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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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• All direct restorations
• All indirect restorations
• Desensitizing/sealing of tooth
• Intra-oral repairs

Dia-X Bond Universal is a universal adhesive capable of total, self, and selective etching as it consists of a single bottle of etching, primer, and adhesive resin. It can be used for both direct bonding of restorations.

The provided text describes a 510(k) premarket notification for a dental bonding agent named "Dia-X Bond Universal." The application focuses on demonstrating substantial equivalence to a predicate device, DIAPLUS Universal, rather than conducting a full clinical study with specific acceptance criteria in the typical sense of a medical diagnostic device.

Therefore, the information requested about acceptance criteria, study design for proving they are met, sample sizes, expert involvement, and ground truth establishment, does not directly apply in the same way as it would for a medical diagnostic device with performance metrics like sensitivity, specificity, or FROC scores.

The "acceptance criteria" here are more about demonstrating that the new device meets established standards and is functionally similar and safe compared to an already approved device. The "study" is a collection of non-clinical tests to show this equivalence.

Here's an attempt to answer your questions based on the provided document, interpreting "acceptance criteria" as compliance with relevant standards and "study" as the non-clinical performance data and biocompatibility tests:

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

For this premarket notification, the acceptance criteria are primarily defined by adherence to harmonized international standards for dental materials and demonstration of comparable physical properties and biocompatibility to the predicate device.

Note on "Cytotoxicity Study": The table states "Not Compatible BSE" for the Cytotoxicity Study but provides an explanation: "Among the components of this product, 10-MDP is an acidic monomer, and depending on the acidity, it is a substance that causes cytotoxicity according to the principle of action of this product, so cytotoxicity test setting the test item is meaningless." This essentially argues that for this specific type of dental adhesive, some level of cytotoxicity is inherent to its mechanism of action and is considered acceptable within the context of its intended use and formulation.

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

The document does not specify sample sizes for the individual non-clinical performance tests (Film Thickness, Shear Bonding Strength, Sensitivity to Ambient Light, Occlusion of dentinal tubules) or for the biocompatibility tests beyond listing the tests themselves.

The data provenance is implicit: the tests were conducted by Diadent Group International, a company based in South Korea. The tests are non-clinical, likely laboratory-based, and would be considered prospective in the sense that they were performed specifically for this submission, but not in the clinical trial sense.

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 question is not applicable to this type of device submission. There was no "test set" in the context of expert review for diagnostic accuracy, nor was there a concept of "ground truth" established by experts in this manner. The studies conducted were laboratory-based physical and biological tests against established standards, not expert-adjudicated clinical cases.

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

This question is not applicable. There was no expert adjudication process for a test set, as the evaluation relied on laboratory measurements and adherence to international 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

This question is not applicable. The device is a resin tooth bonding agent, not an AI-powered diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was conducted or relevant.

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

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

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

The "ground truth" in this context refers to the established scientific and technical standards for dental materials, specifically:

• ISO 4049: Dentistry -- Polymer-based restorative materials
• ISO 29022: Dentistry -- Adhesive -- Notched-edge shear bond strength test
• ISO 7405: Dentistry - Evaluation of Biocompatibility of Medical Devices Used In Dentistry
• ISO 10993 series: Biological evaluation of medical devices (Parts 1, 3, 5, 10, 11)

The "ground truth" for the comparative physical properties was the performance of the legally marketed predicate device (DIAPLUS Universal), implying that its performance established an acceptable benchmark.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a dental bonding agent, as it is a material, not a machine learning model.

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

This question is not applicable for the reasons stated in point 8.

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• 1. All direct restorations
• 2. All indirect restorations
• 3. Desensitizing/sealing of tooth
• 4. Intra-oral repairs

It is a 7th generation dentin adhesive system that handles all the functions of the conditioner primer bonding resin. The polymerization method is photopolymerization type, and after being applied to the tooth surface, the solvent is volatilized and polymerized in the drying process to perform the function as a dentine adhesive.

The provided text describes a 510(k) premarket notification for a dental resin bonding agent, DIAPLUS Universal (K213401). This submission aims to demonstrate substantial equivalence to a predicate device, ALL-BOND Universal w/BAC (K161051).

However, this document does not contain information about an AI-powered medical device or software that would have "acceptance criteria" related to AI performance metrics like accuracy, sensitivity, specificity, or the results of a multi-reader multi-case (MRMC) study.

Instead, the document focuses on demonstrating the substantial equivalence of a physical dental product (resin tooth bonding agent) through:

• Comparison of Indications for Use, Composition, and Principle of Operation with a predicate device.
• Non-clinical performance data which includes physical property tests (e.g., film thickness, shear bonding strength, sensitivity to light, occlusion of dentinal tubules) and biocompatibility tests (e.g., cytotoxicity, genotoxicity, irritation, systemic toxicity) conducted according to established international standards (ISO).
• A statement that no clinical performance data was collected because it was not deemed necessary to demonstrate substantial equivalence for this type of device.

Therefore, it is not possible to answer the request based on the provided text, as the document does not describe an AI medical device or a study proving its performance against AI-specific acceptance criteria.

The questions in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set details) are relevant for AI/ML-based medical device submissions, but they do not apply to the traditional dental material device described in this specific FDA 510(k) clearance document.

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DiaFil & DiaFil Capsule composite material which has resin organic and inorganic fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity. - Direct anterior and posterior restorations

The product belongs to Group 1, Class 2 of Type 1 according to the standard classification of ISO 4049. It is a nano hybrid typed light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. That is, after recovering with the unpolymerized product, to make a hard restoration by polymerizing through dental visible-ray polymerizer.

The provided document is a 510(k) summary for the Diafil & Diafil Capsule, a tooth shade resin material. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for a novel device or AI software. Therefore, much of the requested information regarding acceptance criteria and performance studies (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or not available in this specific document.

The document primarily focuses on non-clinical performance and substantial equivalence based on material properties and intended use.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance metrics of a device, but rather conformity to standards and comparability to predicate devices. The "Performance Standard conformance" in the comparison table serves as the closest equivalent to acceptance criteria for the material.

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

• Not applicable / Not provided. The document describes non-clinical bench testing and conformance to standards, not a specific "test set" in the context of clinical or AI performance evaluation. The data provenance is implied to be from the manufacturer's internal testing.

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

• Not applicable / Not provided. This applies to clinical or AI studies, which were not conducted or reported for this submission.

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

• Not applicable / Not provided. This applies to clinical or AI studies, which were not conducted or reported for this submission.

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

• No. An MRMC study was not done. This device is a dental restorative material, not an AI-powered diagnostic or assistive tool.

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

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

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

• Standardized material property testing. The "ground truth" for this type of device is established through adherence to international standards (e.g., ISO 4049 for physical/chemical properties, ISO 10993 for biocompatibility). The testing involves measuring specific properties (e.g., flexural strength, water sorption, cytotoxicity) and comparing them against the requirements defined in these standards.

8. The sample size for the training set:

• Not applicable / Not provided. This concept is relevant for machine learning models, not for a dental restorative material.

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

• Not applicable / Not provided. This concept is relevant for machine learning models, not for a dental restorative material.

Summary from the document:

The 510(k) submission for Diafil & Diafil Capsule primarily relies on non-clinical performance data demonstrating conformance with harmonized international standards, specifically:

• ISO 4049: Dentistry -- Polymer-based restorative materials
• ISO 7405: Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry
• ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-3, 10993-5, 10993-10, 10993-11: Specific parts of ISO 10993 related to genotoxicity, cytotoxicity, irritation/sensitization, and systemic toxicity.

The document explicitly states: "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices." The basis for substantial equivalence is the comparison of device characteristics, indications for use, construction, composition, human factors, shelf life, period of use, biocompatibility, and performance standard conformance with legally marketed predicate devices. The "Change is only a package addition of DiaFil Capsule" and this addition "does not affect to the original product," which had already demonstrated safety and effectiveness through its own 510(k) clearances.

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Aqueous ointment material that temporarily fills the root canal for the following indications: Apexification Temporary root filling Root canal filling for primary teeth Vital pulpotomy Temporary pulp capping

Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.

The provided document is a 510(k) summary for a medical device called DiaPaste, a root canal filling resin. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with acceptance criteria for device performance in diagnosing or predicting conditions.

Therefore, I cannot extract the information required for a table of acceptance criteria and reported device performance related to diagnostic or predictive capabilities, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a diagnostic AI.

However, I can provide the non-clinical performance data and acceptance criteria as presented in the document for the physical properties of the device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Physical Properties)

2. Sample sized 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 performance data listed (Table 1) pertains to non-clinical physical and material property tests of the device itself, not to 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)

This information is not applicable and not provided. The ground truth for physical properties (flowability, film thickness, radiopacity) is established by standardized laboratory measurements rather than expert human interpretation.

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

This information is not applicable and not provided. Adjudication methods are typically relevant for human interpretation of medical images or clinical data, not for material property testing.

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 and not provided. This document describes a paste used for root canal filling, not an AI-powered diagnostic device.

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

This information is not applicable and not provided. This document describes a physical medical device, not an algorithm.

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

For the physical property tests, the "ground truth" is derived from established laboratory measurement standards and protocols (e.g., ISO 6876). For biocompatibility, the ground truth is established through standardized biological evaluation tests (e.g., ISO 10993 series), confirming that the material does not cause adverse biological responses.

8. The sample size for the training set

This information is not applicable and not provided. This document describes a physical medical device, not an algorithm that requires a training set.

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

This information is not applicable and not provided. As noted above, this is a physical device, not an algorithm with a training set.

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DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy.

DIA-ROOT BIO MTA is a hydraulic product that hardens by reacting with water. It is designed for the protection of pulp such as direct pulp capping, pulpotomy, and perforation. The subject device is packaged with Cap & Body, Mixing pad, and Spatula.

The provided document is a 510(k) Premarket Notification from the FDA regarding a dental device called "DIA-ROOT BIO MTA". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or "human-in-the-loop" performance with AI.

Therefore, many of the requested criteria (e.g., number of experts, adjudication methods, MRMC studies, AI effect size, training set details) are not applicable to this specific type of device submission and the information available in the document. The document describes a biomaterial (root canal filling resin), not an AI-powered diagnostic or therapeutic device.

Here's an analysis of the available information based on the request:

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

The document does not specify "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) for a diagnostic AI. Instead, the "acceptance criteria" for this device, as implied by the FDA 510(k) process, are demonstrating substantial equivalence to a predicate device based on:

• Intended Use: Similar indications for use.
• Technological Characteristics: Similar materials, physical, and mechanical properties.
• Performance Data: Conformance to relevant industry standards and non-clinical bench testing, showing similar safety and effectiveness.

The document reports performance against non-clinical harmonized standards.

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 applicable as there was no "test set" in the context of clinical performance data collection (e.g., patient cases for a diagnostic study). The testing performed was non-clinical bench testing (material properties, biocompatibility).
• The document states: "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices."

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. There was no expert-derived "ground truth" for a clinical test set because no clinical data was collected.

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

• This information is not applicable. No clinical test set.

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. DIA-ROOT BIO MTA is a dental material, not an AI or a device that assists human readers. No MRMC study was conducted.

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

• This information is not applicable. This is a material, not an algorithm.

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

• For the non-clinical performance evaluation, the "ground truth" would be established by the harmonized ISO standards themselves (e.g., the specific parameters and methodologies defined in ISO 6876 for setting time, solubility, radiopacity, or the tests for biocompatibility in the ISO 10993 series).
• The study proves the device meets the criteria specified by these international standards for dental materials, not against clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

• This information is not applicable. This is a material, not an AI. No training set was used.

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

• This information is not applicable. No training set.

Summary of what the document focuses on:

The entire submission is built around demonstrating that "DIA-ROOT BIO MTA" is substantially equivalent to a previously cleared predicate device ("MTA ANGELUS"). This is achieved by comparing their:

• Intended Uses
• Technological Characteristics (composition, physical/mechanical properties)
• Performance (conformance to the same non-clinical ISO standards for dental materials and biocompatibility).

The document explicitly states that no clinical data was collected for this submission. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical bench tests and biocompatibility evaluations conducted according to recognized international standards (ISO 6876, ISO 7405, and various parts of ISO 10993). The "acceptance criteria" are simply the successful demonstration of conformance to these standards and the similarity of the device's properties to the predicate.

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The D-Lux+ is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.

The subject device is packaged with the following: D-Lux+ Handpiece, D-Lux+ Charger, Light Probe, Light Protector, C-Battery, Adapter, Power Cord, Disposable Sheaths(200ea/Box), Instruction Manual. The D-Lux+ Handpiece turns on/off the power, sets the mode and time, and controls the operation. The handpiece includes a battery. The C-Battery is included in the handpiece and supplies power to the handpiece. The D-Lux+ Charger charges the battery when the handpiece is placed on this device. The Adapter supplies power to the charger. The Power Cord is a cord to conduct power to an adapter. Disposable sheaths protect products and patients from contamination. Disposable, so reuse is prohibited. The Light Probe is connected to the handpiece so that the light emitted from the light source (LED) reaches the restoration. The Light Protector is inserted into the handpiece and used to protect the eyes from emitted light. The Instruction Manual is a document that describes information that the user needs to know, such as precautions, operating procedures, and how to use the device.

{"1": "No specific acceptance criteria or performance metrics were reported in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on similar characteristics and non-clinical testing.", "2": "The document states "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices." Therefore, no sample size for a test set or data provenance can be provided.", "3": "No clinical data was collected, thus no experts were used to establish ground truth for a test set.", "4": "No clinical data was collected, thus no adjudication method was used.", "5": "No MRMC comparative effectiveness study was done as no clinical data was collected.", "6": "A standalone study was not done; the evaluation relied on non-clinical bench testing to demonstrate conformance with harmonized standards and substantial equivalence.", "7": "The ground truth for demonstrating substantial equivalence appears to be based on compliance with harmonized standards and successful non-clinical bench testing, rather than expert consensus, pathology, or outcomes data.", "8": "No specific training set size is mentioned as no clinical data was collected or used for an algorithm.", "9": "Not applicable, as no training set was used for an algorithm."}

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DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.

DIA-ROOT BIO Sealer is a hydraulic material, and a premixed form that does not require mixing. It blocks the root canal by hardening by reacting with water in the oral cavity. It is contained in a waterblocked syringe and corresponds to ISO 6876:2012, Dentistry-Root canal sealing materials. DIA-ROOT BIO Sealer has two models and they are packaged with components; Disposable tip, Silicone cap.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DIA-ROOT BIO Sealer, structured according to your request:

Acceptance Criteria and Device Performance Study for DIA-ROOT BIO Sealer (K200175)

This document describes a 510(k) premarket notification for the DIA-ROOT BIO Sealer, a root canal filling resin. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Well-Root ST). The performance assessment for this device is based on non-clinical performance data and biocompatibility tests, as no clinical data was submitted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DIA-ROOT BIO Sealer are derived from the international standard ISO 6876:2012, "Dentistry - Root canal sealing materials." The device's reported performance is compared to these criteria and also to the predicate device (Well-Root ST).

Note: The submission states, "The test results corresponded the requirements of standards. Therefore, the subject device is substantially equivalent to the primary predicate device."

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

• Sample Size: The document does not explicitly state the specific number of units or samples used for each non-clinical test (Flow, Film Thickness, Solubility, Radio-opacity, Biocompatibility). It only refers to "tests conducted on the subject device."
• Data Provenance: The tests are non-clinical in nature and were conducted to verify conformance to international standards. The country of origin of the data is not explicitly stated, but the applicant, DiaDent Group International, is based in the Republic of Korea. The data is retrospective (i.e., collected before the submission date for this premarket notification).

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

This section is not applicable as the provided documentation describes a non-clinical evaluation comparing a new device to a predicate device based on performance standards and biocompatibility, not on human interpretation of clinical data or images. Ground truth in this context would refer to the established values defined by the ISO standards, which are objective measurements, not expert consensus.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation involved objective physical and chemical testing against defined standard criteria, not subjective human assessment requiring adjudication.

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

An MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data was collected or provided to support substantial equivalence between the subject and primary predicate device." The evaluation was based solely on non-clinical performance and biocompatibility.

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

This section is not applicable. The device is a physical medical device (root canal sealer), not an algorithm or AI-based software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on established objective criteria defined by international standards, specifically ISO 6876:2012 for physical and mechanical properties (Flow, Film Thickness, Solubility, Radio-opacity) and the ISO 10993 series for biocompatibility. This is a form of objective measurement/standard conformance rather than expert consensus, pathology, or outcomes data, as no clinical studies were performed.

8. Sample Size for the Training Set

This section is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This section is not applicable as the device is not an AI/ML algorithm requiring a training set.

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As a dentine/enamel total etching bonding system for direct adhesion, it is used in the adhesion of all direct restoration substances.

• Bonding of direct composite
• Bonding to composite and set amalgam
• Bonding of indirect restoration-Porcelain, Composite (Inlays, Onlays, Veneers, Crowns)

DiaPlus is a photopolymerization type dentine and enamel adhesive as a 5th generation dentine adhesion system that can be applied to all types of composite resin restorations.

The provided text details a 510(k) premarket notification for a dental bonding agent named DiaPlus, aiming to demonstrate its substantial equivalence to a legally marketed predicate device (BC Plus).

However, the document does not contain information about an AI/ML-driven device or an AI/ML-based study with acceptance criteria and associated performance. The 510(k) submission relates to a physical dental bonding agent and its chemical composition, physical properties, and biocompatibility testing. The "study" referenced in the prompt (acceptance criteria, sample sizes, expert ground truth, MRMC, etc.) is consistent with a performance study for an AI/ML medical device, which is not what this document describes.

Therefore, it's not possible to extract the requested information from the provided text. The document focuses on bench testing and biocompatibility for a dental material, not an AI/ML algorithm.

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Aqueous ointment material that temporarily fills the root canal for the following indications:

• Apexification
• Temporary root filling
• Root canal filling for primary teeth
• Vital pulpotomy
• Temporary pulp capping

Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.

The provided text is an FDA 510(k) summary for a dental device called "Diapaste." It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, the information provided does not contain any data or discussion regarding the acceptance criteria and study proving a device meets performance criteria related to AI/ML or human-in-the-loop performance, as implied by the original question's structure. The document is a regulatory submission for a dental material (root canal filling resin), not an AI/ML powered medical device.

Therefore, I cannot extract the requested information (table of acceptance criteria with reported performance, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) because it is not present in the provided text.

The closest relevant sections in the document are about non-clinical performance data for the dental material itself, which are physical properties and biocompatibility tests, not AI/ML performance.

Here's an analysis of what is present in the document regarding performance:

1. A table of acceptance criteria and the reported device performance (for physical properties, not AI/ML):

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

• The document does not specify sample sizes for these performance tests.
• Data provenance is not mentioned (e.g., country of origin, retrospective/prospective). These are typical lab tests for material properties.

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

• Not applicable. These are physical property measurements, not data requiring expert interpretation or ground truth establishment in the context of diagnostic AI.

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

• Not applicable for physical property measurements.

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 material, not an AI-powered diagnostic tool.

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

• Not applicable. This is not an algorithm.

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

• For physical properties, the "ground truth" is established by direct measurement against a standard (ISO 6876).
• For biocompatibility, the "ground truth" is established by laboratory tests against ISO standards (ISO 7405, ISO 10993 series).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable.

In summary, the provided document does not contain the information requested about AI/ML device performance. It is a regulatory clearance for a traditional medical device (a dental filling material), primarily demonstrating substantial equivalence through comparison of indications for use, composition, and conformance to relevant material-specific performance and biocompatibility standards.

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