(1 days)
Calibra Abutment Resin Cement is indicated for the cementation of: Extraoral assembly of prosthetic components, e.g., structures made of ceramic or zirconia onto custom or pre-fabricated titanium/titanium alloy or zirconia bases/implant inserts/abutments, e.g., InCoris ZI and CEREC Tessera™ Abutment Block prostheses and mesostructures to TiBases.
Calibra Abutment Resin Cement is a two-component, self-cure, high strength self-adhesive cement. Calibra Abutment Resin Cement has the ability to bond to titanium and is chemically compatible with silanated ceramic materials, making it suitable for extraoral assembly of prosthetic components. This self-cure only, opaque shade has been optimized for extraoral assembly when blocking of metal graying or show-through is desired. Cured Calibra Abutment Resin Cement is essentially hydrophobic, minimizing post-cure water sorption, solubility and hygroscopic expansion.
This document describes the Calibra Abutment Resin Cement and its substantial equivalence to predicate devices, based on non-clinical performance testing. It focuses on the physical and chemical properties of the cement rather than an AI/ML powered device. Therefore, a direct response to your detailed questions regarding acceptance criteria and studies that are typical for AI/ML devices involving human readers, training sets, and ground truth establishment (such as those for image analysis, diagnostics, etc.) is not entirely applicable in this context.
However, I can extract the information relevant to non-clinical testing which serves as the "study" demonstrating the device meets its "acceptance criteria" through comparison with existing, legally marketed devices.
Here's a summary of the non-clinical test data and conclusions provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets and the device's reported performance against those targets. Instead, it states that "The results show that the proposed device meets the requirements of the non-clinical bench testing conducted to support substantial equivalence."
The tests conducted and generally accepted properties for dental cements are:
| Test Type | Reported Device Performance |
|---|---|
| Work Time | Meets requirements for non-clinical bench testing |
| Set Time | Meets requirements for non-clinical bench testing |
| Film Thickness | Meets requirements for non-clinical bench testing |
| Consistency | Meets requirements for non-clinical bench testing |
| Flexural Strength | Meets requirements for non-clinical bench testing |
| Bond Strength | Meets requirements for non-clinical bench testing to multiple prosthetic components |
| Biocompatibility | Likelihood of a toxic effect is low (based on risk assessment) |
| Shelf-Life | Compared to reference device Self-Adhesive Resin Cement (K073173) |
2. Sample size 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. The document refers to "non-clinical bench testing" which typically involves laboratory-controlled conditions. Details on sample sizes for each test, country of origin, or whether the data was retrospective or prospective are not mentioned.
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)
This information is not applicable as this is not a study involving human interpretation or subjective assessment that would require expert adjudication. The tests are for material properties of a dental cement, assessed objectively in a laboratory setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated in point 3.
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 information is not applicable as this is not an AI/ML powered device or a study involving human readers' performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" would be established by standardized test methods and material specifications (e.g., ISO standards for dental materials). The performance criteria are derived from these industry standards and the properties of predicate devices.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device that requires a training set.
Summary of Relevant Information from the Document:
The regulatory submission for Calibra Abutment Resin Cement (K240888) is based on demonstrating "substantial equivalence" to predicate devices. This is achieved through non-clinical bench testing of the cement's physical and chemical properties and a comparison of its indications for use and technological characteristics with those of established predicate and reference devices.
- Predicate Device: Multilink Hybrid Abutment Cement (K130436)
- Reference Device: Self-Adhesive Resin Cement (K073173)
- Tests Performed: Work time, set time, film thickness, consistency, flexural strength, bond strength to multiple prosthetic components, and biological risk assessment.
- Conclusion: The tests confirmed that the proposed device "meets the requirements of the non-clinical bench testing conducted to support substantial equivalence." The device shares the same intended use, fundamental technology, and similar indications for use as the predicate.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.