(136 days)
Enamic® is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
The Vita Enamic® block consists of interpenetrating networks of ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness of a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria in the way a clinical or diagnostic performance study would.
The document is a 510(k) summary for a dental CAD/CAM block called Enamic®. It focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific acceptance criteria through a clinical or diagnostic study.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria and Device Performance (Table): There are no specified performance metrics (e.g., sensitivity, specificity, accuracy) or corresponding target values mentioned. The document focuses on physical properties and material characteristics rather than diagnostic or clinical performance.
- Sample Size for Test Set and Data Provenance: This is not applicable as there's no clinical "test set" in the context of diagnostic performance.
- Number of Experts and Qualifications: Not applicable. Ground truth for diagnostic performance is not established.
- Adjudication Method: Not applicable.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned as this is not a diagnostic device.
- Standalone Performance Study: Not mentioned.
- Type of Ground Truth Used: Not applicable in the context of diagnostic performance. The "ground truth" for this device revolves around its material properties and safety.
- Sample Size for Training Set: Not applicable as this is not an AI/ML device requiring a training set in the conventional sense.
- How Ground Truth for Training Set was Established: Not applicable.
What the document does provide in terms of "proving acceptance criteria":
The document states that a "Summary of Non-Clinical Performance Data" was generated through bench testing:
- Bench Testing: Performed in accordance with FDA recognized standards ISO 10477 and ISO 6872.
- Conclusion: "The results of this testing allowed us to conclude that Enamic is safe and effective for its intended use."
The "acceptance criteria" in this context would be compliance with these ISO standards, and the "study" would be the described bench testing. However, the specific numerical acceptance criteria and the reported device performance values are not detailed in this 510(k) summary. It only states that the device "remains compliant to the ISO standards applied to these material types" and that "Comparisons of the physical properties of the Enamic to the predicate devices are included in this application."
In summary, the provided document does not contain the type of information requested for a diagnostic or clinical performance study. It is a 510(k) summary focused on demonstrating substantial equivalence of a dental material to existing predicate devices, primarily through material characterization and compliance with international standards.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.