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• Restorations in the posterior region (Classes I and II, including replacement of individual cusps)
• Restorations of class V (cervical caries, root erosions, wedge-shaped defects)
• Core build-up
• Restorations in deciduous teeth

Ecosite Bulk Fill is a light-curing, radiopaque restorative material developed especially for use in the posterior region.

This document is a 510(k) premarket notification for a dental material, Ecosite Bulk Fill. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data. Therefore, many of the requested categories related to studies involving human readers, clinical trials, or extensive ground truth establishment are "Not Applicable" or "Not Provided" in this submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the comparative performance to the predicate device, Nanocomposite (K080480), and the adherence to relevant FDA guidance and ISO standards for dental materials. The acceptance is that Ecosite Bulk Fill's properties are "substantially equivalent" to those of the predicate device.

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

The document does not explicitly state the "sample size" for each specific physical and mechanical property test. The study is a non-clinical performance study focusing on in-vitro testing. The data provenance is internal testing conducted by the manufacturer, comparing their proposed device to the reported properties of the predicate device. It is not retrospective or prospective clinical data from patients or humans.

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

Not applicable. This is a non-clinical, in-vitro performance study. Ground truth in the sense of expert consensus on clinical findings is not relevant here. The "ground truth" for the material properties is established by standardized testing methods.

4. Adjudication method for the test set

Not applicable. This is a non-clinical, in-vitro performance study. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies or image interpretation.

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 restorative material, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a dental restorative material, not an algorithm. The "standalone" performance here refers to the physical and mechanical properties of the material itself.

7. The type of ground truth used

The ground truth used for these non-clinical performance tests are measurements and observations from standardized physical and mechanical tests, conducted according to recognized industry standards (e.g., ISO and FDA Guidance for Industry and FDA Staff: "Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions").

8. The sample size for the training set

Not applicable. This is a physical material with properties measured directly, not a machine learning model requiring a training set.

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

Not applicable. As above, there is no training set for this type of device submission.

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TempoCem Clear is indicated for:

• · Temporary or semipermanent luting of temporary and permanent crowns, bridges, inlays and onlays.
• · Temporary luting of temporary veneers.
• · Temporary or semipermanent luting of implant-borne dental prosthesis.

TempoCem Clear is a transparent, dual-curing, resin-based dental cement for the temporary or semipermanent cementing of provisional resin-based composite restorations (crowns, bridges, inlays, onlays, veneers) to a tooth and for temporary or semipermanent luting to an implant abutment. The cement consists of two pastes (base and catalyst) packaged in a double-barreled plastic syringe. The pastes are automatically mixed when dispensed through the single-use mixing tips supplied with the device.

The provided document is a 510(k) summary for a dental cement called TempoCem Clear. It does not contain information about a study proving the device meets specific acceptance criteria in the manner of a clinical efficacy trial with established benchmarks. Instead, it demonstrates substantial equivalence to a predicate device based on non-clinical performance data.

Here's an analysis based on the information provided, attempting to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" against which the device performance is measured in a pass/fail manner. Instead, it compares the performance of TempoCem Clear to a predicate device (Telio CS Link) and references relevant ISO standards and FDA guidance. The "acceptance criteria" here are implied to be "comparable to the predicate device" or "within acceptable ranges for dental cements" as defined by the mentioned standards and guidance.

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

The document does not provide specific sample sizes (e.g., number of test specimens) for each of the physical and mechanical property tests. It states that "Physical and mechanical properties of TempoCem Clear were investigated and compared to the predicate device in accordance with FDA's 1998 Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (chemistry of the setting reaction, working and setting times, solubility, dimensional change, bonding strength, film thickness, heat generated during setting and biocompatibility)." This implies the tests were conducted in a laboratory setting, likely following standard test methodologies but the country of origin of the data is not specified (though the submitter information lists "DMG USA, Inc." in Massachusetts, USA). The data is by nature retrospective for the predicate device and newly generated for the proposed device.

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

This information is not applicable to the type of testing described. The "ground truth" for physical and mechanical properties is established by standardized laboratory measurements rather than expert human interpretation. Biocompatibility "ground truth" is established via cytotoxic assays, not expert panels.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication for these types of non-clinical, quantitative tests.

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 a dental cement, not an AI-assisted diagnostic device. No MRMC study was performed.

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

Not applicable. This is a dental cement, not an algorithm.

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

For the physical and mechanical properties, the "ground truth" is derived from direct measurements using established laboratory test methods (e.g., measuring solubility, strength, etc.) as outlined in the FDA guidance and ISO standards (e.g., ISO Standard 7405).
For biocompatibility, the ground truth is established through cytotoxicity studies, not expert consensus or pathology in a clinical setting.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study, so there is no training set in that context.

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

Not applicable, as there is no training set for this type of device submission.

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For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

The Retraction Paste is a medium viscosity substance that contains aluminium chloride hexahydrate in a water-based kaolin (clay) inert carrier. The kaolin/water paste provides physical displacement of the gingiva as the material is placed into the sulcus via a manual dispensing syringe. The aluminium chloride hexahydrate component has hygroscopic and astringent properties, which produce a hemostatic/drying effect, and assist in temporarily shrinking the gingival tissue and holding it slightly away (retracted) from the tooth surface, thereby allowing complete access of the impression material.

This device, called "Retraction Paste," is a medical product used in dentistry for temporary retraction and hemostasis of the gingival margin. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might see for a novel AI or diagnostic device.

Therefore, many of the requested fields regarding detailed study design, sample sizes, expert qualifications, and AI-specific metrics (like MRMC studies) are not applicable to this type of submission. The "acceptance criteria" here are primarily about demonstrating that the new device shares fundamental characteristics and performance with an already legally marketed device.

Here's the breakdown based on the provided text, with explanations for why certain information is not present:

Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The "study" proving the device meets its (implied) acceptance criteria is the 510(k) Substantial Equivalence comparison provided in the document. This is a non-clinical comparison, not a human clinical trial or a performance study with a test set in the traditional sense for AI.

Detailed 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):

   • Not Applicable. This is a 510(k) premarket notification for a dental retraction paste, not a diagnostic device involving a "test set" of data or patient cases in the context of AI or imaging. The "test" here is a comparison of product specifications and characteristics to a predicate device.

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. No "ground truth" was established by experts for a test set in the context of this 510(k) submission. The comparison is based on the chemical, physical, and functional properties of the device itself and its predicate.

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

   • Not Applicable. No test set or expert adjudication was performed for this 510(k) submission.

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 device is a manual dental paste, not an AI-assisted diagnostic tool.

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

   • Not Applicable. This device is a manual dental paste, not an algorithm.

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

   • Not Applicable. For this 510(k) submission, "ground truth" is established by the known characteristics and performance of the legally marketed predicate device, as well as the intrinsic properties (pH, viscosity, chemical composition) of the submitted device. There is no biological or diagnostic "ground truth" in the AI sense.

7. The sample size for the training set:

   • Not Applicable. No training set was used, as this is not an AI or machine learning device.

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

   • Not Applicable. No training set was used.

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TempoCem is a dental luting agent indicated for:

• . temporary cementation of provisional crowns and bridges
• cementing of semi-permanent implants .

TempoCem is a temporary cement based on zinc oxide / eugenol for automatic mixing. Its low film thickness provides an exceptional fit. TempoCem combines reliable adhesion with easy and clean removal. Excess can be removed easily. TempoCem is offered in different varieties.

The provided text describes a 510(k) premarket notification for a dental temporary cement called TempoCem. The information focuses on regulatory approval based on substantial equivalence to predicate devices and adherence to an international standard.

Based on the provided text, the following information regarding acceptance criteria and a study proving the device meets these criteria can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for TempoCem, as stated, is that it "meets the requirements of ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition." The text does not provide a table with specific numerical acceptance criteria from this ISO standard nor specific reported performance values for TempoCem against these criteria.

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

The document mentions that the submission is an "Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.'" This typically means that new clinical data or extensive performance data might not be required if the device is substantially equivalent to a legally marketed predicate and adheres to recognized standards.

• Sample Size for Test Set: Not specified. The document implies compliance with an ISO standard rather than a specific clinical trial with a defined test set sample size.
• Data Provenance: Not specified. The compliance is with an "ISO" standard, which is an international standard, but the location where the tests were conducted or the origin of any data (if external to the standard's methodology) is not mentioned. It is highly likely the data is from in vitro laboratory testing to demonstrate compliance with the standard. The study is not a retrospective or prospective clinical study in the traditional sense described in the context of device performance in humans.

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

This information is not applicable and not provided. The device's substantial equivalence is based on meeting an ISO standard for dental cements and comparison to predicate devices, not on expert-adjudicated ground truth from a test set of patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As above, the evaluation is based on compliance with an ISO standard, not a human reader or expert adjudication process.

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

An MRMC study was not done. The approval is for a dental cement, not an imaging or diagnostic device that would typically involve human readers.

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

This concept is not applicable to this device. TempoCem is a physical dental cement, not an algorithm or AI system. Its performance is intrinsic to the material properties.

7. Type of Ground Truth Used:

The "ground truth" here is compliance with an international standard (ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition). This standard likely sets forth methodologies and acceptable ranges for various physical and chemical properties of dental cements.

8. Sample Size for the Training Set:

This information is not applicable and not provided. As TempoCem is a manufactured product and not an AI/ML algorithm, there is no "training set" in the context of data science or machine learning.

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

This information is not applicable and not provided. There is no ground truth for a training set in this context.

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SA Flowable Composite is a self-adhesive, light-curing, flowable composite. SA Flowable Composite applications include:

• · Minor restorations of class I (without contact point)
• · Underfillings of classes I and II
• · Fissure sealing
• · Repairs of composite restorations
• · Modifications to temporaries and long-term temporaries
• Blocking out and filling of undercuts

SA Flowable Composite is a self-adhesive, light-curing, flowable composite with optimum consistency for the described indications. The radiopaque composite is immediately ready for use because the preparatory steps of etching, priming and bonding are unnecessary. The SA Flowable Composite will be supplied in convenient applicators.

This is a 510(k) summary for a dental resin material, not an AI/ML device. Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and training/test sets are not applicable or cannot be extracted from this document.

However, I can provide information based on the safety and performance testing described:

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with specific ISO standards for dental materials. These standards define the acceptance criteria, and the device is reported to meet them.

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

This information is not provided in the document. The document refers to general "performance testing" according to ISO standards, but details regarding sample sizes or data provenance for these tests are not included in this summary.

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 as this is a dental material performance test, not a diagnostic device relying on expert interpretation of data. The "ground truth" here is established by standardized laboratory testing methods defined within the ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human interpretation or adjudication required for the physical and chemical property tests performed on a dental material.

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 is not applicable. This document describes a dental material, not an AI/ML device.

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

This is not applicable. This document describes a dental material, not an AI/ML device.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on standardized laboratory measurements and tests of physical and chemical properties of the dental material, as defined by ISO 7405:2008 (biocompatibility) and ISO 4049:2009 (material properties like film thickness, depth of cure, flexural strength, water sorption, and solubility).

8. The Sample Size for the Training Set

This information is not applicable. This document describes a dental material, not an AI/ML device that requires a training set.

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

This information is not applicable. This document describes a dental material, not an AI/ML device that requires a training set.

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Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers.

Luxatemp Ultra/Star is intended for the fabrication of:

• temporary crowns
• bridges
• inlays
• onlays
• long-term temporaries
• temporary veneers .

Luxatemp Ultra/Star is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture or partial denture.

Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers. Luxatemp Ultra/Star will be supplied in 2 formulations; one is self-curing and the other is dual-cure. The 2 formulations vary slightly in composition to achieve the desired curing properties. The lonnations vary circure and self-cure formulations will be supplied in both Smartmix syringes and Automix cartridges. "Luxatemp Ultra" and "Luxatemp Star" are different trade names for the same material

The provided text describes a 510(k) premarket notification for a dental material, Luxatemp Ultra/Star, intended for temporary dental restorations. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with human readers or AI algorithms as would be expected for a diagnostic AI device.

Therefore, many of the requested points are not applicable to this specific submission. However, I will extract the relevant information and explicitly state when a point is not applicable.

Acceptance Criteria and Device Performance

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

The document states that Luxatemp Ultra/Star aims to be "equivalent to or better than the predicate devices." While specific numerical acceptance criteria (e.g., minimum compressive strength) are not provided in detail within the summary, the document indicates compliance with ISO and a comparison to the predicate.

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 dental material and does not involve a "test set" of patient data or images in the context of an AI/diagnostic device. The testing involved material property measurements. The document does not specify the sample size for these material tests or their geographic origin, but typical premarket submissions for materials involve laboratory 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 submission is for a dental material. The "ground truth" for material properties is established by standardized laboratory testing methods, not by expert consensus or interpretations of patient data.

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

Not Applicable. This submission is for a dental material. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving interpretation (e.g., by human readers), which is not relevant here.

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

Not Applicable. This submission is for a dental material and does not involve AI or human readers.

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

Not Applicable. This submission is for a dental material and does not involve an algorithm or AI.

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

The "ground truth" in this context refers to the established physical and chemical properties of dental materials as determined by standardized laboratory tests. These tests are designed to measure properties like compressive strength, flexural strength, tensile strength, hardness, water sorption, working time, and curing time according to recognized international standards (ISO 4049:2000 and ISO 7405:2008). The predicate device's established performance served as the benchmark for demonstrating equivalence or superiority.

8. The sample size for the training set

Not Applicable. This submission is for a dental material and does not involve machine learning or a "training set" of data.

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

Not Applicable. This submission is for a dental material and does not involve machine learning or a "training set." The performance of the material is established through direct, standardized laboratory testing.

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1. The Sealant (Infiltrant) is indicated for:

• -Sealing of pits and fissures
• -Sealing/facing of damaged enamel surfaces
• -Covering of caries predilection sites during orthodontic treatment
• -Sealing of secondary teeth
• -Sealing of deciduous teeth
• Sealing of damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries
• Protective coating for tooth surfaces predisposed to caries or on early non-cavitated lesions (including use in tooth brush abrasion and root surfaces)

2. HCI-Etching-Gel is indicated for:

• -Etching of enamel

The DMG USA Infiltration Kit consists of two components, a light curing methacrylate resin-based Sealant (Infiltrant) combined with a 99.5% ethanol solution, which is used in a drying and conditioning step before the Sealant application and as second component an HCl-Etching-Gel. As preliminary step the HCl-Etching-Gel is used for etching of enamel. The Sealant (Infiltrant) is a low viscosity light-curing dental resin, which is a protective coating for tooth surfaces predisposed to caries or on early non-cavitated Jesions. Other uses include sealing of pits and fissures, damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Infiltration Kit:

Acceptance Criteria and Device Performance Study for Infiltration Kit (K100062)

The provided document describes the substantial equivalence of the "Infiltration Kit" to predicate devices, primarily focusing on a labeling change to expand its indications for use. The study described is a limited in-vitro test for substantial equivalence, not a comprehensive clinical trial establishing new performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "Because the DMG USA Infiltration Kit and 3M ESPE SPK Sealant materials are so close in chemical composition, the substantial equivalence testing provided in this submission is limited to viscosity and depth of cure for the two materials." This suggests that the acceptance criteria for these two parameters were simply a demonstration of close equivalence to the predicate, rather than predefined absolute thresholds.

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

The document describes in-vitro testing for viscosity and depth of cure.

• Sample Size for Test Set: Not explicitly stated. The document mentions "limited to viscosity and depth of cure for the two materials," implying multiple measurements for each, but the exact number of samples is not provided.
• Data Provenance: The nature of in-vitro testing suggests it was performed in a laboratory setting. No country of origin is specified, but given the sponsor (DMG USA, Inc. in Attleboro, MA), it's highly probable the testing was conducted in the USA or a facility associated with the manufacturer. The data is prospective as it was generated specifically for this submission.

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

This section is not applicable to the provided document. The study described is an in-vitro test comparing physical properties (viscosity, depth of cure) of two dental materials for substantial equivalence. Ground truth in this context would typically refer to established scientific standards or the performance of the predicate device itself, not expert interpretation of results by human observers.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1 or 3+1) are relevant for studies involving human interpretation, often in image analysis or clinical endpoint assessment, where disagreement among reviewers needs resolution. This study is an in-vitro comparison of material properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes in-vitro comparisons of material properties, not a study involving human readers' performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This section is not applicable. The device is a "Sealant, Pit & Fissure, and Conditioner" (a dental material), not an algorithm or AI-powered system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for this substantial equivalence submission is the performance of the predicate device (3M ESPE SPK Sealant, K091632) for the properties of viscosity and depth of cure. The goal was to demonstrate that the Infiltration Kit's performance for these properties was equivalent to or very close to that of the already legally marketed predicate device.

8. The Sample Size for the Training Set

This section is not applicable. The device is not an AI/ML model that requires a training set. The study described is an in-vitro comparison of dental materials.

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

This section is not applicable. As the device is not an AI/ML model, there is no training set and therefore no ground truth establishment for a training set.

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Self adhesive composite luting cement is a universal, self adhesive, dual-curing composite luting cement. The Self adhesive composite luting cement is indicated for the adhesive fixing of ceramic, composite and metal-based inlays, onlays, crowns, bridges and posts, screws, veneers and orthodontic appliances.

The Self adhesive composite luting cement is a dental cement that complies with the requirements set forth in the following standards: ISO 7405:1997 Dentistry Preclinical evaluation of biocompatibility of medical . devices used in dentistry - Test methods for dental materials; ISO 4049: 2000; Dentistry Polymer-based Filling, Restorative and Luting materials .

This 510(k) summary (K093338) describes a dental device, specifically a "Self adhesive composite luting cement." The provided document does not describe a study that proves the device meets acceptance criteria in the way typically expected for an AI/ML medical device. Instead, it demonstrates substantial equivalence to predicate devices through conformity with recognized dental standards and FDA guidance documents.

Therefore, many of the requested sections related to acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device performance study. For this dental cement, acceptance criteria are generally defined by performance benchmarks within the referenced ISO standards (ISO 7405:1997 and ISO 4049:2000) for biocompatibility, physical properties, and luting characteristics. The document states the device "complies with the requirements set forth in the following standards," which implies it met the acceptance criteria implicitly defined by these standards. No specific numerical performance results are reported in this 510(k) summary.

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

Not applicable. This is a traditional medical device submission based on compliance with performance standards and substantial equivalence, not an AI/ML device evaluated with a test dataset.

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

Not applicable. Ground truth establishment by experts is not described for this type of device submission. Performance is assessed against international standards.

4. Adjudication method 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. This is not an AI/ML device.

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

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

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

For this device, the "ground truth" (or basis for verification) is established by the performance requirements and test methods defined within the referenced international standards:

• ISO 7405:1997 Dentistry Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials
• ISO 4049: 2000; Dentistry Polymer-based Filling, Restorative and Luting materials

Compliance with these standards implies the device has met the established benchmarks for safety and performance for its intended use.

8. The sample size for the training set

Not applicable. Training sets are relevant for AI/ML models, not for this type of traditional medical device.

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

Not applicable.

Summary of Device Submission Approach:

The K093338 submission for the "Self adhesive composite luting cement" is an Abbreviated 510(k). This type of submission relies on:

• Conformance to Recognized Standards: The primary method for demonstrating safety and performance is by showing compliance with specific FDA-recognized international standards (ISO 7405:1997 and ISO 4049:2000). These standards contain established test methods and acceptance criteria for dental materials.
• Substantial Equivalence: The device's components and indications are compared to already legally marketed predicate devices, implying similar safety and effectiveness profiles.

The document does not contain raw study data, specific performance metrics, or details of a clinical trial that would be required for an AI/ML device or a novel device proving entirely new performance claims. Instead, it asserts compliance with established standards and guides.

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Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets, intended to be combined with amalgam alloy for the direct filling of carious lesions or structural defects in teeth.

Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets.

The provided document (K093587) describes a 510(k) submission for "Dental Mercury," an elemental mercury product used in dental amalgam. This submission is an Abbreviated 510(k), which means it demonstrates substantial equivalence to a predicate device by showing conformity to recognized consensus standards and FDA guidance documents, rather than through a traditional clinical study with detailed performance metrics.

Therefore, the information requested in the prompt, which typically pertains to the performance evaluation of a device through a study with specific acceptance criteria, test sets, ground truth establishment, and statistical analysis, is not explicitly available or applicable in the provided document for "Dental Mercury" in the same way it would be for a diagnostic or AI-driven device.

Here's an attempt to address each point based on the information provided, highlighting the limitations due to the nature of an Abbreviated 510(k) for a material like elemental mercury:

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

The acceptance criteria for "Dental Mercury" are based on compliance with established standards and FDA guidance for this type of material, rather than performance metrics from a specific study.

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 was an Abbreviated 510(k) based on compliance with existing standards and guidance, not a study involving a "test set" of patient data or clinical samples. The "device performance" is demonstrated through adherence to material specifications and regulatory controls.

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. As noted above, there was no "test set" requiring ground truth established by experts in the context of a clinical performance study. The "ground truth" for the acceptance of dental mercury is the established scientific and regulatory consensus on its material properties and safety when used as intended, as codified in ISO standards and FDA guidance.

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

Not applicable. There was no test set or adjudication method for clinical performance. The "adjudication" in this context is the FDA's regulatory review process to confirm that the manufacturer's claims of conformity to the referenced standards and guidance are valid.

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 elemental mercury for dental fillings, not an AI-driven or diagnostic device 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 elemental mercury, not an algorithm.

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

The "ground truth"
for this submission is the expert consensus and scientific understanding formalized in the referenced consensus standard (ISO 24234:2004(E)) and FDA guidance document ("Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy"), which define the acceptable characteristics and safe use of elemental mercury in dentistry.

8. The sample size for the training set

Not applicable. This submission is about a material (elemental mercury), not a machine learning algorithm.

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

Not applicable. There is no training set as this is not an AI/ML device.

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The Sealant (Infiltrant) is indicated for:

• Sealing of Pit and Fissures .
• Sealing/facing of damaged enamel surfaces .
• . Covering of caries predilection sites during orthodontic treatment
• Sealing of secondary teeth .
• Sealing of deciduous teeth .

The HCI Etching Gel is indicated for etching of enamel.

The purposed Infiltration Kit consists of two components, a light curing resin-based sealant (Infiltrant) combined with a 99.5% ethanol solution, which is used in a drying and conditioning step before the sealant application and as second component an HCI-Etching-Gel. The HCI-Etching-Gel is used as a preliminary step for etching of enamel. The proposed sealant (Infiltrant) is designed for use in sealing the enamel pits and fissures of teeth.

The provided text does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The document discusses:

• A 510(k) summary for an "Infiltration Kit" (sealant and etching gel).
• Product description and indications for use.
• Predicate devices for comparison.
• A statement that the submission is an Abbreviated 510(k) as described in FDA's guidance document "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."
• A conclusion stating the device is safe and effective based on indications for use, technological characteristics, and comparison to predicate devices.
• The FDA's decision letter determining substantial equivalence.

An Abbreviated 510(k) relies on conformance to recognized standards, special controls, or guidance documents rather than presenting new clinical study data to demonstrate safety and effectiveness. Therefore, the detailed information about study design, sample sizes, expert qualifications, and ground truth establishment that you've requested is typically not found in such a submission unless specifically required by a recognized standard or guidance document for a particular performance attribute.

Therefore, I cannot provide the requested information from the given text.

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