Search Results

ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructures restorations up to a full arch.

ArgenZ HT+ is a pressed Yttria stabilized Zirconia with primary oxides of Hafnium and Aluminum with naturally occurring trace oxides used to produce various shades.

1. Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.

ArqenZ Zirconia Coloring Liguids are dilute aqueous solutions of transition and lanthanoid metal salts used in combination with ArgenZ Zirconia material (K071410 and K150919) to properly shade teeth. Elements, which may include (but are not limited to) Co, Cr, Er, Fe, Mn, Pr, Ni, Bi, and Nd are combined with water to result in the finished product.

The provided text describes Argen Corporation's ArgenZ Liquids, which are dental coloring liquids for zirconia restorations. The document is a 510(k) premarket notification for the device, seeking substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration.

The ArgenIS Titanium Abutments are compatible with the following implant systems:

Argen IS Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Abutment is then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Abutment is supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw. The final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient-specific form.

Minimum and Maximum Gingival Height is 0-6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30°

The proposed ArgenIS Titanium Abutments are available in a range of diameters and connection type.

The provided document is a 510(k) premarket notification for the ArgenIS Titanium Abutments. This type of FDA submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study or by presenting detailed performance metrics against predefined benchmarks.

Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, a study proving device performance against those criteria, or a detailed breakdown of test sets, ground truth establishment, or clinical study types (MRMC, standalone).

However, I can extract the information that is present and explain why other details are not available in this type of document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and direct "reported device performance" values for clinical outcomes. Instead, it relies on bench testing to show functionality and equivalence to predicate devices. The "performance data" section focuses on demonstrating mechanical integrity and compatibility.

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

The document mentions "worst case scenario samples" for fatigue testing (one implant size from each proposed platform) but does not provide a specific numerical sample size for this or other bench tests. It refers to "non-clinical test data," indicating these are laboratory-based tests, not human subject data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable as this is not a clinical study.

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

This information is not applicable. The "ground truth" for the non-clinical bench testing would be established by engineering specifications, material standards, and regulatory requirements (e.g., ISO 14801). There is no mention of human experts establishing a "ground truth" in the diagnostic or clinical sense for this type of device.

4. Adjudication Method for the Test Set

This is not applicable as the testing described is technical bench testing, not a clinical trial requiring adjudication of patient outcomes or interpretations.

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

No, an MRMC comparative effectiveness study was not done. These are typically for diagnostic devices where human reader performance is being evaluated, often with and without AI assistance. This document is for a physical medical device (dental abutment) and focuses on mechanical and physical properties.

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

This is not directly applicable. A "standalone" study usually refers to the performance of an algorithm or AI without human intervention. While the device itself functions without continuous human interaction once implanted, the performance evaluation here is on its manufactured properties and compatibility, not an "algorithm's" diagnostic accuracy. The bench tests described could be considered "standalone" in that they evaluate the device itself.

7. The Type of Ground Truth Used

For the described performance testing (tolerance analysis, functional fit checks, fatigue testing), the "ground truth" would be engineering specifications, material properties, and regulatory standards (e.g., ISO 14801 for fatigue testing, or dimensional specifications for fit). It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" as this is not an AI/ML device that requires data for model training.

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

This is not applicable as there is no training set for this device.

Ask a specific question about this device

ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.

ArgenZ Esthetic Plus is a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.

The provided text describes a 510(k) premarket notification for a dental ceramic device, ArgenZ Esthetic Plus, and its claim of substantial equivalence to a predicate device, BruxZir Anterior (K143330). The information does not describe a study involving an AI device and human readers, but rather a comparison of physical and biological properties of two ceramic materials.

Therefore, the following points address the questions based on the provided document, acknowledging that most questions related to AI studies are not applicable.

1. Table of acceptance criteria and the reported device performance

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 describes material testing for dental ceramics, not a clinical study involving a test set of data. The testing was conducted on samples of the ArgenZ Esthetic Plus material to ensure it meets ISO standards and is comparable to the predicate device. Details on the number of samples or the country of origin for these material tests are not provided. The tests would be prospective in the sense that they are performed on the manufactured material to evaluate its properties.

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 question is not applicable to the provided document. The ground truth for this device relates to the physical and biological properties of the ceramic material, which are established through standardized laboratory testing (e.g., ISO 6872:2008) rather than expert consensus on a test set of patient data.

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

This question is not applicable. Adjudication methods are typically used in clinical studies or expert reviews of data, which is not the nature of the information presented here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The document describes a medical device in the dental ceramic category, not an AI device.

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

This question is not applicable. The document describes a medical device in the dental ceramic category, not an AI algorithm.

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

The ground truth for the ArgenZ Esthetic Plus device and its predicate is based on standardized laboratory testing and material specifications as defined by ISO 6872:2008 for dental ceramics, as well as the known properties of the base material (Yttrium-stabilized Zirconia) in medical applications. This includes measurements of flexural strength, density, coefficient of thermal expansion, and confirmation of biocompatibility.

8. The sample size for the training set

This question is not applicable. As the document concerns a physical material, there is no "training set" in the context of an AI model. The material's properties are inherent to its composition and manufacturing process.

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

This question is not applicable. There is no training set for an AI model. The "ground truth" for the material's properties is established through adherence to international standards for dental ceramics (ISO 6872:2008) and well-documented scientific principles of material science and biocompatibility.

Ask a specific question about this device

ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.

Polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems.

The provided regulatory submission describes a 510(k) premarket notification for the ARGEN PMMA device, a polymethylmethacrylate (PMMA) disc for dental CAD/CAM systems. The submission asserts substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the information required to directly answer some of the questions (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods) is not explicitly detailed in the provided documents. The approach taken is a comparison of material properties to demonstrate equivalence.

Here's a breakdown based on the available information:

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

Since this is a substantial equivalence submission, "acceptance criteria" are implied by demonstrating that the ARGEN PMMA device has comparable physical and chemical properties and biological performance to its predicate devices. The reported "performance" is that these properties are similar or identical.

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 for Test Set: Not explicitly stated. The submission relies on comparative data and general material properties rather than a specific test set for performance validation in the typical sense of a diagnostic or therapeutic device study.
• Data Provenance: Not explicitly stated. The tests conducted (ASTM F895-84:1984, ISO 10993.5:1999, US Pharmacopeia XXVIII) are international standards, suggesting data would be generated according to these protocols, but the specific origins are not mentioned.

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/Not mentioned. The submission is not a clinical study involving expert interpretation of results, but rather a materials science comparison.

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

• Not applicable/Not mentioned. No expert adjudication process is described for this type of submission.

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 device is a dental material (PMMA discs), not an AI-powered diagnostic or therapeutic system. Therefore, an MRMC study related to AI assistance is not relevant.

6. 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.

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

• The "ground truth" for this submission is based on established material science standards and properties of the predicate devices. The claim is that ARGEN PMMA meets these established material characteristics. For biological performance, it refers to the non-toxic nature of PMMAresin, which is a widely accepted characteristic in dentistry.

8. The sample size for the training set

• Not applicable. This type of submission does not involve a "training set" in the context of machine learning or statistical modeling.

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

• Not applicable, as there is no "training set" in this context.

Ask a specific question about this device

Argen PEARL brand zirconia is intended for CAD/CAM fabrication of all-ceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Not Found

Based on the provided text, the document is a 510(k) clearance letter from the FDA for a dental material (Argen PEARL Brand Zirconia), not a study report for an AI/device for diagnostics or prediction. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic devices, is not present in this document.

The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a detailed performance study against specific acceptance criteria.

Therefore, it is not possible to extract the requested information from this document.

Ask a specific question about this device