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The printodent® GR-10 guide | MSI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.

The printodent® GR-19.1 OA is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, splints, repositioners and retainers.

The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.

The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.

GR-10 guide MSI is made of functional methacrylic resins and inorganic fillers and the GR-19.1 OA, and GR-19.1 OA MSI consist of functional (meth)acrylic resins, initiators, dyes, stabilisers and lactam.

The GR-10 guide MSI, and GR-19.1 OA MSI are available in ocean blue shade, and the GR-19.1 OA is available in clear transparent. The resin is a liquid photo-curable material that is polymerized by image projection systems at ≤ 405 nm to create dental appliances. The GR Resin System MSI is intended to be used in conjunction with an additive Computer-Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems

The provided text describes a 510(k) premarket notification for a GR Resin System MSI, a light-curable polymerizable resin used for fabricating orthodontic and dental objects. However, it does not contain information about a study proving the device meets acceptance criteria related to artificial intelligence (AI) performance, human reader improvement with AI assistance (MRMC), or standalone algorithm performance.

This document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, chemical composition, manufacturing technology, physical state, curing method, and compliance with performance, biocompatibility, and shelf-life standards. The "Performance Testing" section only states that testing was performed in accordance with ISO 20795-2 for Flexural Strength, Flexural modulus / Bending module, Water Sorption, and Solubility.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/human-in-the-loop device, as the provided text pertains to a different type of medical device (a dental resin).

To answer your request, I would need a document describing the study and acceptance criteria for an AI-powered medical device.

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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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Thermeo powder / Thermeo liquid is a heat cured, moldable, acrylic compound system for use in the fabrication of dental appliances such as mouthguards, bruxism and TMJ splint appliances, and bite splints.

The Thermeo blank is a disc intended for the fabrication of dental appliances such as mouthguards, buxism and TMJ splint appliances, and bite splints using CAD/CAM milling machines.

The Thermeo powder/Thermeo liquid is a two-compound mixable device, containing a powder component and a liquid component. The device is heat cured for the fabrication of dental appliances.

The Thermeo blanks are pre-made by pro3dure using the two-part mixable device. The Thermeo blank is intended to be used in conjunction with CAD/CAM milling technology systems.

The provided document is an FDA 510(k) Premarket Notification for a dental device, the "Thermeo System." It is a regulatory submission for establishing substantial equivalence to existing devices, not a study reporting on the performance of an AI/ML diagnostic system.

The request asks for information typically found in clinical validation studies for AI/ML-driven medical devices, such as:

1. Acceptance criteria and device performance table.
2. Sample size and data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC study details and effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for training set.

This document, however, describes a physical dental material system (Thermeo powder/liquid and Thermeo blank for dental appliances) and its substantial equivalence to predicate devices based on material properties, manufacturing processes, and safety (biocompatibility, shelf life), not on the diagnostic performance of an algorithm.

Therefore, most of the information requested, which pertains to the validation of an AI/ML diagnostic algorithm, cannot be extracted from this document, as it is not relevant to the Thermeo System's 510(k) submission.

Here's what can be gathered, addressing the relevant parts of your request within the context of this device:

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

The document indicates that performance testing was conducted according to ISO 20795-2 for the "Thermeo System." This standard covers dental base polymers. The specific mechanical properties measured were:

• Flexural modulus
• Flexural Strength
• Tensile Strength
• Elongation at Break

However, the document does not provide a table with specific acceptance criteria values (e.g., minimum flexural strength) nor the numerical results (reported device performance) for these tests. It only states that testing was "performed in accordance with" the standard. For a 510(k), demonstrating compliance with a recognized standard often suffices without explicitly listing all raw data in the summary.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: The device manufacturer, Pro3dure Medical GmbH, is located in Germany. Testing would likely be conducted at their facilities or a contracted lab. The document does not specify if the testing was retrospective or prospective in terms of data collection for this type of material performance test.

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 physical material compliance test, not a diagnostic algorithm requiring expert ground truth for images. Performance is measured using standardized mechanical and chemical testing methods.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not an AI/ML diagnostic device, so an MRMC study is not relevant.

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

• Not Applicable. This is a physical material, not an algorithm.

7. The type of ground truth used:

• For the performance testing (flexural modulus, strength, etc.), the "ground truth" is established by physical measurement results obtained through standardized testing protocols (ISO 20795-2).
• For biocompatibility, the "ground truth" is established by biocompatibility testing in accordance with ISO 10993-1, which assesses biological responses.
• For shelf-life, the "ground truth" is established by accelerated aging and real-time stability testing per ASTM F1980-16.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning device.

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

• Not Applicable. See point 8.

In summary, the provided document is a regulatory submission for a physical dental product, and the requested performance evaluation criteria are primarily applicable to AI/ML diagnostic software, which is not the subject of this 510(k).

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The GR Splint Resin System is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment:

The GR-10 guide is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.

The GR-19 OA is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, repositioners and retainers.

The GR-22 flex is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, and repositioners.

GR Splint Resin System includes the GR-10 Guide Resin, GR-19 OA Resin, and GR-22 flex Resin. The GR Splint Resin System is made of functional methacrylic resins and inorganic fillers.

The GR-10 Guide Resin, GR-19 OA Resin, GR-22 flex Resin It is available in light blue-transparent, clear transparent and rose-transparent shades. The resin is a liquid photo-curable material that is polymerized by image projection systems at 385 nm and 405 nm to create dental appliances. The GR-10 Guide Resin, GR-19 OA Resin, GR-22 flex Resin are intended to be used in conjunction with an additive Computer-Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems.

The document describes the GR Splint Resin System, a light-curable resin for fabricating orthodontic and dental objects. It references its substantial equivalence to predicate devices based on performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that performance testing for the GR Splint Resin System was performed in accordance with ISO 20795-2. This standard specifies requirements and test methods for denture base polymers. The specific tests performed and their respective acceptance criteria and reported device performance are not explicitly detailed in a comparative table within the provided text. However, the document lists the measured parameters:

The document states, "Performance testing for the GR Splint Resin System was performed in accordance with ISO 20795-2 including Flexural Strength, Flexural modulus / Bending module, Water Sorption and Solubility, Fracture toughness, Total Work of Fracture Testing, Tensile Strength, and Elongation at Break." It also notes that the subject and predicate devices "comply with the same performance standards" and undergo the same biocompatibility and shelf-life testing. However, the specific numerical results of these tests for the GR Splint Resin System and the predicate devices are not provided in this excerpt.

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

The document does not explicitly state the sample sizes used for the performance testing or provide details on the data provenance (e.g., country of origin, retrospective or prospective). It only mentions that "Performance testing for the GR Splint Resin System was performed in accordance with ISO 20795-2".

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

This information is not applicable. The device is a material (resin) and not an AI/diagnostic device that would require expert-established ground truth for a test set. The "testing" refers to physical, mechanical, and chemical properties of the material.

4. Adjudication Method

This information is not applicable as the testing does not involve human interpretation or adjudication in the context of diagnostic accuracy.

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

This information is not applicable. The device is a material, not an AI system or diagnostic tool that would be evaluated in a MRMC study.

6. Standalone (Algorithm Only) Performance

This information is not applicable as the device is a material, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance "study" in this context is established by the specified international and national standards (e.g., ISO 20795-2, ASTM D256, ISO 37, ISO 10993-1, ASTM F1980-16). The material's physical, mechanical, and biocompatibility properties are measured against the requirements set forth in these standards.

8. Sample Size for the Training Set

This information is not applicable. The device is a material, not an AI model that requires a training set. The manufacturing process of the resin would involve formulation and quality control, but not a "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated above.

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The GR-14.1 denture is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.1 denture is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

The GR-14.2 denture HI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.2 denture HI is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

GR-14 Resin System includes the GR-14.1 denture and GR-14.2 denture HI and is made of functional methacrylic resins and inorganic fillers. It is available in three shades based on the shade guide, orange-pink, light-pink and deep-pink. The resin is a liquid photo-curable material that is polymerized by image projection systems at 405nm to create denture baseplates. The GR-14 Resin System is intended to be used in conjunction with an additive Computer- Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems. Preformed teeth are fixed into the denture base by extra gluing process with appropriate glue material.

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

Device: GR-14 Resin System (GR-14.1 denture and GR-14.2 denture HI)

Intended Use: Light-curable polymerizable resin for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical targets for each performance standard. Instead, it states that performance testing was performed in accordance with specific ISO standards. This implies that meeting the requirements specified within these standards constitutes the acceptance criteria. The "Reported Device Performance" column therefore reflects that the device successfully met these standards, as a conclusion of "substantial equivalence" is drawn.

• Flexural Strength
• Flexural modulus / Bending module
• Bond Strength
• Color Stability
• Water Sorption and Solubility
• Fracture toughness
• Total Work of Fracture Testing |
  | ISO 22112 (Dentistry - Artificial teeth for dental prostheses) | Performed in accordance with ISO 22112, indicating compliance with requirements relevant to the resin system's properties for denture bases. |
  | Biocompatibility | |
  | ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Biocompatibility testing conducted in accordance with ISO 10993-1, indicating the device is biocompatible. |
  | Shelf-Life | |
  | ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages) | Shelf life of 2 years demonstrated through testing in accordance with ASTM F1980-16. |

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

The document does not specify the sample sizes used for the test sets in the performance, biocompatibility, or shelf-life studies. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The studies mentioned (performance, biocompatibility, shelf-life) are technical tests on material properties, not diagnostic studies requiring expert interpretation of results to establish "ground truth" in the way it's typically understood for AI/diagnostic devices.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The acceptance criteria are based on defined standards and physical/chemical testing, not on adjudicated expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and the study aims to assess the impact of AI assistance on their performance. The GR-14 Resin System is a material used for manufacturing dentures, not a diagnostic device.

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

This concept is not applicable to the GR-14 Resin System. This device is a material, not an algorithm. The performance tests are inherently "standalone" in that they evaluate the material's properties directly, not its interaction with a human operator beyond proper manufacturing and curing processes.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is defined by the specifications and limits within the cited ISO and ASTM standards. For example, flexural strength must meet a certain value specified in ISO 20795-1. For biocompatibility, the ground truth is simply whether the material passes the tests outlined in ISO 10993-1, indicating it does not elicit adverse biological reactions.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The GR-14 Resin System is a material, not an AI/machine learning algorithm that requires a "training set" of data.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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