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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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• Direct restorations
• Base and Liner
• Block out undercut
• Repair of (in)direct aesthetic restorations
• Core build-up

EsFlow PLUS is a light-cured radiopaque flowable composite resin used for direct restoration. It has a smooth surface, so it is applied smoothly to the teeth, and has good gloss and aesthetics. In addition, it has high mechanical strength, so it can sufficiently withstand the occlusal force. EsFlow PLUS has two types of viscosities, so it can be applied to various clinical cases. The inorganic filler of EsFlow PLUS has a particle size range of 0.01 to 0.5 μm, and a volume ratio of about 42 to 47% depending on the model.

I apologize, but the provided text from the FDA 510(k) Clearance Letter for "EsFlow PLUS" does not contain the information requested about acceptance criteria and the study proving the device meets those criteria, especially not in the context of an AI/ML medical device.

The document is for a "Tooth Shade Resin Material" (a dental composite material), which is a physical material, not an AI/ML software device. The clinical studies mentioned (depth of cure, flexural strength, compressive strength) are material performance tests, comparing the new dental resin to a legally marketed predicate dental resin, and ensuring both meet ISO standards.

Therefore, I cannot extract the following information from the provided text as it is not present for this type of device and study:

• A table of acceptance criteria and the reported device performance (for an AI/ML device)
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• If a standalone (algorithm only) performance was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on the physical and mechanical properties of a dental composite material, comparing it to an existing material to demonstrate substantial equivalence, as required for a 510(k) clearance for this type of Class II device.

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Permanent obturation of root canals of the permanent teeth in combination with root canal points

VioSeal is the epoxy resin-based root canal sealer in the dual syringe for easy mixing and injection and is mixed with the 1:1 mixing ratio. It contains inorganic fillers which has good biocompatibility, physical and chemical properties and produces a complete obturation. Therefore, VioSeal has good biocompatibility with the root canal tissues.

The provided text does not describe an AI/ML powered medical device or software. It pertains to a dental device, specifically a root canal filling resin. Therefore, the questions regarding acceptance criteria, study details, ground truth, sample sizes, and expert qualifications for an AI/ML device are not applicable to this document.

The document discusses the substantial equivalence of the VioSeal root canal filling resin to a predicate device based on non-clinical tests.

Here's the relevant information found in the document regarding the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Study that Proves the Device Meets Acceptance Criteria:

A non-clinical study investigated the performance of VioSeal according to ISO 6876 standards for root canal filling materials.

• Sample size used for the test set and the data provenance: Not explicitly stated, but implies laboratory testing of the material itself. It is a non-clinical study, not a study involving human or image data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a materials science characterization, not an expert-driven ground truth assessment.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI/ML or diagnostic device.
• Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
• Type of ground truth used: The "ground truth" or reference standard for these non-clinical tests is the established methodology and specifications outlined in the ISO 6876 standard.
• Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

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· Pretreatment etchant before resin (help to having a strong bonding strength between resin and teeth)
· Remove smear layer of dentin and enamel
• Pretreatment etchant before sealant (help to having a strong bonding strength between sealant and teeth)

FineEtch - 10, 37 is a phosphoric acid (H3PO4) semi-gel-type agent intended for use on dentin and enamel. FineEtch will effectively remove the smear layer and help successful bonding.

The provided text is a 510(k) premarket notification for a dental etchant called "FineEtch." It discusses the device's classification, indications for use, comparison to a predicate device, and performance testing. However, it does not include the information requested regarding acceptance criteria and the study proving the device meets those criteria for an AI/ML device.

Specifically, the document states: "9. Performance Testing-Clinical tests Not Applicable". This indicates that no clinical studies, which would typically involve human subjects or human readers (as implied by questions 3-5), were conducted or submitted for this device. The non-clinical tests mention pH, viscosity, shape retention, and etching effect, comparing the device to a predicate and another dental etchant. This type of testing is characteristic of a substance or instrument, not an AI/ML diagnostic or assistive device that would rely on human expert interpretation of data.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, ground truth establishment, expert consensus, MRMC studies, or training/test set details, as this document pertains to a chemical dental product, not an AI/ML software device.

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-Bonding of all direct composite restorations
-Bonding of dual/self cure composite and core build-ups
-Repairs of composite fillings
-Root surface desensitization

K-Bond Universal is a bonding system that offers exceptional bonding strength through a convenient single bottle application. This single-component bonding agent is specifically formulated to effectively bond various types of direct composite restorations to dentin, enamel, as well as composite.

The provided text describes the regulatory clearance of a dental bonding agent, K-Bond Universal, and not an AI/ML powered medical device. Therefore, information regarding acceptance criteria and studies for AI/ML devices, such as sample size for test/training sets, expert qualifications, and details about MRMC studies, is not present.

However, I can extract information related to the performance testing described for the K-Bond Universal device:

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (implied to be laboratory testing of the device and predicate).

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

• Not applicable as this is a material performance test, not a diagnostic device requiring expert opinion for ground truth.

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

• Not applicable. Performance was measured against ISO standards and internal requirements.

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

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

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

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

7. The type of ground truth used:

• Performance criteria based on ISO 29022 standard for shear bond testing and internal requirements (for dentin and enamel shear bond strength).
• For root surface desensitization, the ground truth was established by confirming dentin tubule blockage.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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• Direct anterior and posterior restorations
• Restoration of fractured (broken) teeth due to trauma
• Restoration of deciduous teeth
• Direct restorative for diastema closure

EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Filler size ranges from 16nm to 1.2 um. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radioopaque.

The provided text is a 510(k) summary for a dental device called EsCom250. This type of document is a submission to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The information you are requesting pertains to the performance evaluation of a device, particularly an AI/ML-based medical device. The provided document, however, describes a dental restorative material (a tooth shade resin material), not an AI/ML-based device.

Therefore, the concepts of acceptance criteria for AI performance (like accuracy, sensitivity, specificity), sample size for test/training sets, data provenance, expert ground truth adjudication for AI, MRMC studies, standalone AI performance, etc., are not applicable to this document.

This document focuses on the physical, chemical, and biological properties of the dental resin material as compared to a predicate device, using established standards for dental materials (e.g., ISO 4049, ISO 10993 for biocompatibility).

Key points from the document regarding "acceptance criteria" and "proof" for this specific device:

• Acceptance Criteria/Performance Evaluation: The primary method for proving the device meets acceptance criteria is through bench testing and biocompatibility testing.

  • Bench Testing: The device was tested according to ISO 4049:2019, Dentistry Polymer-based restorative materials. This standard specifies requirements and test methods for polymer-based dental restorative materials.
  • Biocompatibility Testing: The device was tested according to various parts of ISO 10993 (Biological evaluation of medical devices) and ISO 7405 (Dentistry Evaluation of biocompatibility of medical devices used in dentistry). These standards assess the biological safety of medical devices.

• Reported Device Performance (Table): The table on page 6 of the document provides a direct comparison of several mechanical properties between the subject device (EsCom250) and the predicate device (Filtek Z250 Universal Restorative). These are the "reported device performance" metrics for this type of product.

  Metric	Acceptance Criteria (Predicate)	EsCom250 Performance
  Mechanical Properties
  Depth of cure (mm) - A3	2.80	2.27
  Depth of cure (mm) - AO3	(Not specified for predicate)	1.53
  Flexural strength (Mpa)	157.96	127.62
  Water sorption (µg/mm³)	16.00	11.52
  Solubility (µg/mm³)	0.0	0.0
  Radio-opacity (mmAl) - A3	2.9	3.6
  Radio-opacity (mmAl) - AO3	(Not specified for predicate)	3.1
  Knoop hardness (kgf/mm²)	77.9	55.4
  Compressive strength (MPa)	346	334
  Elastic modulus (GPa)	4.04	3.03
  Other Properties
  Standard Conformed	ISO 4049	≥ISO 4049
  Biocompatibility	Yes	Yes
  Sensitivity to light	Remained physically homogeneous	Remained physically homogeneous

  Note on "Acceptance Criteria" for this device type: For equivalence, the EsCom250 values generally need to be comparable to or better than the predicate, or at least meet the minimum requirements of the conformed standard (ISO 4049). The document explicitly states that "the performance results of the subject device and predicate device are not the same, but both products meet the requirements of ISO 4049." This implies that meeting the ISO 4049 standard itself is a key acceptance criterion for these properties, rather than strict numerical matching of the predicate.

Given the nature of the device (dental resin) and the provided document, the other requested points are not applicable:

• Sample size for test set and data provenance: Not applicable. These tests are laboratory/bench tests on material samples, not data sets from patients.
• Number of experts used to establish ground truth: Not applicable. Ground truth for these physical/chemical properties is established by standardized laboratory measurements, not human expert consensus.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable. This is for AI/human reader performance.
• Standalone (algorithm only) performance: Not applicable. There is no algorithm.
• Type of ground truth used: For physical properties, it's objective measurements based on ISO standards. For biocompatibility, it's biological response testing per ISO standards.
• Sample size for training set: Not applicable. This material is not an AI/ML model.
• How ground truth for training set was established: Not applicable. There is no training set.

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Final cementation of all-ceramic, metal-based inlays, onlays, posts, crown and bridge

EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with 'one step' system that does not need pre-treatment process, and it is easy to remove excess cement, so it is possible to perform quick operation. It is also easy to identify because it has a radio-opacity(1.2mm Al). And it offers various shades for aesthetics and color stable.

This document describes the performance testing for a dental cement called EsCem, manufactured by SPIDENT Co., Ltd. The purpose of the testing is to demonstrate the substantial equivalence of EsCem to a legally marketed predicate device, G-CEM LinkAce (K120243), manufactured by GC America Inc.

1. Acceptance Criteria and Device Performance

The performance testing was conducted according to various sections of the ISO 4049:2019, Dentistry Polymer-based restorative materials standard. The table below lists the acceptance criteria and the reported device performance for EsCem. Since specific numerical results for EsCem are not provided in the document (only whether it met the requirement), the "Reported Device Performance" column reflects that it met the acceptance criteria. For comparison, the document states that both the subject device and the predicate device meet the requirements of ISO 4049.

2. Sample Size for Test Set and Data Provenance

The document does not specify the exact sample sizes used for each performance test (e.g., number of specimens for film thickness, flexural strength, etc.). The provenance of the data is retrospective bench testing, conducted by SPIDENT Co., Ltd. in South Korea.

3. Number of Experts and Qualifications for Ground Truth

This study is a bench performance testing for a dental cement, not an AI/ML medical device. Therefore, the concept of "ground truth established by experts" in the context of interpretation (e.g., radiological reads) does not apply. The ground truth for this device is based on established international consensus standards (ISO 4049:2019) for physical and chemical properties of dental materials.

4. Adjudication Method for Test Set

Not applicable, as this is bench testing against a standard, not a human reader study requiring adjudication.

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

Not applicable. This is a bench study comparing a new device against a standard and a predicate device's performance through physical and chemical property testing. It is not an MRMC study comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical dental device (cement), not an algorithm or software.

7. Type of Ground Truth Used

The ground truth used for this study is based on established industry standards, specifically ISO 4049:2019 (Dentistry Polymer-based restorative materials). This standard defines the acceptable ranges and properties for dental cements. Additionally, the comparison to a legally marketed predicate device (G-CEM LinkAce) serves as a comparative ground for substantial equivalence.

8. Sample Size for Training Set

Not applicable. This is a physical dental device subjected to bench testing, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

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

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Self-curing temporary crown resin that is used temporarily before repairing a permanent restoration

Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength. Various shades of TW, A1, A2, A3, B1, C2, AO3 and BL for esthetic crown are provided. Hexa-Temp contains about 38% inorganic filler. Inorganic filler has a size of 16nm ~ 3.22µm.

This document is a 510(k) Premarket Notification from the FDA for a dental product called "Hexa-Temp." It is not a document describing an AI device or a study validating AI performance. Therefore, I cannot provide the requested information regarding acceptance criteria and study proving a device meets those criteria, as the document does not contain this information for an AI/algorithm-based device.

The document discusses the substantial equivalence of the "Hexa-Temp" temporary crown and bridge resin to a predicate device, "Structur 2 SC," based on bench performance testing and biocompatibility.

Here's a breakdown of what the document does provide:

• Device: Hexa-Temp (Temporary Crown and Bridge Resin)
• Manufacturer: SPIDENT Co., Ltd.
• Predicate Device: STRUCTUR 2 SC, VOCO GMBH, K040769
• Purpose: To demonstrate substantial equivalence to a legally marketed predicate device.
• Testing methods: Bench performance testing (conforming to ISO 10477:2018) and Biocompatibility testing (conforming to various ISO 10993 standards and ISO 7405:2018).
• Key performance parameters evaluated (acceptance criteria are implicit in meeting ISO standards and showing comparable/superior performance to predicate):
  • Water sorption
  • Solubility
  • Color and color consistency/stability
  • Polymerization Temperature
  • Polymerization Shrinkage
  • Compressive Strength
  • Flexural Strength
  • Surface finish
• Comparison provided in a table: A direct comparison of Hexa-Temp to Structur 2 SC for various characteristics including chemical composition, indications for use, principle of operation, mechanical properties, and biocompatibility.

Therefore, it is impossible to extract the specific information requested in your prompt (about AI acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) from this physical device submission.

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• Impression material in a dual phase impression technique
• Precise duplication of models
• Capturing multiple unit impressions

i-Sil is impression material. It has 5 types: Heavy, Medium, Light, Putty and Bite.

The i-Sil dental impression material has been determined to be substantially equivalent to the predicate device K152766 (Dentkist, Inc.'s CharmFlex products) based on performance data gathered through bench testing, outlined in the 510(k) Summary.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents performance data for the i-Sil device and compares it to the predicate device across various types (Heavy body, Medium body, Light body, Putty, Bite). The acceptance criteria are implicitly defined by the properties and values reported for both the subject and predicate devices, largely referencing ISO 4823 standards for elastomeric impression materials where applicable.

Heavy Body, Medium Body, Light Body Types:

Putty Type:

Bite Type:

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

The document describes "Bench test" data. It does not explicitly state the sample sizes used for each test. The data provenance is not explicitly mentioned as retrospective or prospective, but bench tests are typically conducted in a controlled laboratory environment. The company, SPIDENT Co.,Ltd., is located in Incheon, Korea, suggesting the bench testing may have been conducted there.

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

This is a materials science bench test, not a clinical study involving human assessment of images or diagnoses. Therefore, there are no "experts" in the sense of clinicians establishing ground truth. The "ground truth" for these tests is based on the adherence to objective physical and chemical properties as defined by the ISO 4823 standard and comparison to the predicate device's reported characteristics.

4. Adjudication Method for the Test Set:

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

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

No. This is a bench test for a dental impression material, not a diagnostic imaging device that would involve MRMC studies or human reader performance.

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

No. This terminology applies to AI/software as a medical device (SaMD), not to a physical impression material.

7. The Type of Ground Truth Used:

The ground truth used for these bench tests is derived from:

• ISO 4823 Dentistry-Elastomeric impression materials standard: This standard defines the methodologies and acceptable ranges for various physical and chemical properties of impression materials.
• Predicate device performance data: The reported performance characteristics of the legally marketed predicate device (K152766, CharmFlex products) serve as a comparative benchmark to demonstrate substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical impression material, not an artificial intelligence or machine learning algorithm 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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Base it is a light-cured, radiopaque dental liner and base material that Contains calcium bydroxyl apatite in a urethane dimethacrylate oligomer. Base it is used to line cavity preparations before restoration.

Base it is light-cured Cavity Liner. It is radiopaque cavity liner and base material specially formulated for use with adhesives, composites and conventional restorative materials. It has urethane dimethacrylate base and is similar in chemistry to dental composites.

The provided 510(k) summary for SPIDENT Co., Ltd.'s "Base it" device describes its performance testing in comparison to a predicate device, LIME-LITE (K953079). This submission serves as a notice of intent to market, asserting substantial equivalence to the predicate, rather than a detailed study for a novel device. Therefore, much of the requested information (like specific sample sizes for test sets, training data, number of experts, adjudication methods, or MRMC studies) is not typically included in such a submission for a substantially equivalent device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission implicitly uses the performance characteristics of the predicate device, LIME-LITE, as the acceptance criteria. The claim is that "Base it" is equivalent in these aspects.

• Cytotoxicity: Pass
• Sensitization: Pass
• Irritation or Intracutaneous reactivity: Pass
• Subacute toxicity: Pass
• Genotoxocity: Pass |

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

• Sample Size: Not specified. Standard bench testing typically uses a specific number of samples per test (e.g., 5, 10, or more) to achieve statistical significance for material properties, but this detail is not provided in a 510(k) summary.
• Data Provenance: The tests were "performed" by SPIDENT Co., Ltd. The country of origin for the data collection is implied to be Korea, where the company is located. The nature of the data is prospective bench testing, conducted specifically for this submission.

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

Not applicable. This is a bench study concerning physical and chemical properties of a dental material, not an AI or diagnostic device requiring expert interpretation of results. The "ground truth" for these tests comes from established testing methodologies and material science standards.

4. Adjudication method for the test set

Not applicable. As a bench study, results are quantitative and measured against established material science standards, not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This is not an MRMC study. It is a bench study comparing a new device's material properties to a predicate device, not evaluating human reader performance with or without AI assistance.

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

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

7. The type of ground truth used

The ground truth used for performance validation is based on established material science standards and specifications for dental restorative materials. These standards dictate how properties like Flexural Strength, Depth of Cure, etc., are measured and what acceptable ranges or equivalence criteria are. The biocompatibility tests are based on the ISO 10993 series of standards.

8. The sample size for the training set

Not applicable. This is a new material, not an AI model that requires a training set.

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

Not applicable.

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