptance criteria for device performance (e.g., accuracy, clinical efficacy metrics for orthodontic treatment) alongside the reported performance. Instead, it presents various test results for material properties and general statements regarding biocompatibility and manufacturing validation. The comparisons made are primarily to predicate and reference devices to establish "substantial equivalence," not to pre-defined performance acceptance criteria stated within this summary.

Here's a compilation of the reported physical and mechanical properties:

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

The document does not specify sample sizes for any of the tests conducted (biocompatibility, physical/mechanical properties, transportation, aging, design/manufacturing validation). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

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 in the document. The studies described are primarily material and device characterization tests, not clinical evaluations requiring expert interpretation of patient data to establish ground truth.

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

This information is not applicable and not provided. The document describes laboratory testing and validation, not studies requiring expert adjudication for a test set.

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 and not provided. The LuxCreo Clear Aligner System is a physical medical device (clear aligners) and not an AI-assisted diagnostic tool or software designed to assist human readers.

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

This information is not applicable and not provided. As mentioned above, this device is a physical clear aligner system, not an algorithm, and the application is not an AI-driven standalone system. While it states software is used for ordering workflow, the performance data provided relates to the physical characteristics and safety of the aligners themselves.

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

The concept of "ground truth" as typically applied to diagnostic algorithms or clinical outcomes data is not directly relevant to the performance data presented here. The "ground truth" for the material and physical property tests would be established by the standardized methods and measurements specified (e.g., ASTM D790, ISO 20795-2, ISO 10993 series for biocompatibility). The "truth" for these tests are the measured values themselves as determined by the specific testing protocols.

8. The sample size for the training set

This information is not applicable and not provided. The document describes a physical medical device and its material properties, not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided for the same reasons as point 8.

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