The product is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers.

TempFIT Temporary Crown and Bridge Resin is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers. The mixing ratio, based on volume, base paste: catalyst paste =1:1 or 10:1. TempFIT Temporary Crown and Bridge Resin is delivered in a bio-cartridge. The curing mechanism between methacrylates is self-curing, which fundamentally belongs to free radical polymerization in reaction principle. Free radical polymerization typically occurs in unsaturated molecules containing double bonds. Both methacrylate resins in TempFIT Temporary Crown and Bridge Resin and silane coupling agents on filler surfaces contain numerous carbon-carbon unsaturated double bonds. When the two-component system is mixed, a redox reaction generates abundant free radicals that initiate the polymerization of these double bonds.

This FDA 510(k) clearance letter is for TempFIT Temporary Crown and Bridge Resin. It addresses the substantial equivalence of this device to a legally marketed predicate device (Luxatemp Ultra/Star, K101710).

However, this document does not describe the kind of AI/ML device study that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, and the use of expert readers for ground truth establishment. Instead, it focuses on the equivalence of a dental biomaterial product based on its physical, chemical, and biological properties.

Therefore, I cannot directly extract the detailed information requested regarding acceptance criteria and a study proving device performance in the context of an AI/ML medical device. The document describes a non-clinical testing approach for a dental material.

Here's how I can address your request based on the provided text, while highlighting the limitations:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for a Dental Material):

Study Details (Non-Clinical for a Dental Material):

1. Sample size used for the test set and the data provenance:

   • The document mentions "test results demonstrated the qualification and substantial equivalence." However, it does not specify the sample sizes of the materials tested for each physical property.
   • Data Provenance: The tests were performed according to ISO 10477 and Internal standard SOP of the company (HUGE SOP). Given the submitter's location (Rizhao City, China), the testing was likely conducted in China. The study is a non-clinical, laboratory-based performance test, not involving patient data.

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

   • Not applicable in this context. The "ground truth" for chemical and physical properties are established through standardized laboratory measurement techniques as per ISO standards and the company's internal SOPs, not through expert human interpretation in the way AI/ML ground truth is established.

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

   • Not applicable. This is a non-clinical material test, not a subjective human-reading assessment.

4. 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. This type of study is relevant for AI-assisted diagnostic devices. This submission concerns a dental biomaterial.

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

   • Not applicable. This is not an algorithm-based device.

6. The type of ground truth used:

   • The "ground truth" for the physical and chemical properties of the temporary crown and bridge resin are the established measurement protocols and thresholds defined by ISO 10477 and the company's internal SOPs. These are objective, quantitative measurements (e.g., MPa for flexural strength, µm/mm³ for water sorption).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The "development" of the material would involve chemical formulation and iterative testing, but not a "training set" in the computational sense.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

In summary, the provided FDA clearance letter demonstrates a material's safety and effectiveness through adherence to established material standards and comparison to a predicate device, rather than through an AI/ML performance study.

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Asiga DentaTOOTH is intended exclusively for professional dental work. Asiga DentaTOOTH is a 3D print resin indicated for the manufacturing of 3D printed temporary crowns, bridges, inlays, onlays and veneers.

DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3.

DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce denture temporary dental restorations. DentaTOOTH resin has been validated for use with the Asiga Max Series and Pro Series printers for the manufacture of temporary dental restorations at 385nm wavelengths.

DentaTOOTH is a light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. DentaTOOTH is a Type 2, Class 2 resin per ISO 10477:2020 and Type 1, Class 2, Group 2 resin per ISO 4049:2019.

DentaTOOTH has a shelf life of 36 months. The device may be stored in Asiga Max and Pro Series printers for up to 4 weeks with hood closed.

DentaTOOTH is compliant to ISO 10477:2020 and ISO 4049:2019 for polymer based crown and veneering materials, and polymer based restorative materials, respectively.

The provided FDA 510(k) clearance letter for DentaTOOTH is for a temporary crown and bridge resin, not an AI-powered diagnostic device. Therefore, the information requested regarding acceptance criteria and studies that prove the device meets these criteria (such as MRMC studies, ground truth establishment, expert consensus, etc.) are not applicable to this type of device.

The 510(k) summary clearly states:

• Device Name: DentaTOOTH
• Common Name: Temporary crown and bridge resin
• Classification Name: Crown And Bridge, Temporary, Resin
• Regulation Number: 872.3770 (which corresponds to Temporary Crown And Bridge Resin)
• Product Code(s): EBG

The documentation details non-clinical tests performed in accordance with specific ISO standards relevant to dental materials (ISO 10477:2020 for Polymer-based crown and veneering materials and ISO 4049:2019 for Polymer-based restorative materials). These tests evaluate material properties such as:

• Depth of cure
• Surface finish
• Flexural strength
• Water sorption
• Solubility
• Shade consistency
• Color stability
• Packaging validation
• Shelf life
• Biocompatibility (according to ISO 10993-1:2018)

The clearance is based on the substantial equivalence of DentaTOOTH's material properties and indications for use to legally marketed predicate devices, as demonstrated by these material-specific performance tests.

Therefore, I cannot provide a response to your numbered points as they are designed for the evaluation of AI/ML or diagnostic devices, which is not what DentaTOOTH is.

The questions you posed are typical for the regulatory review of Software as a Medical Device (SaMD) with AI/ML components, particularly those involved in image analysis or diagnosis where performance is measured by metrics like sensitivity, specificity, or reader agreement. DentaTOOTH is a material, not a software or diagnostic device.

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Indication for use:

• Temporary anterior and posterior crowns;
• Implant and abutment supported prosthetics;
• Partial, complete and hybrid denture prosthetics (base and teeth).

Not Found

This FDA 510(k) clearance letter pertains to dental materials (Temporary Crown And Bridge Resin) and does not contain any information about an AI/ML medical device, its acceptance criteria, or the study that proves the device meets those criteria.

Therefore, I cannot extract the requested information regarding:

• Acceptance Criteria Table: There is no mention of performance metrics like sensitivity, specificity, or AUC.
• Sample Size and Data Provenance: No details about test sets, training sets, countries of origin, or retrospective/prospective studies.
• Expert Ground Truth: No information about the number or qualifications of experts or how ground truth was established.
• Adjudication Method: No mention of 2+1, 3+1, or any other adjudication process.
• MRMC Study: No indication of a multi-reader, multi-case comparative effectiveness study or related effect sizes.
• Standalone Performance: No data on the algorithm's performance without human intervention.
• Type of Ground Truth: No mention of pathology, outcomes data, or expert consensus.
• Training Set Sample Size and Ground Truth Establishment: No information provided.

The document is solely a regulatory approval for a physical dental product, not a software or AI/ML device requiring performance evaluation against clinical ground truth.

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TEMP MASTER, PMMA-based dental resin developed by Taiwan Dental Materials CO., LTD. is a self-cured resin indicated for the fabrication of short-term restorations including temporary inlays, crowns, and bridges, which can protect or restore damaged teeth while permanent restorations are being prepared. It is a traditional auto-cured PMMA-based resin composed of powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature.

TEMP MASTER, PMMA-based dental resin, is a self-curing (cold-cure) material designed to fabricate temporary crowns and bridges. It consists of two components: powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature. Classified as a Type 1 (autopolymerizable) acrylic resin according to ISO 10477 standards, TEMP MASTER, PMMA-based dental resin provides reliable performance for temporary restorations.

This document describes a 510(k) premarket notification for a dental material, not an AI/ML powered device. Therefore, much of the requested information regarding AI/ML device studies (such as sample sizes for test and training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable.

However, I can extract the acceptance criteria and reported device performance based on the provided bench testing information for the TEMP MASTER, PMMA-based dental resin.

Here's the information as it relates to the provided document:

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

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

• Sample Size: The document does not specify the exact sample sizes used for the bench tests. It only states that "the nonclinical tests conducted in accordance with ISO 10477 assessed the flexural strength, water sorption, and water solubility."
• Data Provenance: The bench testing was performed to support the 510(k) submission from "Taiwan Dental Materials CO., LTD." The data would therefore originate from Taiwan, likely conducted prospectively for regulatory submission.

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)

Not applicable. This is a dental material, and the performance is evaluated through objective physical and chemical bench testing against international standards (ISO 10477). There were no human experts involved in establishing a "ground truth" in the way it's understood for AI/ML diagnostic devices.

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

Not applicable. As this involves physical/chemical testing, there is no "adjudication method" in the context of human interpretation or consensus. The tests would be performed according to standardized protocols and the results measured objectively.

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 medical device (dental material), not an AI/ML algorithm requiring human interpretation.

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

Not applicable. This is a medical device (dental material), not an AI/ML algorithm.

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

The "ground truth" for the device's performance is established by international standards for dental materials (ISO 10477). These standards define the acceptable ranges and methodologies for evaluating physical and chemical properties like flexural strength, water absorption, and water solubility.

8. The sample size for the training set

Not applicable. This is a medical device (dental material), not an AI/ML algorithm that requires a "training set."

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

Not applicable. This is a medical device (dental material), not an AI/ML algorithm.

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· Lucitone Digital Print™ 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures* and implant overdentures.
· Lucitone Digital IPN™ 3D Premium Tooth is a light-cured resin intended for printing denture teeth. Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is intended for use as:
· Printing resin for fabricating removable dentures for try-in and evaluation prior to fabrication of the final denture.*
· Printing resin for fabricating a temporary denture.
· Printing resin for fabricating denture teeth in full arches and segments that will subsequently be fused into a denture base.
· Printing resin for fabricating provisional crowns, bridges.**
• Lucitone Digital Fuse™ Step 1 – 3D Tooth Conditioning Agent is indicated for use in enhancing the bond of denture teeth to denture base and denture base to denture base.
· Lucitone Digital Fuse™ Step 2 - 3D Denture Bonding Resin is utilized as an aid in bonding denture teeth to denture base as well as repair using traditional techniques.
· Lucitone Digital Fuse™ Step 3 – Total 3D Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.
*Partial and full dentures are replacement for patients with missing teeth.†
**For instructions on printing provisional crowns and bridges with Lucitone Digital Value reference Section G in IFU
+Statement added for EU MDR alignment.

Lucitone Digital Value™ (LDV) 3D Economy Tooth & Trial Placement, which is part of the Lucitone Digital Print™ Denture (LDPD) System, is a methacrylate-based resin system which is used to fabricate dental prostheses using an additive printer and computer aided design and computer aided manufacturing (CAD/CAM) technologies.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary for a dental device (Lucitone Digital Print Denture™ System) that describes the device, its indications for use, and a few performance tests.

Specifically, the following information is not present in the text:

• A comprehensive table of acceptance criteria and reported device performance. While some performance metrics are listed (Flexural Strength, Flexural Modulus, Water Sorption, Water Solubility), these are general and not presented as specific acceptance criteria with corresponding performance test results. For example, for "Flexural Strength," it only states "≥50 MPa" as the acceptance criterion, but it does not report the actual performance value obtained for the subject device.
• Sample size used for the test set and data provenance. The document only mentions "In all instances, the subject device functioned as intended and all test results observed were as expected," without providing details about the test set.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement with AI assistance. This device is a denture system, not an AI or diagnostic tool, so an MRMC study is highly unlikely to be relevant.
• If a standalone (algorithm only without human-in-the-loop performance) study was done. This is not applicable to a physical dental device.
• The type of ground truth used. This is not applicable in the context of a physical materials performance study.
• Sample size for the training set. This is not applicable as it's not an AI model.
• How the ground truth for the training set was established. This is not applicable as it's not an AI model.

The document mainly focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (material properties) and biocompatibility, rather than a clinical study evaluating diagnostic or treatment efficacy that would typically involve test sets, ground truth, and expert adjudication. The "Performance Data" section explicitly states, "Clinical and Pre-clinical testing were not necessary to demonstrate equivalence."

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SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.

SprintRay Digital Temp is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer of the composite material. SprintRay Digital Temp resin is offered in various shades such as Bleach, A1, A2 and B1. Digital Temp is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.

SprintRay Digital Temp resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Digital Temp resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Digital Temp file created in an optical impression system, 3D printer, and curing light equipment.

Digital Temp resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.

The provided text is a 510(k) summary for SprintRay Digital Temp, a light-curable resin used for fabricating temporary dental restorations. It does not contain information on acceptance criteria or studies proving that a device meets such criteria for an AI/ML-based medical device.

Instead, it focuses on the substantial equivalence of the Digital Temp resin to a predicate device based on:

1. Intended Use/Indications for Use: Both are for temporary dental restorations.
2. Technological Characteristics: Both are light-cured acrylate resins used with 3D printers and scanned 3D images.
3. Performance Data: Biocompatibility testing and bench testing based on ISO 10477 were performed, and the resin "functioned as intended."

Therefore, I cannot extract the requested information about acceptance criteria and the study proving an AI/ML device's performance, as the document describes a material (resin) and not an AI/ML algorithm.

The questions you've asked (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies) are highly relevant to AI/ML device evaluations but are not addressed in this material-focused 510(k) summary.

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• Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
• Fabrication of long-lasting temporary restorations;
• Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.

Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.

The provided text is a 510(k) summary for the device PrimmaArt, a temporary crown and bridge resin. It describes the device, its indications for use, comparison with a predicate device (Structur 3), and non-clinical testing results.

However, the document does not contain information regarding a study involving human readers, ground truth establishment, sample sizes for test or training sets, or expert qualifications for AI/ML device performance analysis. The acceptance criteria and "device performance" in the context of this document refer to physical and chemical properties of the dental resin, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and study details related to an AI/ML device per the input prompt's structure. The device described, PrimmaArt, is a material, not a software or AI/ML device.

However, I can extract the acceptance criteria and reported device performance for the dental resin based on the provided tables:

1. Table of Acceptance Criteria and Reported Device Performance (for PrimmaArt dental resin):

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

• This information is not applicable as the study involves material testing, not an AI/ML algorithm or dataset. The tests are performed on samples of the PrimmaArt resin. The data provenance is DentsCare LTDA, Brazil, as the manufacturer.

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

• Not applicable as this is not an AI/ML device. Ground truth, in this context, refers to the adherence of the material's properties to international standards (e.g., ISO) and internal design inputs.

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

• Not applicable as this is not an AI/ML device evaluated by human readers. The assessment is based on direct measurement against established material performance 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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device. The performance tests are for the material itself.

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

• For the non-clinical testing of the dental resin, the "ground truth" or reference for acceptance is defined by recognized international standards (e.g., ISO 7491, ISO 10477, ISO 4049) and the device's internal design input specifications.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no concept of a "training set" for a dental resin material in this context.

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

• Not applicable as this is not an AI/ML device.

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The C&B NFH Hybrid is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The C&B NFH Hybrid material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restoration of C&B NFH Hybrid requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

The C&B NFH Hybrid is a light-cured, methacrylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including occlusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays and veneers. Methacrylate based resin is known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physicalchemical, mechanical and biocompatible properties.

This document is a 510(k) Premarket Notification from the FDA for a dental resin material named "C&B NFH Hybrid." It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria in a clinical study involving experts or human readers with AI assistance.

Therefore, many of the requested details about acceptance criteria and a study proving device meets them are not applicable in this context, as this document pertains to a material's physical and chemical properties and biocompatibility for substantial equivalence, rather than an AI-powered diagnostic device or a device requiring a multi-reader, multi-case study.

However, I can extract the acceptance criteria and reported performance for the physical properties of the dental resin, which are relevant to its substantial equivalence.

Acceptance Criteria and Reported Device Performance (Physical Properties of Dental Resin)

Study Information (Based on the document provided):

1. Sample size used for the test set and the data provenance: Not explicitly stated with specific numbers of samples for each test (e.g., how many specimens were tested for flexural strength). The data provenance is from non-clinical performance testing conducted by the manufacturer, ARUM DENTISTRY Co., Ltd., likely in a laboratory setting. This is not patient-specific or clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For physical property testing of a material, "ground truth" is typically established by standardized testing methods and measurements, not by expert interpretation in the medical sense.

3. Adjudication method for the test set: Not applicable. Standardized laboratory testing methods do not involve adjudication in the way clinical studies with human observers do.

4. 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 dental material, not an AI-powered diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material, not an algorithm.

6. The type of ground truth used: Standardized laboratory measurements according to ISO 10477:2020 and ISO 4049:2013 for physical properties (flexural strength, water sorption, solubility). For biocompatibility, compliance was shown with ISO 7405, ISO 10993-1, -5, -10, -11, -12, and -23.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires training data.

8. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" (Non-Clinical Performance Data) from the document:

The device did not undergo a "study" in the clinical sense with human readers or AI. Instead, the manufacturer provided Non-Clinical Performance Data to support the substantial equivalence determination for the "C&B NFH Hybrid" dental resin.

The data presented focuses on:

• Physical Property Testing: The device was tested for flexural strength, water sorption, and solubility. The reported values demonstrate that the device meets or exceeds the requirements set by the international standards ISO 10477:2020 ("Dentistry - Polymer-based crown and veneering materials") and ISO 4049:2013 ("Dentistry - Polymer-based restorative materials").
• Biocompatibility: The C&B NFH Hybrid material (Dimethacrylate based resins) was shown to be compliant with a series of ISO 10993 and ISO 7405 standards for biocompatibility (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).
• Shelf-Life: Accelerated aging tests in accordance with ASTM F1980 validated a 2-year shelf-life.

The purpose of these tests was to demonstrate that the C&B NFH Hybrid has similar safety and effectiveness characteristics to its predicate device (K202846, TERA HARZ by Graphy Inc.) and meets established performance standards for dental materials. The conclusion is that the subject device is substantially equivalent to the predicate device.

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NextDent Jet Denture Base is a light curing resin intended for 3D printing of a full or partial denture base to form a denture. The product, when used in combination with NextDent Jet Denture Teeth can be used for 3D printing a removable full or partial denture. For dental professional use only.

NextDent Jet Denture Teeth is a light curing resin intended for the 3D printing of artificial teeth to form a denture, temporary crowns or bridges. The product, when used in combination with NextDent Jet Denture Base can be used for 3D printing a removeable full or partial denture. For dental professional use only.

NextDent Jet Denture resins are pre-mixed combinations of acrylate-based light-cure resins with pigments, polymerized via photo initiators in a 3D printer setting for the fabrication of full or partial denture bases and artificial teeth to form a denture and for the fabrication of temporary crowns or bridges. The resins must be used in combination with 3D Systems printers that support MultiJet Printing technology. Devices are produced in an automated additive manufacturing method where ultra-thin layers of photopolymer material are jetted onto a build tray. Immediately after being jetted, each photopolymer layer is cured by UV light. The process repeats layer by layer until the 3D part is complete. Upon completion the support material is removed, and the product is cleaned. When printing a denture base, bonding of artificial teeth to the denture base is possible to form a denture. The bonding agent instructions should be followed. Printed parts are finished using conventional dental methods and instruments.

The provided text is a 510(k) Premarket Notification from the FDA for "NextDent Jet Denture Base" and "NextDent Jet Denture Teeth". It describes the device, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices.

However, the provided text does not contain information related to an AI/ML device. Specifically, there is no mention of acceptance criteria for an AI algorithm, test set details, expert involvement in ground truth establishment, MRMC studies, or training set information. The testing described focuses on the mechanical and biocompatibility properties of the dental resins, adhering to ISO standards for dental materials.

Therefore, I cannot provide an answer that describes the acceptance criteria and the study proving an AI/ML device meets them based on the provided text. The questions posed in your prompt (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for AI, training set details) are relevant to AI/ML device evaluations but are not addressed in this document, as it pertains to a materials-based medical device.

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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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