(111 days)
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.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.