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Choice 2 DC is a dual-cured, resin luting/veneering cement. The indications for use are to cement:

1. Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays
2. Endodontic posts
3. Cement-retained implant restorations/abutments (i.e. screws and crowns)
4. Veneers

Choice 2 DC is a color stable dual-cured, resin luting/veneering cement that is specially formulated for the cementation of indirect restorations made from Glass Ceramic, Lithium Disilicate, Porcelain, Composite, Metal, or Zirconia.

The provided FDA 510(k) clearance letter for Choice 2 DC, a dental cement, does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or similar diagnostic device. The document explicitly states:

"Clinical testing is Not Applicable."

Instead, the submission relies on non-clinical testing to demonstrate substantial equivalence to predicate and reference devices. The acceptance criteria for this device are based on performance metrics defined by ISO standards for dental cements, rather than diagnostic accuracy metrics.

Therefore, many of the requested elements for describing an acceptance criteria study related to AI/ML or diagnostic performance (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific 510(k) clearance.

However, I can still extract details about the non-clinical testing and the "acceptance criteria" as implied by the standards chosen for comparison:

Non-Clinical Performance Study Details for Choice 2 DC Dental Cement

The provided FDA 510(k) summary for Choice 2 DC Dental Cement describes non-clinical testing performed to demonstrate substantial equivalence to predicate and reference devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this dental cement, "acceptance criteria" are implied by adherence to established ISO standards and performance at least equal to predicate devices. The document does not provide specific numerical "reported device performance" values for each test, but states that the device met the requirements of the ISO standard and performed at least equal to predicate and reference devices.

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

• Sample Size: Not explicitly stated in the 510(k) summary. These details would typically be found in the full test reports referenced by the ISO standards.
• Data Provenance: The testing was non-clinical (laboratory testing of material properties). Therefore, concepts like country of origin or retrospective/prospective collection are not applicable.

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

• Not applicable. This was non-clinical material testing based on ISO standards, not a diagnostic study requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This was non-clinical material testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not applicable. This applies to diagnostic devices, not dental cements.

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

• Not applicable. This applies to diagnostic algorithms, not dental cements.

7. The Type of Ground Truth Used

• The "ground truth" (or reference standard) was defined by the methodologies and reference materials/procedures specified in the international standards ISO 4049:2019 (Dentistry — Polymer-based restorative materials) and ISO 29022:2013 (Dentistry — Adhesion — Notched-edge shear bond strength test). This involves standardized laboratory measurements of material properties.

8. The Sample Size for the Training Set

• Not applicable, as this is not an AI/ML device or a clinical study requiring training data.

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

• Not applicable, as there is no training set mentioned or implied.

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Final cementation of

• Metal inlays, onlays, crowns and bridges
• Resin inlays, onlays, crowns and bridges
• Ceramic inlays
• Zirconia crowns and bridges
• Metal, ceramic and fiber posts

EsCem RMGI is a radiopaque resin modified glass ionomer luting cement corresponding to ISO 9917-2, Class 3. This product facilitates the removal of excess cement through the tack-cure option, allowing for quick treatment. The contents consisting of base and catalyst are provided in a dual syringe and are used to cement indirect restoration by mixing the two types of paste.

This is a 510(k) premarket notification for a dental cement, EsCem RMGI. The provided document does not contain any information about an AI/ML powered device or a study involving human readers or AI assistance. It focuses solely on the substantial equivalence of the dental cement to a predicate device based on its physical and chemical properties and biocompatibility.

Therefore, I cannot provide an answer that includes:

• A table of acceptance criteria and reported device performance related to AI/ML.
• Sample sizes, data provenance, expert ground truth establishment, or adjudication methods for an AI/ML test set.
• Information about MRMC studies, effect sizes of AI assistance, or standalone AI performance.
• Details about ground truth for training sets or their establishment for AI/ML.

The document discusses the following performance criteria for the dental cement:

1. Acceptance Criteria and Reported Device Performance (for the dental cement, not an AI device):

The document states that the flexural strength and film thickness tests of EsCem RMGI were conducted in accordance with ISO 9917-2. It also mentions that the technical data sheet of the predicate device (RelyX™ Luting Plus Automix) was referenced for these mechanical properties.

The report's conclusion is: "The flexural strength and film thickness test results of the subject device and predicate device meet the ISO 9917-2 requirements, and the values of those performances are comparable to those of the predicate device."

Without the actual numerical values from the "technical data sheet" or the "test results" for EsCem RMGI, a specific table cannot be created. The document only confirms compliance with the ISO standard and comparability.

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

The document does not specify sample sizes for the flexural strength and film thickness tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, beyond stating that biocompatibility testing was performed in accordance with ISO 10993-1.

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable as the clearance is for a dental cement, not an AI device requiring expert consensus for image interpretation or diagnosis.

4. Adjudication Method:

This information is not applicable as the clearance is for a dental cement, not an AI device requiring adjudication of expert readings.

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

This information is not applicable as the clearance is for a dental cement, not an AI device that assists human readers.

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the clearance is for a dental cement, not an AI algorithm.

7. Type of Ground Truth Used:

For the dental cement's performance:

• Flexural Strength and Film Thickness: The "ground truth" or reference for performance is established by the ISO 9917-2 standard and comparison to the predicate device's technical data sheet. These are objective, measurable physical properties.
• Biocompatibility: Established by adherence to ISO 10993-1 and specific tests (in vitro cytotoxicity, skin sensitization, irritation testing).

8. Sample Size for the Training Set:

This information is not applicable as the clearance is for a dental cement, not an AI device with a training set.

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

This information is not applicable as the clearance is for a dental cement, not an AI device with a training set.

In summary, the provided FDA 510(k) clearance letter pertains to a dental cement and does not describe an AI/ML-powered device. Therefore, most of the requested information regarding AI device acceptance criteria, study design, and ground truth establishment is not present in this document.

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1. Definitive cementation of inlays, onlays, crowns and bridges, in ceramic or zirconia, composite or metal; 2-3 unit Maryland bridges and 3-unit inlay/onlay bridges (to be avoided for patients with bruxism or periodontitis).
2. Definitive cementation of endocanal posts.
3. Definitive cementation of ceramic, zirconia, composite or metal restorations on implant abutments and natural teeth.
4. Definitive cementation of zirconium oxide superstructures for two-unit abutments

OverCEM is dual-curing, self-adhesive resin luting cement. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip. The operating principle of the device is based on two reactions, one self-curing. OverCEM is designed to strongly and stably connect reconstruction materials and endocanal posts to patients' teeth or implants.

The provided text describes the 510(k) summary for the OverCEM SA dental cement devices. While it details performance bench tests conducted, it does not explicitly state specific acceptance criteria for each test or a direct "study" proving the device meets all acceptance criteria in the format of a clinical study report with individual acceptance criteria for each test and its outcome. Instead, it presents a comparison table showing the reported performance of the applicant device (OverCEM) against the predicate device (G-CEM ONE).

However, I can extract the reported device performance from Section 7 ("Performance Bench Tests") and Section 12 ("Comparison of Technology") for the applicant device and infer that these values are presumed to meet internal or regulatory acceptance criteria, as the device received a 510(k) clearance.

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

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific acceptance criteria for each test (e.g., "flexural strength must be X MPa or greater") are not explicitly stated in the document. However, the reported performance values for the OverCEM device are provided, and they are implicitly deemed acceptable for 510(k) clearance by the FDA based on substantial equivalence to the predicate.

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

• Sample Size: Not explicitly stated for each individual test. The document mentions "The device has been tested according to ISO 4049:2009... ISO 13116:2015... ISO 7491:2000... and ISO 29022:2013." These ISO standards typically specify minimum sample sizes for their respective tests, but the document does not report the specific number of samples used in these tests for OverCEM.
• Data Provenance: The document states, "Data for adhesion strength were obtained from a test performed by Overfibers S.r.l according to ISO 29022:2013." This indicates that at least the adhesion strength data is prospective and conducted by the manufacturer (Overfibers S.r.l.) based in Italy for the applicant device. The provenance for other bench tests is not explicitly stated beyond "The device has been tested according to..."

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

This information is not applicable as the document describes physical and chemical performance bench tests of a dental cement, not a diagnostic device or software requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes physical and chemical performance bench tests, not a diagnostic device or software requiring adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing has been performed on this device."

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

Not applicable. This is a dental cement, not a software algorithm. The performance tests are for the physical and chemical properties of the material itself.

7. The Type of Ground Truth Used

For the physical and chemical property tests, the "ground truth" is established by adherence to international standards (e.g., ISO standards) for dental materials testing. The outcomes of these standardized tests (e.g., MPa for flexural strength, µm for film thickness) are the "ground truth" for the device's performance attributes. For biocompatibility, the ground truth is compliance with ISO 10993 series for biological evaluation of medical devices.

8. The Sample Size for the Training Set

Not applicable. This device is a dental cement, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a dental cement, not an AI/ML algorithm that requires a training set and established ground truth.

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Insure® Universal
Cementation of ceramic and composite veneers, inlays and onlays with a thickness

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a dental cement product (Insure® Universal; Insure® Universal Automix).

This letter primarily focuses on:

• Device Clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: Details about regulations (e.g., 21 CFR 872.3275 for Dental Cement, Quality System regulation 21 CFR Part 820), responsibilities of the manufacturer (listing, labeling, adverse event reporting, good manufacturing practices), and guidance documents.
• Indications for Use: What the dental cement is intended to be used for (e.g., cementation of ceramic and composite veneers, inlays, onlays, crowns, and bridges).

There is no mention of specific performance metrics, acceptance criteria tables, study designs (sample sizes, retrospective/prospective, number of experts, adjudication methods, MRMC studies, standalone performance), or how ground truth was established for any AI or software-related device. The product mentioned is a physical dental cement, not an AI software or a device that would typically involve the types of studies you are asking about (like imaging devices with AI assistance).

Therefore, I cannot fulfill your request based on the provided text.

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TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites.

TopCEM-Veneer Light Cure Veneer Cement is a visible light curing cementation system that is designed for use with porcelain/ceramic and composite veneer restorations. The simple and versatile shade selections allow this material to be used with a wide range of veneer cases. The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBP ADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 5 microns. Light Cure Veneer Cement is radiopaque, allowing for easy identification on radiographs. It is classified as Type 2 Class 2 Group 1 in accordance with ISO 4049:2019, which belongs to materials whose use requires the energy to be applied intro-orally.

The provided text is an FDA 510(k) summary for a dental cement (TopCEM-Veneer Light Cure Veneer Cement). It describes the device, its intended use, and bench testing performed to demonstrate substantial equivalence to predicate devices.

However, the request asks for information about acceptance criteria and a study proving a device meets these criteria, specifically in the context of an AI/ML-enabled medical device performance study. The document supplied does not describe an AI/ML-enabled device or any studies involving human readers, AI assistance, or ground truth establishment by experts. Instead, it describes a conventional material science device (dental cement) and its testing against physical and chemical properties standards (ISO 4049, ISO 29022).

Therefore, I cannot extract the requested information (such as AI/ML specific acceptance criteria, sample size for test/training sets in an AI context, expert qualifications, MRMC studies, standalone algorithm performance, or ground truth establishment for AI models) from the provided text. The document refers only to "bench testings" of physical and chemical properties.

Response based on the provided document:

The provided document describes the acceptance criteria and study for a dental cement, not an AI/ML-enabled medical device. Therefore, many of the requested categories related to AI/ML device performance studies (e.g., number of experts, adjudication methods, MRMC studies, standalone AI performance, training/test set details for AI) are not applicable and are not present in the text.

Here's an attempt to answer the relevant parts based only on the provided text, while explicitly stating when information is not applicable or not provided for an AI/ML context.

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 for Test Set: Not explicitly stated in terms of specific number of samples tested for each criterion. The document states "Bench testings were performed on the subject device and the predicate devices."
• Data Provenance: Not specified in terms of country of origin for the testing data. The submitter is Rizhao HuGe Biomaterials Company, Ltd., China. The tests refer to international standards (ISO).
• Retrospective or Prospective: Not applicable for this type of material bench testing.

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

• This is not applicable as the study is not based on expert interpretation of medical images or data requiring "ground truth" establishment by human experts in the context of an AI/ML device. The "ground truth" here is determined by compliance with material properties standards (e.g., a film thickness measurement must be ≤ 50 µm).

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

• Not applicable. This concept typically applies to human reader studies or expert consensus for AI/ML ground truth, which is not described 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

• No, this was not done. The device is a dental cement, not an AI/ML diagnostic or assistive device.

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

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

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

• The "ground truth" or reference for the physical and chemical properties tests is established by international standards (ISO 4049, ISO 29022) and FDA guidance for dental composite resin devices. The "ground truth" is adherence to predefined physical/chemical limits.

8. The sample size for the training set

• Not applicable. This device is a physical material, not an AI/ML model that requires a training set.

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

• Not applicable. As stated above, this is a physical material tested against standards, not an AI/ML model with a training set.

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Calibra Abutment Resin Cement is indicated for the cementation of: Extraoral assembly of prosthetic components, e.g., structures made of ceramic or zirconia onto custom or pre-fabricated titanium/titanium alloy or zirconia bases/implant inserts/abutments, e.g., InCoris ZI and CEREC Tessera™ Abutment Block prostheses and mesostructures to TiBases.

Calibra Abutment Resin Cement is a two-component, self-cure, high strength self-adhesive cement. Calibra Abutment Resin Cement has the ability to bond to titanium and is chemically compatible with silanated ceramic materials, making it suitable for extraoral assembly of prosthetic components. This self-cure only, opaque shade has been optimized for extraoral assembly when blocking of metal graying or show-through is desired. Cured Calibra Abutment Resin Cement is essentially hydrophobic, minimizing post-cure water sorption, solubility and hygroscopic expansion.

This document describes the Calibra Abutment Resin Cement and its substantial equivalence to predicate devices, based on non-clinical performance testing. It focuses on the physical and chemical properties of the cement rather than an AI/ML powered device. Therefore, a direct response to your detailed questions regarding acceptance criteria and studies that are typical for AI/ML devices involving human readers, training sets, and ground truth establishment (such as those for image analysis, diagnostics, etc.) is not entirely applicable in this context.

However, I can extract the information relevant to non-clinical testing which serves as the "study" demonstrating the device meets its "acceptance criteria" through comparison with existing, legally marketed devices.

Here's a summary of the non-clinical test data and conclusions provided:

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets and the device's reported performance against those targets. Instead, it states that "The results show that the proposed device meets the requirements of the non-clinical bench testing conducted to support substantial equivalence."

The tests conducted and generally accepted properties for dental cements are:

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

This information is not provided in the document. The document refers to "non-clinical bench testing" which typically involves laboratory-controlled conditions. Details on sample sizes for each test, country of origin, or whether the data was retrospective or prospective are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this is not a study involving human interpretation or subjective assessment that would require expert adjudication. The tests are for material properties of a dental cement, assessed objectively in a laboratory setting.

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

This information is not applicable for the reasons stated in 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 information is not applicable as this is not an AI/ML powered device or a study involving human readers' performance.

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

This information is not applicable as this is not an AI/ML powered device.

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

For the non-clinical tests conducted, the "ground truth" would be established by standardized test methods and material specifications (e.g., ISO standards for dental materials). The performance criteria are derived from these industry standards and the properties of predicate devices.

8. The sample size for the training set

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

Summary of Relevant Information from the Document:

The regulatory submission for Calibra Abutment Resin Cement (K240888) is based on demonstrating "substantial equivalence" to predicate devices. This is achieved through non-clinical bench testing of the cement's physical and chemical properties and a comparison of its indications for use and technological characteristics with those of established predicate and reference devices.

• Predicate Device: Multilink Hybrid Abutment Cement (K130436)
• Reference Device: Self-Adhesive Resin Cement (K073173)
• Tests Performed: Work time, set time, film thickness, consistency, flexural strength, bond strength to multiple prosthetic components, and biological risk assessment.
• Conclusion: The tests confirmed that the proposed device "meets the requirements of the non-clinical bench testing conducted to support substantial equivalence." The device shares the same intended use, fundamental technology, and similar indications for use as the predicate.

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Cementation of all-ceramic, composite and metal restorations
Post cementation

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental cement called "BeautiLink SA." It discusses regulatory aspects, general controls, and indications for use.

It does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the nature of test sets (retrospective/prospective, country of origin).
• Information on experts, ground truth establishment, or adjudication methods for any test or training sets.
• Any mention of a Multi-Reader Multi-Case (MRMC) study or the effect size of AI assistance.
• Details about standalone algorithm performance.
• Information on the training set size or how its ground truth was established.

This document is a regulatory clearance, not a study report or technical specification outlining performance metrics and supporting validation studies.

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• Resin crowns, bridges, inlays and onlays
• Glass Ceramic, Porcelain crowns, inlays and onlays(includes alumina and zirconia)
• Metal crowns, bridges, inlays and onlays(includes porcelain-fused-to-metal and composite-to-metal)
• Metal(prefabricated or cast) and fiber posts

Dia-Cem is a radiopaque resin cement that can be used in self-cure or light-cure mode. It corresponds to type 2 and 3 of ISO 4049 and contains more than 60% of inorganic filler. Dia-Cem shows high bonding strength on various materials, yet excess material can be easily removed. 3 different shades are available: TR, A2, and A3O.

This document describes the premarket notification (510(k)) for the Dia-Cem dental cement. It focuses on demonstrating substantial equivalence to a predicate device, BisCem, rather than presenting a study proving a device meets specific acceptance criteria in the manner of an AI/ML device.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not directly applicable as this is a material science characterization for a traditional medical device, not an AI/ML algorithm.

Here's the information extracted that aligns with your request:

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

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

• Not applicable in the provided document. The document describes non-clinical performance data based on ISO standards for material properties, not a clinical study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable in the provided document. Ground truth, in the context of expert review, is not relevant for this type of material science testing.

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

• Not applicable in the provided document.

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 in the provided document. This is not an AI-assisted device.

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

• Not applicable in the provided document. This is not an AI/ML algorithm.

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

• For the non-clinical performance data: The "ground truth" or reference for the device's performance is established by international standards such as ISO 4049:2019, ISO 29022:2013, ISO 7405:2018, ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017. These standards define the methodologies and acceptable limits for the physical, mechanical, and biocompatibility properties of dental cement.

8. The sample size for the training set

• Not applicable in the provided document. This device does not use an AI/ML algorithm that requires a training set.

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

• Not applicable in the provided document.

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