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Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure.

Peak Universal Bond adhesive bonds to the following materials:

• · Dentin and Enamel
• · Porcelain, Zirconia
• Metal
• · Composite

Peak™M Universal Bond is a bottle, syringe, or unit dose delivered bonding resin. It can be used with selfetch or with total etch techniques. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Peak Universal Bond adhesive contains 0.2% chlorhexidine which may ensure long term bond strengths. Its mode of action produces a mechanical occlusion of dentin tubules by the resins, thus reducing tooth hypersensitivity.

This is a 510(k) premarket notification for a resin tooth bonding agent, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for AI/ML performance is not found in this document.

The document discusses the substantial equivalence of the "Peak Universal Bond" device to a predicate device, focusing on its physical properties, technological characteristics, and indications for use in dentistry. It references non-clinical testing performed to establish this equivalence, specifically to ISO standards for bonding agents.

Here's why the requested information cannot be provided from this document:

• No AI/ML Component: The device, Peak Universal Bond, is a traditional medical device (a resin tooth bonding agent). It does not involve artificial intelligence or machine learning for diagnosis, prognosis, or treatment.
• Non-Clinical Testing: The "study" mentioned is "verification and validation testing" to show substantial equivalence. This involves testing physical properties according to ISO standards (e.g., ISO 29022 for shear bond strength, SEM imaging for dentinal tubule blockage) and simulated use by dental professionals. This is not a clinical study in the typical sense for AI/ML performance, nor does it generate the metrics you've requested.

Therefore, the specific points of inquiry about acceptance criteria, device performance, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable and not present in this regulatory submission for a conventional dental bonding agent.

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Use for virtually all etching and bonding needs in restorative dentistry for dental patients of all ages. Peak™ Universal Bond bonds to the following materials: Dentin and enamel, Porcelain, Metal, Composite.

Peak™ Universal Bond is a single syringe delivered resin bond. It can be used with Peak™ SE or with a total etch. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Chlorhexidine is used to ensure long term bond strengths.

The provided text describes a Traditional 510(k) premarket summary for Peak™ Universal Bond, a dental resin bond. It outlines the device, its intended use, comparison to predicate devices, and a brief description of the testing performed.

However, the document does not contain a table of acceptance criteria or detailed study results with specific performance metrics and sample sizes that would allow for a comprehensive description as requested. The text only states that "The test data shows that Peak™ Universal Bond has higher shear bond strengths than Peak™ Bond, which was superior to its predicates when tested in (K063557) and NexTemp." without providing the actual values or the specific criteria against which these strengths were judged.

Therefore, many of the requested items cannot be answered definitively from the provided text. Below is an attempt to extract what is available and identify what is missing.

Acceptance Criteria and Device Performance Study for Peak™ Universal Bond

The document provided does not contain a specific table of acceptance criteria or detailed numerical device performance against those criteria. It broadly states that the device demonstrated "higher shear bond strengths."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It implies the testing was performed by Ultradent Products, Inc.

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

This information is not applicable and not provided. The "ground truth" in this context would likely refer to the actual bond strength measurements from laboratory testing, not expert consensus on an image or clinical assessment.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods are typically relevant for human-interpreted data (e.g., medical images).

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is meant for evaluating diagnostic devices where human readers interpret cases, often with and without AI assistance. This document describes a dental bonding agent, and the testing focuses on material properties like bond strength and stability.

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

This question is not applicable to a dental bonding agent, as it is a material, not a software algorithm. The "standalone" performance refers to the inherent physical and chemical properties of the bond itself.

7. The type of ground truth used

The ground truth for the test results (shear bond strength) would be the laboratory measurements obtained from destructive mechanical testing of the bonded specimens.

8. The sample size for the training set

This question is not applicable as the device is a material, not an AI/ML algorithm that requires a training set.

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

This question is not applicable for the reasons stated above.

Summary of Study Described:

The study involved repeating "the exact same testing as was performed on Peak™ Bond (K063557)." This included testing the bond strength of Peak™ Universal Bond compared to Peak™ LC and NexTemp, using both a Total Etch system and a Self Etch System. Additionally, all three products were subjected to thermal cycling, and bond strength parameters were re-tested. The document states that the test data showed Peak™ Universal Bond to have higher shear bond strengths than Peak™ Bond, which was superior to its predicates when previously tested. Stability testing was also conducted, indicating an 18-month shelf life. The specifics of how many samples were tested in each condition, the exact values of the bond strengths, or the methods used to measure them are not detailed in this summary.

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