Search Results

The Synthes 1.0mm Ti. Cortex, Self-drilling Screws are intended for use as follows:

Specific Indications:

• Nasoethmoidal fractures .
• Infraorbital area fractures .
• Frontal sinus wall fractures .
• Infant craniofacial surgery .

General Indications:

• Maxillofacial surgery .

The 1.0mm Ti. Cortex Screws are self-drilling, have a flat head profile with rounded edges with a cruciform recess, and are available in lengths from 2 - 4 mm.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary and FDA clearance letter for a medical device (Synthes 1.0mm Ti. Cortex, Self-drilling Screws), focusing on its substantial equivalence to predicate devices and its intended use. It does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test sets, data provenance, or training sets.
• Information on expert ground truth establishment, adjudication methods, or MRMC studies.
• Mention of standalone algorithm performance or the type of ground truth used for performance evaluation.

Ask a specific question about this device