Direct anterior restorations including: Class III, IV, V and VI Veneers Incisal edge repair - Direct posterior restorations including: Class I or II or V Sandwich technique with glass ionomer resin material Cusp buildups - Core buildups - Splinting . - Indirect anterior and posterior restorations including: . Inlays Onlays Veneers

Device Description

Hermes is a one component dental filling composite. Hermes uses different monomer chemistry and a different polymerization mechanism than most filling composites which are currently commercially available. Based on its particular chemistry, Hermes reveals considerably low shrinkage properties.

AI/ML Overview

The provided document is a 510(k) Summary of Safety and Effectiveness for a dental device called "Hermes," a tooth shade resin material. It is a premarket notification for a Class II device. The document states that the device is substantially equivalent to predicate devices based on performance data and indications for use.

However, the document does not contain any information about acceptance criteria or a specific study proving the device meets acceptance criteria in the format of a clinical study assessing algorithm performance, which is what your query implies.

Instead, it's a regulatory submission demonstrating substantial equivalence to already approved predicate devices. It states that "Biocompatibility testing for Hermes provides evidence that the device is safe for its intended use." And "In summary, it can be concluded that safety and effectiveness requirements for Hermes are completely met."

Therefore, based on the provided text:

A table of acceptance criteria and the reported device performance: Not provided in the context of an algorithm's performance. The document focuses on demonstrating substantial equivalence to predicate dental restorative materials, implying that "acceptance criteria" are met if it performs similarly or equivalently to established devices for its intended use.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of regulatory submission. There is no "test set" in the context of validating an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no ground truth established by experts for a test set in this document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 document is about a dental restorative material, not an AI or imaging device with human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of an algorithm's performance. The "ground truth" for this device's performance is likely measured against established standards for dental materials (e.g., shrinkage, strength, wear resistance), usually through laboratory or in-vitro tests, and clinical performance as observed over time, but these details are not provided here.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided 510(k) summary is for a dental restorative material and does not describe a study involving acceptance criteria and performance metrics for an AI/algorithm-based device as implied by your detailed request. It confirms that the device meets safety and effectiveness requirements, primarily through biocompatibility testing and comparison to predicate devices, rather than through an algorithm performance study.

Summary

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Image /page/0/Picture/1 description: The image shows the date December 22, 2003. The text is written in a simple, sans-serif font. The date is written in the standard month-day-year format. The text is black and the background is white.

FEB 2 4 2004

K03346

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter

Company:	3M ESPE AG
Street:	ESPE Platz
ZIP-Code, City:	D-82229 Seefeld
Federal State:	Bavaria
Country:	Germany
Establishment Registration Number	9611385
Official Correspondent:	Dr. Andreas Petermann,Manager U.S. Regulatory Affairs
Phone:	011-49-8152-700 1395
Fax:	011-49-8152-700 1869
E-mail:	Andreas.Petermann@mmm.com
Date:	December 22, 2003
Name of Device
Proprietary Name:	Hermes
Classification Name:	Tooth Shade Resin Material
Common Name:	Epoxy-Based Universal Restorative,Resin-Based Filling Material
Predicate Devices
3M ESPE HAUR by 3M ESPE	K 010781
Tetric Ceram by Vivadent	K 964285
AH Plus by Dentsply	K 960548
Pertac II by ESPE	K 962440

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Description for the Premarket Notification

Hermes is classified as Tooth Shade Resin Material because it is a device intended to restore carious lesions or structural defects in teeth. Tooth Shade Resin Matcrial is designated at 21 C.F.R. § 872.3690 as a Class II device.

Based on its particular chemistry, Hermes reveals considerably low shrinkage properties. Thus, Hermes may lead to significant advantages in the dental office such as reduced stress to cavity walls. On the other hand, the clinician can fill the cavity in much larger increments (layers) in one stcp compared to methacrylate based composites leading to time savings and reduced stress for the patient.

Comparison to the predicate devices for performance data and indications for use shows that Hermes is substantially equivalent to the predicate devices.

Biocompatibility testing for Hermes provides evidence that the device is safe for its intended use.

In summary, it can be concluded that safety and effectiveness requirements for Hermes are completely met.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circular seal. The eagle is depicted with three stylized lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2004

Dr. Andreas Petermann Manager, U.S. Regulatory Affairs 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY

Re: K033996

Trade/Device Name: Hermes Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF Dated: December 22, 2003 Received: December 24, 2003

Dear Dr. Petermann:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your because to the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreasary of the Medical Device Amendments, or to devices that provision in May 20, 1970, in clarge with the provisions of the Federal Food, Drug, and Cosmetic nave occh tectasion of 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 thereone, manker the device, dables requirements for annual registration, listing of devices, good controls provisions of alleding, and prohibitions against misbranding and adulteration.

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

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Page 2 - Dr. Andreas Petermann

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) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,

Clues

Chiu S. Lin, PhD 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

510(k) Number (if known):

Hermes

Device Name:

Indications For Use:

Direct anterior restorations including: . Class III, IV, V and VI Veneers Incisal edge repair

Direct posterior restorations including: ● Class I or II or V Sandwich technique with glass ionomer resin material Cusp buildups
Core buildups ●
Splinting .
Indirect anterior and posterior restorations including: . Inlays Onlays Veneers

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

{PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rump

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Page 1 of I

510(k) Number. K033996

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.