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Luminesse Shaded Zirconia SZ blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic patient specific dental restorations - full contour crowns and bridges for anterior and posterior location - as prescribed by a dentist.

Luminesse Shaded Zirconia SZ are used for full contour zirconia dental restorations utilizing CAD/CAM system for design and manufactured. Once designed and manufactured, Luminesse Shaded Zirconia SZ will undergo sintering. The shaded zirconia products are pre-shaded to meet all 16 VITA® shading guide; hence, no further coloring is necessary post-sintering. Once sintered, Luminesse Shaded Zirconia SZ will exhibit maximum strength for posterior and anterior dental restorations.

The provided text is a 510(k) Pre-market Notification for a dental device, Luminesse Shaded Zirconia SZ. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new AI/CADeX device. Therefore, much of the requested information regarding AI/CADeX studies is not available in the document.

However, I can extract the acceptance criteria and performance data for the physical properties of the dental material as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study proving the device meets acceptance criteria:

The study conducted was a non-clinical performance testing and a comparison against a predicate device to establish substantial equivalence.

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

• Sample size: Not explicitly stated for each specific test (e.g., number of samples for flexural strength). The document mentions "performance testing (flexural strength, shading consistency and coefficient of thermal expansion – CTE) in accordance with ISO 6872:2008."
• Data provenance: Not explicitly stated (e.g., country of origin). The study was conducted by Talladium, Inc. in Valencia, CA, which implies the testing was likely done in the US, but this is not explicitly stated for the raw data. It is a retrospective comparison to the predicate device's data and ISO standards.

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

• This type of information is not applicable to this document as it concerns physical material properties and biocompatibility, not diagnostic image interpretation or clinical judgment requiring expert consensus on ground truth. The "ground truth" here is defined by international standards (ISO 6872:2008 for dental ceramic).

4. Adjudication method for the test set:

• Not applicable. See point 3. This is not a study requiring adjudication of expert opinions.

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

• No. This is not an AI/CADeX device or a device requiring human efficacy studies of this nature.

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

• Not applicable. This is not an AI/CADeX device. The performance tests were done on the physical material itself.

7. The type of ground truth used:

• The "ground truth" for the physical properties (flexural strength, CTE, etc.) is established by international standards (ISO 6872:2008) for dental ceramic materials.
• For biocompatibility, the ground truth is established by ISO 10993-1: Biological evaluation of medical devices, with reference to the predicate device's successful biocompatibility testing.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/CADeX device that learns from data.

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

• Not applicable. See point 8.

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Luminesse Anterior Zirconia blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic custom dental restorations - full contour crowns and bridges for anterior location - as prescribed by a dentist.

Luminesse Anterior Zirconia are used for full contour Zirconia dental restorations utilizing CAD/CAM system for design and manufactured. Once designed and manufactured, Luminesse Anterior Zirconia will undergo sintering. The anterior Zirconia products are pre-shaded to meet all 16 VITA® shading guide; hence, no further coloring is necessary post-sintering. Once sintered, Luminesse Anterior Zirconia will exhibit maximum strength anterior dental restorations.

The provided text describes the Luminesse Anterior Zirconia device, which is a material used for dental restorations. The document is a 510(k) summary submitted to the FDA, indicating that the device is seeking substantial equivalence to a legally marketed predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

8. The Sample Size for the Training Set

This information is not applicable as this device is a material, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

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Luminesse Pre-Sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse ZR blanks to provide individualized tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of all ceramic restorations for individual dental patients.

Luminesse® Pre-sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse® ZR blanks to provide individualized tooth (or teeth) shading. It is a liquid ceramic aid for complete or partial coloring of all zirconium oxide blanks. Dental restorations are designed and manufactured by a certified dental professional (Technician) using CAD/CAM technology.

The provided document is a 510(k) Pre-Market Notification for a medical device called "Luminesse® Pre-Sintered Zirconia Coloring Liquid." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel, high-risk device.

Therefore, the document does not contain a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical or performance study for an AI/software device. Instead, it demonstrates substantial equivalence based on a comparison of technological characteristics and performance data that the new device shares with a predicate device.

Here's a breakdown of the requested information based on the provided document, highlighting where the information is not applicable due to the nature of a 510(k) substantial equivalence submission for this type of device:

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

Since this is a 510(k) for a coloring liquid, the "acceptance criteria" are not framed as performance metrics for an AI or diagnostic device, but rather as characteristics of the material that show it is similar to the predicate. The performance data presented refers to standard physical and chemical properties.

Conclusion from Document: The document concludes that "the differences…do not raise new questions of safety and effectiveness." The data supplied for both new and predicate device on physical and mechanical properties demonstrate similarity, "albeit unequal results," and are "within the expected specifications for zirconia dying liquid materials for dental application."

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 (N/A): This is a 510(k) submission for a coloring liquid, not a diagnostic or AI device that typically involves test sets of patient data. The "test set" here refers to the samples of the coloring liquid itself that were tested for physical and chemical properties. There is no mention of the specific number of liquid samples tested, nor is there information about data provenance in terms of country of origin or retrospective/prospective studies. The performance data is based on material property 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)

• Not Applicable (N/A): Ground truth established by experts is relevant for diagnostic or AI systems where human interpretation is the gold standard. For a coloring liquid, the "ground truth" is determined by objective physical and chemical measurements (e.g., pH, density, boiling point), which are standard laboratory procedures, not expert consensus on qualitative data.

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

• Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretation, typically in studies involving human readers or AI. This is not relevant for the objective physical and chemical testing of a dental coloring liquid.

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 (N/A): MRMC studies are used to evaluate the performance of diagnostic tools (often AI-assisted) by comparing multiple readers on multiple cases. This device is a coloring liquid, not a diagnostic or AI tool, 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 (N/A): This concept applies to standalone AI algorithms. The Luminesse® Pre-Sintered Zirconia Coloring Liquid is a physical material, not an algorithm. Its performance is inherent to its physical and chemical properties.

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

• Laboratory Measurements / Physical and Chemical Standards: The "ground truth" or reference for the device's characteristics are standardized measurements of physical properties (e.g., general physical form, specific physical form, odor, color, boiling point, density, specific gravity, solubility) and chemical properties (e.g., pH). These are determined in a laboratory setting using established analytical methods, not through expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

• Not Applicable (N/A): This device is a material, not a machine learning model. Therefore, there is no "training set" in the context of AI or data-driven model development.

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

• Not Applicable (N/A): Since there is no training set as described above, this question is not applicable.

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The Luminesse PMMA is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges.

The Luminesse PMMA is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. The document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Luminesse PMMA" and its indications for use. It primarily discusses regulatory compliance and contact information. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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The Luminesse Porcelain System is dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.

The Luminesse Porcelain is dental porcelain used by dental technicians to create biocompatible crowns, bridges, and veneers. It consists of three categories: low fusing, high fusing, and zirconia porcelain. The application, indication, and performance is the same for all three categories; therefore, it is a porcelain system. It includes Pressable Ingots, Opaque Powders, Opaque Powders, Opacious Dentins, Dentins, Incisal Powders, Stains, Incisal Transluscents, Dentin Modifiers, Correction Powder, Glaze Powder, Glaze Liquid, Modeling Liquid, and Opaque Liquid. The dental technician will use various components of the system to create the specific, desired dental prosthetic, for the sole use of individual dental patients. It is for prescription use only.

The provided text describes the Luminesse Porcelain System, a dental porcelain material, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance acceptance criteria.

The document is a 510(k) premarket notification letter and a 510(k) summary. These types of documents focus on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing detailed acceptance criteria and performance study data in the way you've requested for an AI/CADe device.

Here's a breakdown of what is available based on your request, and what is missing:

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

• Missing. The document does not specify quantitative acceptance criteria (e.g., minimum flexural strength, maximum solubility) that the Luminesse Porcelain System needed to meet.
• Reported performance: The document states that "Bench testing to determine flexural strength, solubility, and glass transition temperature was conducted in accordance with ISO 6872." However, the results of these tests (the actual reported device performance values) are not provided in the summary. It only indicates that "All components found in Luminesse Porcelain have been used in legally marketed devices and were found safe for dental use. It has the same technological characteristics, chemical composition, manufacturing process, and same intended use as the predicate devices." This implies that the performance was deemed comparable to the predicates, but specific numbers are absent.

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

• Missing. The document does not describe a "test set" in the context of clinical or AI performance evaluation. The "bench testing" mentioned for flexural strength, solubility, and glass transition temperature would have involved material samples, but the specific sample sizes, provenance, or whether it was retrospective/prospective 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)

• Missing. This information is completely irrelevant to this type of device (dental porcelain) and submission (510(k) for substantial equivalence). Ground truth and expert adjudication are concepts typically associated with medical diagnostic devices, especially those involving image analysis or expert interpretation.

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

• Missing. See point 3.

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

• Missing. See point 3. This device is a material, not a diagnostic tool or an AI/CADe system.

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

• Missing. See point 3.

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

• Missing. See point 3. The "ground truth" for a material device like this would typically be its physical and chemical properties as measured by standardized tests (like ISO 6872), compared against established standards or predicate device properties.

8. The sample size for the training set

• Missing. This concept of a "training set" is for AI/machine learning devices, which this medical device is not.

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

• Missing. See point 8.

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Luminesse ZR Blanks are intended for CAD/CAM fabrication of all-ceramic ( no metal ) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks. They are isostatically cold pressed so they can be milled using any compatible CAD/CAM machine such as Sirona InLab by Sirona Dental Systems, LLC, Charlotte, NC or KaVO Everest by KaVo Dental, Lake Zurich, IL.

After the ZR Blank is milled, it is sintered, causing the materials to densify into a high strength ceramic material which is suitable for dental inlays, onlays, crowns and bridges.

Luminesse Zirconia blanks, are high purity, bisque fired zirconia machining blanks. The powders pressed to form these blanks are of a uniform size and well dispersed, ensuring no agglomerates. The resultant fine grained, bisque body allows intricate shapes to be machined with tight tolerances. Luminesse Zirconia blanks are phase stabilized with 3 mol % yttria and therefore do not undergo the usual phase transitions associated with pure zirconia. This phase transformation "toughens" the zirconia and stops crack propagation, yielding high fracture toughness and high strength. The highest purity powders are used to make Luminesse Zirconia Blanks minimizing trace oxides. Luminesse Blanks are 99.9 wt% ZrO 2+ Y20 3 + HfO2 + A1203. The natural zirconia minerals HfO2, which is so similar in structure and chemical properties to zirconia, that it has no effect on product properties. A small addition of alumina minimizes hydrothermal aging.

Luminesse Zirconia Blanks are dental ceramic blanks designed for the manufacturing of substructures for ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining or using the copying technique. All appliances are for the sole use of the particular patient only. A metal chuck is glued on the end of blank or a metal ring that holds it in the CAD/CAM machine which is used to machine the final dental restoration. After completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO 2.

Luminesse ZR Blanks are intended for CAD/CAM fabrication of all-ceramic ( no metal ) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks. They are isostatically cold pressed so they can be milled using any compatible CAD/CAM machine such as Sirona InLab by Sirona Dental Systems, LLC, Charlotte, NC or KaVO Everest by KaVo Dental, Lake Zurich, IL.

After the ZR Blank is milled, it is sintered, causing the materials to densify into a high strength ceramic material which is suitable for dental inlays, onlays, crowns and bridges.

The provided text describes a 510(k) summary for "Luminesse Zirconia Blanks," which are dental ceramic blanks for manufacturing substructures for ceramic dental appliances. This submission argues for substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device's functionality. Therefore, many of the requested points related to device performance studies, ground truth, and expert evaluation are not directly applicable or provided in this document.

Here's an analysis based on the provided text:

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

The document does not present specific acceptance criteria for device performance for Luminesse Zirconia Blanks. Instead, it states that the predicate device, IPS e.max ZirCAD by Ivoclar (K051705), used the Biaxial Performance Criteria: Strength method to test Flexural Strength (ISO 6872) and Chemical Solubility for mass loss (ISO 6872) using a 4% solution of acetic acid.

The submission claims that "Since the predicate and proposed devices are exactly identical in formulation, there is no need for further testing." This implies that the Luminesse Zirconia Blanks are expected to perform comparably to the predicate device, meeting the same (unspecified in this document) performance criteria as evaluated for the predicate device.

Table of (Implied) Acceptance Criteria and Reported Device Performance:
(Based on the predicate device's testing and the claim of identical formulation)

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

No specific test set or data provenance is mentioned for the Luminesse Zirconia Blanks as direct testing was not conducted. The reliance is on the predicate device's data.

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. No ground truth establishment by experts for a test set is mentioned for the Luminesse Zirconia Blanks. The basis for equivalence is material composition.

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

Not applicable. No adjudication method for a test set is mentioned.

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 material for dental restorations, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

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

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

Not applicable. The "ground truth" in this context is the performance of the predicate device based on standardized material testing (ISO 6872).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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