The provided document is a 510(k) premarket notification for a dental composite restorative material named "Prestige." It does not describe an AI/ML-driven device or study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment for such a device is not applicable to this document.

The document discusses the "Prestige" dental composite restorative material and its substantial equivalence to a predicate device (Herculite XR & XRV). It focuses on non-clinical performance testing for material properties.

However, I can extract the relevant information from the document that pertains to the non-clinical performance testing conducted for the "Prestige" device to demonstrate substantial equivalence.

Here's the information that can be extracted, interpreted in the context of material performance rather than AI/ML algorithms:

1. A table of acceptance criteria and the reported device performance

The document states that the substantial equivalence is supported by "Physical and Mechanical Properties performance testing." While explicit acceptance criteria values are not given in this summary, the reported performance is that the Prestige™ device "has the same performance and technological characteristics" as the predicate device, and that bench testing indicates its suitability for the intended purpose. The overall acceptance criterion for the 510(k) submission is to demonstrate substantial equivalence to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Device performance is substantially equivalent to predicate.	"Results of our bench testing indicate that Prestige™ has the same performance and technological characteristics [as the predicate]." "The substantial equivalence or suitability to the intended purpose of Prestige™ has been demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices currently on the market." "The differences between the subject device and the predicate device do not affect substantial equivalence, or raise different questions of substantial equivalence."
Performance of specific physical and mechanical properties.	Testing was performed for: Flexural Strength, Depth of Cure, Sensitivity to Ambient Light, Diametral Strength, Water Sorption, Shade and Color Stability, Radiopacity. (Specific quantitative results or direct comparisons to predicate values are not provided in this summary, but the general conclusion is equivalence).
Functions of chemicals and components are identified and similar.	"Chemicals, function of each component of the product are identified." (Implied similarity to predicate)
Indications for Use are similar.	Stated as similar and shown in a table where both "Prestige™" and "Herculite XR & XRV" are described as "a dental composite restorative material designed to be used in all classes of cavities."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided summary. The non-clinical testing refers to "in-house testing" and "side-by-side comparisons" but does not give specific numbers of samples or units tested for each property (e.g., number of specimens for flexural strength).
Data Provenance: The testing was conducted as "in-house testing" by Danville Materials LLC, located in San Ramon, California, USA. The data would be prospective in relation to the submission, as it was generated specifically to support the 510(k) application.

3. 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)

This is not applicable as the document describes a dental restorative material, not an AI/ML device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" for this device would be the objective measurements of its material properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the document describes a dental restorative material, not an AI/ML device requiring adjudication of human interpretations.

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

This is not applicable as the document describes a dental restorative material, not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the document describes a dental restorative material, not an AI/ML device. The "standalone" performance here would refer to the intrinsic material properties measured in a lab, which are described as being tested.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be the objective, empirically measured physical and mechanical properties of the material itself (e.g., actual flexural strength values, depth of cure measurements, radiopacity readings, etc.) using established testing standards and methodologies for dental materials.

8. The sample size for the training set

This is not applicable as the document describes a dental restorative material, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the document describes a dental restorative material, not an AI/ML device that requires a training set and associated ground truth.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 21,2015

Danville Materials LLC Dong Hua Regulatory Affair Director 3420 Fostoria Way Suite A-200 San Ramon, California 94583

Re: K151514

Trade/Device Name: Prestige Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 18, 2015 Received: June 23, 2015

Dear Dong Hua:

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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, 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)

Device Name

Prestige

Indications for Use (Describe)

Prestige is a dental composite restorative matieral designed to be used in all classes of cavities

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image is a logo for Danville Engineering & Materials. The logo features a blue square with a stylized image of a light source emitting rays. To the right of the square is the company name, "Danville," in a bold, sans-serif font, with the words "ENGINEERING & MATERIALS" in a smaller font underneath.

3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA

007_ 510(K) Summary

This summary of the Traditional 510(K) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92

Applicant's Name and Address A.

A Name: Danville Materials LLC
A Address: 3420 Fostoria Way Suite A-200 San Roman, CA 94583 USA
A Contact Person: Dong Hua
A Title: Regulatory Affair Director and QA Manager
800-827-7940/925-973-0710. Ext. 212 Phone:
Fax: 925-973-0764
A Date Summary Prepared: May 26, 2015

B. The Name of the Device:

Trade/Proprietary Name: Prestige™ A
The common name of the device: Tooth Shade Resin Material A
A The Classification Name: Material, Tooth Shade, Resin per 21 CFR 872.3690
A Product Code EBF has been classified as a Class II device

C. Legally Marketed Predicate Device to Which Substantial Equivalence (SE) is claimed:

K943642 Herculite XR & XRV By Sybron Dental Specialties, Inc A

D. Description of the Device:

Indication For Use: Indication For Use: Prestige™ is a dental composite restorative A material designed to be used in all classes of cavities
Intended Use of the Device: Prestige™ is a light-cured, Nanohybrid dental A restorative material intended for use for the restoration in all classes of cavities

E. A comparison between the Herculite XR & XRV by Sybron Dental Specialties, Inc and Prestige™ by Danville Materials to determine SE:

The equivalence to the predicate device is supported by the Physical and Mechanical Properties performance testing
Chemicals, function of each component of the product are identified
Similarities in the Indications for Use:

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Image /page/4/Picture/0 description: The image contains the logo for Danville Engineering & Materials. The logo features a blue square with a stylized design inside, resembling a light source with rays emanating from it. To the right of the square is the company name "Danville" in a bold, sans-serif font, with the words "ENGINEERING & MATERIALS" in a smaller font size underneath.

www.danvillematerials.com

3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA

Product	510(K) Number	Classification Name	Indications For Use
Herculite XR & XRV By Sybron Dental Specialties, Inc	K943642	Tooth Shade Resin Material	dental composite restorative material designed to be used in all classes of cavities
PrestigeTM	New	Tooth Shade Resin Material	PrestigeTM is a dental composite restorative material designed to be used in all classes of cavities

A Discussion of Non-Clinical and Clinical tests performed for determination of Substantial Equivalence:
Prestige™ is a resin based material that is light cured, the same as used by our predicates, Herculite XR & XRV By Sybron Dental Specialties, Inc (K943642). These materials have been widely used by numerous manufacturers in the medical/dental industry.

Non-Clinical Testing performed on Prestige™ included the followings:

Flexural Strength
· Depth of Cure
Sensitivity to Ambient Light
Diametral Strength
Water Sorption
Shade and Color Stability
Radiopacity

The substantial equivalence or suitability to the intended purpose of Prestige™ has been demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices currently on the market. Results of our bench testing indicate that Prestige™ has the same performance and technological characteristics.

Summary of the differences between the subject and the predicate devices

Three main differences between Prestige™ and Herculite XR & XRV are:

Increased radiopacity
· Different initiating
Decreased film thickness

Conclusion: F.

Our records indicate that our predicates have been used by dentists and large group practices in the United States and purchased by a large number of international distributors.

In conclusion, the differences between the subject device and the predicate device do not affect substantial equivalence, or raise different questions of substantial

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Image /page/5/Picture/0 description: The image contains the logo for Danville Engineering & Materials. The logo features a blue square with a white design inside, followed by the word "Danville" in large, bold, black letters. Below "Danville" is the text "ENGINEERING & MATERIALS" in smaller, black letters.

www.danvillematerials.com

3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA

equivalence. The subject device, Prestige™ has been designed and manufactured with the intended use and claims for the product in mind. Prestige™ is substantially equivalent to the predicate device and may be released to the market.

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.