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• Base under Class I and II direct restorations
• Pit and fissure sealant
• Class III and V restorations
• Repair of resin, porcelain and acrylic temporary materials
• Liner under direct restorative materials

Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent enabling up to a depth of 3~5mm at a time. Jet Flow Bulk is packaged in disposable tips and two syringes that include restorative materials. The shades offered with Jet Flow Bulk are Universal(U), Dentin(D), A1, A2, A3. Jet Flow Bulk contains bisGMA, UDMA, bisEMA. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.053 to 6.76 microns and silica with a particle size range of 0.04 to 0.452 um. The inorganic filler loading is approximately 35.6 vol.% (61.0wt.%).

The document provided is a 510(k) premarket notification clearance letter for a dental device, "Jet Flow Bulk." It does not contain information about an AI/ML device or its performance characteristics in the context of a clinical study or acceptance criteria related to software performance. The acceptance criteria and "study" described in the document are for material properties and biocompatibility of a dental resin, not for an AI algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for "the device" as requested by the user, because the provided text is about a physical dental material and not an AI-powered medical device.

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• Repair of Root Perforation
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp Capping

CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent root canal repair and filling applications. It is made of Calcium silicate composite, zirconium dioxide which is a radiopaque agent, and a thickening agent. CeraPutty sets and hardens by the moisture inside the oral cavity. CeraPutty does not shrink during setting and demonstrates excellent physical properties. CeraPutty does not require additional mixing for procedures, and its white color which allows aesthetic treatment. Ceraputty is packaged in a preloaded syringe.

The provided document is a 510(k) premarket notification for a medical device called "CeraPutty," which is a root canal filling resin. It describes the device, its intended use, and its equivalence to a predicate device. This document is a regulatory filing and does not contain information about a study proving the device meets acceptance criteria in the way a clinical or diagnostic performance study would. It presents information regarding the device's technical characteristics and non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a study against a specific performance benchmark for diagnostic accuracy or effectiveness with human subjects.

Therefore, many of the requested elements regarding acceptance criteria for a diagnostic device performance study, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and training set details are not applicable or available in this type of regulatory submission. The document focuses on showing that the new device (CeraPutty) is similar enough to an already approved device (iRoot BP Plus) to be considered safe and effective for the same indications.

Here's the information that can be extracted or inferred from the provided text:

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

The document doesn't explicitly state "acceptance criteria" in the typical sense of a diagnostic performance study (e.g., minimum sensitivity, specificity). Instead, it compares the performance of the subject device (CeraPutty) to the predicate device (iRoot BP Plus) based on performance standards (ISO 6876) and specific physical properties. The implicit "acceptance criterion" is that the subject device's performance is comparable to or better than the predicate device for these properties, and within the bounds of the standard.

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

• Sample Size: Not explicitly stated. The document refers to "Performance tests" and "Biocompatibility Tests" but does not provide details on the number of samples or specimens tested for these non-clinical evaluations.
• Data Provenance: Not specified. These are laboratory/bench tests, not clinical data from patients. The manufacturer is Meta Biomed Co., Ltd. in South Korea.

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

Not applicable. This is not a study requiring expert ground truth in the diagnostic sense. The "ground truth" for the performance tests would be the results obtained from calibrated laboratory equipment according to the specified ISO standards.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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 material for dental procedures, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a material for dental procedures, not an algorithm.

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

The "ground truth" for the non-clinical performance tests mentioned (setting time, solubility, radio-opacity) would be derived from measurements obtained via standardized laboratory protocols according to ISO 6876:2012. For biocompatibility, it would be results from standardized biological tests according to ISO 10993 series.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

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ADSEAL Plus is a biocompatible root canal sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).

ADSEAL Plus is intended for use by qualified healthcare personnel trained in its use.

ADSEAL Plus root canal sealer is a two component paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting.

The device consists of two components, the epoxy resin paste (Paste A) and the amine-containing paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).

Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator.

The ADSEAL Plus device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.

This document describes a 510(k) premarket notification for a dental device, specifically a root canal filling resin named "ADSEAL Plus." The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, "ADSEAL ROOT CANAL SEALER."

However, the provided text does not describe a study involving device performance evaluated against clinical acceptance criteria or human reader performance. The studies conducted are non-clinical and relate to the physical, chemical, and biological properties of the material itself, as well as its shelf life, to ensure it meets established standards for root canal filling materials.

Therefore, many of the requested details about acceptance criteria, study types (MRMC, standalone), sample sizes, ground truth establishment, and expert involvement are not applicable to the information provided in this 510(k) summary.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the ISO 6876 standard for dental root canal sealing materials. The reported performance is for the "ADSEAL Plus" device.

Note: The document states that "ADSEAL Plus is different from the predicate devices in raw materials, however, the test results provided in this submission supports that it is substantially equivalent to the predicate device." This indicates that while the numerical values for flowability and radio-opacity differ, they are still considered to be within acceptable limits as per the ISO standard and comparable to the predicate for substantial equivalence.

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

• Sample Size: Not explicitly stated for each test beyond indicating "tests" were conducted. These are material characteristic tests, not clinical performance studies with a "test set" in the context of imaging or diagnostic devices.
• Data Provenance: The tests were conducted by Meta Biomed Co., LTD. which is based in South Korea. The nature of these tests (e.g., in vitro, benchtop) suggests they are not derived from human subjects or retrospective/prospective clinical data.

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

• Not Applicable. The ground truth for material properties is established by adherence to international standards (e.g., ISO 6876) and scientific measurement, not by expert consensus in the diagnostic sense.

4. Adjudication method for the test set

• Not Applicable. No human adjudication process is described for these material characteristic 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 device is a root canal filling resin, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

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

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

• The ground truth for the non-clinical tests is based on established international standards (ISO 10993 and ISO 6876) for biocompatibility and physical/chemical properties of dental materials.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. See point 8.

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• All classes of fillings (according to Black) with light-curing composite or compomer filling materials
• Repair of composite resin or compomer fillings
• Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
• Protective varnish for glass ionomer fillings

EZ Bond Universal, manufactured by Meta Biomed, is classified as a Resin tooth bonding agent (21 C.F.R. §872.3200). EZ Bond universal is a single-bottle solution. Depending on the indication, the adhesive can be used for direct and indirect restorations with light cured composites in a "self-etching" procedure, "total-etching" procedure or" selective-etching" procedure. EZ Bond Universal is methacrylate-based restoratives, cement and sealant materials to dentin, enamel, glass ionomer and various indirect restorative substrates (glass ceramics, alumina and zirconia) without an extra primer step.

The provided text describes the regulatory clearance of a dental bonding agent and includes a section on non-clinical testing. However, it does not contain information about a study involving AI assistance, human readers, or image analysis, which the requested questions (2-9 and parts of 1) are primarily focused on. The device is a "Resin Tooth Bonding Agent," not a device that involves AI algorithms or image interpretation by experts.

Therefore, I can only address the acceptance criteria and performance data available for this specific type of dental product based on the provided document.

Acceptance Criteria and Reported Device Performance

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

The document provides the reported performance values for the subject device and the predicate device against certain technical characteristics. It states that the subject device was tested to evaluate its safety and effectiveness according to ISO standards. While specific numerical acceptance criteria (e.g., "must be > X MPa") are not explicitly listed in a separate column, the values are compared to the predicate device and implicitly against relevant ISO standards.

Regarding the other requested information (2-9):

The provided text does not contain any information related to:

• 2. Sample size used for the test set and data provenance: No information on sample sizes for the performance tests (e.g., number of dentin/enamel samples). No geographical or temporal provenance for the test data.
• 3. Number of experts used to establish the ground truth and their qualifications: Not applicable for this type of product/testing. Ground truth is based on physical material properties and ISO standard tests, not expert consensus on interpretations.
• 4. Adjudication method for the test set: Not applicable for this type of product/testing.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: This type of study involves human readers interpreting cases, often with AI assistance. This is not relevant to a dental bonding agent.
• 6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
• 7. The type of ground truth used: The ground truth for this device's performance is based on physical and chemical property measurements conducted according to established international standards (ISO), not expert consensus, pathology, or outcomes data in the context of interpretation.
• 8. The sample size for the training set: Not applicable; this device does not use machine learning or AI with training sets.
• 9. How the ground truth for the training set was established: Not applicable; this device does not use machine learning or AI.

In summary, the document details non-clinical testing for a dental bonding agent, focusing on physical and chemical performance characteristics against ISO standards and comparison to a predicate device. It does not involve any imaging, AI, or human interpretation studies.

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Metapaste Plus is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery. Metapaste Plus can be used on its own and for vital pulpotomy in deciduous teeth. Metapaste Plus is intended for use by qualified healthcare personnel trained in its use.

Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary filling. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of barium sulfate contained. Also, it is water-soluble and easy to remove.

The provided document is a 510(k) premarket notification for a medical device called "Metapaste Plus." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition, performance specifications, and biocompatibility, rather than clinical efficacy studies involving human readers or AI algorithms.

Therefore, the information required to fully answer your request regarding acceptance criteria, human reader studies, AI performance, and expert ground truth establishment is not available in the provided text. The document describes non-clinical testing only.

However, I can extract what is available regarding the device's performance and the standards it meets.

Device: Metapaste Plus (Root Canal Filling Resin)

Study Focus: Non-clinical (performance testing, biocompatibility, shelf life) to demonstrate substantial equivalence to a predicate device (Metapaste). The study does not involve AI, human readers, or a test set with expert ground truth in the context of diagnostic performance.

1. Table of Acceptance Criteria (from ISO 6876:2012) and Reported Device Performance

(Note: The document states these are the acceptance criteria from ISO 6876:2012, to which the device conformed.)

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

Given this is non-clinical testing of a material, "test set" here refers to samples of the material itself subjected to physical and chemical tests. The document does not specify the sample sizes of Metapaste Plus used for these non-clinical tests (e.g., how many samples were tested for flowability or radio-opacity).

Data Provenance: The tests were conducted by the manufacturer, Meta Biomed Co., Ltd., based in South Korea. The data is from non-clinical testing on the device material. It is not applicable in terms of retrospective/prospective human data.

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

Not Applicable. The ground truth for this device's performance is established by international standards (ISO 6876:2012) for material properties and biocompatibility standards (EN ISO 10993 series). No human experts were involved in defining "ground truth" for diagnostic accuracy or image interpretation, as this is not a diagnostic device and no such study was performed.

4. Adjudication Method for the Test Set

Not Applicable. As no human experts were establishing diagnostic ground truth, there was no need for an adjudication method. The testing involved standardized laboratory procedures.

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

No. An MRMC study was not conducted as this is a non-clinical evaluation of a material, not a diagnostic imaging device involving interpretation by human readers, with or without AI assistance.

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

No. This is not an AI-based diagnostic device. Therefore, no standalone algorithm performance study was relevant or conducted.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptance is based on:

• International standards for dental root canal filling materials: ISO 6876:2012 (for flowability and radio-opacity).
• International standards for biocompatibility: EN ISO 10993-1:2009, EN ISO 10993-3:2014, EN ISO 10993-5:2009, EN ISO 10993-6:2009, EN ISO 10993-10:2013, EN ISO 10993-11:2017.
• Manufacturer's internal standards for appearance, weight, and packaging.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI device, so there is no training set in the context of machine learning.

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

Not Applicable. (See point 8)

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Metapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material. Application : Root canal filling material/Apexification and hard tissue formation/Apexogensis

This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of iodoform contained. Metapex Plus is used for patients of all ages requiring root canal treatment.

The provided text describes the 510(k) premarket notification for "Metapex Plus," a root canal filling material. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on AI performance or diagnostic accuracy.

Therefore, the provided input does not contain the information requested to describe acceptance criteria and a study proving a device meets them in the context of an AI/human reader performance study.

The information in the document pertains to:

• Device Type: A medical device (root canal filling material), not an AI-powered diagnostic tool.
• Approval Type: 510(k) clearance, which focuses on substantial equivalence to a legally marketed predicate device, primarily through comparing technological characteristics and performance standards (like ISO 6876 for dental materials), rather than clinical efficacy trials or AI performance evaluations.
• Testing: Non-clinical testing for performance (e.g., flowability, radiopacity) and biocompatibility, as well as shelf-life testing, all against established ISO standards for dental materials. There is no mention of a test set, training set, ground truth established by experts, or human reader performance studies.

To answer your request, if this were an AI-powered diagnostic device, the following information would be expected but is NOT present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: This would define metrics like sensitivity, specificity, AUC, or F-score and specify threshold values for acceptance.
2. Sample Size and Data Provenance: For an AI study, this would detail the number of images/cases in the test set, their origin (e.g., country, hospital), and whether the data was collected retrospectively or prospectively.
3. Number and Qualifications of Experts for Ground Truth: This would specify how many radiologists (or other medical specialists) with what level of experience established the ground truth.
4. Adjudication Method: How discrepancies between experts were resolved (e.g., 2+1 agreement, majority vote).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Whether human readers were tested with and without AI assistance, and the effect size of the AI's improvement on human performance.
6. Standalone Performance: The AI algorithm's performance without human interaction.
7. Type of Ground Truth: How the definitive diagnosis was established (e.g., pathology, long-term outcomes, expert consensus).
8. Training Set Sample Size: The number of cases used to train the AI model.
9. Training Set Ground Truth Establishment: How the labels for the training data were determined.

In summary, the provided FDA 510(k) clearance letter and summary discuss a dental material's substantial equivalence based on material properties and non-clinical testing against ISO standards, not a study evaluating the performance of an AI-powered diagnostic device or human-in-the-loop performance.

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• Direct anterior and posterior restorations (including occlusal surfaces)
• Core Build-ups
• Splinting
• Indirect restorations including inlays, onlays and veneers

Dental composite resin is a device intended to restore carious lesions or structural defects in teeth.
Ezfil is indicated for Class I , II, IV, V restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs.
The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL.

The document provided details for a traditional medical device (dental resin) and not a medical device with AI/ML components. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test/training sets, expert qualifications, MRMC studies) is not applicable or available in this document.

However, I can extract the acceptance criteria and performance data for the non-clinical tests performed on the Ezfil device, which are relevant to its substantial equivalence determination.

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

The document states that performance tests were conducted "according to EN ISO 4049:2009" and other ISO standards. Conformance to these standards serves as the acceptance criteria. The document explicitly states that the device "Conformed to ISO 4049" and that "the test results provided in this submission supports that it is substantially equivalent to the primary predicate." While specific numerical performance values are not provided in this summary, the acceptance is that the device meets the requirements of these 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 provided in the document. The tests are non-clinical, likely laboratory-based, and performed on material samples rather than clinical patient data. The manufacturer is based in South Korea (Meta Biomed Co., Ltd.).

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

Not applicable. This is a non-clinical device that does not involve expert interpretation or ground truth establishment in the context of diagnostic performance.

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

Not applicable. This is a non-clinical device.

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 non-AI/ML device.

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

Not applicable. This is a non-AI/ML device.

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

For the non-clinical tests, the "ground truth" or reference standard would be the defined physical, chemical, and biological properties as specified in the referenced ISO and EN ISO standards. For biocompatibility, this refers to the absence of adverse biological reactions. For performance tests (depth of cure, flexural strength, etc.), it refers to meeting the quantitative limits or qualitative descriptions set by the standards.

8. The sample size for the training set

Not applicable. This is a non-AI/ML device.

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

Not applicable. This is a non-AI/ML device.

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For fabrication of temporary fillings and other temporary prosthetics for use until the permanent prosthetic is ready for insertion. intended to temporarily restore carious lesions or structural defects in teeth. Intended for use in cavities, Class I, II, III, IV (inlays and onlays).

MD-Temp Plus is used for temporary filling material. It is supplied in a 20, 30 or 40g jar in either white (tooth-like) or pink (gum-like), and individually boxed. It is intended primarily as a temporary filling material for most cavities or damages but may be used by the dentist for other temporary restorations. MD-Temp plus is water-based temporary filling materials used for part of a tooth or multiple teeth. The curing reaction is the hydration reaction of the gypsum, and the semi-gypsum is cured as it is exposed to saliva or water in the oral cavity.

This document is a 510(k) Premarket Notification for a dental temporary filling material called MD-Temp Plus. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, MD-Temp. The document details non-clinical testing performed to establish safety and effectiveness.

Based on the provided text, it's important to note that this submission is for a dental material (a physical device), not an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Therefore, many of the requested criteria related to AI/ML device performance (like MRMC studies, human reader improvement with AI, training set details, and expert consensus for ground truth) are not applicable to this type of device submission.

The acceptance criteria and study proving the device meets them are based on physical and chemical performance standards for dental materials, and biocompatibility testing.

Here's an analysis of the provided information, addressing the applicable points:

Acceptance Criteria and Study for MD-Temp Plus (Dental Temporary Filling Material)

This submission focuses on demonstrating substantial equivalence of a new dental material (MD-Temp Plus) to a previously cleared material (MD-Temp) through non-clinical performance and biocompatibility testing. The "acceptance criteria" are the relevant ISO and ASTM standards for such materials, and the "study" involves conducting tests to ensure the device performs within acceptable parameters defined by these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was tested to evaluate its safety and effectiveness according to various standards. While it explicitly lists standards for Biocompatibility, Shelf Life, Compressive Strength, and Setting Time, and mentions others for Flexural Strength and Tensile Strength, it does not provide specific numerical "acceptance criteria" directly from these standards within the document. Instead, it presents the measured performance of both the subject and predicate devices and states that the improvements in the subject device's performance (setting time and compressive strength) are "within the range of the test standards and it doesn't affect the safety and effectiveness."

Here's a table summarizing the reported device performance and the related, implied acceptance criteria based on standard compliance:

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of specimens) used for each of the physical and chemical tests (compressive strength, setting time, etc.). These numbers would typically be defined by the respective ISO/ASTM standards.
• Data Provenance: The testing was conducted by Meta Biomed Co., Ltd. (the manufacturer) in South Korea, as indicated by the company's address. The data appears to be prospective as it was generated specifically for this 510(k) submission to demonstrate the performance of the MD-Temp Plus device.

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

• Not Applicable. For this type of physical/chemical material testing, "ground truth" is established by adherence to standardized test methods (e.g., ISO, ASTM standards) and measurements conducted in accredited laboratories. It does not involve human experts in the way AI/ML performance evaluation does (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements in human expert interpretations, particularly in medical image analysis. For material testing, results are typically quantitative measurements, and repeatability/reproducibility are ensured through standardized protocols and calibration.

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

• No. An MRMC study is designed for evaluating the impact of AI on human readers in diagnostic tasks, typically involving medical imaging. This is a physical dental material, so such a study is irrelevant.

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

• Not Applicable. This is not an AI algorithm. Its "performance" is its physical and chemical properties as measured by the non-clinical tests.

7. The Type of Ground Truth Used

• For physical and chemical properties (e.g., setting time, compressive strength): The ground truth is the measured value obtained through standardized laboratory testing procedures (e.g., ISO 3107, ISO 4049, ANSI/ADA 27) using calibrated equipment.
• For biocompatibility: The ground truth is determined by the results of specific biological assays (e.g., cytotoxicity, sensitization, irritation tests) as outlined in the ISO 10993 series.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a "training set." The device is manufactured based on a defined material composition and manufacturing process, and its performance is validated through testing of manufactured lots.

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth establishment for such a set. The "ground truth" during product development (analogous to training for AI) would be the desired material properties and how to achieve them through formulation and manufacturing, which is part of the R&D process prior to formal validation testing.

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· Permanent obturation of the root canal following vital pulp-extirpation

· Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings

CeraSeal is suitable for use in the single cone and lateral condensation technique.

CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.

The provided text is a 510(k) summary for a medical device called CeraSeal, a root canal filling resin. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

Based on the content, here's an analysis regarding acceptance criteria and supporting studies:

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

   The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that would be typically seen in an AI/algorithm performance study. Instead, it lists performance tests conducted according to ISO 6876:2012, which is an international standard for root canal sealing materials. The reported device performance is that CeraSeal "conformed" to ISO 6876.

   Performance Test Category	Acceptance Criteria (Implicit: Conformance to ISO 6876:2012)	Reported Device Performance
   Visual	Conforms to ISO 6876:2012	Conformed
   Capacity	Conforms to ISO 6876:2012	Conformed
   Package	Conforms to ISO 6876:2012	Conformed
   Flow	Conforms to ISO 6876:2012	Conformed
   Setting Time	Conforms to ISO 6876:2012	Conformed
   Film Thickness	Conforms to ISO 6876:2012	Conformed
   Solubility	Conforms to ISO 6876:2012	Conformed
   Radio-opacity	Conforms to ISO 6876:2012	Conformed

   Additionally, biocompatibility tests were conducted according to ISO 10993 series and a Shelf Life test was performed, confirming conformance.

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 a "sample size" in the context of a dataset for an AI/algorithm. The tests mentioned (biocompatibility, performance characteristics like flow, setting time, etc.) are laboratory-based and pertain to the physical and chemical properties of the material itself, not to the performance of an AI model on a dataset of patient data. Therefore, this information is not applicable to an AI device.

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. The device is a physical root canal filling material, not an AI/software device that requires expert-established ground truth on a dataset.

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

   This information is not applicable, as there is no test set in the context of AI/algorithm performance requiring adjudication.

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

   This information is not applicable. The device is a physical medical material, not an AI system intended to assist human readers.

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

   This information is not applicable. The device is not an algorithm.

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

   This information is not applicable. The "ground truth" for this device would be its physical and chemical properties as measured against international standards (ISO 6876 for root canal filling materials and ISO 10993 for biocompatibility), rather than a clinical ground truth like pathology or outcomes data for an AI.

8. The sample size for the training set

   This information is not applicable, as there is no AI algorithm with a training set for this device.

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

   This information is not applicable, as there is no AI algorithm with a training set for this device.

In summary, the provided document is a 510(k) summary for a root canal filling material. It does not describe an AI/software as a medical device (SaMD) and therefore, most of the questions related to AI acceptance criteria and studies are not applicable. The "acceptance criteria" discussed are compliance with international standards for material properties and biocompatibility.

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GuttaSil is a material for permanent obturation of root canals after treatment of pulpal gangrene and temporary filling of the canal.

GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.

This document describes the acceptance criteria and study proving the device meets those criteria for the GuttaSil, a root canal filling material.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for each specific test within the non-clinical testing. It only generally refers to "the following testing was conducted." The provenance of the data is not specified (e.g., country of origin, retrospective or prospective), but it is implied to be laboratory testing conducted by or for Meta Biomed Co., Ltd.

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

This information is not provided in the document. The tests conducted are non-clinical, primarily physical, chemical, and biocompatibility tests based on ISO standards. These types of tests typically do not involve human expert adjudication of results in the way clinical performance studies do.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical performance and biocompatibility tests against quantitative ISO standards, not evaluations requiring human rater 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 describes non-clinical performance and biocompatibility testing. The device is a material for root canal filling, not an AI-assisted diagnostic or treatment planning tool.

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

Not Applicable. This device is a material (gutta-percha with a sealer) used in a medical procedure, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by the specifications and acceptable ranges outlined in the ISO 6876:2012 standard for root canal sealing materials.

For the biocompatibility tests, the "ground truth" is adherence to the biocompatibility criteria specified in the relevant ISO 10993 series standards.

8. The Sample Size for the Training Set

Not Applicable. This device is a physical material, not an AI algorithm or model that requires a training set.

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

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

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