(56 days)
Zhermack OCCLUFAST CAD is a dental impression material intended to be placed on a dental patient's teeth for bite registration to reproduce the structure of a patient's teeth to provide models for study or for production of restorative prosthetic devices.
Occlufast CAD has been developed for use with CAD/CAM systems.
dental impression material
The provided document is an FDA 510(k) clearance letter for a dental impression material named Occlufast® CAD. This type of document primarily confirms that a new device is "substantially equivalent" to a predicate device already on the market, based on its indications for use and sometimes on performance data.
However, the letter does not contain any information regarding specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria. It's a regulatory clearance, not a technical performance report.
Therefore, I cannot provide the requested information from the given text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination typically relies on comparing the new device's technological characteristics and intended use to those of a predicate device, sometimes supported by basic performance testing to ensure safety and effectiveness are comparable, but detailed study reports and acceptance criteria are not typically included in the publicly available clearance letter itself.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).