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Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.

The subject device is a self-etch adhesive resin cement in a catalyst/base paste formulation and is a dual cure luting agent. Due to its self-etching and adhering properties, Cement-It All Purpose does not require the use of an etchant, primer or adhesive. Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Cement-It All Purpose is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.

This exemption refers to a 510(k) premarket notification for a dental cement product. For such submissions, the acceptance criteria are generally established through a comparison to a legally marketed predicate device, demonstrating substantial equivalence rather than through a standalone study with specific performance metrics and acceptance criteria.

Therefore, the provided documents do not contain the typical information one would find for a study that proves a device meets specific, quantitative acceptance criteria through a clinical or performance study with statistical endpoints. Instead, the "study" demonstrating performance is the comparison to a predicate device, supported by laboratory testing to ensure physical and chemical properties are comparable and safe.

Here's an analysis based on the provided text, outlining what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document focuses on substantial equivalence rather than meeting specific quantitative acceptance criteria like those found in a clinical trial. The "acceptance criteria" here are implicitly that the new device performs "the same intended function" and has similar "safety and effectiveness" as the predicate device.

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

The document does not specify a sample size for a "test set" in the context of a clinical performance study. The evaluation for 510(k) clearance is primarily a comparison to a predicate device, often involving:

• Bench testing: To compare physical, chemical, and mechanical properties (e.g., bond strength, radiopacity, wear resistance, setting time). Sample sizes for these tests would be determined by standard test methods but are not provided.
• Biocompatibility testing: To ensure safety.

The data provenance is not explicitly stated as retrospective or prospective for a clinical study, as a full clinical study with human subjects requiring such categorization is typically not performed for dental cements seeking 510(k) clearance if substantial equivalence can be demonstrated through other means. The data would be generated from laboratory/bench testing and possibly literature reviews comparing the new device's properties to the predicate.

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 for this type of submission. "Ground truth" established by experts is typically relevant for diagnostic devices or AI-driven systems where human interpretation is a key component of performance. For a dental cement, "ground truth" would relate to its physical and chemical properties and its clinical performance as a bonding agent, which is assessed through standardized laboratory tests and comparison to established predicate devices.

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

This information is not applicable and not provided. Adjudication methods are relevant in studies where human readers/experts are evaluating outcomes or interpretations (e.g., radiology studies). For a dental cement, performance is assessed via objective measurements from laboratory tests.

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

This information is not applicable. This is a dental cement, not an AI-driven diagnostic or treatment planning system. Therefore, MRMC studies and "human readers improve with AI" are irrelevant to this device.

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

This information is not applicable. This is a physical dental cement product, not an algorithm or software. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence for this dental cement would be based on:

• Laboratory test results: Objective measurements of physical, chemical, and mechanical properties (e.g., flexural strength, compressive strength, wear characteristics, radiopacity, bond strength, setting time) compliant with relevant ISO or ADA standards.
• Biocompatibility testing: To ensure the material is non-toxic and compatible with the human body.
• Comparison to predicate device: The established performance and safety profile of the legally marketed predicate device (MaxCem, K041474).

8. The sample size for the training set

This information is not applicable. "Training set" refers to data used to train machine learning models. This is a physical dental cement, not an AI model.

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

This information is not applicable for the same reasons as point 8.

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