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Use for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to:

• Dentin and enamel
• Porcelain
• Metal
• Composite

Peak TM SE Bonding System is a syringe delivered self-etching primer component of the PeakTM Resin Bonding System.

The provided document is a 510(k) premarket notification for a dental bonding system called Peak™ SE. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on testing. However, the document does not include detailed acceptance criteria or a study write-up with specific performance metrics, sample sizes, or ground truth establishment relevant to the format requested in the prompt.

The document states: "All of our testing concluded that Peak™ SE has met or exceeded our testing expectations." but does not provide the specifics of these expectations or the results. Therefore, I cannot generate the requested table and detailed study information.

Here's an explanation of what can be extracted and what is missing based on your and the prompt's requirements:

Information Present in the Document:

• Device Name: Peak™ SE
• Intended Use: For use in most light-accessible bonding procedures in both the anterior and posterior, with Peak™ Bond Adhesive for dentin, enamel, porcelain, and composite bonding.
• Legally Marketed Predicate Devices: PermaQuick™ SE Bonding System (Ultradent Products, Inc.) and Clearfil SE Bond (Kuraray America Inc.).
• Testing Performed (General Categories): Intended Use, Description, Biocompatibility and Safety, Properties, Ease of Use, Ingredients, Radiopacity, Shrinkage, and Bond Strength.
• Conclusion of Testing: Peak™ SE "met or exceeded our testing expectations" and is "substantially equivalent" to predicate devices.
• Regulatory Classification: Class II, Resin Tooth Bonding Agent.

Information NOT Present in the Document (and therefore cannot be provided in the requested format):

1. Detailed Acceptance Criteria and Reported Device Performance (Table): The document generally states that "testing concluded that Peak™ SE has met or exceeded our testing expectations" but does not specify what those expectations (acceptance criteria) were or the actual numerical results (reported device performance) for any of the categories (e.g., specific bond strength values, shrinkage percentages, radiopacity standards).
2. Sample Sizes Used for the Test Set: Not mentioned.
3. Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned.
4. Number of Experts Used to Establish the Ground Truth and Qualifications: Not applicable as it's a materials science/engineering test, not an AI diagnostic device.
5. Adjudication Method: Not applicable.
6. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable (this is not an AI diagnostic device).
7. Standalone Performance (algorithm only without human-in-the-loop performance): Not applicable.
8. Type of Ground Truth Used: The testing involved physical/chemical properties of a bonding agent, likely measured against established material standards (e.g., ISO standards for dental materials). The document doesn't specify these standards.
9. Sample Size for the Training Set: Not applicable as this is not an AI/machine learning device that uses a "training set." The testing described is for a physical product, not a model.
10. How the Ground Truth for the Training Set Was Established: Not applicable.

Summary of Device Performance (Based on available qualitative statements):

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

Note: The document only provides qualitative statements ("met or exceeded our testing expectations") and does not specify the quantitative acceptance criteria or the numerical performance results for these categories.

2. Sample sized used for the test set and the data provenance: Not specified in the document. The testing was conducted by the manufacturer, Ultradent Products, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; this is a materials test, not an expert-based diagnostic assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a dental material, the "ground truth" would typically be established by objective physical and chemical testing methods (e.g., mechanical testing standards for bond strength, material composition analysis, radiopacity measurement against a standard) rather than expert consensus on diagnostic images or pathology. The specific standards or methods are not detailed in this summary.

8. The sample size for the training set: Not applicable; this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

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