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Position® Penta and Position® Penta Quick are indicated for use for impressions for temporary restorations, preliminary impressions, opposing dentitians and orthodontic models.

Position® Penta and Position® Penta Quick are slightly modified impression materials. Position® Penta, Position® Penta Quick and Dimension® Penta H are all composed of a base paste and catalyst. Position® Penta, Position® Penta Quick and Dimension® Penta H have the same catalyst composition except for use of a pigment identified as an alternative in the Dimension® Penta 510(k). The base paste composition of the products are similar, with the exception of: (1) variations of ingredient amounts; (2) use in Position® Penta and Position® Penta Quick of a new form/chemical structure of a previously used ingredient (silyl polyethylene oxides); and (3) use of new pigments identified as alternatives in the Dimension® Penta 510(k).

The provided text is a 510(k) summary for a medical device (Position® Penta and Position® Penta Quick impression materials) and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the new devices (Position® Penta and Position® Penta Quick) to a predicate device (Dimension® Penta H).
• Device Description: Discussing modifications made to the impression materials.
• Intended Use: Listing the applications for the impression materials.
• Biocompatibility Tests: Mentioning that these were undertaken, but not detailing results or acceptance criteria.
• Regulatory Communication: Providing the FDA's letter of clearance.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the provided text. The output will reflect the absence of this information.

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The Sinfony® system is indicated for use as a light-curing composite veneer material for:

• full and partial coverage of:
  • fixed crown and bridgework .
  • telescopic and conical crowns .
  • precision attachments
  • implant superstructures .
  • adhesive bridgework .
  • laminate veneers .
  • o individualizing denture teeth
  • individualizing long-term temporary restorations .

light-curing composite veneer material

The provided text describes a 510(k) premarket notification for a dental material (Sinfony®), focusing on its substantial equivalence to previously cleared devices. It outlines the intended use and states that physical and technical characteristics were compared using specific ISO and DIN standards. However, it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving device performance as typically understood for AI/ML device evaluations.

Specifically, the document discusses a dental material and its mechanical properties, not an AI/ML device, and thus the concepts of "device performance," "sample size for test set," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set," and "ground truth for training set" are not applicable in the context of this traditional medical device submission.

Therefore, I will only be able to provide information relevant to the material described in the input text.

Here's what can be extracted and inferred from the text provided:

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

Note: The document states "To support substantial equivalence... characteristics of Sinfony® have been compared to those of Visio-Gem® using tests undertaken pursuant to ISO 10477 and DIN 53456." It does not provide the specific numerical acceptance thresholds or the detailed quantitative results for each characteristic, only that they were compared to establish substantial equivalence.

Regarding the other points, the provided text does not contain the information requested, as it pertains to a different type of medical device (a dental material) than what your questions imply (an AI/ML device). Therefore, the following points cannot be answered from the provided input:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a material test.
• 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 for a material test.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a material test.
• 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 as this is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For material testing, "ground truth" is typically established by standardized physical/chemical measurements rather than expert consensus on diagnostic images or pathology. The "ground truth" here is the performance of the predicate device and the standards ISO 10477 and DIN 53456.
• 8. The sample size for the training set: Not applicable as this is not an AI device.
• 9. How the ground truth for the training set was established: Not applicable as this is not an AI device.

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Ketac-Fil® Aplicap® Plus is a glass ionomer cement material indicated for the following uses: (1) fillings of Black Classes III and V cavities; (2) wedge-shaped defects; (3) fissure sealing; (4) small Black Class I cavities: (5) deciduous teeth; and (6) core build-ups.

Ketac-Fil® Aplicap® Plus is a modified glass ionomer cement material. Modifications have been made to the following ESPE 510(k)s for glass ionomer cement material: (1) Photac-Fil® Aplicap® (K925027); and (2) Ketac-Molar® Aplicap® (K960954), to create a slightly modified product with two new pigments.

This 510(k) summary describes a modified glass ionomer cement material, Ketac-Fil® Aplicap® Plus, which is a dental material and not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable.

Here's an analysis based on the provided text, focusing on the available information for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This submission is for a physical material (dental cement), not an AI/ML device involving test sets of data. The "tests" refer to physical, chemical, and biological laboratory testing of the material itself.
• The tests were conducted by ESPE in Germany.

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 is not an AI/ML device where "ground truth" is established by human experts on a dataset. The "ground truth" in this context would be objective measurements from laboratory tests and compliance with recognized standards.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of data (e.g., medical images) in AI/ML studies. For a dental cement, acceptance is based on predefined physical, chemical, and biological test outcomes against specified standards.

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/ML device, and no human "readers" or diagnostic tasks are involved in its primary function that would necessitate an MRMC study.

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

• Not applicable. This is not an AI/ML algorithm.

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

• For this device, the "ground truth" for demonstrating substantial equivalence and safety/effectiveness relies on:
  • Objective laboratory measurements: Physical properties (e.g., relevant to DIN/ISO standards), chemical composition, and biocompatibility assays (cytotoxicity, mutagenicity, etc.).
  • Compliance with recognized standards: Adherence to DIN and ISO standards for dental cement.
  • Comparison to predicate devices: Demonstrating similar performance and characteristics to already cleared devices.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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Temporary fillings for inlay and onlay preparations .
Temporary fillings of cavities ●
Temporary filling of implant sites ●
Relining of prefabricated temporary crowns and bridges .

light-curing temporary filling material, tradenamed Cavit®-LC

The provided text describes a 510(k) premarket notification for a dental material, Cavit®-LC, and references comparative testing. However, it does not include detailed information regarding acceptance criteria or the specific study that proves the device meets those criteria in a format that would allow me to fill out all the requested fields for a typical AI/software device evaluation.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Fermit-N and Clip®) by comparing physical and technical characteristics, and reporting on biocompatibility tests (cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization).

Here's an attempt to extract the relevant information based on the provided text, with many fields being marked as "Not Applicable" or "Not Provided" due to the nature of the submission (a dental material, not an AI/software device):

Acceptance Criteria and Device Performance

This section is difficult to fully populate with numerical acceptance criteria and reported performance from the provided text, as the submission focuses on substantial equivalence to predicate devices rather than specific performance metrics against predefined thresholds. The "tests undertaken" are primarily biocompatibility tests.

Notes on Acceptance Criteria: For a 510(k) submission for a material, the "acceptance criteria" are generally that the new device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, is as safe and effective, and has similar technological characteristics. The comparison of physical and technical characteristics and biocompatibility tests serve to demonstrate this equivalence, rather than meeting specific numerical performance thresholds for an AI algorithm.

Study Details

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

   • Sample Size: Not specified in terms of number of cases or patients. The tests mentioned (biocompatibility, physical/technical characteristics) would involve material samples or in vitro/animal models.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were "undertaken on the final Cavit®-LC product."

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

   • Not Applicable. This type of information is relevant for AI/software devices requiring expert review for ground truth establishment. For a dental filling material, ground truth would be established through material testing standards and biocompatibility guidelines.

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

   • Not Applicable. As above, this pertains to expert review of diagnostic findings for AI/software, not material science or biocompatibility testing.

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 material science product, not an AI-assisted diagnostic device.

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

   • Not Applicable. This is a material science product. The performance of the material is assessed directly, not via an algorithm.

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

   • For biocompatibility: Standardized in vitro tests (e.g., cytotoxicity, Ames) and in vivo animal studies (skin irritation, eye irritation, acute oral toxicity, sensitization) with defined endpoints and acceptance criteria from regulatory guidelines.
   • For physical/technical characteristics: Material science testing methods and standards.
   • For substantial equivalence: Comparison to the established characteristics and performance of predicate devices.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of a dental material submission demonstrating substantial equivalence through physical and biocompatibility testing.

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

   • Not Applicable. See above.

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The CoJet™-System's intraoral adhesive restoration repair and adhesive cementation uses include:

• adhesive repair of defects in porcelain
• adhesive repair of defects in porcelain with exposed metal -
• adhesive repair of defects in composite -
• adhesive repair of defects in composite with exposed metal
• conditioning of metal restorations prior to cementation, e.g., crowns, bridges, inlays, onlays, root posts, core posts, etc.
• conditioning of porcelain or composite restorations prior to adhesive cementation, e.g., inlays, onlays, laminate veneers, etc.

4-component system for intraoral adhesive repair of porcelain and composite restorations and pretreatment for adhesive cementation, trade named CoJet™-System. The components are CoJet™-Sand, a silane coupling agent, a bonding material, and an Opaquer.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML or diagnostic performance. The document is a 510(k) summary for a dental adhesive system (CoJet™-System) and focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested information, as there is no data related to:

1. Acceptance criteria and reported device performance in a diagnostic sense (e.g., sensitivity, specificity, AUC).
2. Sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance in the context of an AI/ML device or diagnostic test.

The document discusses the regulatory clearance of a dental product based on its components and their prior clearances, with a brief mention of "performance data demonstrate that the products' performance is not affected by intraoral preparation and use." However, it does not elaborate on what this performance data entails, nor does it present specific metrics or study designs relevant to the questions asked.

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Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.

compomer luting cement, tradenamed Hycem® Aplicap®

This 510(k) summary for K963737 describes the Hycem® Aplicap® compomer luting cement. However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance, or data related to AI/algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, expert involvement, or ground truth, as none of this information is present in the provided document.

The document focuses on:

• Intended Use: Final cementation of restorations (crowns, bridges, inlays/onlays, pins, screws, brackets, bands).
• Substantial Equivalence Claim: To Dentsply Caulk's Advance™ Hybrid Ionomer Cement, based on similar intended use and composition.
• Performance Claim: Hycem® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement. This is a general statement about physical properties, not specific clinical performance metrics.

To answer your questions accurately, a document detailing performance studies (clinical or benchtop with specific acceptance criteria) would be required.

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The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent.

3-component resin tooth bonding system, tradenamed EBS® (ESPE Bonding System). The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent.

The provided text is a 510(k) summary for a dental bonding system (EBS®) and does not contain the detailed information required to answer the questions about acceptance criteria, study design, and performance metrics typically found in clinical studies for AI/software-as-a-medical-device (SaMD).

The document focuses on demonstrating substantial equivalence to a predicate device based on shear bond strength testing, which is a physical performance characteristic, not a clinical outcome or diagnostic accuracy.

Therefore, for each point requested:

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

   • Acceptance Criteria: Not explicitly stated in terms of a numerical range or threshold for "substantial equivalence." The document implies that the shear bond strength of the EBS® System should be comparable to that of the Scotchbond™ System to achieve substantial equivalence.
   • Reported Device Performance: The document states that "the shear bond strength of the EBS® System has been compared to that of the Scotchbond™ System." However, the actual numerical results of this comparison (e.g., mean shear bond strength for EBS, mean for Scotchbond, p-value of comparison) are not provided in this summary.

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., animal teeth, extracted human teeth, in-vivo human studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study focuses on physical performance (shear bond strength), which doesn't involve "ground truth" derived from expert interpretation in the way AI/SaMD studies do.

4. Adjudication method for the test set: Not applicable. (See #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: Not applicable. This is not an AI/SaMD study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/SaMD study.

7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" here would be the measured shear bond strength, which is an objective physical measurement.

8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is a physical performance test, not a machine learning study.

9. How the ground truth for the training set was established: Not applicable. (See #8)

In summary, the provided document is a 510(k) summary for a dental bonding agent, demonstrating substantial equivalence through a physical performance test (shear bond strength). It lacks the specific details regarding clinical study design, performance metrics (beyond the general mention of comparison), or AI-related information typically requested in your template.

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(1) fillings in Class I, III, IV, V and small Class II cavities; (2) fillings in deciduous teeth; (3) eroded and abraded cervical areas (wedge-shaped defects); (4) fabricating indirect anterior laminate veneers and tooth colored inlays; and (5) repairing facings on crowns and bridges.

modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling materials

This 510(k) summary (K962440) describes a modification to an already cleared tooth shade resin material (Pertac-Hybrid). The new materials, Pertac II and Pertac II Aplitip, are composite filling materials.

Based on the provided text, the acceptance criteria and study details are quite limited. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data as would be expected for a novel, high-risk device. The information primarily addresses material properties and safety tests for a component.

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

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

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

• Sample Size (Test Set): Not specified. The document mentions "certain tests have been performed" on the peroxide component and "physical and technical characteristics...have been compared," but doesn't quantify the number of samples or specimens used for these comparisons or tests.
• Data Provenance: The manufacturer, Peroxid-Chemie, performed tests on the peroxide component. The overall comparison to the predicate was carried out by ESPE (the applicant). The manufacturing location (and thus likely the origin of some data) is implied to be Germany (ESPE's address is in Germany, and Peroxid-Chemie is mentioned as the manufacturer of the peroxide component). The data is retrospective in the sense that it's a comparison to an already cleared device and materials.

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

• Not applicable/Not specified. This application is for a material modification and relies on demonstrating equivalence through material properties and basic safety tests, rather than clinical performance interpreted by experts. There's no mention of experts establishing ground truth for performance.

4. Adjudication method for the test set

• Not applicable/Not specified. There is no mention of an adjudication process, as the tests described are primarily objective material property tests and general safety assessments, not clinical outcome 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

• Not applicable. This device is a dental filling material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

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

7. The type of ground truth used

• The "ground truth" here is based on objective material properties (physical and technical characteristics) and established safety testing protocols (skin irritation, eye irritation, Ames, acute toxicity) for chemical components, as well as compliance with relevant DIN and ISO standards for dental composite materials. For the substantial equivalence claim, the "ground truth" is the performance and safety profile of the predicate device (Pertac®-Hybrid®).

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set" in the context of the provided information.

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

• Not applicable, as there is no training set.

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Hytac® Aplitip® is a compomer filling material indicated for the following uses: (1) fillings in deciduous teeth; (2) fillings in Class V cavities; (3) eroded and abraded cervical areas; (4) fillings in Class III cavities; and (5) temporary fillings in Class I and II cavities. Hytac® OSB is a light cured bonding agent for use with compomer filling materials.

Hytac® Aplitip® is a compomer filling material. Hytac® OSB is a light cured bonding agent.

This appears to be a 510(k) summary for a dental filling material and bone agent, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement is not applicable in the context of AI/ML performance evaluation.

The document discusses substantial equivalence to predicate devices based on physical and technical characteristics, ingredient composition, and biological safety tests (cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization). It also states that the products meet relevant DIN and ISO standards for dental composite material. However, these are not the "acceptance criteria" and "study" as one would describe for an AI/ML device's performance metrics (e.g., sensitivity, specificity, AUC).

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Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: (1) linings for Class I and II cavities filled with composite; (2) core build-ups; (3) fillings in deciduous teeth; (4) fillings in Class I cavities located in non-occlusal load bearing areas; (5) fillings in Class V cavities if the aesthetics are not of primary importance; and (6) temporary fillings in Class I and II cavities.

slightly modified glass ionomer cement material, referred to by the tradename Ketac-Molar Aplicap®. The reason for this modification is to provide for an improved compressive strength.

This document describes a 510(k) premarket notification for modifications to a dental cement material (Ketac-Molar Aplicap®), focusing on improved compressive strength. The request is to identify acceptance criteria and study details. However, the provided text does not contain information about acceptance criteria or a study with performance results relevant to the specified questions.

The document states: "Ketac-Molar® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement." This indicates that the product adheres to general dental cement standards, but it doesn't provide specific quantitative acceptance criteria or a study detailing device performance against those criteria in the format requested.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document focuses on the reason for modification (improved compressive strength) and claims substantial equivalence based on physical and technical characteristics and water-soluble fluoride content compared to predicate devices, and adherence to standards, but not a detailed study report with performance metrics.

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