Search Results

FRIALIT-2 implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.

Not Found

I am sorry, but based on the provided document, the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria is not available.

The document is an FDA 510(k) clearance letter for the "Frialit-2 Cylinder" device. It indicates that the device has been found substantially equivalent to pre-amendment devices for the stated indications for use. However, it does not include details on:

• Specific acceptance criteria (like performance metrics, thresholds, etc.)
• Any performance study results (e.g., accuracy, sensitivity, specificity, etc.)
• Sample sizes for test sets or training sets
• Data provenance
• Details about experts or ground truth establishment
• MRMC studies or standalone algorithm performance.

The letter focuses on the regulatory clearance based on substantial equivalence, not on the detailed technical or clinical study outcomes that would typically define and demonstrate meeting acceptance criteria for an AI/device performance study.

Ask a specific question about this device