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CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations

CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations

Here's an analysis of the provided text regarding the acceptance criteria and study for the CERCOM Cement device, based on the information available in the 510(k) submission:

Key Takeaway: The K083398 submission for CERCOM Cement is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria for a novel device. Therefore, much of the requested information regarding specific performance studies, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The FDA's 510(k) clearance process for CERCOM Cement is based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This means that the acceptance criteria are not specific performance metrics against a predefined threshold, but rather a demonstration that the new device is as safe and effective as the predicate devices, and does not raise new questions of safety and effectiveness.

Study Details (Where Applicable for a 510(k) Submission)

Given that this is a 510(k) submission based on substantial equivalence, the following points address the questions in that context:

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

• Not applicable for a performance study. The submission does not describe a "test set" in the context of a prospective clinical study or a retrospective data analysis designed to measure performance against specific metrics. The "testing" involved would primarily be bench testing to confirm material properties and mechanical performance, and potentially comparison of properties to predicate devices, but without specific clinical test sets often associated with AI/software devices. The document does not provide details on such bench tests or data provenance.

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

• Not applicable. There is no "test set" and thus no ground truth established by experts in the context of evaluating device performance for this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable. No test set requiring expert adjudication is described.

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 device is a dental cement, not an AI software or diagnostic imaging device that would involve human readers or AI assistance.

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

• Not applicable. This device is a physical dental cement, not an algorithm.

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

• Not applicable. For a material device like dental cement in a 510(k), "ground truth" typically refers to established material science properties (e.g., bond strength, solubility, cure time) that are compared against industry standards or the properties of predicate devices. The document does not detail specific "ground truth" methodologies beyond stating equivalence to predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an algorithm or AI device.

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

• Not applicable. There is no "training set" or explicit ground truth establishment described for this type of device submission.

Summary of the 510(k) Approach for CERCOM Cement:

The 510(k) for CERCOM Cement follows a common path for medical devices, particularly those that are materials or instruments with well-understood mechanisms of action. Instead of presenting new clinical performance studies, the manufacturer (Denali R&D Corporation) demonstrates that CERCOM Cement is "substantially equivalent" to several already-cleared predicate devices (RelyX Cement, Variolink Cement, Calibra Cement, Nexus Cement) in terms of:

• Design: How it's formulated or structured.
• Composition: The components it's made from.
• Intended Use: The purpose for which it's marketed (bonding ceramic and composite restorations).
• Effectiveness: Its ability to achieve its intended purpose.
• Performance: Its functional characteristics.

The FDA's review confirms that this claim of substantial equivalence is valid, implying that the safety and effectiveness of CERCOM Cement are comparable to those established for the predicate devices. The absence of detailed clinical study data, expert panels, or AI-related metrics is therefore expected and appropriate for this type of submission.

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