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MAZIC Claro Press is an all-ceramic system for the creation of Occlusal veneers Thin Veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.

MAZIC Claro CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, onlays and full ceramic 3-unit anterior bridges.

The MAZIC Claro Press, dental glass ceramic ingot, is to make dental restorative prosthesis such as inlays, onlays, veneers, crowns and bridges. Having a variety of shade, the user can choose a suitable color that matches the natural teeth of the patient. The prosthesis can be made through regular press process.

The MAZIC Claro CAD, dental glass ceramic block, is to make dental restorative prosthesis such as inlays, onlays, veneers and crowns. Having a variety of shade, the user can choose a suitable color that matches the natural teeth of the patient. The prosthesis can be made through milling procedure by dental CAD/CAM.

This document describes the acceptance criteria and the study proving the device meets those criteria for the MAZIC Claro CAD and MAZIC Claro Press dental materials.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for both MAZIC Claro CAD and MAZIC Claro Press are based on conformance to ISO 6872: Dental ceramic. The reported device performance indicates that both devices conform to this standard for the specified physical and chemical properties.

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for the non-clinical performance tests or the data provenance (country of origin, retrospective/prospective). The tests were conducted according to ISO standards, implying controlled laboratory conditions.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This submission is for dental materials, and the "ground truth" is established through standardized physical, chemical, and biocompatibility testing, not through expert radiological or clinical interpretation of images.

4. Adjudication Method

Not applicable, as this is for material testing, not diagnostic performance.

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

Not applicable. This is not a diagnostic device that involves human readers.

6. Standalone (Algorithm Only) Performance

Not applicable. This is for dental materials, not an algorithm. The performance is based on the material's inherent physical and chemical properties.

7. Type of Ground Truth Used

The ground truth used for these devices is established by international standards for dental ceramics and biocompatibility:

• ISO 6872 (Dental ceramic) for physical and chemical properties.
• ISO 10993 (Biological evaluation of medical devices) for biocompatibility.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of material performance testing for these dental ceramics. The material itself is the subject of the performance tests.

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

Not applicable, as there is no training set for these dental materials. The "ground truth" for evaluating the device's performance is the adherence to the established parameters and limits defined in the ISO 6872 and ISO 10993 standards. The performance tests are designed to measure these parameters directly.

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• 1. Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties
• 2. Luting resin crowns, bridges, inlays, onlays and veneers
• 3. Luting metal or non-metal/fiber posts
• 4. Luting orthodontic appliances
• 5. Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)

The U-Cem™ Premium and the MAZIC® Cem are dual-cured self-adhesive resin cement. The U-Cem™ Premium and the MAZIC® Cem are the same product yet with different label design for different volume packages as shown below. The brand name, MAZIC® Cem, is specifically for 8.5g.

It is fluoride-releasing paste type, and has radiopaque. U-Cem™ Premium is available in both Automix and Double Dispenser types, and offers three different shades: Clear, Universal, and Opaque for esthetics.

It is used for cementation of ceramics, metals or composite inlays, onlays, crowns, bridges, posts and screws.

The provided document is a 510(k) premarket notification for a dental cement (U-Cem™ Premium & MAZIC® Cem). It describes the device, its intended use, and compares its performance to a predicate device (BisCem, K082449) to establish substantial equivalence.

This document does not describe a study involving an AI/Machine Learning device or a diagnostic device that would require the establishment of ground truth by experts, MRMC studies, or specific acceptance criteria related to classification metrics (e.g., sensitivity, specificity).

Instead, it focuses on the physical and performance properties of a dental cement, a tangible medical device. The "acceptance criteria" in this context refer to the device's ability to meet certain established standards and to demonstrate comparable performance to a legally marketed predicate device.

Therefore, many of the requested items (e.g., number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device submission.

However, I can extract the relevant "acceptance criteria" (which are performance specifications and compliance with standards) and the "reported device performance" from the document.

Overview of "Acceptance Criteria" and Reported Device Performance

For the U-Cem™ Premium & MAZIC® Cem dental cement, the "acceptance criteria" are implied by its compliance with recognized international standards for dental materials and its demonstration of comparable or superior physical properties to a predicate device. The study proves the device meets these criteria through a series of non-clinical performance tests and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance

The device is deemed acceptable if its performance parameters meet or exceed those of the predicate device and comply with relevant ISO standards.

Study Details (Non-Applicable sections are explicitly stated)

Since this is a submission for a dental cement based on physical and chemical properties and comparison to a predicate device, the standard questions relating to AI/ML or diagnostic image analysis are largely not applicable.

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

• The document implies that various samples of the U-Cem™ Premium & MAZIC® Cem were used for each physical, chemical, and biological test. Specific sample sizes for each test are not provided in this summary.
• The data provenance is from non-clinical bench testing and biocompatibility testing. The country of origin for the testing itself is not explicitly stated, but the manufacturer is Vericom Co., Ltd. from the Republic of Korea. The data is prospective in the sense that the tests were specifically performed for this submission to demonstrate substantial equivalence.

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. Ground truth, in the AI/ML sense, is not established for this device. The "ground truth" for dental cement is its objective physical and chemical properties, measured using standardized laboratory methods (e.g., ISO standards).

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

• Not Applicable. Adjudication methods are relevant for subjective human assessments, typically in diagnostic studies. The performance of this device is measured objectively through lab 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:

• No, an MRMC comparative effectiveness study was not done. This is not relevant for a dental cement.

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

• Not Applicable. This is not an algorithm or software device. The "standalone performance" refers to the intrinsic physical and chemical properties of the cement itself, as measured by the non-clinical tests.

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

• The "ground truth" for this device's performance is based on objective measurements derived from standardized laboratory testing methods (e.g., ISO standards for dental materials) and direct comparison to the characteristics of a legally marketed predicate device.

8. The sample size for the training set:

• Not Applicable. This device is a manufactured product, not an AI/ML model that requires training data.

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

• Not Applicable. (See point 8)

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Permanent sealing of root canal

Well-Root™ ST is a convenient premixed ready-to use composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder.

The provided text describes the regulatory clearance of a root canal filling resin, Well-Root™ ST, and its substantial equivalence to predicate devices. It does not present a study with acceptance criteria and reported device performance in the context of diagnostic accuracy, clinical outcomes, or human-in-the-loop performance, as implied by the request. Instead, the "performance data" section refers to bench testing against ISO standards and biocompatibility tests. These are typically used to demonstrate the physical, chemical, and biological safety of a material, not to evaluate the diagnostic or clinical efficacy of an AI-powered medical device.

Therefore, many of the requested items, particularly those related to diagnostic accuracy, a test set, ground truth, experts, and comparative effectiveness studies, cannot be answered from the provided text.

Here's an attempt to answer the questions based only on the information available in the provided text, highlighting where the information is not present or not applicable to the context of AI device studies:

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

The document lists performance standards it conformed to (ISO 6876 and ISO 10993 series), and mentions that "the test result of the subject device satisfies the requirement of the ISO 6876" and "the results of the bench and the biocompatibility tests performed demonstrates that any of these differences do not raise a new question as to safety and effectiveness." However, specific numerical acceptance criteria and reported performance values for these tests are not detailed in the provided text.

The document mentions compliance with the following ISO standards and specific tests within them:

Note: The text explicitly states, "the test result of the subject device satisfies the requirement of the ISO 6876 and does not raise an issue of safety and/or performance." It also mentions for shelf life "Appearance, ISO 6876 tests (Flow, Setting Time, Film Thickness)" were conducted, implying compliance.

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

Not applicable/Not provided. This document describes physical, chemical, and biocompatibility testing of a root canal filling resin, not an AI-powered diagnostic device that would typically have a "test set" of data (e.g., images, patient records). The testing methods for ISO standards usually involve a defined number of samples for each test (e.g., N=3 or N=5 for flow, setting time, etc.), but these specific numbers are not given in this summary.

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/Not provided. Ground truth, in the context of diagnostic AI, refers to the confirmed correct diagnosis or outcome. For a physical device like a root canal sealer, "ground truth" would relate to the validated methods of the ISO standards themselves, not expert judgment on cases.

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

Not applicable/Not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations (e.g., in reading medical images) for establishing ground truth, which is not the type of study described here.

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

No. This is not a study involving human readers or AI assistance. It is a submission for a physical medical device.

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

No. This is not an algorithm or AI device.

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

For the ISO and biocompatibility tests: The "ground truth" is established by the specified methodologies and criteria outlined within the respective ISO standards (e.g., ISO 6876 for physical properties of root canal filling materials, ISO 10993 series for biocompatibility). These standards define the acceptable range or characteristics for the device's performance.

8. The sample size for the training set

Not applicable/Not provided. As this is not an AI device, there is no "training set."

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

Not applicable/Not provided. As this is not an AI device, there is no "training set" or corresponding ground truth establishment in that context.

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Fabrication of inlays, onlays, veneers and crowns

MAZIC™Duro, a dental restorative material, is a radiopaque, block type, hybrid ceramic that is intended for the fabrication of inlays, onlays, veneers and crowns. The device can be matched to the patient's tooth shade and is intended for use in dental CAD/CAM milling procedures.

The provided text describes the 510(k) summary for the dental device MAZIC™ Duro, which is a tooth shade resin material. It focuses on demonstrating substantial equivalence to a predicate device (CERASMART) rather than proving performance against specific acceptance criteria for an AI/algorithm-based medical device.

Therefore, the requested information regarding acceptance criteria, study design for AI evaluation (sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance), and training set details cannot be extracted from this document, as it is not relevant to an AI/algorithm-based device. The document describes a physical material, and its performance is evaluated through material properties and biocompatibility as opposed to AI accuracy metrics.

The document states:

• Device Type: MAZIC™ Duro is a "radiopaque, block type, hybrid ceramic that is intended for the fabrication of inlays, onlays, veneers and crowns." It's a dental restorative material used in CAD/CAM milling procedures.
• Performance Testing: "MAZIC™ Duro and the predicate device, CERASMART were tested for the nonclinical performance including compressive strength, flexural strength, elastic modulus, radio-opacity, vicker's micro hardness, water sorption, and solubility."
• Biocompatibility: Evaluated according to ISO 10993 standards.

Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/algorithm-based device, and this document pertains to a physical dental material, the requested information is absent.

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For treatment of dentinal hypersensitivity secondary to exposed dentin and root surfaces

V-varnish™ Premium is cavity varnish containing 5% sodium fluoride(F ion: 22,600ppm). It is applied to teeth for the purpose of treatment dentinal hypersensitivity. V-varnish™ Premium consists of rosin which adheres to the surface of the teeth, seals exposed dentin tubules. V-varnish™ Premium has four flavors such as bubblegum, strawberry, melon and mint and two colors(clear and white). It is packed in single dose package allows easy mixing and application.

The provided document is a 510(k) summary for V-varnish™ Premium, a cavity varnish. It details a comparison study against a predicate device, Enamel Pro® Varnish (K062683). The study is for the purpose of demonstrating substantial equivalence, not conducting a comparative effectiveness study in the typical sense of human reader performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating that the V-varnish™ Premium's physical and performance properties are "substantially equivalent" to the predicate device, Enamel Pro® Varnish. The values for the predicate device serve as the de facto "acceptance criteria" against which the new device's performance is measured.

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

The document does not explicitly state the sample sizes for the "in vitro" tests (consistency, pH, fluoride content, dentinal tubule occlusion). It also does not specify the provenance (country of origin, retrospective/prospective) of the data for these tests. However, the tests were conducted in vitro using the devices themselves.

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

This type of study does not involve expert readers establishing ground truth as it is a bench study evaluating physical and chemical properties, and biocompatibility, of a dental varnish.

4. Adjudication Method for the Test Set

Not applicable for a bench study of physical and chemical properties and biocompatibility.

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

No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) premarket notification for a medical device (cavity varnish), which relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing rather than human reader studies. Therefore, there is no effect size of human readers improving with or without AI assistance.

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

Not applicable. This is a physical device (cavity varnish), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the non-clinical performance tests are the measured physical and chemical properties of the devices themselves, as determined by laboratory testing. For biocompatibility, the ground truth is adherence to internationally recognized standards (ISO 10993 series).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study that requires a training set. The study involves bench testing of a physical product.

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

Not applicable. There is no training set for this type of device submission.

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• Impression material in a dual phase impression technique
• Precise duplication of models
• Capturing multiple unit impressions
• Impression of inlay, crown, bridge and partial denture etc.

Vonflex S™, as the additional polymerization silicone type, is composed of a two component (base and catalyst, mixing ratio 1:1) hydrophilic vinyl polysiloxane impression material for all dental impression techniques. Vonflex S™ consists of light-bodied, medium-bodied or heavy-bodied consistencies in delivery systems of cartridges and/or tubes. It has normal set and fast set that would be desired by the operator.

The provided text is a 510(k) Summary for a dental impression material named "Vonflex S™". This document aims to demonstrate substantial equivalence to a predicate device, not necessarily to set and prove acceptance criteria in the same way one might for an AI/ML medical device.

The study presented here is a comparison of the performance characteristics of the new device (Vonflex S™) against a legally marketed predicate device (Aquasil Ultra Smart Wetting Impression Material). The goal is to show that Vonflex S™ is substantially equivalent and therefore safe and effective for its intended use, not to prove that it meets specific, pre-defined acceptance criteria in isolation.

However, we can infer "acceptance criteria" as the performance characteristics of the predicate device, against which the new device is compared. The study involves bench testing of physical and chemical properties.

Here's an attempt to structure the information based on your request, with the understanding of the nature of this 510(k) submission:

1. Table of Acceptance Criteria (Inferred from Predicate Device Performance) and Reported Device Performance

The acceptance criteria are inferred from the performance of the predicate device, as the goal is to demonstrate substantial equivalence. The tables in the document compare varying consistencies (Heavy, Medium, Light, Light XLV) of Vonflex S™ against their respective predicate device counterparts. Below are representative tables for "Vonflex S™ Heavy" and "Vonflex S™ Light XLV". Similar tables are present for Medium and Light consistencies in the original document.

Vonflex S™ Heavy - Acceptance Criteria (Predicate) vs. Device Performance

Vonflex S™ Light XLV - Acceptance Criteria (Predicate) vs. Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of impressions or tests performed for each physical property). It only presents the measured values.
• Data Provenance: The tests were conducted by Vericom Co., Ltd. in the Republic of Korea. The data is reported for the new device (Vonflex S™) and the predicate device (Aquasil Ultra Smart Wetting Impression Material). The study is retrospective in the sense that it evaluates the manufactured product against existing standards and a predicate device.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. This study does not involve human readers or interpretations of images/data that would require expert consensus. The "ground truth" for each characteristic (e.g., flow properties, tear strength) is determined by laboratory measurements according to established international standards (ISO 4823).
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is a scientific and technical bench testing comparison, not a clinical study involving human judgment that would require adjudication.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic interpretation devices, not for a dental impression material's physical and chemical properties.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Not applicable. This device is not an algorithm or software. The performance evaluation focuses on the physical and chemical properties of the material itself.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the performance characteristics is derived from measurements of defined physical and chemical properties conducted according to the ISO 4823 standard. For biocompatibility, the ground truth is established through standard biological evaluation tests (Cytotoxicity, Genotoxicity, Oral mucous Irritation, Sensitization) as per ISO 10993. The performance of the predicate device also serves as a comparative ground truth to establish substantial equivalence.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a material, not a machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

• How Ground Truth was Established: Not applicable.

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It is used for all crown, bridge and orthodontic impression techniques.

Vonflex S™ Putty, as the additional polymerization silicone type, is composed of vinyl polysiloxane impression materials that make oral tissue shape precisely. polychoxane improofien materials that natio of a looks probobility, helps to make precise impression taking.

This is a 510(k) premarket notification for a dental impression material, Vonflex S™ Putty, and not an AI or software device. Therefore, many of the requested categories related to AI/software performance, such as sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, and AI-specific acceptance criteria, are not applicable to this document.

The acceptance criteria and performance data presented here are for the physical and biological properties of a dental material.

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance:
This document describes performance testing for a dental impression material. The specific sample sizes for each physical property test are not detailed in this summary. The data provenance is Vericom Co., Ltd., Republic of Korea, as they conducted the tests (prospective in the context of 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 for performance testing of a physical material, not for a diagnostic device requiring expert interpretation or ground truth establishment in the typical AI/software sense. The "ground truth" for these tests are the defined standards within ISO 4823 and ISO 10993.

4. Adjudication method for the test set:
Not applicable. This is for performance testing of a physical material, not for a diagnostic device with human interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered device.

7. The type of ground truth used:
For physical properties, the "ground truth" is defined by the requirements and test methods specified in the international standard ISO 4823 (Dentistry - Elastomeric impression materials). For biocompatibility, the "ground truth" is based on the safety endpoints and test methods specified in ISO 10993 (Biological evaluation of medical devices).

8. The sample size for the training set:
Not applicable. This is not an AI-powered device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI-powered device that requires a training set or its associated ground truth establishment.

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• Standard bite registrations in the end bite position -
• Portrayal of antagonists -
• Coating of bite forks -
• Key material for needle point registration -
• -Production of small model segments

Not Found

1. Acceptance Criteria and Reported Device Performance:

The provided document (K140966) is a 510(k) clearance letter for a dental impression material, "Vonflex™ S Bite." It appears to be a traditional 510(k) submission seeking substantial equivalence to a predicate device. This type of regulatory submission typically focuses on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" for this device are not framed as specific performance metrics against a pre-defined threshold for an AI algorithm. Instead, the acceptance criteria revolve around demonstating substantial equivalence to an existing predicate device. The "reported device performance" would be the summary of the tests and data provided by the manufacturer in their 510(k) submission to support this substantial equivalence.

Without additional documents (like the full 510(k) submission), it's impossible to provide a table of specific quantitative acceptance criteria directly from the FDA letter. However, based on the nature of a 510(k) for an impression material, the acceptance criteria and likely performance evaluation would revolve around characteristics relevant to dental impressions.

Likely Acceptance Criteria and Reported Performance (General based on impression materials):

• Portrayal of antagonists
• Coating of bite forks
• Key material for needle point registration
• Production of small model segments (as stated in the "Indication for use" section) |
  | Technological Characteristics Equivalence:
• Material composition and properties
• Physical/mechanical properties relevant to impressions
• Biocompatibility | - Composition: Likely similar elastomer (e.g., vinyl polysiloxane, polyether) to predicate.
• Setting Time: Within clinically acceptable range, comparable to predicate.
• Dimensional Stability/Accuracy: Demonstrated to be stable and accurate post-setting, comparable to predicate via in-vitro testing.
• Tear Strength: Sufficient to prevent tearing during removal, comparable to predicate.
• Hydrophilicity/Wettability: Adequate for good adaptation to oral tissues, comparable to predicate.
• Flowability/Viscosity: Appropriate for specific impression techniques, comparable to predicate.
• Biocompatibility: Demonstrated via ISO 10993 testing or reference to predicate's biocompatibility. |
  | Performance Data Equivalence:
• Functional performance
• Safety | - Clinical Performance (if studies were performed): E.g., successful impression taking and model fabrication. If clinical studies were performed, they would compare Vonflex™ S Bite to the predicate device.
• Safety: Evaluation for adverse reactions, allergic responses, or cytotoxic effects (often covered under biocompatibility). |

Note: The FDA letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This confirms the focus on substantial equivalence.

The document provided does not contain information on points 2 through 9, as it is a 510(k) clearance letter and not a detailed study report. The information requested in points 2-9 is typical for the evaluation of a novel AI/ML-driven medical device, especially regarding diagnostic accuracy or performance improvement studies. Since this device is a dental impression material, these specific types of studies (MRMC, expert adjudication for AI ground truth, training and test sets for AI) are not applicable.

However, to address the prompt for completeness based on typical medical device evaluations for non-AI devices, I can infer the general approaches for similar materials:

Hypothetical General Information for a Non-AI Device (like an Impression Material), if Study Details were Available:

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

• Test Set: For an impression material, "test set" typically refers to the number of impressions taken, or the number of samples subjected to physical/mechanical testing.
  • In-vitro testing: Might involve dozens to hundreds of samples for various physical and mechanical properties (tensile strength, tear strength, dimensional accuracy, etc.).
  • Clinical testing (if performed): Could range from 20-50 patients for a pilot study, to several hundred for a larger comparative study, depending on the endpoints.
• Data Provenance:
  • In-vitro: Lab-controlled environment, likely conducted by the manufacturer or a contract research organization.
  • Clinical: Could be retrospective (review of existing patient records where the material was used) or prospective (new clinical study specifically designed for the 510(k)). Country of origin would be where the manufacturing and/or clinical sites are located (e.g., Republic of Korea, based on the applicant's address).

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

• For an impression material, "ground truth" isn't typically established by expert consensus in the same way it is for diagnostic AI. Instead, "ground truth" often refers to:
  • Reference standards in physical/mechanical tests: E.g., measurements against a known calibration standard, or a predicate device's established performance.
  • Clinical outcomes: E.g., success of prosthetic fit, patient satisfaction, absence of complications.
• "Experts" involved:
  • Lab technicians/Engineers: With expertise in material science and dental materials testing.
  • Dentists/Prosthodontists: With clinical experience in taking impressions and evaluating restoration fit. Qualifications would be standard dental degrees and potentially specialty certifications.

4. Adjudication Method for the Test Set:

• Not applicable in the AI sense. For clinical outcomes, if multiple clinicians evaluate the impressions or restorations, agreement might be assessed via inter-rater reliability statistics (e.g., Kappa statistic). For lab tests, standard quality control and reproducibility measures are used.

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

• No. MRMC studies are specific to evaluating human reader performance with and without AI assistance, particularly in diagnostic contexts. This is not relevant for an impression material.

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

• No. This concept is specific to AI algorithms.

7. The Type of Ground Truth Used:

• Defined Standards/Reference Materials: For physical and mechanical properties, ground truth comes from established metrics (e.g., ISO standards for dental materials), standardized measurement techniques, and comparison to the predicate device.
• Clinical Success/Outcomes: In clinical studies, the "ground truth" would be the successful clinical application as judged by objective criteria (e.g., excellent marginal fit of restoration, stable bite registration, no patient discomfort) and potentially subjective patient feedback.

8. The Sample Size for the Training Set:

• Not applicable in the AI sense. For an impression material, "training set" doesn't exist for an algorithm. Instead, it would refer to the data used in the material's development and optimization phase. This might involve numerous iterations of formulation changes and subsequent small-batch testing.

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

• Not applicable in the AI sense. For material development, "ground truth" during "training" would be established by desired performance targets (e.g., "we need a setting time of 3-5 minutes," "tear strength must exceed X MPa") derived from clinical needs, market analysis, and predicate device performance. These targets guide the iterative development process.

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• Impression material in a dual phase impression technique
• Precise duplication of models
• Capturing multiple unit impressions
• All impression techniques where the operator needs a heavy or low viscosity material

Vonflex™ Heavy/ Vonflex™ Light as the additional polymerization silicone type, is a rubber impression material that makes oral tissue shape precisely. And it is very easy to handle and has low deformation, helping to make precise impression taking.

The provided text describes a 510(k) summary for a dental impression material named Vonflex™ Heavy/ Vonflex™ Light. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and statistical measures from a study proving device performance is not explicitly available in this document.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria for performance are not explicitly stated as quantitative metrics with pass/fail thresholds in this summary. Instead, the summary asserts "similar characteristics" to the predicate device.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The submission is from Vericom Co., Ltd. in the Republic of Korea. It implies that any testing would have been conducted by the manufacturer or a contracted lab. The document does not indicate if the data is retrospective or prospective.

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

• This information is not provided as the submission focuses on demonstrating equivalence to a predicate device through non-clinical characteristics rather than a study requiring expert-established ground truth.

4. Adjudication method for the test set

• This information is not provided.

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 device (dental impression material) is a physical, passive material and does not involve AI or human readers in the context described for an MRMC study. Therefore, an MRMC study was not done.

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

• This device does not involve an algorithm. Therefore, a standalone algorithm performance study was not done.

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

• The concept of "ground truth" as typically applied to diagnostic AI/imaging devices is not directly applicable here. The evaluation of this device would involve physical and chemical property testing (e.g., rheology, setting time, dimensional stability, biocompatibility) rather than diagnostic accuracy against a ground truth diagnosis.

8. The sample size for the training set

• This device does not involve a "training set" in the context of an algorithm or statistical model. The term is not applicable.

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

• As in point 8, the concept of a "training set" and associated ground truth is not applicable to this type of medical device submission.

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Pit and fissure sealant

Eco-S™ is a single part, light curing, pit and fissure sealant. It is based on methacrylate resin chemistry. It can be used as a pit and fissure sealant. It is intended to be used on posterior teeth and is not permanent.

The provided text describes a 510(k) summary for a dental sealant called "Eco-S™". It makes claims of substantial equivalence to a predicate device (3M Clinpro™ Sealant, K992326) based on similar technological characteristics and physical properties. However, the document does not describe acceptance criteria or a study that rigorously proves the device meets specific performance metrics in a clinical or standalone study context.

Based on the provided text, here's a breakdown of the requested information:

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

Important Note: The document frames "acceptance criteria" as similarity to a predicate device rather than specific quantitative thresholds for performance.

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

The document does not specify a sample size for a test set or data provenance because it primarily relies on demonstrating similarity to a predicate device through physical and technological characteristics. There is no mention of clinical data or a test set in the traditional sense for evaluating AI or diagnostic device performance.

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

This information is not applicable as there is no test set or mention of expert-established ground truth for evaluating the device's performance against clinical outcomes or diagnoses. The evaluation relies on comparing physical and technological properties to a predicate device.

4. Adjudication method for the test set

This information is not applicable as there is no test set or clinical study described that would require an adjudication method.

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 pit and fissure sealant, a dental material, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

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

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

The concept of "ground truth" as typically applied to diagnostic or AI devices is not directly relevant here. The "ground truth" for this device's acceptance is based on its physical and technological similarity to a legally marketed predicate device (3M Clinpro™ Sealant, K992326) and compliance with safety regulations (biocompatibility).

8. The sample size for the training set

This information is not applicable as the device is not an AI algorithm and therefore does not have a training set.

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

This information is not applicable as the device is not an AI algorithm and therefore does not have a training set.

Summary of the Study/Evaluation described:

The document describes a Predicate Device Comparison as the primary method to demonstrate safety and effectiveness.

• Study Design: The submission asserts that Eco-S™ has "similar technological characteristics" and "similar physical properties" to the predicate device (3M Clinpro™ Sealant, K992326).
• Performance Metrics Compared: Device design, appearance, main materials, indication for use, shear bond strength, ambient light sensitivity, cure time, depth of cure, and uncured film thickness.
• Safety Evaluation: Biocompatibility tests were performed, and the device is stated to comply with applicable International and US regulations.

The study presented is not a traditional clinical trial or an evaluation of an AI algorithm's performance. Instead, it's a demonstration of substantial equivalence through comparison of material properties and characteristics to a previously approved device.

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