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510(k) Data Aggregation
(50 days)
The intended use of Post Cement Hi-X is:
- for the cementation of posts
- .for the cementation of metal posts fabricated with precious, semi-precious or non-precious metals
Post Cement Hi-X Dental Cement is a self-cured, radiopaque composite and is designed to be used with Bisco's dental adhesive systems such as All-Bond 2 or One-Step Universal Adhesive Systems. Post Cement Hi-X will bond micro-mechanically to fiber posts, metal, silane-treated porcelain, fibers and tooth structure. Due to its high opacity in thin layers, Post Cement Hi-X is intended for cementation of posts. When viewed on x-ray film, the outline of any post material with the use of Post Cement Hi-X. Post Cement Hi-X, a low-viscosity, tooth-colored, silica and glass-filled, resin-based composite, is a two-paste, self-cured system. The material is supplied in syringes.
The provided text describes a 510(k) summary for a dental cement called "Post Cement Hi-X". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics that would typically involve a "test set," "ground truth," or "expert adjudication" in the context of AI/medical device performance studies.
Therefore, many of the requested items (2-9) are not applicable or cannot be extracted from the given text because the regulatory submission is not for an AI/imaging device requiring such detailed performance study information. The submission is for a material (dental cement) where "acceptance criteria" are related to its physical and chemical properties and intended use.
Here's the information that can be extracted or inferred based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific submission, "acceptance criteria" are implicitly defined by the properties of the predicate device that the new device aims to be substantially equivalent to. The "reported device performance" are the characteristics of the new device.
| Technological Characteristic | Acceptance Criteria (Predicate: C & B Luting Cement) | Reported Device Performance (Post Cement Hi-X) |
|---|---|---|
| Intended Use | Cementation of fixed restorations of precious, semi-precious and non-precious metals and of porcelain and composite fixed prostheses. | Cementation of posts and cementation of precious, semi-precious and non-precious metal posts. |
| Chemical Composition | Self-cured | Self-cured |
| Physical/Mechanical Properties | High strength, resistant to wear and abrasion | High strength, resistant to wear and abrasion |
| Working Time (room temp) | 3-4 minutes | 2.5-3.0 minutes |
| Setting Time (room temp) | 5-7 minutes | 4.5-5.0 minutes |
| Radiopacity | Not explicitly stated for predicate in table, but implied by new device's description of being "radiopaque composite" and "outline of any post material... on x-ray film." | Radiopaque (description states: "radiopaque composite", "high opacity in thin layers", "viewed on x-ray film"). |
| Viscosity/Composition | Not explicitly stated for predicate. | Low-viscosity, tooth-colored, silica and glass-filled, resin-based composite. |
| System | Not explicitly stated for predicate. | Two-paste, self-cured system. |
| Delivery | Not explicitly stated for predicate. | Supplied in syringes. |
Study to Prove Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (i.e., is substantially equivalent to the predicate) is not a formal clinical trial or a performance study with a test set in the conventional sense of an AI/imaging device. Instead, it is a comparison of technological characteristics as presented in the table above, demonstrating that the new device has the same technological characteristics as the predicate device or that any differences do not raise new questions of safety or effectiveness. The FDA's 510(k) clearance process itself serves as the "proof" that the regulatory body has accepted this comparison.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/imaging device requiring a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/imaging device.
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/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/imaging device's ground truth. For this dental cement, the "ground truth" for its properties would be established through standard material testing methods (e.g., ISO standards for dental materials) which are not detailed in this summary.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
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