The provided text describes a 510(k) submission for a dental composite material named Meridian. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel performance against specific acceptance criteria using clinical studies with complex statistical methodologies often seen for other types of medical devices.

Therefore, many of the requested sections are not applicable to this type of device and submission. Based on the provided information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are defined by the performance standards outlined in ISO 4049:2009 for polymer-based dental restorative materials, and the "reported device performance" demonstrates that Meridian meets these standards and is substantially equivalent to the predicate device (Tetric EvoCeram, K042819).

Acceptance Criteria (ISO 4049:2009 Performance Parameters)	Reported Device Performance (Meridian)	Study Proving Acceptance
Water Absorption	Meets ISO 4049:2009 standards	Testing Summary states: "The device was tested in accordance with ISO 4049:2009 for Polymer based dental restorative materials for Water Absorption, Water solubility, Radiopacity, Flexural Strength, Depth of Cure. Modulus of Elasticity, and Compressive Strength and the results from testing demonstrates that Meridian is substantially equivalent to the predicate device."
Water Solubility	Meets ISO 4049:2009 standards
Radiopacity	Meets ISO 4049:2009 standards
Flexural Strength	Meets ISO 4049:2009 standards
Depth of Cure	Meets ISO 4049:2009 standards
Modulus of Elasticity	Meets ISO 4049:2009 standards
Compressive Strength	Meets ISO 4049:2009 standards
Biocompatibility	Meets ISO 10993 standards	Testing Summary states: "Biocompatibility testing and evaluation was also carried out according to ISO 10993."

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the in vitro tests conducted according to ISO 4049:2009 and ISO 10993. These are laboratory-based material tests, not clinical studies involving patient data. Therefore, concepts like "country of origin of the data" or "retrospective or prospective" are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this device is based on standardized laboratory testing protocols (ISO 4049:2009, ISO 10993), not on expert consensus or clinical interpretation.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpretation of results, typically involving human readers. This device underwent in vitro material testing.

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 composite material, not an AI-powered diagnostic device. No MRMC studies were performed.

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

Not applicable. This is a material, not an algorithm.

7. The type of ground truth used

The ground truth used for this device is the physical and chemical properties of the material as measured by standardized, objective laboratory tests defined by international standards (ISO 4049:2009 for performance, ISO 10993 for biocompatibility). The comparison is against the predicate device, showing "substantial equivalence" based on these measurements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "training" for this device involved meeting established material standards.

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

Not applicable. As above, this is not an AI/ML device.

Summary

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K131753

510(K) SUMMA

Meridian

Contact:	Donna Marie Hartnett
Company:	Ardent, Inc. 175 Pineview Drive, Amherst, NY 14228(716) 691-0010
Date Prepared:	June 13, 2013
Proprietary Name:	Meridian
Classification Name:	Material, Tooth Shade, Resin (872.3690)
Predicate Devices:	Tetric EvoCeram (K042819)

Meridian is a light curing universal dental composite material of the Device Description: latest nanohybrid type having an optimized chemical composition.

The predicate device to which Meridian has been compared is Tetric EvoCeram (K042819). For this application. Tetric EvoCeram has been compared to its predicate with regard to chemical composition, performance data and indications for use. The comparison shows that Meridian is substantially equivalent to the predicate device.

Intended Use: Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.

Technological Characteristics: The device design, i.e. delivery form, and intended use of Meridian and the predicate device are the same. The composition of the subject device has been modified from the predicate, however, there are no ingredients in the subject device which pose any new issues of safety and effectiveness.

Guidance Document: The submission was prepared in accordance with FDA Guidance document entitled Dental Composite Resin Devices - Premarket Notification (510K) Submissions dated October 26, 2005.

Testing Summary: The device was tested in accordance with ISO 4049:2009 for Polymer based dental restorative materials for Water Absorption, Water solubility, Radiopacity, Flexural Strength, Depth of Cure. Modulus of Elasticity, and Compressive Strength and the results from testing demonstrates that Meridian is substantially equivalent to the predicate device. Biocompatibility testing and evaluation was also carried out according to ISO 10993.

Conclusion: Meridian is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 14, 2013

AB Ardent C/O Ms. Donna Marie Hartnett Director Quality Assurance/Regulatory Affairs 175 Pineview Drive AMHERST NY 14228

Re: K131753

Trade/Device Name: MERIDIAN Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 3, 2013 Received: September 5, 2013

Dear Ms Hartnett:

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.

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Page 2 - Ms. Hartnett

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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): K134753

Device Name: MERIDIAN

Indications For Use:

Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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) Page 1 of 1

Andrew I. Steen -S 2013.11.14 08:21:40 -05'00'

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.