The provided text is a 510(k) Summary for a dental restorative material, "XP Composite." It describes the device, its intended use, and its substantial equivalence to a predicate device, Tetric EvoCeram. This document does NOT contain information about an AI/ML-based medical device study, nor does it provide details about acceptance criteria and performance data in the context of an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size
If a standalone (algorithm only) performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

The document focuses on the physical and chemical characteristics, intended use, and non-clinical performance data (e.g., compressive strength, water sorption) of a dental composite material to demonstrate substantial equivalence to a predicate device, as required for a 510(k) submission. It's a traditional medical device clearance, not an AI/ML device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 3, 2019

S&C Polymer Silicon- und Composite Spezialitaeten GmbH Christian Boettcher Offical Correspondent to FDA, Reg. Compliance Officer Robert-Bosch-Str. 2 Elmshorn, 25335 GERMANY

Re: K182780

Trade/Device Name: XP Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: April 4, 2019 Received: April 8, 2019

Dear Christian Boettcher:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

{1}------------------------------------------------

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K182780

Device Name

XP Composite

Indications for Use (Describe)

Restoration of deciduous teeth
Posterior restorations (class I and II)
Anterior restorations (class III and IV)
Class V restorations
Veneering of discoloured anterior teeth
Splinting of mobile teeth
Extended fissure sealing in molars and premolars
Repair of composite and ceramic veneers

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the pata needed annound the and review the collection of information. Send comments regarding this burden estimate or any other only other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

510(k) Summary

K182780

Submitter

Name of Company:	S&C Polymer Silicon- und Composite Spezialitaeten GmbH
Address:	Robert-Bosch-Strasse 2, D-25335 Elmshorn (Germany)
Phone:	0049 4121 483 0
Fax:	0049 4121 483 184
Contact Person:	Dr. Christian Boettcher
Date of Preparation:	01. April 2019
Device Name:
Trade Name:	XP Composite
Common Name:	Dental restorative material

Classification Name: Material, Tooth Shade, Resin, per 21CFR § 872.3690 Classification: ll Product Code: EBF

Devices for which Substantial Equivalence is Claimed:

Tetric EvoCeram (Ivoclar Vivadent), K042819

Device Description:

"XP Composite" is a light cure composite.

Intended Use of the Devices:

"XP Composite" as well as "Tetric EvoCeram" (Ivoclar Vivadent) are light cure resin based dental restorative materials.

Indication for Use of the Devices:

The indications for use of "XP Composite" as well as "Tetric EvoCeram" (Ivoclar Vivadent) are identical and are as follows:

	Subject DeviceXP Composite	Predicate DeviceTetric EvoCeram
Restoration of deciduous teeth	yes	yes
Posterior restorations (class I and II)	yes	yes
Anterior restorations (class III, IV)	yes	yes
Class V restorations	yes	yes
Veneering of discoloured anterior teeth	yes	yes
Splinting of mobile teeth	yes	yes
Extended fissure sealing in molars and premolars	yes	yes
Repair of composite and ceramic veneers	yes	yes

{4}------------------------------------------------

Performance Data:

Non-clinical performance data for this device included the following: compressive strength, working time, consistency and radiopacity.

Testing also included water sorption, water solubility, flexural strength and depth of cure were all tested according to ISO 4049.

Technological Characteristics:

	Subject device	Predicate device
	XP Composite	Tetric EvoCeram
Appearance	paste	paste
Form of delivery	black syringeapplication tips	black syringeapplication tips
Method of polymerization	light cure	light cure
Application	extrusion via pressure(onto the back of the syringeresp. onto the back of the tip)followed by application	extrusion via pressure(onto the back of the syringeresp. onto the back of the tip)followed by application
Ingredients (general description)	methacrylate-based resinsphoto initiatorsfillerspigments	methacrylate-based resinsphoto initiatorsfillerspigments
Mechanism of Action	applicationlight curing	applicationlight curing

Conclusion:

In regard to the intended use, the indication for use, the target population, the anatomical sites, the design, the performance, the standards to be met, the materials, and the biocompatibility the product of this submission is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.