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.

AI/ML Overview

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.

Summary

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510(k) SUMMARY

JAN 2 3 2003

DENSFLY

NAME & ADDRESS:

est College Avenue PA 17405-087

P. J. Lehn Telefax (717) 849-4343

P. Jeffery Lehn CONTACT:

November 11, 2002 DATE PREPARED:

TRADE OR PROPRIETARY NAME: XENO® III DENTAL ADHESIVE

CLA SSIFICATION NAME: Resin tooth bonding agent (872.3200)

Prime & Bond™ NTTM Nano-Technology PREDICATE DEVICES: K982394 Light Cured Dental Adhesive

XENO® III DENTAL ADHESIVE is a single step self-etching DE'/ICE DESCRIPTION: den al adhesive designed to bond direct light-cured composite restorative materials to enamel and dentin.

INTENDED USE: XENO® III DENTAL ADHESIVE is indicated as a dental adhesive for dire ct light-cured composite restorative materials.

TE CHNCLOGICAL CHARACTERISTICS: All of the components found in XENO® III DENTAL ADHESIVE have been used in marketed devices or have been found to be safe for der tal use.

XE NO® III DENTAL ADHESIVE was evaluated for biocompatibility and found acceptable.

W : believe that the prior use of the components of XENO® III DENTAL ADHESIVE in legally mr rketed devices, the biocompatibility data provided, and the performance data provided support the safety and effectiveness of XENO® III DENTAL ADHESIVE for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

JAN 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

·Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17404

Re: K023776

Trade/Device Name: Xeno III Dental Adhesive Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 11, 2002 Received: November 12, 2002

Dear Mr. Lehn:

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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lehn

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runoey

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

51C(K) Number (if known): K₀ 23 7.76

XENO® III DENTAL ADHESIVE Device Name:

Indications for Use:

Dental adhesive for direct light-cured composite restorative materials

(P) EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Kevin Mulvey for MSR

nesthesiology, General Hospital, Infection Control, Dental D

510(k) Number.________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.