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InSync ZR High Translucency Zirconia blanks are intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures.

InSync ZR High Translucency Zirconia is a y-tzp (yttria stabilized tetragonal zirconia polycrystals) material that features very high translucency. It is intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units using CAD/CAM technology. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures. InSync ZR High Translucency Zirconia meets requirements for Class 5 (type II) ceramics when tested according to ISO 6872:2008.

This document describes a medical device submission (K142043) for InSync ZR High Translucency Zirconia. It is a 510(k) Summary for a dental ceramic. The document asserts the device's substantial equivalence to a predicate device (NexxZr T; K130991).

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

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)

The document does not specify sample sizes for non-clinical testing. It also does not provide information on data provenance (country of origin, retrospective/prospective). The testing focused on physical properties (flexural strength, chemical solubility) to confirm adherence to ISO 6872:2008.

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 device is a dental material, not an AI or diagnostic device that relies on expert interpretation of data. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not applicable to this submission. The ground truth for material properties is established by adherence to international standards (ISO 6872:2008) and testing methodologies described within those standards.

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

Not applicable. This is not a diagnostic device requiring adjudication of interpretations.

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-assisted diagnostic device.

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

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

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

The "ground truth" for this device's performance is adherence to the physical and chemical property requirements of ISO 6872:2008 for a Class 5 (type II) ceramic.

8. The sample size for the training set

Not applicable. This is a material, not a machine learning model that requires a training set. The "development" of the material itself is a chemical/engineering process, not an AI training process.

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

Not applicable. As above, this is a material, not a machine learning model.

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Jensen Zirconia consists of pressed Zirconia – Yttrium blocks intended for milling of full contour crowns, crown and bridge substructures and implant super structures to produce prostheses for replacement of missing / damaged dentition.

Jensen Zirconia ceramic is pressed and sintered blocks of Yttria stabilized Zirconia used to make copings and full contour crowns for dental restorations. Restorations are fabricated according to a dental impression scanned into a computing device. By CAD/CAM technology, the blocks are machined in an automated milling machine. After machining, the units are heat treated. Full contour units may then be stained and glazed with available finishing materials. Coping units can be completed by conventional veneering with available Zr compatible dental porcelains and stained and glazed.

Based on the provided documents for Jensen Zirconia (K112806), it is not possible to describe acceptance criteria and a study that proves the device meets them in the way requested. The document is a 510(k) summary for a dental material (zirconia blocks) and focuses on demonstrating substantial equivalence to a predicate device, not on the performance of an AI-powered diagnostic device.

The questions asked pertain to the validation of an AI device (e.g., accuracy, sensitivity, specificity, human reader improvement with AI assistance, ground truth establishment, training and test sets). The Jensen Zirconia device is a physical dental material used for fabricating crowns and bridges.

Therefore, I cannot provide the requested information because:

• No AI component: The device (Jensen Zirconia) is a material, not an AI or diagnostic device.
• No performance metrics for diagnostics: The document discusses mechanical properties and chemical qualities for substantial equivalence, not diagnostic accuracy metrics (like sensitivity, specificity, AUC).
• No clinical study for diagnostic performance: The 510(k) summary refers to "data has been presented to demonstrate that the respective mechanical properties, chemical qualities, and the indications for use make Jensen Zirconia substantially equivalent to the predicate device LAVA Frame." This is a comparison of material properties, not a clinical study on diagnostic accuracy or AI performance.
• No elements for AI validation: There is no mention of test sets, training sets, ground truth establishment by experts, adjudication methods, or MRMC studies, as these are concepts relevant to AI validation, not material equivalence.

In summary, the provided text describes a 510(k) submission for a dental material, not an AI-powered medical device. The questions are specifically tailored for AI/diagnostic device validation, which is out of scope for this document.

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The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.

The InSync Ceramic System consists of pressable silica based ceramic pellets and silica based ceramic layering porcelain and liquids.

The provided text is a 510(k) summary for "The InSync Ceramic System" by Jensen Industries. It is a premarket notification to the FDA for a dental porcelain product.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

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

The document states: "Independently, the InSync Ceramic System meets the applicable sections of concensus standards ISO 9693 and ISO 6872."

The text does not provide a table of specific numerical acceptance criteria from ISO 9693 and ISO 6872, nor does it report specific numerical device performance against those criteria. It only makes a general statement 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 specify the sample size used for any testing or the data provenance. It refers to "Data has been presented to demonstrate that the respective composition, mechanical properties, chemical qualities, and the indications for use make the InSync Ceramic System substantially equivalent to the predicate devices," but no details of this data or its origin are provided.

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 provided in the document. The study described is a comparison of material properties, not an evaluation requiring expert interpretation of diagnostic images or clinical outcomes.

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

This information is not applicable/not provided in the document as it describes a study of material properties, not a study requiring adjudication of expert interpretations.

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

An MRMC comparative effectiveness study was not done. This document describes a dental porcelain system, and the study focuses on its material properties and chemical qualities, not on human reader performance with or without AI assistance.

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

A standalone performance study as typically understood for AI algorithms was not conducted. The device itself is the material (dental porcelain), not an algorithm. The "study" described is the testing of the material's properties against established consensus standards (ISO 9693 and ISO 6872) and comparison to predicate devices.

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

The "ground truth" for the material property comparison would be defined by the consensus standards (ISO 9693 and ISO 6872) for mechanical and chemical properties of dental ceramics. The performance of the device (its material properties) is compared against the specifications within these standards and against the properties of the predicate devices.

8. The sample size for the training set

The document does not mention a training set, as this is not an AI/machine learning device. The "training" in this context would be the development and formulation of the ceramic system itself, not a data-driven training process.

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

The concept of a "training set" and "ground truth for the training set" as it relates to AI/machine learning is not applicable to this device or its reported data. The "ground truth" for the material's development would be established through established scientific principles of material science, chemistry, and engineering validated by industry standards (like ISO).

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Creation CP-ZI Porcelain is a pressable ceramic material intended to be used by dental technicians to construct veneers, inlays and ceramic crowns. CP-ZI can be pressed to zirconium oxide ceramic substructures for construction of ceramic crowns and bridges.

Creation CP-ZI porcelain consists of pressable ceramic pellets that are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and bridges. Creation CP-ZI is also suitable a s a stand-alone press ceramic for fabricating inlays and onlays.

The provided text describes a dental product (Creation CP-ZI Porcelain) and its 510(k) summary for FDA clearance. However, it does not contain any information about acceptance criteria, device performance metrics, or a study design involving statistical analysis, sample sizes for test/training sets, expert involvement, or comparative effectiveness studies (MRMC or standalone AI performance).

The document focuses on:

• Device Description: A pressable ceramic material for dental restorations (crowns, bridges, inlays, onlays).
• Predicate Devices: Willi Geller Creation CP and Creation ZI.
• Substantial Equivalence: The submission argues that Creation CP-ZI is substantially equivalent to the predicate devices based on shared chemical qualities and mechanical properties.
• FDA Clearance: The letter confirms 510(k) clearance based on substantial equivalence.
• Indications for Use: Specifies how the material is intended to be used by dental technicians.

Therefore, I cannot fulfill the request to provide the acceptance criteria, reported device performance, or details of a study with the specific elements requested (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC/standalone studies, etc.) because such information is not present in the provided text.

The text states: "Data has been presented to demonstrate that the respective mechanical properties, chemical qualities, and the indications for use make Creation CP-ZI substantially equivalent to the predicate devices Willi Geller Creation CP and Willi Geller Creation ZI porcelains The safety and effectiveness of Creation CP-ZI, being determined by the shared chemical qualities and mechanical properties, is therefore equivalent to the predicate devices." This indicates that some form of data comparing the new device's chemical and mechanical properties to the predicate devices was provided, but the specific details of that data, the performance metrics used, and any acceptance criteria for those metrics are not included in this summary.

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the LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veners) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing.

The LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veneers) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing.

The provided text does not contain information about specific acceptance criteria, device performance, or a study demonstrating that the device meets such criteria.

The document is a 510(k) summary for "The LF-P Ceramic System," a dental porcelain. It states that data has been presented to demonstrate that the mechanical properties, chemical qualities, and indications for use make the device substantially equivalent to predicate devices. It also mentions that the safety and effectiveness are determined by chemical qualities, cytotoxicity test results, and mechanical properties. However, it does not provide the specific values for these properties or the methodologies of any studies conducted to evaluate them.

Therefore, I cannot provide the requested information.

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Willi Geller Creation ZI Porcelain is a ceramic material intended for the veneering of zirconium oxide based cores and substructures to form dental restorations

Williw Geller Creation ZI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of zirconium oxide-based cores.

This document (K043201) describes a dental porcelain device, not an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and AI-specific metrics cannot be extracted.

The document primarily focuses on establishing substantial equivalence for the "Willi Geller Creation ZI Porcelain" with predicate devices based on its mechanical properties, chemical qualities, and indications for use as a dental ceramic for veneering zirconium oxide-based cores.

No information regarding acceptance criteria for an AI/ML powered medical device, study design for performance evaluation, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies is present in the provided text.

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Willi Geller Creation CP Porcelain is a pressable ceramic material intended for constructing veneer, onlay, inlay, and crown substructures and full contour restorations. Veneering of substructures can be performed with suitable conventional or low fusing porcelains such as Willi Geller Creation GC or Willi Geller Creation LF (K02904).

Willi Geller Creation CP porcelain consists of pressable ceramic pellets that are used by dental technicians to fabricate full contour restorations (crowns, onlays, inlays, veneers) and substructures for full ceramic demtal restorations that are completed by being veneered with conventional or low fusing dental porcelains.

This document, K043221, is a 510(k) Pre-market Notification for a dental porcelain product called "Willi Geller Creation CP Porcelain." As such, it does not contain the kind of study information you are asking for, which is typical for diagnostic medical devices or those with more complex performance claims. This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on mechanical properties, chemical qualities, and indications for use, rather than clinical performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.

The document states: "Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation CP substantially equivalent to the predicate device Match Press pressable ceramic. The safety and effectiveness of Willi Geller Creation CP, being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices."

This implies that the "study" for this device involved comparing its physical and chemical properties to those of the predicate device (Match Press pressable ceramic, K024250) to establish substantial equivalence. However, the details of these comparisons (e.g., specific tests, acceptance criteria, results) are not included in the provided 510(k) summary.

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AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelainfused-to-metal technique of fabricating dental restorations. The mechanical and rated to moter veemmake AP-052-5 suitable for use as a substrate for single unit restorations in the anterior region (Bicuspids, cuspids, and incisors)

AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelain-fusedto-metal technique of fabricating dental restorations.

The provided text describes a 510(k) submission for a dental alloy, AP-052-5. The submission focuses on demonstrating substantial equivalence to a predicate device (Helioform - K990670) based on mechanical, physical, and biocompatibility properties.

Unfortunately, the text does not contain any information about acceptance criteria or a study proving that a device (in the sense of a medical imaging or diagnostic AI device) meets those criteria.

Instead, the document is concerned with the regulatory clearance of a material (a dental alloy). Therefore, most of the requested points are not applicable to the provided context.

Here's a breakdown of why and what information is available:

• No "device performance" in the AI/diagnostic sense is reported. The "performance" described is the material properties of the alloy.
• No "study" in the sense of a clinical or image-based diagnostic study is mentioned. The "data" presented focuses on mechanical, physical, and biocompatibility properties.
• No ground truth, experts, adjudication, MRMC, or standalone performance studies are relevant or discussed. These concepts are specific to diagnostic or AI device evaluations.

Based on the provided text, the dental alloy AP-052-5:

• Acceptance Criteria for Approval (Implicit, inferred from the text):

  • Mechanical properties demonstrating suitability for porcelain-fused-to-metal technique.
  • Physical properties demonstrating suitability for porcelain-fused-to-metal technique.
  • Biocompatibility according to International Standard ISO 10993-1.
  • Substantial equivalence to the predicate device (Helioform - K990670) for these properties.

• How the "Device" (Alloy) Meets Criteria:

  • "Data has been presented to demonstrate that the mechanical and physical properties of AP-052-5 make it substantially equivalent to the predicate device listed, and therefore it is suitible for use as a substrate for single unit restorations in the anterior region."
  • "Biocompatibility of AP-052-5 has been assesed according to International Standard ISO 10993-1."
  • "The safety and effectiveness of AP-052-5 is therefore determined to be equivalent to the predicate device."

Summary of Requested Information vs. Available Information:

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Jensen Gold Foil is pure gold direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations.

Jensen Gold Foil is pure gold, direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations, Indications for use and chemical composition are identical to those of the predicate devices.

This document describes a medical device submission (K022206) for "Jensen Gold Foil," a pure gold direct filling gold foil used by dentists for various dental preparations. The submission is a 510(k) summary, indicating that the device is seeking clearance based on substantial equivalence to predicate devices, rather than requiring extensive new clinical trials.

Therefore, the customary information about acceptance criteria and a study proving device performance (as would be typical for software or complex medical devices with performance metrics like sensitivity/specificity) is not applicable in this context.

Here's why and what information is provided:

1. Acceptance Criteria and Reported Device Performance:

• Not Applicable. The submission states, "There are no standards for direct filling gold foil." Therefore, there are no specific numerical acceptance criteria like sensitivity, specificity, accuracy, or F1-score that would be applicable to AI or diagnostic devices.
• Reported Device Performance: Instead of numerical performance metrics, the "performance" of Jensen Gold Foil is based on its long-standing history of clinical use and material properties. The submission refers to:
  • "centuries long clinical success of direct filling gold foil."
  • "Gold foil is the reference standard for biocompatibility and longevity."
  • A citation from "Skinner's Science of Dental Materials" states, "there can be no doubt that a properly inserted direct gold restoration is unsurpassed from the standpoint of service."

2. Sample Size for Test Set and Data Provenance:

• Not Applicable. There was no formal "test set" or clinical study with a specific sample size conducted for this 510(k) submission. The clearance is based on substantial equivalence to existing devices and the historical clinical performance of the material itself.

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

• Not Applicable. No ground truth was established by experts for a specific test set. The efficacy and safety are inferred from the general understanding and historical use of gold foil in dentistry, as supported by dental literature.

4. Adjudication Method:

• Not Applicable. No adjudication method was used as there was no test set requiring ground truth establishment.

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

• Not Applicable. This is a material device, not a diagnostic or AI-powered system designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. Standalone Performance Study:

• Not Applicable. This device does not have a "standalone algorithm only" performance as it is a physical dental filling material, not software.

7. Type of Ground Truth Used:

• Historical Clinical Consensus / Textbook Reference. The "ground truth" for the safety and effectiveness of Jensen Gold Foil is derived from:
  • The "centuries long clinical success" of direct filling gold foil.
  • Its status as the "reference standard for biocompatibility and longevity."
  • Evidence cited from "Skinner's Science of Dental Materials," a fundamental textbook in dental materials.

8. Sample Size for the Training Set:

• Not Applicable. There was no "training set" in the context of an algorithm or AI model development. The manufacturing processes and material composition would be based on established dental metallurgy and quality control, not machine learning training.

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

• Not Applicable. As there was no training set, this question is not relevant. The "ground truth" regarding the material's properties and manufacturing would adhere to established scientific principles and industry standards for dental materials.

In summary: The Jensen Gold Foil 510(k) submission relies on the established safety and efficacy of direct filling gold foil as a known dental material, rather than presenting a new study with specific performance metrics and acceptance criteria. The FDA's clearance is based on its substantial equivalence to predicate devices and the long clinical history of the material itself.

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