Search Results
Found 1 results
510(k) Data Aggregation
(97 days)
ULTRACEM
UltraCem™ is indicated for cementation of indirect restorations (including inlays, onlays, crowns and bridges) made of metal, porcelain fused to metal, zirconia, and resin to natural teeth. This product is also intended for cementation of orthodontic bands to natural teeth.
UltraCem™ is a chemical cure, resin reinforced (modified) glass ionomer cement. UltraCem™ is supplied in a pre-mixed syringe for easy delivery and no waste, and also in two part bottles to be mixed with application brushes then directly applied to surfaces.
The provided text describes a 510(k) submission for the dental cement UltraCem™ and primarily focuses on demonstrating its substantial equivalence to a predicate device, K111855 Hy-Bond Resiglass. The study presented is a bench testing comparison, not a clinical study involving human patients or complex AI algorithms. Therefore, much of the requested information regarding AI performance, human readers, ground truth for training sets, etc., is not applicable to this document.
Here's the breakdown of the information that can be extracted and a clear indication of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for each performance metric. Instead, it states that UltraCem™ is "comparable to Hy-Bond" or that "test results indicate that UltraCem™ is substantially equivalent to the predicate device." The detailed numerical results from "Section 18 Bench Testing" are not included in the provided text.
| Performance Metric | Acceptance Criteria (Not explicitly stated as numerical, but implied as "comparable to predicate") | Reported Device Performance (Summary) |
|---|---|---|
| Shear Bond | Implied: Comparable bonding enhancement to various surfaces as the predicate device (Hy-Bond system). | "UltraCem™ is comparable to Hy-Bond which is currently on the market and is well-received." (Detailed in-vitro test results from Section 18 not provided). |
| Working-Setting Time | Implied: Performance within an acceptable range for dental cement application, comparable to predicate. (Specific criteria and predicate values not provided). | Working time: "when the product began to display gel-like polymerization properties." Setting time: "when the product was polymerized to the point when the mass could be moved as a whole." (Specific times from Section 18 not provided). |
| Film Thickness | Implied: Acceptable film thickness for dental cement applications, comparable to predicate. (Specific criteria not provided). | Measured in microns. (Specific values from Section 18 not provided). |
| Flexural Strength | Implied: Sufficient flexural strength for indirect restorations, comparable to predicate. (Specific criteria not provided). | "Strengths were recorded." (Specific values from Section 18 not provided). |
| Radiopacity | Implied: Sufficient visibility under X-ray, comparable to predicate. (Specific criteria not provided). | "Compared to determine how well the products can be viewed in an X-Ray." (Specific comparison results from Section 18 not provided). |
| Biocompatibility | Not performed. Acceptance criterion is based on the predicate device's prior testing: "the same exact formula and ingredients" as the predicate device, which was tested for Cytotoxicity, Sensitization, Irritation, and Genotoxicity according to ISO 10993-1. (This serves as the "acceptance" for UltraCem™ not requiring its own separate biocompatibility study). | Biocompatibility was not performed for UltraCem™ because its formula is identical to the predicate device (K111855 Hy-Bond Resiglass), which was previously tested and found compliant with ISO 10993 (Cytotoxicity, Sensitization, Irritation, Genotoxicity). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for each bench test. The document refers to "samples were prepared," "specimens were allowed to cure," but no specific numbers.
- Data Provenance: The bench tests were "in-house testing," implying the data was generated by Ultradent Products, Inc. The exact country of origin for the data generation and whether it was retrospective or prospective is not detailed, but "in-house testing" strongly suggests prospective lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This study involves bench testing of physical properties of a dental cement, not clinical image analysis or expert review requiring ground truth established by medical experts for diagnostic purposes. The expertise would likely be in materials science and dental product testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this is a bench testing study comparing physical properties, there is no expert adjudication method like those used for clinical readings or diagnostic AI algorithms. The results would be objectively measured.
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 document describes a traditional 510(k) for a dental cement, involving bench tests. There is no mention or implication of AI or human readers, so an MRMC study or effect size related to AI assistance is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. There is no algorithm or AI component in this device described in the submission. It is a material-based dental cement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Test Measurements/Predicate Device Comparison: For the physical tests (shear bond, working/setting time, film thickness, flexural strength, radiopacity), the "ground truth" would be the objective measurements obtained in the lab. For substantial equivalence, the performance of UltraCem™ is compared directly to the measured performance of the legally marketed predicate device, K111855 Hy-Bond Resiglass, which effectively serves as the benchmark or "ground truth" for acceptable performance. For biocompatibility, the "ground truth" for not needing direct testing was the identical formulation to the predicate, which had approved ISO 10993 results.
8. The sample size for the training set
- Not Applicable. There is no AI component or machine learning model that would require a training set in this submission.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth for a training set to be established.
Ask a specific question about this device
Page 1 of 1