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510(k) Data Aggregation
(15 days)
Cementation of temporary and provisional restoration such as crowns, bridges, inlay and onlay.
EsTemp NE is light-curing temporary filling materials. It has characteristics of high elasticity and high compressive strength. This elastic consistency assures easy removal from cavity, even in case of undercuts, final treatment of cavity is not necessary.
This document describes the EsTemp NE dental cement, and its evaluation for substantial equivalence to a predicate device. It is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. Therefore, the study described is a comparison study against a predicate device, not a standalone performance study with defined acceptance criteria in the same way one might evaluate a novel AI algorithm.
However, based on the provided text, we can infer and construct elements related to acceptance criteria and the "study" (which is a comparative analysis in this context).
1. Table of Acceptance Criteria and Reported Device Performance
Because this is a 510(k) submission for a dental cement, the acceptance criteria are primarily based on demonstrating comparable performance to a predicate device across key characteristics. The "performance" is the new device's properties as compared to the predicate.
| Acceptance Criteria (Inferred from 510(k) Equivalence) | Reported Device Performance (EsTemp NE vs. TempBond NE) |
|---|---|
| Similar Intended Use: Cementation of temporary and provisional restorations. | EsTemp NE's indication for use is "Cementation of temporary and provisional restoration such as crowns, bridges, inlay and onlay," which is consistent with the general intended use of dental cements like the predicate, TempBond NE. The document explicitly states: "EsTemp NE has the similar device characteristics as the predicate device, the TempBond NE; intended use... are similar." |
| Similar Material/Chemical Composition/Design: Material compositions and design principles should be comparable. | The document states: "EsTemp NE is similar to other commercially available products based on the ... material composition employed and performance characteristics. They are substantially equivalent in design, function and intended use to the predicate devices." Also, "EsTemp NE has the similar device characteristics as the predicate device, the TempBond NE; ...material, chemical composition, design and use concept are similar." |
| Comparable Mechanical Properties: Key physical properties relevant to dental cement function should be similar to the predicate. | The document states: "EsTemp NE have the similar mechanical properties as the predicate device: compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience." While specific values are not provided in this summary, the claim of "similar" indicates that these properties met the acceptance range for substantial equivalence. |
| Safety Data/Biocompatibility: The device should be safe for its intended use, typically demonstrated through biocompatibility testing. | The document states: "Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 3107." This demonstrates that safety, a fundamental acceptance criterion, was met. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify sample sizes for the empirical tests (e.g., for compressive strength, flexural strength, etc.) comparing EsTemp NE to TempBond NE.
- Data Provenance: The company, SPIDENT Co., Ltd., is located in Incheon, Korea. It is highly probable that the data was generated in Korea, but the summary does not explicitly state the country of origin of the raw test data. The study is retrospective in the sense that the data was collected to support an existing product for market clearance, rather than a prospective trial with human subjects. However, the tests themselves (mechanical properties, biocompatibility) would have involved newly created samples of the EsTemp NE and predicate for direct comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. Dental cement testing for substantial equivalence relies on objective, quantifiable physical and chemical property comparisons, and biocompatibility studies. It does not involve "expert ground truth" in the way an AI diagnostic device would with image annotations.
4. Adjudication Method for the Test Set
This is not applicable as the "test set" involves objective laboratory measurements, not subjective expert reviews requiring adjudication.
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 is not applicable. This submission is for a dental cement, not an AI 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
This is not applicable as the device is a physical dental cement, not an algorithm.
7. The Type of Ground Truth Used
For this dental cement, the "ground truth" for comparison against the predicate device is established by:
- Standardized Laboratory Measurements: Utilizing established ASTM, ISO, or similar standards for testing properties like compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage, and thermal expansion coefficient.
- Biocompatibility Standards: Compliance with ISO 3107 (and likely other relevant ISO standards for medical device biocompatibility).
- Predicate Device Performance: The established performance characteristics of the legally marketed predicate device (TempBond NE) serve as the benchmark for "truth" in terms of what constitutes acceptable performance for this class of device.
8. The Sample Size for the Training Set
This is not applicable. Dental cements are not "trained" in the way AI algorithms are. Their performance is inherent in their material composition and manufacturing process.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated above.
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