(107 days)
Build-It Total Core is indicated for use as a core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material and dentin replacement material.
Build-It Total Core is a dual-cure, self-adhesive composite with a continuous fluoride release. Build-It Total Core utilizes 4-MET technology to adhere to dentin and cut enamel without a separate bonding agent. Ideal flow characteristics, esthetic and contrast shades, and outstanding physical properties make Build-It Total Core an indispensable tool in every clinician's armamentarium.
The provided document describes a 510(k) submission for a dental composite material called "Build-It Total Core." It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Here's an analysis based on the information provided, addressing your specific points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria with corresponding device performance values against those criteria. Instead, it lists characteristics evaluated and states that the performance characteristics were compared to predicate devices (Build-It F.R. and Cement-It All Purpose).
| Characteristic Evaluated | Reported Device Performance | Acceptance Criteria (Implicit) |
|---|---|---|
| Water absorption | Compared to predicate devices | Performance similar to predicate devices |
| Solubility | Compared to predicate devices | Performance similar to predicate devices |
| Flexural strength | Compared to predicate devices | Performance similar to predicate devices |
| Compression strength | Compared to predicate devices | Performance similar to predicate devices |
| Linear expansion in water | Compared to predicate devices | Performance similar to predicate devices |
| Fluoride release | Compared to predicate devices | Performance similar to predicate devices |
| Bond strength | Compared to predicate devices | Performance similar to predicate devices |
| Biocompatibility | Demonstrated material is safe | Material is safe for its intended use |
Explanation of "Acceptance Criteria (Implicit)": Since this is a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" for these performance characteristics are implicitly met if the test results for Build-It Total Core are similar to or equivalent to the legally marketed predicate devices. The document does not provide the specific numerical values for these characteristics for either the new device or the predicates.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "bench testing used to evaluate performance characteristics" but does not specify the sample sizes used for any of the tests (water absorption, solubility, flexural strength, etc.).
- Data Provenance: The data is from "bench testing," implying in-vitro testing conducted by the manufacturer, Sybron Dental Specialties, Inc. The country of origin of the data is not explicitly stated, but given the submitter's address in California, USA, it's likely U.S.-based. This is retrospective in the sense that the testing was performed to support the 510(k) submission for a finished device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of submission. The "ground truth" for the performance characteristics measured (e.g., flexural strength) is established by standardized test methods and calibrated equipment, not by expert consensus on, for example, diagnostic images.
4. Adjudication Method for the Test Set
This question is not applicable as there's no diagnostic or interpretive element requiring expert 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 question is not applicable. This submission is for a dental material, not an AI-powered diagnostic device, and therefore no MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This submission is for a dental material, not an algorithm, so no standalone algorithm performance study was done.
7. The Type of Ground Truth Used
For the biocompatibility study, the ground truth is established through standardized biological evaluations as outlined in relevant standards (e.g., ISO 10993 series), leading to a conclusion of safety for intended use.
For the bench testing performance characteristics (flexural strength, bond strength, etc.), the "ground truth" is the measured physical properties of the material under controlled laboratory conditions, obtained through validated test methods.
8. The Sample Size for the Training Set
This question is not applicable. This is not an AI/machine learning device, so there is no "training set." The product is a physical dental material.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.