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This device is a one step no-mix adhesive for direct bonding of orthodontic bracket to tooth structure

The DMRC Self-Cure Bracket Adhesive One Step and Primer is a resin based adhesive designed for direct bonding of orthodontic brackets with no-mix step.

The document describes the DMRC Self-Cure Bracket Adhesive One Step and Primer and its substantial equivalence to a predicate device based on non-clinical testing.

Here's the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative sense with pass/fail thresholds. Instead, it presents the results of bench testing for the DMRC Self-Cure Bracket Adhesive One Step and Primer alongside the predicate device's performance to demonstrate "equivalence." The implied acceptance criterion is that the new device's performance is comparable to or better than the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes (e.g., number of specimens tested) for the Vicker's Hardness, Shear Bond Strength, or Self-Cure Set Time tests. It also does not explicitly mention the country of origin of the data or whether the data was retrospective or prospective. These were non-clinical bench tests, not human studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. The "test set" here refers to non-clinical bench tests on materials, not a set of clinical cases requiring expert interpretation.

4. Adjudication Method for the Test Set:

Not applicable for non-clinical bench tests. The results are quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This product is a dental adhesive, and the evaluation was based on non-clinical material properties.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is the quantitative measurement obtained through standardized laboratory testing procedures for properties like Vicker's Hardness, Shear Bond Strength, and Self-Cure Set Time.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI/machine learning device.

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DMRC Dual Cure Orthodontic Band Cement is a dual-cure adhesive intended for use as an orthodontic band cement for bonding of orthodontic bands to enamel

DMRC Dual Cure Orthodontic Band Cement is a resin based material containing a dual-cure adhesive for cementation of orthodontic bands. The DMRC Dual Cure Orthodontic Band Cement is a polymer based filling and restorative material; it contains a base and catalyst for dual curing process as orthodontic band cement.

The provided text is related to a 510(k) premarket notification for a dental adhesive device, DMRC Dual Cure Orthodontic Band Cement. This type of document is for regulatory clearance of a medical device and thus does not include information on acceptance criteria for software, detailed clinical study designs, or AI performance metrics.

Therefore, I cannot provide the requested information for the following reasons:

1. The document is not about AI software or a device that uses AI. It concerns a dental adhesive for orthodontic bands, which is a physical material, not a digital diagnostic or treatment support tool.
2. The document does not detail acceptance criteria for software performance. The "acceptance criteria" mentioned in the context of the device are for its physical properties and biocompatibility, not for accuracy, sensitivity, or specificity of an algorithm.
3. No study is mentioned that proves the device meets AI-specific acceptance criteria. The "studies" mentioned are non-clinical bench tests (Vickers Hardness, Ultradent Bracket Shear Bond Strength, Work and Set times, ISO 10993 cytotoxicity) to demonstrate performance comparable to a predicate device. These are standard for material-based medical devices.
4. There is no mention of sample sizes for test sets, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone algorithm performance, or training set details, as these are all relevant to AI/software performance evaluation, which is not applicable to this device submission.

In summary, the provided text does not contain any information relevant to the acceptance criteria or study design for an AI-powered medical device.

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