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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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Rodin Titan 3D Resin is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable denture teeth to be used in a denture. It is indicated as a permanent restorative for both anterior restorations, including occlusal surfaces. It is used for fabricating permanent restorations such as inlays, veneers and full crown restorations.

RODIN Titan 3D Resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need. Fabrication of dental prosthetics with RODIN Titan 3D Resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment. The material is an alternative to traditional dental prostheses material Rodin Titan 3D Resin is intended exclusively for professional dental work. RODIN Titan 3D Resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

The provided text describes a medical device, RODIN Titan 3D Resin, and its acceptance criteria, along with performance data to demonstrate substantial equivalence to predicate devices. The study conducted is primarily a set of performance tests against established standards and comparisons to existing products, rather than a clinical trial with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with international standards (ISO, ASTM) and performance comparable to predicate devices. The "Specification" column in Table 1 represents the acceptance criteria for most physical properties, usually a minimum or maximum value. For some parameters, "N/A" is listed, indicating that there is no specific quantitative acceptance criterion listed in the table, but the result is provided.

Note: For properties listed as N/A under "Specification", their acceptance is often implied by demonstrating comparable performance to predicate devices or simply reporting the value without a specific threshold stated within the document. The comparability to predicate devices is shown in Table 2.

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

The document does not explicitly state the numerical sample size (e.g., number of specimens tested for flexural strength). It refers to the tests being conducted according to specific ISO and ASTM standards, which would define the required sample sizes for each test method.

• Data Provenance: The data appears to be from laboratory testing performed by the manufacturer, or a contracted lab, to characterize the material properties. There is no information provided regarding the country of origin of the data or whether it is retrospective or prospective, but it is characteristic of premarket submission data based on physical and chemical testing.

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

This type of study does not involve expert readers establishing ground truth in the way a diagnostic imaging AI would. The "ground truth" for the performance tests outlined here is defined by:

• Established physical and chemical test methods: The performance data (e.g., flexural strength, water sorption) are objective measurements derived from standardized laboratory tests (ISO, ASTM protocols).
• Predicate device data: The "ground truth" for substantial equivalence comparison is the performance of legally marketed predicate devices, which have already been deemed safe and effective.

Therefore, there were no human experts (e.g., radiologists) establishing ground truth for the test set in this context. The "experts" would be the scientists and engineers who conducted the material characterization tests and those who established the ISO/ASTM standards.

4. Adjudication Method for the Test Set

Not applicable for this type of material characterization study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly for diagnostic accuracy, where there is subjective interpretation of findings (e.g., by multiple radiologists) requiring a consensus mechanism.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers' Improvement with AI vs. without AI Assistance

Not applicable. This device is a dental resin material, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assisted human reader improvement analysis was performed or described.

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

Not applicable. This is a physical material, not an algorithm. The performance data presented are "standalone" in the sense that they are intrinsic properties of the material itself, measured in laboratory settings.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this device's performance is based on:

• Standardized Physical and Chemical Characterization: Data derived from established and validated laboratory test methods (ISO, ASTM standards). This is the primary ground truth for material properties.
• Predicate Device Performance: Performance data from already cleared predicate devices serve as a comparative ground truth to establish substantial equivalence.
• Biocompatibility Standards: Compliance with ISO 10993 provides the ground truth for biological safety.

8. The Sample Size for the Training Set

Not applicable. This device is a material, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a material or a traditional AI model discussed.

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SprintRay OnX Tough is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture.

OnX Tough resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.

Fabrication of dental prosthetics with OnX Tough resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment.

The material is an alternative to traditional dental prostheses material. OnX Tough resin is intended exclusively for professional dental work.

OnX Tough resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SprintRay OnX Tough device.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically on a standalone clinical study demonstrating the device's diagnostic performance against a "ground truth" established by experts, as would be common for AI/ML devices. Therefore, many of the requested points from your prompt (like sample size for test sets, expert qualifications, MRMC studies, standalone algorithm performance, training set details) are not applicable in this context as this is a dental material, not an AI/ML diagnostic device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device, OnX Tough, was tested against industry consensus standards, primarily ISO 20795-1 and ISO 20795-2, which set the acceptance criteria for denture base polymers. Biocompatibility testing was also conducted according to ISO 10993-1, among others.

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

The document does not specify the exact sample sizes (e.g., number of test specimens for each mechanical test) used for the bench testing. This information is typically detailed in the full test reports, not usually in the 510(k) summary. Given this is a material properties verification, the "data provenance" is typically laboratory testing results, not patient data from a specific country or collected retrospectively/prospectively.

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

Not Applicable. This is a material science and biocompatibility assessment, not a diagnostic device relying on expert interpretation of results to establish ground truth for a clinical condition. The "ground truth" for these tests is the quantitative measurement against established physical/chemical standards.

4. Adjudication Method for the Test Set

Not Applicable. As above, this is laboratory bench testing against objective criteria, not a clinical study requiring adjudication of expert interpretations.

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

Not Applicable. This is a dental material, not an AI-assisted diagnostic tool. Therefore, MRMC studies evaluating human reader improvement with or without AI assistance are irrelevant to this device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not Applicable. This is a physical dental material, not an algorithm or software. Its performance is evaluated through material property testing and biocompatibility.

7. Type of Ground Truth Used

The "ground truth" used for this device is based on established international standards for physical, mechanical, and chemical properties of dental materials (ISO 20795 series) and biocompatibility standards (ISO 10993 series). These are objective, quantitative benchmarks, not subjective expert consensus, pathology, or outcomes data in the sense of a diagnostic medical device.

8. Sample Size for the Training Set

Not Applicable. This is a manufactured dental resin, not a machine learning model that requires a training set. The development of the resin would involve material science research and iterative formulation, not data training in the context of AI.

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

Not Applicable. As explained above, there is no "training set" in the context of an AI/ML algorithm for this device. The material's formulation and properties are developed through chemical engineering and material science principles, with validation against performance specifications derived from ISO standards.

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Harvest Printable Resin is indicated for the fabrication of dental bases for full removable dentures, artificial teeth, dental bite splints and guards and try-in devices, i.e., denture base and teeth. The material is an alternative to traditional heat-curable and auto-polymerizing resins and is intended for professional dental work only. This material is intended to be used by dental lab technicians and approved by licensed practitioners before being provided to the patient.

Harvest Printable Resin is a light-cured resin developed for additive manufacturing (3D printing) of individual full denture bases, artificial teeth, bite splints and guards and try-in devices, i.e., denture base and teeth. After being utilized in a 3D stereolithographic printer to generate a dental device based on a solid model, the device is placed in a UV light curing unit for final polymerization. Fabrication using Harvest Printable Resin requires an appropriate computer-aided Design and Manufacturing (CAD/CAM) system, a digital light processing (DLP) printer, and post-processing light curing equipment. It has been optimized for use with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Pro95 S and Pro55 S) printers and, therefore, may only be used in conjunction with these printers and their associated software systems. It is also only to be used in conjunction with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Procure and Procure 2) curing units for post-processing. The 3D printer is not included with the device.

The provided document describes a medical device, "Harvest Printable Resin," and its substantial equivalence to predicate devices based on technological characteristics and performance data, primarily through biocompatibility testing and ISO 20795-1 & -2 testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

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

The document does not explicitly state the sample sizes used for the ISO 20795-1 & -2 tests or the biocompatibility tests. It also does not specify the provenance (e.g., country of origin, retrospective or prospective) of the data. These tests are typically conducted in a laboratory setting on standardized test specimens.

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

This information is not applicable and not provided in the document. The "ground truth" for material property testing (like ISO 20795-1 & -2) and biocompatibility is established by adherence to recognized international standards and laboratory measurements, not by expert consensus on clinical cases. No human-in-the-loop performance is being evaluated here.

4. Adjudication method for the test set

Not applicable. As noted above, this is material property and biocompatibility testing, not a clinical assessment requiring adjudication of human expert opinions.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "No human clinical testing was conducted to support substantial equivalence." This device is a material, not an AI-assisted diagnostic tool.

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

Yes, "standalone" performance was effectively done in the form of laboratory testing of the material properties described in section 1 and biocompatibility. The performance evaluation focuses solely on the inherent characteristics of the Harvest Printable Resin itself, without any human intervention in its measurement or any AI algorithms.

7. The type of ground truth used

The ground truth for the performance evaluation relies on:

• Established International Standards: ISO 20795-1:2013 and ISO 20795-2:2013 for physical/mechanical properties. These standards define the methodology and acceptance criteria.
• Recognized Biocompatibility Standards: ISO 7405:2018 and ISO 10993-1 as recognized by the FDA for biocompatibility. These standards outline tests to ensure the material is safe for biological contact.

8. The sample size for the training set

Not applicable. This device is a material, not an AI model, so there is no "training set."

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

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

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SprintRay Digital Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.

SprintRay Digital Crown resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.

Fabrication of dental prosthetics with SprintRay Digital Crown resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital crown file created in an optical impression system, 3D printer, and curing light equipment. SprintRay Digital Crown Resin is intended exclusively for professional dental work. Digital Crown Resin is offered in following shades/colors: Bleach, A1, B1.

The device is manufactured via additive manufacturing process using a 3D printer with 405 nm wavelength, 50 m print layer thickness, and light energy of 28.8 mW/cm².

Digital Crown 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 are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

The provided document is a 510(k) Summary for the SprintRay Digital Crown resin. It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values. Instead, it states that "In all instances, Digital Crown resin functioned as intended and the outcomes were as expected" for the various bench tests. It also indicates that the device met ISO standards.

However, the "Comparison of Technology Characteristics" table implicitly conveys acceptance criteria by listing the standards that both the predicate and the subject device adhere to, and then stating "Similar" for the reported performance.

Here's a reconstructed table based on the provided information, focusing on the standards and the conclusion of compliance:

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

The document does not explicitly state the sample size used for the test set or the data provenance for any of the performance studies (biocompatibility or bench testing). It only refers to "a battery of testing" and "additional bench testing."

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 and therefore not provided in the document. The device is a material (resin) for fabricating dental prosthetics, and its performance is evaluated through objective physical, chemical, and biological tests, not through expert assessment of diagnostic accuracy or interpretation of images. Therefore, there's no "ground truth" to be established by experts in the context of diagnostic performance.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies involving interpretation of medical data (e.g., radiology reads) where discrepancies between assessors need to be resolved to establish ground truth. As this document describes the bench testing of a material, clinical adjudication is irrelevant.

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 type of study is not applicable to this device. An MRMC study is relevant for AI-powered diagnostic devices that influence human interpretation. The SprintRay Digital Crown is a material for manufacturing dental prosthetics, not an AI diagnostic tool.

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

This information is not applicable. The device is a material, not an algorithm. The performance tests described (biocompatibility and bench testing) evaluate the intrinsic properties of the material and the fabricated dental appliance, not an algorithm's performance.

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

For the biocompatibility and bench testing, the "ground truth" is established by adherence to internationally recognized standards (ISO standards) and scientific test methodologies. For example, flexural strength is measured according to specific protocols outlined in ISO 10477 and ISO 4049, and the result is compared against the requirements specified in those standards. The outcomes of these tests inherently serve as their own "ground truth" concerning the material's properties according to those standards.

8. The sample size for the training set

This information is not applicable as the device is a material and not a machine learning model. There is no concept of a "training set" for the material itself.

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

This information is not applicable (see point 8).

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Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work.

Stratasys TrueDent™ is a light-curable methacrylate-based resin, that enables fabrication of monolithic, high quality, functional, and aesthetic dental appliances, including full and partial removable dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays and veneers in a CAD/CAM additive manufacturing process. This material is intended to be used by trained dental professionals for the fabrication of various dental appliances in a CAD/CAM additive manufacturing process that includes the following components: digital dental files based on a digital impression, a Stratasys Poly Jet 3D printer, and curing light equipment. It is an alternative to traditional heat cured and auto polymerization resins. The predesigned color of the dental appliance is achieved by digitally mixing colored resins. The resins are available in five (5) different base colors (clear, white, cyan, magenta, and yellow). Stratasys TrueDent can be used only with Stratasys J5 Series printers. Stratasys J5 Series printers include a 3D printing system that utilizes PolyJet technology, with drop-on-demand inkjet printing process, 3 print heads, and a UV LED (395nm) curing process. The dental appliance is then cured in the Stratasys TrueDent™ Cure curing chamber and sent back to the dentist for try-in and final adjustment.

The provided text describes the regulatory clearance for the Stratasys TrueDent™ device and includes a comparison to predicate and reference devices. It details non-clinical performance data but does not include information about clinical studies with human subjects, AI assistance, or expert adjudication. Therefore, many of the requested items related to clinical studies and AI are not available in the given document.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to international standards for dental materials and biocompatibility. The reported device performance indicates that the Stratasys TrueDent™ meets these requirements.

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

The document does not specify the sample sizes used for the non-clinical performance and biocompatibility tests. The data provenance is "Non-clinical testing data submitted to demonstrate substantial equivalence." No country of origin for the data is specified, but the manufacturer is Stratasys Ltd. based in Israel. The tests are non-clinical (bench testing), so the terms "retrospective or prospective" do not directly apply in the same way as clinical trials.

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

This information is not provided in a clinical context. The provided study is non-clinical (bench testing and biocompatibility assessments). The "ground truth" for these types of tests is the established scientific and regulatory standards (e.g., ISO standards, FDA guidance).

4. Adjudication method for the test set

Not applicable, as this was a non-clinical study focused on meeting specified standards. There was no mention of human-in-the-loop performance or expert adjudication of outputs.

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

No such study was mentioned. The device is a dental material for fabrication of appliances, not an AI-powered diagnostic or assistive tool for human readers.

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

This would not be applicable in the context of this device. The device itself (a resin) is the "standalone" component being evaluated for its physical, mechanical, and biocompatibility properties. The manufacturing process involves CAD/CAM, but the focus of the performance data is on the cured material, not an algorithm's diagnostic performance.

7. The type of ground truth used

The ground truth for the non-clinical performance data (mechanical and physical properties) and biocompatibility data is defined by established international standards (ISO 10477, ISO 4049, ISO 20795 for mechanical properties; ISO 7405, ISO 10993 for biocompatibility). These standards specify the test methodologies and acceptance criteria.

8. The sample size for the training set

This information is not applicable. The device is a physical material (resin), not an AI model that requires a training set.

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

Not applicable, as the device is not an AI model requiring a training set.

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saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print CROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations. saremco print CROWNTEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

saremco print CROWNTEC is a resin-based material for the production of permanent and temporary restorations, veneers and artificial teeth on 3D printers. The material is an alternative to traditional heat-cured and auto polymerization resins. It requires a computer-aided and manufacturing (CAD/CAM) system including scanner, design software, additive printer and a post-curing unit.

The provided document does not contain information related to an AI/ML device or a multi-reader, multi-case (MRMC) study. The device, "saremco print CROWNTEC," is a light-curing 3D-printed material for dental restorations (e.g., crowns, inlays, veneers, artificial teeth).

The "study" described in the document is a non-clinical performance testing and biocompatibility evaluation of this dental material, specifically to demonstrate its substantial equivalence to predicate devices for FDA 510(k) clearance.

Therefore, I cannot provide answers to the requested information about acceptance criteria, study details, expert involvement, or AI/ML performance metrics, as these are not relevant to the described device and its evaluation process.

Instead, the document details the following:

• Acceptance Criteria (inferred from testing): The device (material) was tested and met the applicable requirements of the following ISO standards:
  • ISO 4049:2019 - Dentistry - Polymer-based restorative materials
  • ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials
  • ISO 22112:2017 – Dentistry – Artificial teeth for dental prostheses
  • ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
  • ISO 7405:2018 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry
• Reported Device Performance:
  • Flexural Strength: Average ≥ 135 MPa (compared to predicate devices ranging from > 50 MPa to 148.73 MPa).
• Study Type: Non-clinical bench testing and biocompatibility assessment.
• Ground Truth: The "ground truth" in this context refers to the established requirements and performance metrics defined by the aforementioned ISO standards, against which the material's properties were measured.
• Clinical Performance Data: The document explicitly states, "No human clinical testing was performed to support the substantial equivalence of saremco print CROWNTEC."
• Training Set/Test Set (as per ML context): Not applicable, as this is a material science characterization, not an AI/ML model development.
• Data Provenance: The tests were conducted by the manufacturer (Saremco Dental AG). Data provenance for the material properties would be from the laboratory tests.
• Experts and Adjudication: Not applicable in the context of an AI/ML study, but the ISO standards represent a consensus of expert knowledge in dental material science.

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E-Dent 1000 is a light-curable resin indicated for the fabrication of:

• individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area,
• individual and fixed single veneers,
• artificial teeth for dental prostheses, which are used for removable permanent full dentures,
• individual and removable monolithic full and partial dentures

in dental laboratories. The material is an alternative dental material. E-Dent 1000 is intended exclusively for professional dental work. Fabrications with E-Dent 1000 requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment.

The E-Dent 1000 system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized E-Dent 1000 restorative dental products.

The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories to make the customized temporary crowns and bridges for patients who need restoration of their natural teeth.

E-Dent 1000 is available in six different colors.

The resin is packaged in lightproof 1 kg PE bottles along with a programmed RFID chip (referred to as TAG), which is required for use with the validated 3D printers. The TAG contains information identifying the resin material, name and amount.

E-Dent 1000 resin is an alternative material to heat-curable and auto-polymerizable resins.

EnvisionTECs Perfactory® 3D-Printer DLP models designed and validated for use with the E-Dent 1000 light cured resin are:
• EnvisionOne cDLM, with LED
• Micro series, with LED
• Vida Series, with LED
• P4K Series, with LED
• D4K Series, with LED

The provided text describes a 510(k) premarket notification for a dental material (E-Dent 1000), not an AI/ML medical device. Therefore, a direct answer to the request regarding acceptance criteria and a study proving an AI/ML device meets them, including details like sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details, cannot be extracted from the given document.

The document focuses on the substantial equivalence of the E-Dent 1000 resin to predicate dental materials based on physical and chemical properties, biocompatibility, and manufacturing processes, not on the performance of a software algorithm.

However, I can extract the relevant information about the non-AI device's performance testing and acceptance criteria as described in the document:

Here's the information about the E-Dent 1000 device's performance and acceptance criteria, adapted to the closest relevant sections of your request, noting where the information is not applicable to an AI/ML device:

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

The document states that testing was conducted to evaluate the performance of manufactured crowns, artificial teeth, veneers, and dentures according to specific ISO standards. The "acceptance criteria" are implied by compliance with these standards, and "reported device performance" is the statement that the device meets these requirements.

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

• Sample Size: Not explicitly stated for each test, but implied by the successful completion of testing according to ISO standards. Sample sizes for material testing are standard for these types of evaluations.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a material test, not a patient data study.

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

• Not Applicable: This is a material science and biocompatibility study, not a study involving expert-established ground truth from images or clinical data. The "ground truth" is defined by compliance with established international standards for dental materials.

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

• Not Applicable: No human adjudication is involved in these laboratory material tests.

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 not an AI/ML device.

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

• Not Applicable: This is not an AI/ML device.

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

• Type of Ground Truth: Established international standards for dental materials (e.g., ISO 10477, ISO 4049, ISO 7491, ISO 20795-1) for physical/mechanical properties, and ISO 10993 for biocompatibility.

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI/ML device. For material development, formulation and process optimization would occur, but these are not referred to as "training sets" in this context.

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

• Not Applicable: See point 8.

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DENTCA Denture Teeth is a light-curable polymerizable resin to fabricate, by additive manufacturing, preformed denture teeth to be used in a denture.

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The provided text is a 510(k) premarket notification letter from the FDA to Dentca, Inc. regarding their DENTCA DENTURE Teeth. This document is a regulatory approval letter and does not contain information about acceptance criteria, device performance, or study details like sample sizes, ground truth, or expert qualifications.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text.

The document primarily states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. It also lists the Indications for Use for the DENTCA DENTURE Teeth.

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Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.

Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.

The provided 510(k) summary describes a device, SR Vivodent S, SR Orthotyp S, SR Ortholingual S, which are preformed denture teeth. This notification is for a dental device, not an AI/ML powered medical device. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size) are not applicable to this type of device submission.

The submission focuses on demonstrating substantial equivalence to predicate devices (SR Vivodent PE, SR Orthotyp PE, and Phonares II) through material composition, performance data, and indications for use.

Here's the information that can be extracted from the provided text according to your request:

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)

• Not applicable for this type of device. The submission references compliance with international standards for material properties and performance rather than clinical test sets with specified sample sizes or data provenance. The testing would have been conducted in a laboratory setting.

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. Ground truth in the context of AI/ML or diagnostic devices is not relevant here. The "ground truth" for this device is its adherence to established material and performance standards.

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

• Not applicable.

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 physical dental device, not an AI-assisted diagnostic tool.

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

• Not applicable.

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

• The "ground truth" for this device's performance is compliance with international standards (ISO 22112:2005, ISO 10477:2004, DIN EN ISO 2039-1, ISO 10993) for material properties and physical performance.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable.

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