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This product is suitable for making invisible orthodontic appliances by additive manufacturing (light curing 3D printing) process. The orthodontic appliance is designed for orthodontic treatment. It uses continuous gentle force to adjust tooth position, correct malocclusion, and maintain the results of completed orthodontic treatment.

It can also be used for printing splints and night guards.

Additively Manufactured Aligner Resin 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.

Additively Manufactured Aligner Resin is a light-curing resin used to print orthodontic appliances. The resin is a light yellow transparent liquid. The appliance printed by a 3D printer is de-supported, cleaned and post-cured to obtain an orthodontic appliance that can correct the patient's malocclusion. This product is a light-curing 3D printing resin composed of acrylate resin oligomers and acrylate monomers as well as initiators and additives.

Additive manufacturing (light cured) orthodontic resin is a light cured acrylic resin commonly used in the manufacture of orthodontic appliances. The resin is stored in a black HDPE bottle according to the weight of the resin liquid. The color of the resin is colorless or yellowish liquid, polymerized by UV light at 385 nm or 405 nm.

The provided FDA 510(k) clearance letter details the clearance of an "Additively Manufactured Aligner Resin." This document is for a material, not a diagnostic AI device. Therefore, the information typically requested in a description of an AI device's acceptance criteria and study proving its performance (e.g., sample sizes for test and training sets, number of experts establish ground truth, MRMC studies, standalone performance) is not applicable to this submission.

The acceptance criteria and supporting studies for this material device primarily focus on bench testing (physical and mechanical properties), biocompatibility, sterility, and shelf-life. The purpose of these tests is to demonstrate that the new aligner resin is safe and effective for its intended use, comparable to already marketed predicate devices.

Here's an interpretation of the relevant information provided:

Acceptance Criteria and Performance of "Additively Manufactured Aligner Resin"

As this is a material device, the "acceptance criteria" are based on meeting established international standards for dental materials and demonstrating comparable or superior performance to existing predicate devices. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing, biocompatibility testing, and shelf-life testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

The primary standard referenced for mechanical characteristics is ISO 20795-2:2013 Dentistry – Base polymers – Part 2: Orthodontic base polymers. The acceptance criteria for each property are implicitly defined by the requirements of this standard, and the device's performance is reported as meeting these requirements or being comparable to predicate devices.

*Note: For Flexural Modulus and Ultimate Flexural Strength, the subject device's performance was statistically significantly higher than the predicate, which is considered an improvement and not an adverse difference in terms of safety or effectiveness for the material properties. For Water Solubility and Sorption, slight differences were observed but all conformed to the ISO standard.

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

The document does not specify the exact sample sizes for each mechanical property test (e.g., number of specimens tested for flexural strength). This level of detail is typically found in the full testing report, not the 510(k) summary. However, tests were conducted as "bench testing" meaning in a laboratory setting. The data provenance is implied to be from the manufacturer's internal testing facilities, Aidite (Qinhuangdao) Technology Co., Ltd., which is based in China. The testing is retrospective in the sense that it's pre-market validation performed on manufactured material samples.

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

This question is not applicable as this is a material device and not an AI or diagnostic device that requires expert-established ground truth for a test set. Ground truth for material properties is established by objective physical and chemical testing methods adhering to international standards (e.g., ISO, ASTM).

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

This question is not applicable as there is no human interpretation or subjective assessment being performed that would require an adjudication method. The testing results are quantitative measurements.

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 question is not applicable. An MRMC study is relevant for diagnostic AI devices where human readers (e.g., radiologists) interpret images with and without AI assistance. This submission is for a dental material.

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

This question is not applicable. There is no algorithm or software for standalone performance evaluation in this material device submission.

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

The "ground truth" for this material device is established by objective, standardized laboratory testing methods against pre-defined specifications and international material standards (e.g., ISO 20795-2:2013). This is analogous to a "gold standard" for material properties.

8. The sample size for the training set

This question is not applicable. This is a material device, not an AI/machine learning model, and therefore does not have a "training set" in the computational sense.

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

This question is not applicable for the same reason as point 8.

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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.

Dental health professionals achieve orthodontic tooth movement through prescription of aligners which apply force to the patient's teeth so that each tooth follows a prescribed, predetermined displacement. 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 twelve-month-shelf-life to the prescribing physician, who is accountable for ensuring the patient uses the device properly and safely.

The LuxCreo Clear Aligner System mechanism of operation, and software usage, are identical to the predicate devices, and support a determination of substantial equality. Both the LuxCreo Clear Aligner System and the predicate devices are manufactured from a biocompatible, non-sterile polyurethane materials that supports a determination of substantial equality.

This FDA 510(k) clearance letter and supporting Special 510(k) Summary for the LuxCreo Clear Aligner System (K250343) does not describe an AI medical device or a study involving AI.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K212680) by comparing:

• Intended Use/Indications for Use: Identical for both devices.
• Mode of Action: Identical (application of continuous gentle force for teeth alignment).
• Method of Use: Identical (sequential use of preformed plastic trays).
• Manufacturing Process: Identical (light-cured 3D printing).
• Material: Different, but the new material's mechanical and chemical properties were tested against pre-determined acceptance criteria and found to be equivalent or better.
• Biocompatibility: Extensive ISO 10993 testing was performed to demonstrate biocompatibility of the new material, with all results meeting requirements.
• Shelf Life: Increased from 6 months to 12 months, supported by stability and packaging integrity testing.

The document does not mention any software that performs medical functions requiring AI/ML performance evaluation, nor does it refer to terms like "algorithm performance," "diagnostic accuracy," "human-in-the-loop," "ground truth," or "expert readers" in the context of an AI study. The "software usage" mentioned (Section H, page 7) refers to ordering workflow, not a medical function.

Therefore, I cannot extract the requested information (acceptance criteria, study details for AI performance, sample sizes, expert qualifications, etc.) because the provided text describes a medical device clearance based on material and shelf-life changes, not an AI/ML component.

If the LuxCreo Clear Aligner System had an AI component (e.g., AI-powered treatment planning, AI for predicting tooth movement, or AI for assessing aligner fit from scans), that information would typically be detailed in a separate section addressing the software's performance, validation, and clinical results. This document does not contain such information.

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

The Proposed Device, DigiLine Direct Print Aligner System consists of multiple stages of 3D printed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental movements that move teeth by way of gentle continuous force to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.

The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. Once the treatment plan is reviewed and approved by a dental health professional, each aligner stage is fabricated by additive manufacturing, specifically 3D printing. The 3D printed aligner then undergoes post-processing and cleaning prior to packaging for patient use. DigiLine Direct Print Aligner System are direct-printed using DigiLine Direct Print Resin. DigiLine Direct Print Resin is a light-cured, methacrylate-based resin. Methacrylate-based resins are commonly used for the production of dental structures.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Device Name: DigiLine Direct Print Aligner System
Regulation Name: Orthodontic Plastic Bracket
Product Code: NXC
Predicate Device: Tera Harz Clear (K223355)
Reference Device: LuxCreo Clear Aligner (K212680)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for device performance (e.g., a specific percentage of dimensional accuracy or a force measurement). Instead, it describes general compliance with standards and internal specifications. The performance is assessed by demonstration of manufacturing validation and material testing meeting requirements.

2. Sample Size Used for the Test Set and Data Provenance

• The document does not specify the sample size for any test sets.
• Data Provenance: The document does not provide information about the country of origin of the data or whether the studies were retrospective or prospective. Given that no clinical studies were performed, this information is not applicable to patient data. The non-clinical tests would have been performed in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This submission relies on non-clinical performance testing (manufacturing validation, material testing, biocompatibility) against established standards rather than clinical data requiring expert review for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical studies requiring expert review for ground truth were conducted, there was no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The submission explicitly states, "Clinical Testing was not required for the Predicate Device or the DigiLine Direct Print Aligner System."
• Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. The device is a physical orthodontic aligner system, not an AI software.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. The DigiLine Direct Print Aligner System is a physical orthodontic device manufactured using 3D printing. It is not an algorithm or AI software for which standalone performance would be measured. While a "digital scan" is used for design, the core device under review is the physical aligner.

7. Type of Ground Truth Used

• The "ground truth" for proving the device meets acceptance criteria is based on engineering standards, internal design specifications, and quality control metrics established for manufacturing, materials, and biocompatibility.
• Specifically:
  • Compliance with ISO 20795-2:2013 for material performance.
  • Compliance with ISO 10993-1 for biocompatibility.
  • Demonstration of successful fabrication and meeting pre-established dimensional accuracy and quality criteria during manufacturing validation.

8. Sample Size for the Training Set

• Not applicable. This section relates to the training of an AI algorithm. The DigiLine Direct Print Aligner System is a physical medical device. The "design" phase involves digital scans and physician approval, but this is distinct from a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no AI algorithm training set for this physical device.

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