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510(k) Data Aggregation
(112 days)
HyperFil®-LV is a dual-cure, tooth shade, resin composite which is indicated for Class I, II, III, IV, and V restorations, including root surface cavities, post cementing, and core build-ups.
HyperFil®-LV is a dual-cure, highly radiopaque, flowable, bulk-fill composite restorative material suitable for direct and indirect restorations. HyperFil®-LV is light-curable to a depth of about 3-4 mm in 40 seconds with a dental curing light emitting at 430 - 480 nm with an intensity of >600 mW/cm². It will also self-cure to any depth in about 4-5 minutes at mouth temperature. HyperFil®-LV contains a combination of filling agents which give restorations constructed with HyperFil®-LV high compressive, tensile, and flexural strength. HyperFil®-LV will be packaged in single dual-chamber 5 mL syringes. The device comprises catalyst and base components, which are combined just prior to use via a mixing tip which is affixed to the dual chamber syringe.
This document, a 510(k) summary for the medical device HyperFil-LV, does not contain information related to an AI/ML device study. Instead, it describes a dental resin composite and its equivalence to a predicate device based on physical and chemical properties. Therefore, I cannot provide details on acceptance criteria, test sets, expert ground truth establishment, or clinical performance related to AI/ML as these are not present in the provided text.
The document discusses the following non-AI related aspects:
1. A table of acceptance criteria and the reported device performance:
| Property (pass/fail criteria, if applicable) | Acceptance Criteria for Predicate Device (Celerity) | Reported Device Performance (HyperFil®-LV) |
|---|---|---|
| Compressive Strength | >300 MPa | >300 MPa |
| Flexural Strength | >100 MPa | >100 MPa |
| Tensile Strength | >40 MPa | >40 MPa |
| Depth of Cure | >1 mm | >1 mm |
| Modulus of Elasticity | >10 GPa | >10 GPa |
| Radiopacity | >200% | >200% |
| Water Sorption | <40 µg/mm³ | <40 µg/mm³ |
| Water Solubility | <7.5 µg/mm³ | <7.5 µg/mm³ |
2. Sample size used for the test set and the data provenance: Not applicable. The document refers to "testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these physical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a material, and its properties are measured objectively, not through expert interpretation of a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the performance criteria are established by standard material testing methods in accordance with ISO and ASTM standards.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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