Peak® Z is a single component surface treatment that enhances bond values when applied to zirconia, alumina, and metal/alloys. It contains 12methacryloyIdoeceylphosphate (MDP), which produces a chemical bond that significantly increases adhesion between a resin-based material and the bonding surface of the restoration. Peak® Zr Primer can be applied through a syringe delivery or brush and bottle. Peak® Z is supplied in a pre-mixed syringe for easy delivery and no waste, and also in bottles with brushes that can be directly applied to surfaces.

AI/ML Overview

I am sorry, but I cannot provide a detailed analysis of acceptance criteria, study design, and results based on the provided text. The document is a 510(k) summary for a dental bonding agent (Peak® Z) and focuses on establishing substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report from the R&D and clinical phases.

Here's a breakdown of why the requested information cannot be fully extracted and what can be inferred:

Key Missing Information for a Comprehensive Answer:

Explicit Acceptance Criteria: The document mentions "acceptance criteria" generally but does not list specific quantitative or qualitative acceptance criteria that the device must meet in the same format as the table requested.
Detailed Study Results (Quantitative): While it mentions "bench tests" and "literature review," it does not provide the actual raw data, statistical analysis, or performance metrics (e.g., specific bond strength values with standard deviations, p-values, or confidence intervals). It only states that Peak® Z "performs as well or better than the predicate device."
Test Set/Training Set Details: There is no mention of distinct test sets or training sets, as the studies described are bench tests comparing the new device to a predicate and a literature review.
Expert Details, Adjudication, MRMC, Standalone Performance: These concepts are typically relevant for AI/ML-based diagnostic devices, which is not the nature of this dental bonding agent. Therefore, this information is not present.
Ground Truth Definition and Establishment: For bench tests, the "ground truth" is the measured physical property (e.g., shear bond strength). For the literature review, it's about established safety and efficacy from existing products, not a directly established "ground truth" on a new dataset.

What can be extracted or reasonably inferred from the text regarding the provided questions:

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

Acceptance Criteria (Inferred)	Reported Device Performance
Shear Bond Strength: Comparable or superior to predicate device (K091705 Prime Plus) for various surfaces (Zirconia, Aluminum oxide, Metal/Alloy, Titanium), under normal and artificial aging conditions.	Peak® Z "performs as well or better than the predicate device" in shear bond tests.
Biocompatibility: Meets ISO 10993 standards for Cytotoxicity, Sensitization, Irritation, and Genotoxicity.	Peak® Z "was tested for biocompatibility in Cytotoxicity, Sensitization and Genotoxicity tests according to ISO 10993-1." (Implicitly passed, as it received clearance).
Stability: Function of product does not degrade under normal and accelerated conditions.	Material "tested at various data points to verify that the function of the product did not degrade under normal and accelerated conditions." (Implicitly passed).
Safety and Effectiveness: Demonstrable safety and effectiveness for intended use.	Supported by "literature study to show safety and effectiveness" and "bench testing indicates that Peak® Z performs as well or better than the predicate device."

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 for Bench Tests: Not explicitly stated. The document only mentions "various surfaces" for shear bond tests.
Data Provenance: "In-vitro test," "in-house testing," and comparison to a "predicate device currently on the market." This suggests laboratory-based testing, likely conducted by the applicant (Ultradent Products, Inc.) or contracted labs. The literature review provides "safety and effectiveness of this product," which would be based on existing published studies. This would be prospective for the bench tests (new measurements) and retrospective for the literature review (using existing data).
Country of Origin: Implied to be the US, as the applicant is a US company (South Jordan, UT) and the submission is to the FDA.

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

Not applicable as this is not an AI/ML diagnostic device requiring expert interpretation of results for ground truth. For the bench tests, "ground truth" is established by direct physical measurement (e.g., bond strength).

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

Not applicable for this type of device and 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 not an AI-assisted diagnostic or interpretive device.

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

Not applicable. This is a physical product (dental bonding agent), not an algorithm.

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

For Shear Bond Strength tests: The ground truth is the measured bond strength (quantitative physical characteristic).
For Biocompatibility tests: The ground truth is determined by the results of standardized ISO 10993 tests (e.g., cell viability for cytotoxicity, skin reaction for sensitization).
For Stability tests: The ground truth is the measured performance/functionality over time under different conditions.
For overall safety and effectiveness: This was supported by a literature review, relying on previously established scientific and clinical evidence for similar products.

8. The sample size for the training set

Not applicable. The document describes bench testing and a literature review for substantial equivalence, not the training of an algorithm or model.

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

Not applicable (as above).

Summary

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Section 5 Traditional 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

Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095

SEP 06 2013

Contact Person: Title: Telephone: FAX: Date Summary Prepared: Diane Rogers Manager of Regulatory and Global Affairs (800) 552-5512 x4491, (801) 553-4491 (801) 553-4609 May 10, 2013

Name of the Device

Trade Name:	Peak® Z
Common Name:	Resin tooth bonding agent
Device Classification:	Class II
Classification Product Code:	KLE

Legally Marketed Predicate Devices to Which Equivalence is Claimed

The predicate device is: K091705 Prime Plus (Z Prime Plus) by Bisco Inc. located at 1100 W. Irving Park Road, Schaumburg IL 60193.

Peak® Z is very similar to our predicate device in that both devices are intended to be used as resin tooth bonding agents.

Indications for Use: Peak® Z is intended for use as a surface treatment for restorations made of the following materials:

Zirconia .
Aluminum oxide �
Metal/Alloy .
Titanium �

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Product Description: Peak® Z is a single component surface treatment that enhances bond values when applied to zirconia, alumina, and metal/alloys. It contains 12methacryloyIdoeceylphosphate (MDP), which produces a chemical bond that significantly increases adhesion between a resin-based material and the bonding surface of the restoration. Peak® Zr Primer can be applied through a syringe delivery or brush and bottle.

Technological characteristics

Product	510(k) Number	Indications for Use
Peak® Z		Peak® Z is intended for use as a surface treatment for restorations made of the following materials:Zirconia Aluminum oxide Metal/Alloy Titanium
Primer plus ( Z-Prime)	K091705	The principal uses of the Primer Plus are:1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics)2. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, or composite resin).
Characteristics	Surface treatment to enhancerestorations and repairs	Surface treatment to enhancerestorations and repairs
Human Factors	Syringe delivery or brush andbottle	Brush and bottle

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Biocompatibility	ISO 10993	ISO 10993
	Cytotoxicity	Cytotoxicity
	Sensitization	Sensitization
	Irritation	Irritation
	Genotoxicity	Genotoxicity

Peak® Z is supplied in a pre-mixed syringe for easy delivery and no waste, and also in bottles with brushes that can be directly applied to surfaces.

Primer plus is supplied in single bottles that can be directly applied to surfaces.

The patient population is intended for all ages that need a restoration or repair as prescribed by a dentist. The device is a primer that is intended to prepare surface treatments of restorations and repairs.

Brief Description of Testing Performed

The following bench tests were conducted during the R & D phase on Peak ® Z and compared to K091705 Primer Plus) by Bisco Inc. Final test results are in Section 18 "Bench Testing".

Shear bond: This in-vitro test determines how well the material enhances the bonding to various surfaces compared to both the Bisco's system and the Ultradent system without a primer. This shows whether or not a primer is needed and if the R&D formulation, Peak® Z, (PAZR41) is comparable to a product that is currently on the market and is well-received.

Shear bond with artificial aging and conditions: This in-vitro test artificially replicates a possible extreme condition that may occur in the clinical setting. This will indicate whether or not the material is robust enough compared to a product currently on the market.

Stability: The material was tested at various data points to verify that the function of the product did not degrade under normal and accelerated conditions.

Clinical Summary

A complete Clinical Summary of Peak® Z is included in Section 20: We conducted a literature study to show safety and effectiveness of this product can be used on any age patient when treatment is prescribed by a dentist. The device has the same technological characteristics compared to K091705 Primer Plus (Z Prime Plus) by Bisco inc.

Primer Plus has been widely used by numerous dentists in the dental industry.

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The efficacy or suitability to the intended purpose of Peak® Z has been demonstrated by a combination of in-house testing and side-by-side comparisons to a predicate device currently on the market. Results of our bench testing indicates that Peak® Z performs as well or better than the predicate device currently on the market.

Summary Risk/Benefit Review

Considering the safe history of our predicate, K091705 Primer Plus (Z Prime Plus) by Bisco Inc., Peak® Z is substantially equivalent and considered to be a safe medical device. Our research indicates that our predicate has been used by many dentists and large group practices in the United States and purchased by a large number of international distributors. To date, there have been no reported complaints of local or systemic adverse effects associated with the use of the predicate product.

Peak® Z was tested for biocompatibility in Cytotoxicity, Sensitization and Genotoxicity tests according to ISO 10993-1. An abstract of the testing along with signed test reports are included in Section 15 "Biocompatibility" of this submission.

In conclusion, Peak® Z has been designed and manufactured with the intended use and claims for the product in mind. Scientific literature, etc. has been collected and evaluated to determine safety and efficacy of similar products used for the same indication. Following the clinical review as documented above, Ultradent Products, Inc. deems that when this device is used under the conditions and for the purposes intended, it will not compromise the clinical condition or the safety of the patient and the association with its use constitutes acceptable risks when weighed against to the patient. Therefore, the product is compatible with a high level of protection of health and safety and may be released to the market.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

September 6, 2013

Ultradent Products, Incorporated Ms. Diane Rogers Manager of Regulatory and Globel Affairs 505 West 10200 South SOUTH JORDAN UT 84095

Re: K131357

Trade/Device Name: PEAK® Z Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 6, 2013 Received: June 10, 2013

Dear Ms. Rogers:

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. Rogers

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/Resourcesfor You/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/ReportalProblem/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.

Image /page/5/Picture/7 description: The image shows the name "Mary S. Runner - S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a signature or label. The letters are clearly legible, with consistent spacing between the words and initials.

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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Statement of Indications for Use

K131357 510(k) Number (if known): __

Device Name: Peak® Z

Indications for Use:

Peak® Z is intended for use as a surface treatment for restorations made of the following materials:

Zirconia .
Aluminum oxide .
Metal/Alloy �
. Titanium

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)

Page 1 of 1

Andrew I. Steen -S 2013.09.06 09:32:53 -04'00'

. '

(Posted November 13, 2003)

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

10(k) Number: K13357

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.