Search Results

FluoroCore® 2 is indicated for vital or non-vital tooth core build-up (replacement of existing restorations and/or lost tooth structure) as a base prior to fabricating an indirect restoration and as a post cement.

FluoroGore®, 2 is a fluoride releasing dual cure (chemical and/or light cure), radiopaque two-component core build-up material and post cement. The material is available in two shades and is delivered in double-barrel syringes.

The document provided describes the FluoroCore® 2, a fluoride-releasing, dual-cure, radiopaque two-component core build-up material and post cement. The submission is a 510(k) for substantial equivalence to predicate devices, rather than a de novo approval requiring extensive clinical efficacy studies against acceptance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria definitions and studies proving those criteria are met is not fully applicable in the context of this 510(k) submission as it would be for a novel medical device demonstrating clinical performance benchmarks.

Instead, this submission focuses on demonstrating substantial equivalence to already approved predicate devices. This means that its acceptance criteria are implicitly met by demonstrating that its technological characteristics, safety, and intended use are similar to those of legally marketed devices.

Here's an breakdown of the information that is available, and what is not present given the nature of a 510(k) submission for substantial equivalence:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: While explicit numerical acceptance criteria for clinical performance (like sensitivity/specificity for an AI device) are not stated, the acceptance criteria for FluoroCore® 2 are centered around biocompatibility and physical properties as per recognized international standards.
  • Biocompatibility Acceptance: In accordance with ISO 10993 (Biological evaluation of medical devices) and ISO 7405 (Evaluation of biocompatibility of medical devices used in dentistry).
  • Physical Properties Acceptance: In accordance with ISO 4049 (Dentistry - Polymer-based filling, restorative and luting materials).
• Reported Device Performance:
  • Biocompatibility: "FluoroCore® 2, including all colorants, has been demonstrated as biocompatible and safe for the same indication and type of tissue contact as the predicate devices."
  • Physical Properties: "FluoroCore® 2 complies with ISO 4049."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not applicable/Not provided in the context of this 510(k) submission. No clinical "test set" in the sense of patient data for performance evaluation (like in AI or diagnostic devices) is mentioned. The testing involved international standards for materials, not patient data sets.

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/Not provided. This type of expert ground truth establishment is relevant for diagnostic or AI-driven devices assessing patient conditions, not for material properties testing in a 510(k) for substantial equivalence.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. This is relevant for studies involving human interpretation or expert consensus on clinical findings, not for materials testing.

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-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are entirely outside the scope of its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For biocompatibility: The "ground truth" is adherence to ISO 10993 and ISO 7405 standards for biological safety.
• For physical properties: The "ground truth" is adherence to ISO 4049 standards for dental polymer-based materials.
  These are international consensus standards for material science and biological compatibility, not clinical outcomes or expert consensus on patient conditions.

8. The sample size for the training set:

• Not applicable/Not provided. This refers to machine learning, which is not relevant to this device. Material testing often involves specific numbers of samples for each test (e.g., x number of specimens for compressive strength), but these details are not provided in this summary.

9. How the ground truth for the training set was established:

• Not applicable/Not provided. (See point 8).

Study Proving Device Meets Acceptance Criteria:

The document states that the studies performed were:

• Toxicological Testing: Cytotoxicity and genotoxicity tests conducted in accordance with ISO 10993 and ISO 7405. These tests "demonstrated [FluoroCore® 2] as biocompatible and safe" meeting the implicit acceptance criteria of these standards.
• Physical Properties: Testing performed in accordance with ISO 4049. The device "complies with ISO 4049," meeting the implicit acceptance criteria of this standard.

In summary, this 510(k) submission for FluoroCore® 2 relies on demonstrating compliance with recognized international standards for biocompatibility and physical properties of dental materials, rather than clinical performance metrics measured against a "test set" with expert-established ground truth, which is typical for diagnostic or AI-powered devices. The "study" proving acceptance criteria are met is the successful execution of these ISO-compliant tests.

Ask a specific question about this device