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Missing tooth structure in anterior and posterior teeth

Types of restorations:

• Veneers

• Inlays

• Onlays (e.g. occlusal veneers, partial crowns)

• Crowns

IPS e.max® One is a glass-ceramic block for the fabrication of fixed, full-contour single-tooth restorations in anterior and posterior teeth. IPS e.max One can be processed in milling machines and polished afterwards. A crystallization process is not necessary. The dentist starts with shade selection, preparation of the tooth based on guidelines for all-ceramic restorations, follow the recommended griding instruments and minimum layer thickness during finalizing and finishing, and finish with dental polishing.

Types of restorations: -Veneers -Inlays -Onlays (e.g. occlusal veneers, partial crowns) -Crowns

This document describes the premarket notification for the IPS e.max® One dental material. As such, it does not contain details of an AI/ML powered medical device. Therefore, the requested information on acceptance criteria, reader studies, and ground truth for an AI/ML device is not applicable and cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence of the IPS e.max® One to a predicate device, IPS e.max CAD (K051705), based on non-clinical performance testing and biocompatibility.

Here's the relevant information about the non-clinical performance testing:

1. Table of Acceptance Criteria and the Reported Device Performance:

Note: The document states "Bench testing was performed... according to EN ISO 6872:2015" for these properties. It does not provide specific numerical results of the performance.

2. Sample size used for the test set and the data provenance: Not applicable. This is a material test, not a test on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

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.

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 consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for material properties is defined by the standards and physical testing methodologies.

8. The sample size for the training set: Not applicable. This is material testing, not an AI model.

9. How the ground truth for the training set was established: Not applicable.

Biocompatibility:

The biocompatibility evaluation was performed according to ISO 10993-1:2009, ISO 7405:2018, and ISO 14971:2019. The evaluation concluded:

• Not cytotoxic
• No sensitizing potential for lithium disilicate glass-ceramic blocks (LS2)
• Does not induce oral mucosal irritation
• No potential for material-mediated pyrogenicity
• No risks for acute, sub-acute, sub-chronic toxicity
• Not genotoxic
• Negligible risk of carcinogenicity
• No direct contact to pulp or dentin.

Conclusion of the study:

The study concludes that IPS e.max® One is substantially equivalent to the predicate device IPS e.max CAD based on the non-clinical performance testing and biocompatibility assessment, despite differences in chemical composition and the elimination of a crystallization step for the new device. The new device covers similar indications (veneers, inlays, onlays, and crowns) but lacks the indication for bridges that the predicate device has.

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Tetric® CAD is intended for:

• Veneers
• Inalys
• Onlays (e.g. occlusal veneers, partial crowns)
• Crowns in the anterior and posterior region

Tetric® CAD is a composite block for the fabrication of esthetic permanent inlays, onlays, veneers and crowns in the anterior and posterior region. Fabrication of the dental restoration is performed at the dentist's office in a compatible milling machine. The blocks are composed of cross-linked dimethacrylate and inorganic fillers. In the processing technique, the restoration is polished and seated after milling in the CAD/CAM system. The blocks are attached to a metal mandrel, the geometry of such is compatible with a milling machine, e.g. Cerec/InLab (Sirona), PlanMill (PlanMeca) or Programill One (Ivoclar Vivadent).

Tetric® CAD composite blocks are available in the translucency levels MT (5 shades - A1, A2, A3, A3.5, BL) and HT (4 shades 0 A1, A2, A3, A3.5), and in the sizes I12 and C14.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tetric® CAD device:

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for the new device's performance against specific clinical benchmarks. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical efficacy is not directly available in this type of submission. Instead, the focus is on showing similarity in functional performance and safety compared to an already approved device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence claim, the "acceptance criteria" are implicitly that the new device (Tetric® CAD) performs comparably or better than the predicate device (Cerasmart K133824) for the listed physical properties. The data presented are for comparison.

Note on Acceptance Criteria: For a 510(k), "acceptance criteria" mainly revolve around demonstrating the new device is as safe and effective as the predicate. For physical properties, this usually means meeting or exceeding the predicate's performance when tested under relevant standards. The document explicitly states "the results of the bench testing show the products to be substantially equivalent," meaning the Tetric® CAD met the implicit acceptance criterion of being comparable.

The subsequent points (2-9) are largely not applicable or not explicitly detailed in the provided 510(k) summary because this document focuses on bench testing and biocompatibility for material properties and substantial equivalence, rather than clinical efficacy studies with human subjects.

2. Sample size 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 for specific tests like flexural strength or water solubility in the summary. For ISO standard compliance (like ISO 10477 and ISO 6872), specific sample sizes are prescribed by the standards, but these aren't given in this summary.
• Data provenance: Not specified in the summary. This would typically be from the manufacturer's R&D labs.
• Retrospective or prospective: Not applicable for bench (non-clinical) testing.

The following points (3-6) are typically relevant for clinical studies, which are not detailed in this 510(k) summary for Tetric® CAD, as the focus is on material properties and substantial equivalence through 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)

• Not Applicable. This pertains to clinical studies often involving expert review of images or patient outcomes. The provided document details bench testing of material properties and biocompatibility, which does not involve establishing ground truth by human experts in this manner.

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

• Not Applicable. This is for clinical studies with human assessors.

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 type of study is typically for diagnostic AI devices, not for dental restorative materials like Tetric® CAD.

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

• Not Applicable. This refers to AI algorithm performance.

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

• For Flexural Strength and Water Solubility: The "ground truth" is established by the standardized measurement methods defined in ISO 6872:2015 and ISO 10477:2004, respectively.
• For Biocompatibility: The "ground truth" is determined by the results of specific in-vitro tests for cytotoxicity (EN ISO 7405:2008 + A1:2013; ISO 10993-5:2009) and genotoxicity (ISO 10993-3:2014), following the principles of ISO 10993-1:2009 + AC:2010.

8. The sample size for the training set

• Not Applicable. This is relevant for AI models. The document describes a material and its testing, not an AI system.

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

• Not Applicable. This is relevant for AI models.

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IPS e.max® Press Abutment Solutions for Viteo Base Ti is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multi-unit cement retained restorations.

IPS e.max Press Abutment Solutions is recommended for the fabrication of:

• Hybrid abutments for single-tooth restorations
• Hybrid abutment crowns for restorations

IPS e.max Press Abutment Solutions for Viteo Base Ti is a prefabricated prosthetic component for endosseous dental implants to support prosthetic restorations in partially or fully edentulous jaws. The Viteo Base-Ti is the apical component of a two-piece abutment. A separate mesostructure fabricated out of IPS e.max Press ceramic is attached to the Viteo Base-Ti extraorally using Multilink Hybrid Abutment Cement (K130436). This part then serves as an intermediary to facilitate the connection of the 2-part abutment to the prosthetic material (crown). The abutment as a whole is intended to be used as an aid in prosthetic rehabilitation for the purpose of providing a suitable chewing function. A compatible screw is included with the Viteo Base-Ti for attachment of the completed hybrid abutment to the implant body. Alternatively, the mesostructure may be fabricated into the prosthetic restoration and attached to the Viteo Base-Ti via the screw to form a hybrid crown/abutment, thereby incorporating the top half of the two-piece abutment into the body of the crown.

The Viteo Base Ti is made of Ti-6Al-4V ELI Titanium Grade 23 and is provided with a compatible screw made of the same materials. Viteo Base-Ti is available in two platform sizes (SD and MD) for various cleared implant systems as described in this summary. The upper part (pillar) of the Viteo Base Ti can be shortened individually, has a blasted surface to support bonding of the restorative part, and has an internal retentive lock to circumvent rotation. The IPS e.max Press Abutment Solutions for Viteo Base Ti are parts of the implant system which consists of:

• Implant Body – marketed by the Implant Manufacturer
• Viteo Base Ti - Titanium part Included in subject device
• Screw - Titanium screw Included in subject device
• IPS e.max Press either as a part of the abutment or a Hybrid Abutment crown included in the subject device.
• Multilink Hybrid Abutment Cement – to bond together the Viteo Base Ti abutment part and the IPS e.max Press ceramic part included in the subject device.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the IPS e.max® Press Abutment Solutions for Viteo Base Ti:

It's important to note that this document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device, not necessarily a comprehensive clinical study report. Therefore, some information typically found in a full study report (like detailed statistical methods for performance or specific ground truth for training) might be aggregated or summarized to support the substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

Study Information:

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

   • Sample Size (Test Set): Not explicitly stated with specific numbers of devices or tests beyond "Worst case evaluation was done for each implant type listed in Table 1." For fatigue testing, ISO 14801 typically requires a minimum of 5-10 specimens per test group, but the exact number for each implant system is not provided. For dimensional compatibility, "measuring Data & tolerance analysis" likely involved multiple measurements, but a sample size isn't given.
   • Data Provenance: Not specified. These are typically laboratory bench tests, so geographic origin isn't critical. The nature is prospective in the sense that fresh devices are tested for performance.

2. 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. This document describes the performance of a mechanical and material dental implant component, not an AI or diagnostic device that requires expert-established ground truth. The 'ground truth' here is adherence to engineering standards and material specifications, verified by testing.

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

   • Not applicable. See point 2.

4. 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. This is a mechanical/material device, not a diagnostic or AI-assisted system.

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

   • Not applicable. This is not an algorithm or AI device. The "standalone" performance here relates to the physical and material properties of the device itself under specified test conditions, which were indeed performed.

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

   • The "ground truth" for this device's performance is adherence to established international and national standards (e.g., ISO 14801 for fatigue, ISO 10993-1 for biocompatibility, ASTM F136-08 for material composition). These standards define acceptable performance metrics and testing methodologies, which serve as the objective benchmarks for validation.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or AI, so there is no training set.

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

   • Not applicable. See point 7.

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Intended Use: IPS Style Press

• Pressing on metal frameworks and superstructures for the fabrication of full-contour crowns and bridges (staining technique)

• Pressing on metal frameworks and superstructures for the fabrication of partially anatomic crowns and bridges (cut-back technique)

• Pressing of ceramic margins (metal-ceramic)

• Pressing of gingiva components (metal-ceramic)

• Processing on the most popular dental alloys in the CTE range of 13.8 14.5 10-6/K

• (25 500°C) (Cu< 1%, Ag < 10%)

• -- Veneering with the layering materials of IPS Style in the conventional layering technique

• Characterization with IPS Ivocolor Shade and Essence stains

• Glazing with IPS Ivocolor Glaze

Intended Use: IPS Style Ceram and IPS Style Ceram Onc

• Conventional multi-layer veneering ceramic for the most popular dental alloys (including electroplating) in the CTE range of 13.8 - 15.2 x 10-6/K (25 - 500°C)

(IPS Style Ceram)

• One-layer veneering ceramic for the most popular dental alloys (including electroplating)

in the CTE range of 13.8 - 15.2 x 10-6/K (25 - 500°C) (IPS Style Ceram One)

• Veneers on refractory die material (only IPS Style Ceram)
• Characterization and veneering of IPS Style Press restorations
• Characterization with IPS Ivocolor Shade and Essence stains
• Glazing with IPS Ivocolor Glaze

IPS Style comprises both materials for the conventional veneering technique and the press technique.

• . IPS Style Ceram: is available as Opaquer 870 in 42 Shades, Opaquer 960 in 42 shades, Margin Powder in 11 Shades, Dentin porcelain in 32 Shades, deep Dentin porcelain in 16 Shades, Incisal Porcelain in 10 Shades, Transparent Porcelain 7 Shades, Mamelon in 3 shades, Occlusal Dentin 2 Shades, Incisal Edge 1 Shade, Opal Effect in 6 Shades, Special Incisal 2 Shades, Inter Incisal 1 Shades, Cerv. Transparent 4 Shades, Add on Ceramic 4 Shades, Bleach Ceramic in 14 Shades, Gingiva Porcelain in 11 Shades and 4 Liquids.
• IPS Style Ceram One: is available in 16 Shades and Shades Guides .
• . IPS Style Press: Press Ingots LT is available in 8 Shades, Press Ingot HT in 8 Shades and Press Ingot Gingiva in 1 Shade.
• . IPS Style Liquids including Build-up and Opaquer which burn out after firing.

The provided text is a 510(k) Premarket Notification from the FDA regarding dental ceramic materials (IPS Style Ceram, IPS Style Ceram One, and IPS Style Press). This type of document focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for the new device as would be found in a clinical trial report or a performance study for a novel device.

Therefore, the requested information cannot be fully extracted from the provided text for the following reasons:

• Nature of the Document: A 510(k) summary primarily demonstrates that a new device is "substantially equivalent" to a predicate device already on the market. This often involves comparing chemical compositions, physical properties, indications for use, and working principles, as well as showing compliance with relevant international standards. It does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or an MRMC study comparing AI performance against human readers.
• Device Type: The devices described are dental ceramic materials (porcelain powders and press ingots) used for fabricating dental restorations. These are materials, not diagnostic AI devices or devices that produce a clinical "read" that would typically be evaluated with metrics like sensitivity, specificity, or reader performance improvement.
• Focus on Equivalence: The document explicitly states, "The comparison shows that IPS Style Ceram and IPS Style Ceram One are substantially equivalent to the predicate device" and "IPS Style Press is substantially equivalent to the predicate device." The "acceptance criteria" here are essentially meeting the standards of the predicate and relevant ISO standards for physical and biocompatibility properties.

However, I can extract information related to the physical properties and biocompatibility assessments, which serve as foundational "acceptance criteria" for this type of material device within the context of a 510(k) submission.

Analysis of the Provided Text for "Acceptance Criteria"

Based on the information provided, the "acceptance criteria" for these dental ceramic materials are primarily focused on:

1. Biocompatibility: The device must not cause adverse biological reactions.
2. Physical Properties: The device must meet the requirements of relevant ISO standards for dental ceramics, especially regarding flexural strength and metal-ceramic bond strength.
3. Chemical Composition: The key ingredients should be silica-based dental glass ceramic with similar elements to the predicate.
4. Indications for Use & Working Principle: The device should have similar intended uses and working principles to its predicate devices.

Extracted Information:

1. Table of "Acceptance Criteria" and Reported Device "Performance" (Based on Material Characteristics and Standards)

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

• Not explicitly stated for physical property tests. The document mentions that "The product has been tested to ISO 6872" and "ISO 9693" and "The test results for flexural strength are significantly above the specification." However, the exact sample sizes (number of specimens tested) for these mechanical tests are not provided in this summary.
• Data Provenance: Not specified, but generally, such tests are conducted in-house by the manufacturer (Ivoclar Vivadent Ag, Liechtenstein) or by accredited testing laboratories on behalf of the manufacturer. The date prepared is May 16, 2016.

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 stated. This type of information is relevant for studies involving human interpretation or clinical outcomes, typically for diagnostic or treatment devices. For material science properties and biocompatibility, "ground truth" is established through standardized laboratory tests and analytical methods, not expert consensus on interpretations.

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

• Not applicable. 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

• No. An MRMC study is not relevant for this type of material device. This is typically used for AI-powered diagnostic imaging or medical decision support systems involving human readers/interpreters.

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

• No. This device is a material, not an algorithm.

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

• For biocompatibility: Laboratory test results following ISO 10993-1, including cytotoxicity and genotoxicity assessments.
• For physical properties: Measurements obtained through standardized laboratory testing methods conforming to ISO 6872 and ISO 9693. This generates objective, quantitative data.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a training set.

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

• Not applicable. This device is not an AI algorithm that requires a training set.

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Staining and/or characterization and glazing of ceramic materials from Ivoclar Vivadent and Wieland Dental:

• Veneering ceramics
• Press ceramics
• Milling ceramics
• Zirconium oxide (framework and full-contour)

IPS Ivocolor is a universal stains and glaze assortment consisting of 23 shades of Essence porcelain, 9 shades of Dentin porcelain, 3 incisal porcelains, 2 Glaze powders, 2 glaze pasts, 2 Mixing Liquids, Essence fluid and shade guides. The range of products has been coordinated with the layering, press and CAD Ceramics from Ivoclar Vivadent and the zirconium oxides from Wieland Dental and be used regardless of the CTE of the ceramic. The difference is that IPS Ivocolor can be used with both metal-ceramic and fullceramic materials.

This document is a 510(k) summary for a dental product called IPS Ivocolor. It details the product's description, indications for use, comparison to predicate devices, and a conclusion of substantial equivalence. However, it does not describe a study that proves the device meets acceptance criteria in the way that an AI/ML device submission would.

The document discusses the physical properties and compatibility of the dental material itself, rather than the performance of a diagnostic algorithm. Therefore, the requested information categories (sample size, experts, adjudication, MRMC, standalone, etc.) are structured for AI/ML device studies and are not applicable to this type of traditional medical device submission.

I can extract the acceptance criteria (in terms of physical properties) and the reported device performance related to those criteria from the document, but it will not be presented in the context of an AI/ML study.

Here's the information that can be extracted, interpreted within the context of a traditional device submission (not AI/ML):

Acceptance Criteria and Reported Device Performance (as related to physical properties of dental materials)

Study Details (Note: These categories are for AI/ML studies and are not directly applicable to this traditional dental material submission. The information below is an interpretation based on the document's content, if an analogy were to be forced.)

1. Sample size used for the test set and the data provenance: Not applicable. This device is a dental material, and the "test set" would be the physical samples tested according to ISO 6872. The document does not specify the number of samples. The provenance of the "data" (i.e., test results) would be from in-house laboratory testing by the manufacturer.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For dental material properties, "ground truth" is established by standardized laboratory testing methods (e.g., ISO 6872), not by expert consensus on diagnostic images.

3. Adjudication method for the test set: Not applicable. Standardized lab tests have pass/fail criteria based on ISO standards.

4. 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 diagnostic device nor a reader study.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a dental material, not an algorithm.

6. The type of ground truth used: Standardized physical property measurements according to ISO 6872.

7. The sample size for the training set: Not applicable. There is no training set for a material like this. Development would involve experimental formulation and testing.

8. How the ground truth for the training set was established: Not applicable.

Summary of the Document's "Study" Information (in its actual context):

The document describes material testing to demonstrate that IPS Ivocolor meets the requirements of ISO 6872 for ceramic materials. This is a standard for dental ceramic materials and specifies various physical properties and their acceptable ranges. The manufacturer performed tests on IPS Ivocolor for properties such as uniformity, cleanliness, radioactivity, color coding, flexural strength, coefficient of linear thermal expansion (CTE), glass transition temperature, and chemical solubility. The document states that the product "meets the requirements" for these tests. It also notes that the CTE and Glass transition temperature are "slightly lower than those of the primary predicate," which is presented as a design choice to ensure compatibility with a wider range of ceramics.

The primary "proof" of meeting acceptance criteria for this type of device is compliance with relevant international standards for dental materials (like ISO 6872) and demonstrating substantial equivalence to a legally marketed predicate device through comparative data (chemical composition, physical properties, indications for use, and operating principles).

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Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts:

• Telio CAD Abutment Solution
• Ti base and
• CAD/CAM software
  Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants.

Telio CAD Abutment Solutions are resin blocks with an interface hole in Small and large sizes to accommodate Sirona Ti bases (K100152 and K111421) in the fabrication of temporary hybrid abutment crowns. The Device is milled using CAD/CAM Technology then cemented to the Sirona Ti base and used for the purpose of temporary hybrid abutment crowns in coniunction with endosseous dental implants. Hybrid abutment crowns are characterized by combining a Ti base and monolithic crown in one piece.
Telio® CAD Abutment Solutions are CAD/CAM-fabricated implant-supported hybrid restorations for individual, temporary single-tooth reconstructions. The material consists of a cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base. Shape, esthetics and emergence profile can be easily designed and adjusted any time.

This document is a 510(k) premarket notification for a medical device called "Telio CAD Abutment Solutions." It focuses on demonstrating the substantial equivalence of the new device to previously marketed predicate devices. The information provided heavily emphasizes physical, mechanical, and biological testing rather than artificial intelligence or diagnostic algorithms. Therefore, many of the typical acceptance criteria questions related to AI performance, such as sensitivity, specificity, or AUC, as well as aspects like reader studies, are not applicable here.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it describes tests performed and states the results were "comparable to the predicate device" or "suitable for use." The focus is on demonstrating equivalence rather than meeting specific numerical thresholds for improved performance.

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

The document provides details on types of testing (flexural, fatigue, biocompatibility) and the standards used (EN ISO 10477:2004, EN ISO 14801:2007, ISO 10993-1, ISO 7504). However, it does not specify the sample sizes (e.g., number of test specimens) used for each of these mechanical tests. It also doesn't mention the provenance of any "data" in terms of country of origin or whether it was retrospective/prospective, as this is typically relevant for clinical data, which is not the primary focus of this submission. The testing appears to be laboratory-based physical/mechanical testing.

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

This question is not applicable. The device is a dental abutment, and its performance is evaluated through physical, mechanical, and biocompatibility testing, not through a diagnostic algorithm requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This question is not applicable. There is no "test set" in the context of expert review or diagnostic output that would require an adjudication method. The testing described is laboratory-based.

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

This question is not applicable. MRMC studies are used to evaluate AI performance with human readers. This submission is for a physical medical device (dental abutment) and does not involve AI or human interpretation of diagnostic results.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable. There is no algorithm or AI component mentioned in this submission. The device is a physical product.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through standardized laboratory testing and material characterization according to international ISO and EN standards. For example, flexural strength is measured directly, dynamic fatigue is assessed against defined cycles and loads, and biocompatibility is evaluated based on established biological safety protocols. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in the way it would be for a diagnostic tool.

8. Sample Size for the Training Set

This question is not applicable. As there is no AI/machine learning algorithm involved, there is no "training set."

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

This question is not applicable. As there is no AI/machine learning algorithm involved, there is no "training set" or ground truth for such a set to be established.

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– As initial layer / first increment in Class I and II composite restorations in permanent teeth

• Restorations in deciduous teeth

Tetric EvoFlow® Bulk Fill is a flowable, light-curing radiopaque composite. As its opacity increases during polymerization, it is also suitable for discolored tooth structure. It is applied in increments of up to 4 mm as an initial layer in Class I and II restorations. Tetric EvoFlow Bulk Fill is intended for use as a dental filling material.

The provided text is a 510(k) summary for a dental device, Tetric EvoFlow Bulk Fill. It details the device's characteristics and its comparison to a predicate device, Tetric EvoCeram Bulk Fill, to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

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

The document does not specify general "acceptance criteria" for the device as a whole beyond demonstrating substantial equivalence to the predicate. Instead, it lists specific properties that were tested and compared to the predicate, often referencing ISO 4049.

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 provide details on the sample sizes used for the testing, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states that the device was "evaluated" and "tested."

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 section is not applicable as the studies described are laboratory-based physical and chemical property tests, not clinical studies requiring expert ground truth for interpretation.

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

This section is not applicable for the same reason as 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

This section is not applicable. The device is a dental filling material, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

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

This section is not applicable. The device is a physical dental material, not an algorithm.

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

For the physical and chemical property tests, the "ground truth" or reference points are defined by established international standards (ISO 4049, ISO 10993-1, EN ISO 7405) and the characteristics of the legally marketed predicate device (Tetric EvoCeram Bulk Fill). For biocompatibility, it also includes literature review.

8. The sample size for the training set

This section is not applicable as the device is a physical material and does not involve AI or machine learning that would require a training set.

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

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

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Conditioning of silica-based ceramic surfaces for the adhesive bond with luting composites

Monobond Etch & Prime is used to condition silica-based ceramic surfaces for the adhesive bond with luting composites from the Variolink or Multilink product lines, for example, Monobond Etch & Prime etches and silanizes silicate ceramic suffaces in one working step. The new product combines the role of bonding agent with that of etchant. Typically the dental technician would etch the ceramic with 5% hydrofluoric acid but this step is achieved using Monobond Etch & Prime. The etching step was carried out outside the mouth and the new product is also limited to extra-oral applications of the new product are limited to silica ceramics, Oxide ceramics, metal, composite and fibre-reinforced composites are not indicated. This is because only silica glass ceramics required etching with hydrofluoric acid and therefore the benefit of using Monobond Etch & Prime is primarily relevant for this group of materials.

This document is a 510(k) premarket notification for a dental device, specifically a resin tooth bonding agent called Monobond® Etch & Prime (K150164). The document primarily focuses on establishing substantial equivalence to a predicate device, Monobond Plus (K090826), rather than providing detailed acceptance criteria and a comprehensive study report for the proposed device itself.

Based on the provided text, the information requested cannot be fully extracted for the new device, Monobond® Etch & Prime, because the document is a regulatory submission for substantial equivalence, not a detailed clinical study report with specific performance metrics defined as acceptance criteria.

However, I can extract the available information and highlight what is missing.

Here's an attempt to answer your questions based on the provided text:

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

Note on Acceptance Criteria: The document states, "As no product specific standard exists for the subject device," indicating that formal, externally defined acceptance criteria for the new device were not applied verbatim. Instead, the performance was compared to its own internal specification and to the predicate device for substantial equivalence. "Conforming to the specification" implies internal acceptance criteria were met, but the specific numerical values are not provided.

2. Sample size 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 specified. The document mentions "tests for Monobond Etch & Prime and Monobond Plus tensile bond strength" but does not provide details on the number of samples or specimens tested.
• Data Provenance: Not specified. The country of origin of the data is not mentioned, nor is it stated whether the study was retrospective or prospective.

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/not provided as this is not a study involving expert assessment or ground truth establishment in a clinical context. The testing described is laboratory-based physical and biocompatibility testing.

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

This information is not applicable/not provided as this is not a study involving human interpretation of data requiring adjudication.

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 information is not applicable/not provided. The device is a dental bonding agent, not an AI or imaging diagnostic tool that would typically involve MRMC studies or human readers.

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

This information is not applicable/not provided. The device is a physical product (a chemical agent), not an algorithm.

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

For the tensile bond strength testing, the "ground truth" would be the physically measured bond strength under controlled laboratory conditions, not expert consensus, pathology, or outcomes data. For biocompatibility, the ground truth would be the results of standardized biological assays per EN ISO 10993-1:2009 and EN ISO 7405:2008.

8. The sample size for the training set

This information is not applicable/not provided. This is not a machine learning device that requires a training set.

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

This information is not applicable/not provided. As above, no training set for an algorithm is involved.

Summary of what can be gleaned from the document:

The primary "study" mentioned for Monobond® Etch & Prime is laboratory testing for tensile bond strength and biocompatibility. The purpose of these tests was to demonstrate substantial equivalence to the predicate device, Monobond Plus (K090826).

• Tensile bond strength on glass ceramics was tested and found to conform to specification and be "substantially equivalent" to the predicate. The methods for the new device were tensile bond strength, while the predicate historically used shear bond strength, making direct comparison difficult, but a specific comparison was still made for tensile bond strength to show equivalence.
• Biocompatibility was assessed according to EN ISO 10993-1:2009 and EN ISO 7405:2008.

The document is a regulatory submission for a Class II medical device, and as such, it emphasizes comparison to a predicate device and adherence to regulatory standards rather than presenting detailed clinical trial data or comprehensive study results with explicit, quantifiable acceptance criteria and multi-reader analyses typical for diagnostic AI devices.

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Variolink Esthetic LC:
– Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)

• Only use Variolink Esthetic LC for restorations with a low thickness of <2mm that have sufficient translucency (e.g. restorations made of IPS e.max R HT).

Variolink Esthetic DC:

• Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays, partial crowns, crowns, bridges).
• Restorations made of opaque ceramics, e.q. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured.

Variolink Esthetic Trv-In
To evaluate the overall effect of the restoration in conjunction with the various Variolink Esthetic shades prior to permanent cementation.

Variolink® Esthetic is a color-stable adhesive luting system for the permanent cementation of ceramic and composite resin restorations. Variolin Esthet6ic is offered in a purely light-curing (LC) and dual-curing (DC) version. Try-In pastes are also included for shade matching purposes. The materials are offered in five shade gradations (Light+, Light, Neutral, Warm and Warm+)

The provided text describes a 510(k) premarket notification for a dental device, Variolink® Esthetic. It includes a comparison to a predicate device and a brief summary of testing performed. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance, nor details about a comprehensive study proving acceptance criteria were met as typically found in clinical trial reports or detailed performance studies for AI/medical imaging devices.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on chemical composition, physical properties, and indications for use, rather than presenting a detailed performance study against specific acceptance criteria for an AI-based device.

Therefore, I cannot directly answer your request about acceptance criteria and the study proving the device meets them in the format you provided because the necessary details are not present in the given text.

Based on the information provided, here's what can be extracted and what is missing:

Missing Information (Not provided in the document):

• A table of acceptance criteria and the reported device performance: The document mentions that the device has been tested and designed in accordance with certain ISO standards (ISO 4049:2009 for physical properties and EN ISO 10993-1:2009 / EN ISO 7405:2008 for biocompatibility). However, it does not list specific acceptance criteria values (e.g., "flexural strength must be > X MPa") or the actual reported performance values (e.g., "flexural strength was Y MPa") against those criteria. It only states that the device was designed and tested in accordance with these standards.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/imaging device requiring expert ground truth for interpretation.
• Adjudication method for the test set: Not applicable.
• 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, as this is not an AI-assisted device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For physical/chemical properties, the "ground truth" would be the standard measurement methods defined by the ISO/EN standards. For biocompatibility, it's about meeting the safety profiles outlined in the standards.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What is present:

• Device Name: Variolink® Esthetic
• Predicate Device: Variolink II (K971372)
• Type of tests performed:
  • Physical properties (in accordance with ISO 4049:2009): film thickness, Depth of Cure, sensitivity to ambient light, working time, flexural strength, water sorption, solubility, and radiopacity.
  • Biocompatibility testing (in accordance with EN ISO 10993-1:2009 and EN ISO 7405:2008).
• Conclusion: The device is substantially equivalent to the predicate device based on comparison of chemical composition, physical properties, and indications for use.

To fully answer your question, information typically found in detailed test reports or clinical studies would be needed, which is beyond the scope of this 510(k) summary document.

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• Treatment of dentinal hypersensitivity
• Treatment of exposed cervicals
• Treatment of sensitivity after tooth whitening

Fluor Protector S is a desensitizing agent used for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparation. The primary difference between the subject device and the predicate device is the use of Ammonium fluoride in the subject device. Even though there is an approximately 8-fold difference in fluoride content in solution between the subject device and the predicate device, the difference is only 3.6-fold in the dry varnish, which is the "active state" of the device. Apart from fluoride content, the varnishes are very similar (low viscosity, clear, transparent, multi- and single dose).

This document is a 510(k) summary for a dental product called "Fluor Protector S" and does not contain the information requested in the prompt about acceptance criteria and a study proving a device meets them. The document is primarily focused on demonstrating substantial equivalence to a predicate device, as required for FDA clearance.

Therefore, I cannot extract the requested information from the provided text.

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