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• [1] Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
• [2] Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
• [3] Cementation of metal cores, resin cores, metal posts or glass fiber posts

PANAVIA SA CEMENT Handmix is a dual-curc (light- and/or self-cure), radiopaque self-adhesive resin cement for porcelain, ceramic, composite resin and metal restorations. It is intended for the following indications:
(1) Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
(2) Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
(3) Cementation of metal cores, resin cores, metal posts or glass fiber posts
It is classified into dental cement (21 CFR section 872,3275. Product code: EMA ) according to 21 CFR§872 since it is composed of various materials other than zinc oxide-eugenol.
Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials). According to ISO 4049: 2009, the subject device is classified into the following:
Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present
(This product contains the adhesive monomer. ISO 4049:2009 does not cover the polymer-based luting materials that have an adhesive component within the structure of the material. However, we tested referring to this standard.)

Here's a breakdown of the acceptance criteria and study information for the PANAVIA SA CEMENT Handmix device, based on the provided text:

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 a specific sample size for a "test set" in the context of clinical performance or a separate evaluation. The performance claims are based on compliance with an ISO standard and comparison to predicate devices, which implies lab-based testing. Therefore, we cannot determine a sample size for a test set, its provenance, or whether it was retrospective or prospective from this document.

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

Not applicable. The "ground truth" for the device's performance is established by its compliance with the physical and mechanical property requirements of ISO 4049:2009 and comparison of bond strength to predicate devices. This type of evaluation does not typically involve expert consensus on a test set of clinical cases.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a clinical test set or adjudication process in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed for this device. The evaluation focuses on the physical and mechanical properties of the dental cement itself, not on 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 cement, not an AI algorithm. Therefore, a standalone performance evaluation of an algorithm is not relevant.

7. The type of ground truth used

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

• A recognized international standard: ISO 4049:2009 (Dentistry - Polymer-based restorative and materials). This standard defines specific physical and mechanical properties that the material must meet.
• Comparison to predicate devices: The bond strength of the device was compared to that of existing, legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical material (dental cement), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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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• [1] Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
• [2] Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
• [3] Cementation of metal cores, resin cores, metal posts or glass fiber posts

PANAVIA SA CEMENT Automix is a dual-cure (light- and/or self-cure), radiopaque self-adhesive resin cement for porcelain, ceramic, composite resin and metal restorations. It is supplied in an automix delivery system which can mix equal amount of two components.

The provided text describes a 510(k) submission for a dental cement (PANAVIA SA CEMENT Automix) and explicitly states that it complies with ISO 4049: 2009. However, the document does not present specific acceptance criteria in a table format with corresponding device performance data, nor does it detail a study that proves the device meets specific acceptance criteria in the manner requested (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance).

The information available is primarily focused on demonstrating substantial equivalence to predicate devices rather than proving performance against quantitative acceptance criteria through a detailed study.

Here's an analysis of what is provided, and where information is missing based on your request:

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

• Available Information: The document states, "PANAVIA SA CEMENT Automix complies with all requirements of ISO 4049: 2009 as polymer-based restorative materials." It also mentions, "And also, the bond strength of the subject device is equivalent to that of the predicate devices."
• Missing Information/Cannot Create Table: The specific requirements of ISO 4049: 2009 (e.g., flexural strength, water sorption, solubility, film thickness, radiopacity) are not detailed, nor are the actual measured performance values for PANAVIA SA CEMENT Automix presented alongside those specific ISO requirements. The document only provides a high-level statement of compliance. No numerical acceptance criteria or performance data are given for "bond strength."

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

• Missing Information: This information is not provided in the document. The text does not describe a "test set" in the context of clinical or performance evaluation with a specified sample size or data provenance. The assessment is based on compliance with ISO standards and chemical ingredient comparison, not a "test set" in the typical sense for AI/medical device performance evaluation.

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)

• Missing Information: Not applicable to the type of information presented. This document is related to material properties and substantial equivalence, not a diagnostic device requiring expert ground truth for image interpretation or similar tasks.

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

• Missing Information: Not applicable for the reasons stated above.

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

• Missing Information: Not applicable. This is not an AI-assisted diagnostic device, but a dental cement.

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

• Missing Information: Not applicable. This is not an algorithm or AI device.

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

• Available Information (Implicit): The "ground truth" for this device's performance relies on ISO 4049: 2009 standards for physical and mechanical properties, and chemical ingredient equivalence to predicate devices. For bond strength, the "ground truth" appears to be comparative testing against predicate devices.
• Missing Information: Specific details of these "ground truths" (e.g., the specific parameters from ISO 4049: 2009, the methodology for comparing bond strength) are not provided.

8. The sample size for the training set

• Missing Information: Not applicable as this document is not about an AI/ML device with a "training set."

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

• Missing Information: Not applicable.

Summary of Device Acceptance Criteria and Study Information (Based on provided text):

Acceptance Criteria:

Study and Performance Information:

• Bond strength is equivalent to that of predicate devices. |
  | Sample Size (Test Set) | Not specified (no clinical or performance test set described in detail). |
  | Data Provenance (Test Set) | Not specified. |
  | Number of Experts (Ground Truth) | Not applicable (device evaluation is based on standards compliance and chemical composition, not expert interpretation). |
  | Qualifications of Experts | Not applicable. |
  | Adjudication Method (Test Set) | Not applicable. |
  | MRMC Comparative Effectiveness Study? | No. |
  | Standalone Performance Study? | No (this refers to an algorithm's performance; the device is a material). Its "standalone performance" is compliance with ISO 4049. |
  | Type of Ground Truth Used | - ISO 4049: 2009 standards for physical/mechanical properties.
• Chemical composition equivalence.
• Comparative bond strength data (details not provided). |
  | Sample Size (Training Set) | Not applicable. |
  | Ground Truth for Training Set | Not applicable. |

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• [1] Direct restorations using light cured composite resin
• [2] Cavity sealing as a pretreatment for indirect restorations
• [3] Treatment of exposed root surfaces
• [4] Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin
• [5] Surface treatment of non-precious metal posts
• [6] Post cementation and core build·ups using dual·cured composite resin CLEARFIL DC CORE PLUS
• [7] Core build-ups using light-cured composite resin

The subject device is a single-component. light-cured bonding agent that allows simultaneous treatment of both dentin and enamel. A single dose of it comes in a container with an applicator tip for fast, direct placement into the cavity.

The provided text describes a 510(k) premarket notification for a dental bonding agent, CLEARFIL TRI-S BOND PLUS Single Dose. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on chemical ingredients, safety, and technological characteristics/performance.

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

Acceptance Criteria and Study Details for CLEARFIL TRI-S BOND PLUS Single Dose

The provided information focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel safety or efficacy criteria that would necessitate a rigorous clinical trial with pre-defined acceptance criteria for a new device. For devices seeking 510(k) clearance, the "acceptance criteria" are generally that the new device performs "as good as or better than" the predicate device in key performance characteristics relevant to its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, formal, quantitative acceptance criteria with specific threshold values (e.g., "tensile strength > X MPa") are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" can be inferred as demonstrating similar or superior performance to the predicate devices.

Study Description:
The study was conducted to demonstrate substantial equivalence to predicate devices, specifically "CLEARFIL TRI-S BOND" for performance aspects. It involved:

• Biocompatibility testing: For two new chemical ingredients, evaluation was done referring to ISO 10993 series and ISO 7405.
• Performance testing: Tensile bond strength test and Fluoride releasing property were performed.

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

The document does not explicitly state the sample sizes used for the tensile bond strength test, fluoride releasing property test, or the biocompatibility evaluations.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be laboratory testing for performance characteristics and ingredient evaluations rather than patient data.

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

This information is not applicable in the context of this 510(k) summary. The "ground truth" for chemical composition, biocompatibility, and physical properties (like bond strength) is established through standardized laboratory tests and material science principles, not through expert consensus on patient data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for clinical image interpretation or diagnostic studies involving human readers, which is not the nature of the tests described for this dental bonding agent.

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. This type of study involves human readers interpreting cases with and without AI assistance and is relevant for diagnostic imaging devices. The CLEARFIL TRI-S BOND PLUS Single Dose is a material (dental bonding agent), not a diagnostic or AI-powered device.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a material, not a software algorithm. The "standalone" performance refers to the device's inherent material properties as tested in the laboratory.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed was based on objective laboratory measurements and material science standards.

• Biocompatibility: Determined by adherence to ISO 10993 series and ISO 7405 standards for material safety.
• Tensile Bond Strength: Measured quantitatively in a laboratory setting to evaluate the material's adhesive properties.
• Fluoride Releasing Property: Measured quantitatively to assess this specific characteristic of the material.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms or AI models. This submission is for a medical device (dental bonding agent) that does not involve AI or machine learning. The studies described are for material characterization and performance comparison.

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

This information is not applicable as there is no "training set" for this device.

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1. Direct restorations for anterior and posterior teeth (Class I - V cavities)
2. Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
3. Intraoral repairs of fractured crowns/bridges

CLEARFIL MAJESTY Posterior is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring casy handling and placement.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: CLEARFIL MAJESTY Posterior (KURARAY MEDICAL INC.)
Device Type: Light-cure, radiopaque restorative composite resin (Tooth shade resin material)

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission leverages the concept of "substantial equivalence" to a predicate device (K063595). Therefore, the acceptance criteria are primarily based on meeting the same performance standards as the predicate device and complying with a recognized international standard.

2. Sample Size for Test Set and Data Provenance

The primary study cited is a comparison of physical and mechanical properties based on ISO 4049.

• Sample Size (Test Set): Not explicitly stated in the provided text. The document mentions "physical and mechanical properties of the subject device were evaluated according to ISO 4049 in comparison with the predicate device." ISO standards typically define the number of samples required for specific tests, but the exact number used in this particular evaluation is missing.
• Data Provenance: The study was conducted by KURARAY MEDICAL INC., which is based in Japan ("1621 Sakazu, Kurashiki, Okayama 710-0801, Japan"). The testing described appears to be prospective laboratory testing for the purpose of premarket submission.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This submission relies on an equivalency study to a predicate device and compliance with an international standard (ISO 4049) for physical and mechanical properties. There is no mention of a clinical study or expert review to establish ground truth for a test set in the traditional sense, as this is a material science testing rather than a diagnostic or interpretive device.

4. Adjudication Method for Test Set

• Not applicable. See point 3.

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

• No. This is a material science product; MRMC studies are typically for diagnostic imaging devices or algorithms where human interpretation is involved.

6. Standalone Performance Study

• Yes, in essence. The evaluation of the device's physical and mechanical properties against ISO 4049 and in comparison to the predicate device can be considered a standalone performance study in the context of material science. The algorithm, in this case, is the material itself and its inherent properties.

7. Type of Ground Truth Used

• ISO 4049: 2000 Standard Requirements: The primary ground truth for performance is the set of specifications and test methods defined by this international standard for "Dentistry - Polymer-based filling, restorative and luting materials."
• Predicate Device Performance: The performance characteristics of the legally marketed predicate device (K063595) also serve as a comparative ground truth.

8. Sample Size for Training Set

• Not applicable / Not explicitly mentioned. Material science testing typically doesn't involve "training sets" in the way machine learning algorithms do. The "training" for the device design would involve research and development to formulate the material to meet desired specifications, but no data set of this nature is described.

9. How Ground Truth for Training Set Was Established

• Not applicable. See point 8. The "ground truth" for material development generally stems from established dental material science principles, clinical needs, and the performance characteristics of existing successful products (like the predicate device).

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1. Direct restorations for anterior and posterior teeth (Class I V cavities)
2. Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
3. Intraoral repairs of fractured crowns/bridges

CLEARFIL MAJESTY Posterior PLT (PLT:Pre-loaded tip) is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. CLEARFIL MAJESTY Posterior PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.
In this application, we have precisely defined the amount of dl-Camphorquinone and N.N-Diethanol-p-toluidine (DEPT) contained in CLEARFIL MAJESTY Posterior PLT in range of chemical composition shown in the original application in order to improve its sensitivity to ambient light.

The provided text describes a 510(k) premarket notification for a dental restorative material, CLEARFIL MAJESTY Posterior PLT. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with new acceptance criteria and performance evaluations for the subject device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in this document.

The document primarily relies on:

• Comparison of Chemical Composition: The subject device has precisely defined amounts of dl-Camphorquinone and N,N-Diethanol-p-toluidine (DEPT) within the range of the predicate device.
• Compliance with Standards: The subject device, like the predicate, complies with ISO 4049:2000 "Dentistry - Polymer-based filling, restorative and luting materials" for physical and mechanical properties.
• Similarity of Intended Use: The intended uses are identical to the predicate device.
• Biocompatibility by Reference: All chemical ingredients are the same as the predicate and its safety has been previously established and confirmed by the predicate device being on the market for 2 years with no reported problems or recalls.

In lieu of a table of acceptance criteria and reported device performance, the document states:

"Furthermore, physical and mechanical properties of the subject device were evaluated according to ISO 4049 in comparison with the predicate device, in which the substantial equivalence between the subject device and the predicate device was shown in terms of effectiveness/performance."

And, "As to comparison with the predicate device, according to ISO 4049: 2000, both the subject device and the predicate device comply with ISO 4049: 2000, indicating that the subject device is as effective as and performs as well as the predicate device."

Summary of available information:

1. A table of acceptance criteria and the reported device performance: Not explicitly stated as acceptance criteria in the context of a new efficacy study. The device's performance is demonstrated by its compliance with ISO 4049:2000, which is also met by the predicate device.
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 for this type of submission. Performance was shown through compliance with an international standard.
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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental restorative material, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Compliance with an engineering standard (ISO 4049:2000) was used to demonstrate performance.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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1. Cementation of crowns, bridges, inlays and onlays made of conventional porcelain, ceramic, hybrid ceramics, composite resin or metal
2. Cementation of metal cores, resin cores, metal posts or glass-fiber posts

CLEARFIL SA CEMENT is a dual-cure (light-and/or self-adhesive resin cement for conventional porcclain, ceramic, hybrid ceramics (e.g. ESTENIA C&B), composite resin and metal restorations. It is classified into dental cement (21 CFR section 872.3275, Product code: EMA ) according to 21 CFR § 872 since it is composed of various materials other than zinc oxide-eugenol. According to the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials", this device is classified into the following: Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present

Here's the analysis of the provided text regarding the acceptance criteria and study for the device:

Device: CLEARFIL SA CEMENT (Dental adhesive resin cement)
510(k) Number: K081583

This submission focuses on demonstrating substantial equivalence to predicate devices, rather than an independent clinical study to establish acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" discussed here are primarily compliance with an existing standard and comparative performance to predicates.

Acceptance Criteria and Reported Device Performance

Study Information:

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

   • The document does not explicitly state the sample size used for specific tests within ISO 4049: 2000 or for the comparative effectiveness study against MAXCEM.
   • Data provenance is not specified (e.g., country of origin, retrospective/prospective). Dental material testing standards like ISO 4049 typically involve in vitro laboratory tests.

2. 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 the studies described appear to be in vitro laboratory tests (compliance with ISO 4049) rather than studies requiring expert interpretation of clinical data or images.

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

   • This information is not applicable for in vitro laboratory tests.

4. 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 device is a dental cement, not an AI-assisted diagnostic tool.

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

   • Not applicable. This isn't an algorithm; it's a dental material.

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

   • For compliance with ISO 4049, the "ground truth" would be established by the measurement protocols and physical properties defined within the ISO standard itself, measured by laboratory equipment. For example, mechanical strength, film thickness, water sorption, solubility, etc.

7. The sample size for the training set:

   • Not applicable. This is a physical product, not an AI model requiring a training set.

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

   • Not applicable. (Same as above).

Summary of the "Study":

The "study" referenced in the 510(k) summary is primarily focused on demonstrating compliance with the international standard ISO 4049: 2000 ("Dentistry - Polymer-based filling, restorative and luting materials") for the physical and chemical properties of the dental cement. Additionally, a comparative evaluation against a predicate device (MAXCEM) was performed to show that both met the ISO standard, leading to the conclusion that the subject device is "effective as well as the predicate one." The primary evidence for substantial equivalence lies in the chemical composition being identical to or derived from predicate devices, and the material's physical properties meeting an established performance standard. No clinical trials or human-reader studies are mentioned or evidently required for this type of device and submission.

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1. Direct restorations for anterior and posterior teeth (Class I - V cavities)
2. Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
3. Intraoral repairs of fractured crowns/bridges

CLEARFIL MAJESTY Posterior PLT (PLT: Pre-loaded tip) is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. CLEARFIL MAJESTY Posterior PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.

CLEARFIL MAJESTY Posterior PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Posterior, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device, except for the color. The applicant device is substantially equivalent to the predicate devices.

This document is a 510(k) premarket notification for a dental restorative material, not a software or AI-powered device. Therefore, many of the requested elements for an AI/software device study are not applicable or present in this submission.

Based on the provided text, here's a breakdown of the acceptance criteria and the "study" (validation) for the device:

Acceptance Criteria and Reported Device Performance

Study Information (as applicable to this type of device submission):

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

  • This document does not describe a clinical study of the device that would involve a "test set" in the context of an AI/software device. The validation is primarily based on bench testing against an international standard (ISO 4049:2000) and a comparison of chemical compositions and intended uses to existing predicate devices.
  • No specific sample sizes for physical property testing (as would be done for ISO 4049) are provided in this summary.
  • No information on data provenance for testing is provided, beyond the standard itself being international.

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

  • Not applicable. Ground truth, in the context of this device, is adherence to a recognized international standard for dental materials and chemical composition.

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

  • Not applicable.

• 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 or imaging device.

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

  • Not applicable. This is not an algorithm.

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

  • The "ground truth" for demonstrating substantial equivalence is:
    • Compliance with ISO 4049:2000 for physical properties.
    • Identical chemical composition to a predicate device.
    • Similar intended uses to predicate devices.
    • Prior safe use of the chemical components in other legally marketed devices.

• The sample size for the training set:

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

• How the ground truth for the training set was established:

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

Key Takeaways from the 510(k) Summary:

The manufacturer is seeking Substantial Equivalence for a new form factor (pre-loaded tips) of an existing dental restorative material. The core of their argument is:

1. Chemical Identity: The new device has the exact same chemical composition as a previously cleared predicate device (CLEARFIL MAJESTY Posterior).
2. Performance Standard Compliance: Both the new device and a predicate device meet the requirements of the international standard ISO 4049:2000 for dental polymer-based restorative materials.
3. Use of Previous Components: The pre-loaded tips themselves are adopted from another existing predicate device (CLEARFIL AP-X PLT), with only a color change.
4. Identical Intended Uses: The indications for use are equivalent to the predicate devices.

This type of 510(k) relies heavily on demonstrating that the new device is fundamentally the same as a legally marketed predicate device, rather than requiring extensive new clinical trials or complex AI model validation.

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CLEARFIL MAJESTY Esthetic PLT is indicated for the following restorative applications:

• 1. Direct restorations for anterior and posterior teeth (Class I V cavities)
• 2. Direct veneers
• 3. Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
• 4. Intraoral repairs of fractured crowns/bridges

CLEARFIL MAJESTY Esthetic PLT (PLT: Pre-loaded tip) is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. CLEARFIL MAJESTY Esthetic PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.

CLEARFIL MAJESTY Esthetic PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Esthetic, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device. Therefore, the applicant device is substantially equivalent to the predicate devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CLEARFIL MAJESTY Esthetic PLT dental device:

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

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative acceptance criteria for this particular device's performance beyond compliance with a recognized standard.

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

The document does not specify a "test set" in the context of a clinical study or evaluation with human or patient data. The evaluation appears to be based on compliance with a standard (ISO 4049: 2000) and comparisons of material composition and physical properties to predicate devices. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a test set is not provided.

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 device's evaluation relies on compliance with an ISO standard and comparison to a predicate device, rather than a diagnostic performance study requiring expert ground truth establishment.

4. Adjudication method for the test set

This information is not provided as there is no described test set that requires 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

An MRMC comparative effectiveness study was not conducted. This device is a dental restorative material, not an AI-powered diagnostic tool, so this type of study is not applicable.

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

A standalone performance study of an algorithm was not done. This device is a dental restorative material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance, as implied by the document, is established through:

• Compliance with a recognized standard: ISO 4049: 2000 "Dentistry -Polymer-based filling, restorative and luting materials".
• Equivalence to existing predicate devices: Demonstrating that its chemical composition, intended uses, and performance characteristics (as defined by the ISO standard) are the same as or comparable to legally marketed devices.

8. The sample size for the training set

The concept of a "training set" is not applicable to this device. It is a physical dental material, not a machine learning model.

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

This question is not applicable as there is no training set for this device.

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Etching the enamel and dentine for adhesive restorations.

K-ETCHANT GEL is an etching agent consists of 40 % phosphoric acid aqueous solution and colloidal silica. It is classified into resin tooth honding agent, 21 CFR Section 872.3200, because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration.

This document is a 510(k) summary for K-ETCHANT GEL, an etching agent. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, most of the requested information cannot be found in the provided text.

Here is what can be extracted and what is not available:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary aims to demonstrate substantial equivalence, not to report specific performance metrics against pre-defined acceptance criteria from a study.

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. The document mentions K-ETCHANT GEL has been a component of CLEARFIL PHOTO BOND and is now being marketed independently. It asserts that the applicant device is "essentially the same" as the K-ETCHANT GEL in CLEARFIL PHOTO BOND, implying prior established safety and effectiveness. No new test set data is presented for the independent 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 provided. As no specific test set study is detailed, there's no mention of experts or ground truth establishment in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 information is not applicable/not provided. The device is an etching agent, not an AI-powered diagnostic tool, so an MRMC study or AI assistance is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a chemical etching agent, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.

8. The sample size for the training set
This information is not applicable/not provided. The device is a chemical product, not a system that uses a training set for machine learning.

9. How the ground truth for the training set was established
This information is not applicable/not provided.

Summary based on the provided text:

The document is a 510(k) summary for K-ETCHANT GEL, an etching agent composed of 40% phosphoric acid aqueous solution and colloidal silica.

Overall Study Information:
The "study" presented is not a new clinical performance study but rather a demonstration of substantial equivalence to existing legally marketed predicate devices. The primary assertion is that K-ETCHANT GEL, when marketed independently, is essentially the same as its previous formulation within the CLEARFIL PHOTO BOND system and shares the same intended use.

Predicate Devices:

• CLEARFIL PHOTO BOND (510(k) Numbers: K943165, K012432 (modification))
• PULPDENT ETCH-RITE ROYALE (510(k) Number: K031915)

Claim of Substantial Equivalence:
The applicant states that the safety and effectiveness of the independent K-ETCHANT GEL are substantially equivalent to the K-ETCHANT GEL component in CLEARFIL PHOTO BOND and to other single-item etching agents like PULPDENT ETCH-RITE ROYALE. This means the existing evidence for the predicate devices and the prior use of K-ETCHANT GEL within CLEARFIL PHOTO BOND are being leveraged to support its independent marketing. No new clinical or performance data against specific acceptance criteria for the standalone device are detailed in this summary.

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1. Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin
2. Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin

CLEARFIL CERAMIC PRIMER is a silane-coupling agent that provides an enhanced adhesive surface to porcelain, ceramics, hybrid ceramics or composite resin.

The provided text describes a 510(k) submission for the "CLEARFIL CERAMIC PRIMER" device, which is a silane-coupling agent. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for a detailed AI/ML device study.

Instead, the core of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as devices already on the market, rather than meeting specific quantifiable performance benchmarks like sensitivity/specificity for a diagnostic AI.

Here's an analysis based on the provided text, highlighting what is and is not present:

Key Takeaways from the document:

• The device is a silane-coupling agent intended to enhance the adhesive surface for dental materials (porcelain, ceramics, hybrid ceramics, composite resin) and for intraoral repairs.
• Substantial Equivalence: The primary method for proving the device's acceptability is through its similarity to predicate devices.
• Performance Data: The document mentions "Tensile bond strength tests on the applicant device in comparison to the predicate devices" as evidence of effectiveness/performance. This is the only direct performance study mentioned, but no specific acceptance criteria or detailed results are provided.

Analysis against the Requested Information:

Since the provided document is a 510(k) summary focused on substantial equivalence rather than a detailed performance study with explicit acceptance criteria for an AI/ML device, much of the requested information (especially regarding AI-specific details like sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable or not present.

Here's a breakdown based on the categories you requested, with responses tailored to the information available:

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

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

   • Sample Size: Not specified. The document only mentions "Tensile bond strength tests" without details on the number of samples, replicates, or cases.
   • Data Provenance: Not specified. The manufacturer is KURARAY MEDICAL INC., located in Japan. The tests were likely conducted internally or by a contracted lab, but the location and whether the data is retrospective or prospective are not mentioned.

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

   • Not Applicable / Not Present: This device is a chemical primer, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" here would be the measured physical properties (e.g., tensile bond strength), not an expert consensus on an image or clinical case.

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

   • Not Applicable / Not Present: As this is not an AI/ML diagnostic or interpretive device, adjudication methods for expert disagreement are irrelevant to the tensile bond strength testing mentioned.

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 / Not Present: This is not an AI-assisted device. Therefore, no MRMC study or analysis of human reader improvement with AI assistance was conducted or is relevant.

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

   • Not Applicable / Not Present: This is not an AI algorithm; it's a dental material.

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

   • Ground Truth Type: For the "Tensile bond strength tests," the "ground truth" would be the quantifiable physical measurement of the bond strength itself, obtained through laboratory testing. This is not subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

   • Not Applicable / Not Present: This device is not an AI/ML algorithm that requires a "training set."

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

   • Not Applicable / Not Present: No training set exists for this type of device.

In summary: The provided document is a 510(k) summary for substantial equivalence of a dental primer, not a detailed technical report for an AI/ML device. Therefore, the information regarding specific acceptance criteria, detailed study design, sample sizes for training/test sets, expert involvement, and AI-specific performance metrics is largely absent or not applicable. The basis for acceptance is a qualitative assertion of "as well as or better than" predicate devices concerning chemical ingredients and tensile bond strength performance.

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