Here's a summary of the acceptance criteria and the study details for the 3M ESPE Filtek™ Supreme Ultra Universal Restorative, based on the provided text:

Device: Filtek™ Supreme Ultra Universal Restorative

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for each physical property. Instead, it indicates that the new device's performance was compared to a predicate device (3M™ ESPETM HAUR) to establish substantial equivalence. The "reported device performance" is essentially that the new device performed comparably or acceptably against the predicate in these properties.

Property Evaluated	Acceptance Criteria (Implied)	Reported Device Performance
Compressive strength	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Diametral Tensile Strength	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Flexural strength	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Flexural Modulus	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Surface hardness	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Radio-opacity	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Water Sorption	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Water Solubility	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Polish Retention	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Fluorescence	Substantially equivalent to predicate device 3M™ ESPETM HAUR.	Data from bench testing shows performance comparable to the predicate.
Biocompatibility	Safe for intended use based on standard risk assessment techniques and FDA/international guidelines.	Concluded to be safe for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

The document states that data included "bench testing to evaluate the performance." However:

Sample Size: The specific sample sizes for each bench test are not mentioned in the provided text.
Data Provenance: The provenance is bench testing, which implies controlled laboratory conditions. There is no information regarding country of origin, nor whether it was retrospective or prospective, as these terms are generally not applicable to bench testing of material properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: This information is not applicable as the study described is bench testing of physical properties, not a clinical study involving human interpretation or expert ground truth for medical imaging/diagnosis.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable for this type of bench testing. Adjudication methods like 2+1 or 3+1 are used for clinical trials where multiple experts assess cases and resolve discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images with and without AI assistance). The provided study is bench testing of material properties.
Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Not applicable. This concept applies to AI algorithms operating independently to produce a diagnostic output. The described study evaluates the physical properties of a dental restorative material through bench testing.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this study comes from objective measurements of the physical properties (e.g., strength, hardness, radio-opacity) of the material as determined by standardized laboratory bench tests. The performance of the new device was compared against a legally marketed predicate device, implying that the predicate's established performance served as a benchmark for "acceptable" property values.

8. Sample Size for the Training Set

Sample Size: This information is not applicable. The device is a dental restorative material and its evaluation involved bench testing of its physical properties, not machine learning or AI models that require training sets.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable as there is no training set for this type of device evaluation.

Summary

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3M ESPE

K083610

510(k) Summary 5.

3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110

DEC 1 7 2008

3M ESPE

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

510(k) Submitter................................	3M Company3M ESPE Dental Products3M Center, Bldg. 275-2W-08St. Paul, MN 55144-1000 USAEstablishment Registration Number2110898
Contact person................................	Scott EricksonRegulatory Affairs SpecialistPhone: (651) 736-9883Fax: (651) 736-1599sterickson@mmm.com
Date Summary was Prepared.........	12/05/2008
Trade Name................................	FiltekTM Supreme Ultra UniversalRestorative
Common Name(s).........................	Tooth shade resin material
Recommended Classification........	Tooth shade resin material(21 CFR 872.3690,Product Code: EBF)

Predicate Devices: 3M™ ESPE™ HAUR

Description of Device: Filtek™ Supreme Ultra Universal Restorative is a visible-light activated, radiopaque, restorative composite.

Filtek™ Supreme Ultra Universal Restorative 510(k)

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3M ESPE

Indications for Use:

· Direct anterior and posterior restorations (including occlusal surfaces)
· Core Build-ups
· Splinting
· Indirect restorations including inlays, onlays and veneers

Substantial Equivalence:

Information provided in this 510(k) submission shows that Filtek TM Supreme Ultra Universal Restorative is substantially equivalent to the predicate device 3M™ ESPETM HAUR in terms of intended use, indications for use, composition, physical properties and technological characteristics. A biocompatibility assessment was developed for FiltekTM Supreme Ultra Universal Restorative using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines. The conclusion of the assessment is that Filtek™ Supreme Ultra Universal Restorative is safe for its intended use.

This 510(k) submission includes data from bench testing to evaluate the performance of Filtek™ Supreme Ultra Universal Restorative compared to predicate device 3MTM ESPETM HAUR. The properties evaluated include Compressive strength, Diametral Tensile Strength, Flexural strength, Flexural Modulus, Surface hardness, Radio-opacity, Water Sorption, Water Solubility, Polish Retention and Fluorescence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott Erickson Regulatory Affairs Specialist 3M Company 3M ESPE Dental Products 3M Center, Building 275-2W-08 St. Paul, Minnesota 55144-1000

DEC 1 7 2008

Re: K083610

Trade/Device Name: Filtek™ Supreme Ultra Universal Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 5, 2008 Received: December 8, 2008

Dear Mr. Erickson:

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. Erickson

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snjite H. Michie Dmd

Chiu S. Lin. Ph. D Division 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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3M ESPE

Indications for Use Statement 4.

Indications for Use

1.683610 510(k) Number (if known):

Device Name: Filtek™ Supreme Ultra Universal Restorative

Indications for Use:

· Direct anterior and posterior restorations (including occlusal surfaces)
Core Build-ups
· Splinting
· Indirect restorations including inlays, onlays and veneers

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) 1000 Kunte

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

Page _ of _

510(k) Number: K053610

Filtek™ Supreme Ultra Universal Restorative 510(k)

Page 13 of 262

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.