(115 days)
- Base under Class I and II direct restorations
- Liner under direct restorative materials
- Class III and V restorations
- Undercut Blockout
- Minimally invasive cavities (including small non stress-bearing occlusal restorations)
- Tunnel preparations
- Repair of small enamel defects
- Repair of small defects in esthetic indirect restorations
- Repair of resin and acrylic temporary materials
The new Bulk Fill Flowable Composite manufactured by Septodont Louisville is a low viscosity, radiopaque flowable composite which sets upon exposure to a high-intensity blue light source. After polymerization, it exhibits low stress on the bond with the tooth, and it has a high polymerization conversion. This high degree of polymerization is achieved with short curing times and creates improved physical and mechanical properties. The new Bulk Fill Flowable Composite is packaged in single dose capsules and syringes. The shades offered with Bulk Fill Flowable Composite are: A1, A2, A3, A3.5.
The provided text is a 510(k) summary for a dental device, "Bulk Fill Flowable Composite." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data from bench tests. It is not a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details) because this document does not describe such a study for an AI/ML device.
Instead, the document focuses on:
- Bench testing: Physical tests conducted according to ISO 4049:2009 for properties like Depth of Cure, Conversion, Compressive Strength, Diametral Tensile Strength, Microhardness, Volume Shrinkage Stress, Water Absorption, and Solubility.
- Biocompatibility testing: Following ISO 10993-1:2009 and ISO 7405:2008.
- Comparison to predicate devices: Demonstrating similar indications for use and technological characteristics.
Here's a summary of what information is available related to performance and testing, but it does not fit the requested format for an AI/ML device study:
1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide a table of acceptance criteria or specific numerical performance results for the listed physical tests. It only states that the device "was tested following" the ISO standards and that the data "evaluate the performance... in comparison with its predicates." The conclusion is that the device is "substantially equivalent" and "biocompatible and safe for its intended use."
2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device test set. The document refers to "bench testing" of the "Bulk Fill Flowable Composite" itself. No specific sample sizes for these bench tests are mentioned, nor is data provenance in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert labels on images) is not relevant to this bench testing.
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 device is a dental material, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical properties, the "ground truth" would be the standard scientific measurements themselves as defined by the ISO 4049:2009 standard. For biocompatibility, it would be the results against the criteria in ISO 10993-1:2009 and ISO 7405:2008.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
9. How the ground truth for the training set was established: Not applicable.
§ 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.