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Premium Teeth Resin, when utilized to print 3D printed dental appliances such as denture teeth for complete and partial removable dentures, try-in dentures, provisional full arch implant-supported restoration and provisional restorations such as temporary crowns and bridges, inlays, onlays and veneers, is indicated to replace or restore missing tooth structures or missing teeth.

Formlabs Premium Teeth Resin is a light-curable polymer-based resin of 3D printed dental appliances, such as denture teeth for complete and partial res, try-in dentures, provisional full arch implant-supported restoration, and provisional restorations including temporary crowns and bridges, inlays, onlays and veneers. Formlabs Premium Teeth Resin is used to fabricate patient-specific dental appliances in a stereolithographic (SLA) 3D printer using layer additive manufacturing.

This document is a 510(k) summary for a medical device (Premium Teeth Resin) and does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-based medical device.

The provided text focuses on demonstrating substantial equivalence of a new 3D printing resin (Premium Teeth Resin) to a legally marketed predicate device (VarseoSmile Temp) for dental applications. It details the product, its intended use, and compares its technological characteristics and performance to the predicate through non-clinical testing.

Therefore, I cannot extract the information required for your request from this document. The concepts of "acceptance criteria" and "study proving device meets acceptance criteria" as they relate to AI/ML device performance (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, ground truth establishment, sample sizes for AI model training/testing) are not present in this regulatory submission for a material.

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Dental LT Comfort Resin when utilized to print dental or orthodontic appliances such as occlusal splints, nightguards, mouthguards and repositioners is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.

Dental LT Comfort Resin is a light-curable polymer-based resin designed for the fabrication of biocompatible, long-term use, removable dental and orthodontic appliances, such as occlusal splints, nightguards, mouthguards and repositioners by additive manufacturing.

The provided text describes the submission and clearance of "Formlabs Dental LT Comfort Resin" by the FDA. It is not an AI/ML medical device submission, it is a statement of substantial equivalence for a new dental resin product to existing predicate devices. Therefore, the information required to answer the questions about acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML medical device is not present in the provided text.

The document details the following regarding the Dental LT Comfort Resin:

• Indications for Use: To print dental or orthodontic appliances to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism.
• Predicate Devices: Dental LT Clear V2 Resin (K222061) and KeySplint Soft (K183598).
• Technological Characteristics: Light-curable polymer-based resin for additive manufacturing (3D printing) of dental appliances, followed by post-processing (washing, curing, sanding, polishing, disinfecting).
• Performance Data:
  • Biocompatibility Testing: Evaluated according to ISO 10993-1:2018 and ISO 7405:2018. Results indicated biocompatibility for long-term (>30 days) mucosal membrane contact.
  • Performance Attributes: Tested according to ISO 20795-2, ASTM D 638-14, and ASTM D 2240-15. The results "meet passing criteria or fall between the two predicate devices."

Key takeaway: The document does not describe an AI/ML algorithm or its performance criteria, but rather the material properties and biocompatibility of a dental resin intended for 3D printing. Therefore, it is impossible to answer the questions about AI/ML device acceptance criteria and study details based on the provided text.

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Dental Clear LT V2 Resin when utilized to print dental or orthodontic appliances such as occlusal splints, night guards, or mouth guards is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.

Dental LT Clear V2 Resin is a light-curable polymer-based resin designed for the fabrication of biocompatible, long-term use, removable dental and orthodontic appliances by additive manufacturing.

The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for Dental LT Clear V2 Resin, a light-curable polymer-based resin for fabricating dental and orthodontic appliances.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The non-clinical testing data for the Dental LT Clear V2 Resin is summarized in Table 1 on page 4 of the document.

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

The document does not explicitly state the sample size used for each of the non-clinical tests (e.g., number of specimens for flexural modulus, tensile strength). The data provenance is derived from non-clinical laboratory testing conducted by the manufacturer, Formlabs Ohio, Inc. This typically implies prospective testing specifically for this device's submission. The country of origin of the data is implied to be the US, where Formlabs Ohio, Inc. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This document describes a submission for a material/device, not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" for this device is established through standardized physical and chemical laboratory testing using established ASTM and ISO methods. The qualifications involved would be those of laboratory technicians and engineers experienced in material science and dental material testing. No external expert reviewers/readers are mentioned or required for this type of submission.

4. Adjudication Method for the Test Set

Not applicable for this type of non-clinical material testing. The results are quantitative measurements against predefined acceptance criteria from established standards.

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 is a submission for a physical dental resin, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This is a material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance parameters (flexural modulus, tensile strength, elongation, hardness, water sorption, water solubility) is established through scientific and engineering measurements conducted according to recognized international standards (ASTM and ISO). For biocompatibility, the ground truth is established through evaluation against ISO 10993-1:2018 and ISO 7405:2018 standards, with specific biological endpoint testing.

8. The Sample Size for the Training Set

Not applicable. This is a material, not a machine learning model that requires a training set. The development of the resin would involve material science research and development, which is a different concept than a "training set" for AI.

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

Not applicable. As above, this is for a physical material, not an AI algorithm. The performance of the material is validated through the non-clinical testing described.

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