(72 days)
XENO® III DENTAL ADHESIVE is indicated as a dental adhesive for dire ct light-cured composite restorative materials.
XENO® III DENTAL ADHESIVE is a single step self-etching den al adhesive designed to bond direct light-cured composite restorative materials to enamel and dentin.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Xeno® III Dental Adhesive:
It's important to note that this document is a 510(k) summary for a dental adhesive, not for an AI/ML powered medical device. Therefore, many of the typical questions for an AI/ML device study will not be applicable. The information provided focuses on material safety and equivalence to predicate devices, rather than diagnostic performance or efficacy studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Device components must be found acceptable. | XENO® III DENTAL ADHESIVE was evaluated for biocompatibility and found acceptable. |
| Prior Use of Components: Components must have been used in legally marketed devices or found safe for dental use. | All components found in XENO® III DENTAL ADHESIVE have been used in marketed devices or have been found to be safe for dental use. |
| Safety and Effectiveness: Data must support the safety and effectiveness for indicated uses. | The prior use of the components, biocompatibility data, and performance data support the safety and effectiveness of XENO® III DENTAL ADHESIVE for the indicated uses. (No specific performance metrics are provided in this summary, but the claim implies adequate performance for its intended purpose as an adhesive). |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of an AI/ML diagnostic or predictive device. The evaluation of XENO® III Dental Adhesive appears to be based on:
- Material composition review: Ensuring components have a history of safe use.
- Biocompatibility testing: This typically involves in-vitro and/or in-vivo studies according to ISO standards, but specific sample sizes of test materials or animal subjects are not detailed in this summary.
- Performance data: While mentioned, specific performance metrics or studies directly comparing its adhesive properties against a "test set" with quantitative results are not provided in this 510(k) summary. The focus is on substantial equivalence to predicate devices.
Therefore, "sample size used for the test set" and "data provenance" as understood for an AI/ML device are not applicable to this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. This is a material science and safety submission, not a diagnostic or classification device requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not Applicable. There is no "test set" in the context of a diagnostic evaluation requiring 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
Not Applicable. This is a dental adhesive, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. There is no algorithm to evaluate.
7. The Type of Ground Truth Used
The "ground truth" here is established primarily by:
- Regulatory standards and existing scientific literature: For the safety of the components and biocompatibility.
- Predicate device performance: The basis for substantial equivalence is that the new device performs as intended, similar to legally marketed predicate devices. The "performance data" mentioned would likely demonstrate this through standard dental material tests (e.g., bond strength, fluoride release, wear resistance, etc.), but those specific results are not included in this summary.
8. The Sample Size for the Training Set
Not Applicable. There is no training set for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no training set for an AI/ML algorithm.
Summary of Device and Acceptance Criteria (Based on Provided Text):
The XENO® III DENTAL ADHESIVE is a single-step self-etching dental adhesive indicated for bonding direct light-cured composite restorative materials to enamel and dentin.
The acceptance criteria for its clearance appear to be based on:
- Biocompatibility: The device must be biocompatible.
- Component Safety: All components must have a history of safe use in marketed devices or be otherwise proven safe for dental use.
- Performance and Equivalence: The device's performance data, alongside biocompatibility and component safety, must support its safety and effectiveness for its intended use, demonstrating substantial equivalence to predicate devices (Prime & Bond™ NT™ Nano-Technology Light Cured Dental Adhesive K982394).
The study that "proves" the device meets these criteria is not detailed within this 510(k) summary itself, other than stating that the device "was evaluated for biocompatibility and found acceptable" and that "performance data provided support the safety and effectiveness." This implies that DENTSPLY International conducted the necessary biocompatibility tests and performance tests (likely bench tests related to bond strength, etc.) to satisfy these criteria, and presented this data to the FDA in the full 510(k) submission, which is not fully included here. The summary focuses on the conclusion of these evaluations rather than the methodology or specific results.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.