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For relining denture surfaces, to repair a fractured denture, or to form a new denture base.

The product is a chairside denture relining material for relining, repairing and rebasing removable dentures. It is substantially equivalent to the company's Tokuso Rebase (K896981). The product is offered in two versions of differing in curing time; i.e., Fast and Normal. The product complies with ADAS No. 17 and has been approved for marketing by the Japanese Ministry of Health and Welfare.

The provided text describes a 510(k) submission for a dental device, "Tokuyama Rebase II," but it does not contain any information regarding acceptance criteria, device performance, a study, or any of the specific details requested in your prompt (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

This document is a regulatory submission for a dental relining material, primarily focused on establishing substantial equivalence to a legally marketed predicate device (Tokuso Rebase K896981) and its conformity to ADAS No. 17 standards. It lists the device's intended use and contraindications, but it does not include performance data or a study report in the format you've requested.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number or qualifications of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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For use as a dental cement for adhesion and fixation between tooth and prosthesis, tooth and tooth, and between two or more prostheses.

The product is a self cured adhesive resin cement.

The provided text is a 510(k) summary for a dental adhesive resin cement called "Tokuyama M-Bond." This type of document is for regulatory clearance of a medical device and does not contain details about acceptance criteria or specific studies to prove performance in the way a clinical trial report would.

The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than detailed performance studies against specific acceptance criteria. The information provided is insufficient to populate the requested table and study details.

Here's why and what information is available:

Why the requested information is absent:

• Nature of 510(k) Summary: A 510(k) summary (like Exhibit D) is a brief overview submitted to the FDA to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. It doesn't typically include detailed clinical study protocols, results, acceptance criteria, or ground truth methodologies that would be found in a full clinical trial report or a performance study to establish specific diagnostic or therapeutic efficacy.
• Device Type: Tokuyama M-Bond is a dental adhesive resin cement. Its performance is generally assessed through in vitro (laboratory) tests measuring bond strength, setting time, solubility, and biocompatibility, as well as in vivo (clinical) observation of retention and marginal integrity over time. The concept of "acceptance criteria" and "ground truth" as applied to diagnostic algorithms is not directly applicable here.
• Focus on Substantial Equivalence: The document explicitly states, "It is substantially equivalent to various marketed dental cement products." The regulatory approval is based on this equivalence, not on specific performance metrics that would be validated in a prospective study with blinded readers, ground truth established by experts, etc., as typically done for AI/diagnostic devices.

Information that is available from the text:

• Device Name: Tokuyama M-Bond
• Intended Use: "For use as a dental cement for adhesion and fixation between tooth and prosthesis, tooth and tooth, and between two or more prostheses." Clinical applications include cementation of inlays, onlays, crowns, metal posts and cores.
• Predicate Devices (mentioning substantial equivalence):
  • Bistite II SC (Tokuyama) - K991711
  • C&B Metabond (Parkhill) - K960464
  • Panavia 21 (Kurarey) - K933030
• Contraindications: Hypersensitivity to methacrylate monomers. Avoid contact with skin, mucosal membrane, eyes, or clothing.
• Regulatory Class: II
• Product Code: EMA

Conclusion:

Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets them in the format requested. The document is a 510(k) summary, which is a regulatory submission for substantial equivalence, not a detailed performance study report. The questions about sample size, data provenance, number of experts, adjudication methods, multi-reader comparative effectiveness studies, standalone performance, types of ground truth, and training set details are not addressed in this type of filing for a dental cement.

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For use as a dental cement in various applications, including luting, repair of fractured bridge resins, cementation of adhesive bridge prostheses and CR core posts.

The product is a dental cement which can be either light cured or self cured.

The provided text is a 510(k) Pre-Market Notification for a dental cement (Bistite II DC). It outlines the intended use, safety information, and substantial equivalence to other marketed devices. However, the document does not contain the results of a study demonstrating that the device meets specific acceptance criteria.

The 510(k) summary (Exhibit D) and the FDA's response letter (Pages 1 & 2) primarily focus on:

• Device Description: What the device is (a dental cement), its intended use (luting, repair of fractured bridges, etc.), and user (dental practitioners).
• Substantial Equivalence: Listing predicate devices to which Bistite II DC is claimed to be substantially equivalent (Bistite II SC, Panavia 21, C&B Metabond).
• Safety Information: Contraindications and precautions.
• Regulatory Classification: The FDA confirms the device's classification (Class II, Product Code EMA, Regulation Number 872.3275).

Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment because this data is not present in the provided text.

To answer your request, a document detailing performance testing, clinical studies, or engineering bench testing with defined acceptance criteria and their outcomes would be necessary.

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For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth and for sealing of exposed cervical dentin and root surfaces.

The product is a resin tooth bonding agent for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth and for sealing of exposed cervical dentin and root surfaces.

The provided text describes a 510(k) submission for a dental bonding agent, Tokuyama America - One-Up-Bond F. This document is a regulatory submission to the FDA, not a study report detailing clinical performance or acceptance criteria of an AI device. The information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, and specific study designs (MRMC, standalone), are typically found in detailed clinical or analytical validation studies for software or AI medical devices.

The text does not contain any information about:

• Acceptance criteria for performance metrics.
• Reported device performance (e.g., sensitivity, specificity, accuracy).
• Any study (clinical or otherwise) that proves the device meets specific acceptance criteria based on performance metrics.
• Sample sizes for test or training sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies.
• AI components or standalone algorithm performance.
• How ground truth was established.

Instead, the document focuses on:

• Device Description: A resin tooth bonding agent for use with light-cured composite resins to enhance bonding and seal exposed dentin/root surfaces.
• Intended Use: For use by dental practitioners in general dentistry, not OTC.
• Regulatory Equivalence: Stating that the product is substantially equivalent to various marketed bonding agents, including Tokuyama's Tokuso Mac Bond II (K980058), and has received Japanese Government approval.
• FDA Clearance: An FDA letter granting 510(k) clearance based on substantial equivalence to a predicate device, allowing it to be marketed.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert details, or study designs, as this information is not present in the provided text. The document pertains to a traditional medical device (a dental material) and its regulatory clearance process, not an AI/software as a medical device (SaMD) that would typically involve the types of performance validation studies described in the prompt.

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For use as a dental cement in various applications, including luting, repair of fractured porcelains or crown and bridge resins, cementaiton of adhesive bridge prostheses and CR core posts.

The product is a self curing dental cement for use in the cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges and CR core posts.

The provided text is a 510(k) summary for a dental cement called Bistite II SC. It outlines the product's intended use, substantial equivalence to other marketed devices, and regulatory approval. However, it does not contain any information about acceptance criteria, device performance metrics, or the details of a study that would demonstrate the device meets such criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

The document primarily focuses on:

• Product Identification: Bistite II SC, a self-curing dental cement.
• Intended Use: Cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges, and CR core posts.
• Regulatory Status: Substantially equivalent to previously marketed dental cement products (Panavia 21, Panavia EX, C&B Metabond).
• Contraindications and Warnings: Hypersensitivity to methacrylate monomers, avoid contact with skin/eyes.
• Regulatory Approval: Received approval from the Japanese Government and FDA 510(k) clearance.

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For use as a denture reliner

The product is a denture relining resin material for use in relining the tissue contact surface of dentures. It is not intended for over-the-counter (OTC) use. It contains materials that are common in dental use and pose no health hazard when used according to directions.

I am sorry, but the provided text does not contain information about the acceptance criteria or any study that proves a device meets such criteria. The document is a 510(k) summary for a denture relining resin material (Tokuyama SOFRELINING) and a letter from the FDA determining substantial equivalence to predicate devices. It discusses the device's classification, indications for use, and regulatory compliance but does not detail performance acceptance criteria or specific studies beyond referencing the 510(k) notification.

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For use in dental procedures as a resin filling material

The product is a tooth shade resin material for use in dental restorations. It consists of the company's Tokuyama's Mac Bond II bonding agent and Palfique Estelite Paste.

Mac Bond II is a tooth enamel/dentin bonding resin for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth. It may be used in anterior and posterior applications. After mixing and applying the primer and allowing it to dry, as directed, the bonding agent is applied to the whole cavity preparation. After air drying, the bonding agent is cured with currently marketed visible light curing devices.

After curing, restoration is completed with Palfique Estelite Paste or other composite resin brands.

The provided text is a 510(k) summary for the Tokuso Mac Bond II and Palfique Estelite, and the FDA's response regarding its substantial equivalence. This type of document, particularly from 1998, focuses on demonstrating equivalence to predicate devices based on material composition and intended use, rather than rigorous performance studies with detailed acceptance criteria as one might find for a more complex medical device in a modern submission.

Therefore, the requested information regarding acceptance criteria, specific study details (sample sizes, expert adjudication, MRMC, standalone performance), and ground truth establishment is largely not present in the provided text. The document primarily attests to the device's composition and intended use being similar to existing, legally marketed devices.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in the document. For a 510(k) of this nature in 1998, the primary "acceptance criterion" was demonstrating substantial equivalence to predicate devices in terms of materials, intended use, and safety, rather than specific performance metrics like accuracy or sensitivity.
• Reported Device Performance: Not detailed in terms of quantitative metrics. The document states that the product is "a tooth shade resin material for use in dental restorations" and "Mac Bond II is a tooth enamel/dentin bonding resin... to enhance the bonding of these materials to the tooth." This implies performance related to bonding and restorative function, but no specific data or metrics are provided.

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

• Not Applicable/Not Provided. The document does not describe a "test set" in the context of evaluating performance metrics with a specific sample size. The evaluation for this 510(k) was based on comparison to predicate devices, not a clinical trial with a defined test set of patients or samples.

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

• Not Applicable/Not Provided. The concept of "ground truth" established by experts for a test set is not present in this document, as it's not a study evaluating diagnostic or prognostic accuracy.

4. Adjudication method for the test set:

• Not Applicable/Not Provided. No test set or adjudication method is described.

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 a dental material, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant here.

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

• No. This is a dental material, not an algorithm.

7. The type of ground truth used:

• Not Applicable/Not Provided. The concept of "ground truth" as typically used in performance studies (e.g., pathology, outcomes data) is not relevant for this type of device and submission. The "truth" being established here is that the device is substantially equivalent to existing, legally marketed dental materials based on its composition and stated intended use.

8. The sample size for the training set:

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

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

• Not Applicable/Not Provided. As there is no training set.

Summary of available information from the text:

• Device Name: Tokuso Mac Bond II (bonding agent) and Palfique Estelite (composite resin paste)
• Intended Use: Tooth shade resin material for use in dental restorations; Mac Bond II enhances bonding of light-cured composite resins to enamel/dentin.
• Predicate Devices: Palfique Estelite, Scotchbond Multipurpose Adhesive, 3M Brand Restorative Z-100, Clearfil A P-X & Liner Bond II. This comparison forms the basis of the "study" for substantial equivalence.
• Safety Information: Contra-indicated for patients hypersensitive to methacrylate monomers; should not contact skin or eyes; not for OTC use.

The document represents an older style of 510(k) submission for a relatively low-risk device (dental restorative material), where the focus was heavily on chemical composition, material properties (implied by comparison to predicates), and intended use rather than detailed clinical performance studies with quantitative metrics.

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For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth

The product is a tooth enamel/dentin bonding resin for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth. It may be used in anterior and posterior applications. After mixing and applying the primer and allowing it to dry, as directed, the bonding agent is applied to the whole cavity preparation. After air drying, the bonding agent is cured with currently marketed visible light curing devices.

This document is a 510(k) premarket notification for a dental bonding agent, Tokuso Mac Bond II. It confirms the device's substantial equivalence to previously marketed devices and permits its market entry. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text lacks this specific data.

The document primarily focuses on:

• Device Identification: Tokuso Mac Bond II, a resin tooth bonding agent.
• Intended Use: As a bonding primer with light-cured resin filling material to enhance adhesion to the tooth in dental procedures (anterior and posterior applications).
• Predicate Devices: Tokuso Light Bond, Scotchbond Adhesive System, Clearfil Liner Bond 2.
• Regulatory Information: Classified as Class II, Product Code EBF.
• Safety Information: Contains common dental materials, contraindicated for methacrylate monomer hypersensitivity, precautions for skin/eye contact, and flammability.

To answer your specific questions, information from a different part of the 510(k) submission (e.g., performance data, bench testing results, clinical study reports) would be necessary.

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