(145 days)
The FIBIOCORE composite posts are intented for use by dentists to give retention for reconstruction of non-vital teeth. The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.
Glass Fiber composite root canal post
The provided text describes a 510(k) premarket notification for the FIBIOCORE Glass Fiber Composite Posts. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than on detailed performance criteria typically associated with software or AI-based devices. Therefore, much of the information requested in your prompt (e.g., acceptance criteria tables, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or available in this document.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to legally marketed predicate devices. This is achieved by showing the new device has similar:
- Quality of mechanical characteristics
- Mechanical safety
- Materials
- Design
- Performance
- Indications for use
- Reported Device Performance:
- Biocompatibility: Standard ISO 10993-5 "Biological evaluation of medical devices - Tests for Cytotoxicity : in vitro methods" was conducted, showing "no evidence of a cytotoxic response."
- Mechanical Strength: Mechanical tests were conducted in conformance with ISO 3597-2 (Three-point Bending Standards). The results "showed the material to be suitable for root canal posts." Other unspecified mechanical tests were also conducted to characterize the material.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Similar Mechanical Characteristics | Met (as claimed by submitter) |
| Similar Mechanical Safety | Met (as claimed by submitter) | |
| Similar Materials | Met (as claimed by submitter) | |
| Similar Design | Met (as claimed by submitter) | |
| Similar Performance | Met (as claimed by submitter) | |
| Similar Indications for Use | Met (as claimed by submitter) | |
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | No evidence of cytotoxic response |
| Mechanical Strength | ISO 3597-2 (Three-point Bending) | Material suitable for root canal posts |
| Other Mechanical Tests | Material characterized (details not provided) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document as it is not typically required for a 510(k) submission for a Class I dental device. The "test set" in this context refers to samples of the physical device used for mechanical and biological testing, not a dataset for an algorithm.
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. This device is a physical dental post, not an AI or imaging device requiring expert interpretation for ground truth. Technical experts would have conducted the ISO standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to adjudication of expert interpretations for AI/imaging studies, which is not relevant here.
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
- No. This is not an AI-assisted device, so MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm, so standalone performance is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by conformance to international standards (ISO 10993-5 for biocompatibility and ISO 3597-2 for mechanical strength) and by demonstrating similar physical and mechanical properties to predicate devices.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.