Search Results

Not Found

The IMTEC/TitaniumMesh consists of a laser cut segment of precision expanded, flattened and annealed Titanium Mesh of a specific size dimension and pore dimension. The device will be marketed sterile.

I apologize, but the provided text from the K970841 510(k) summary does not contain any information regarding clinical studies, device performance, acceptance criteria, ground truth, or sample sizes.

The document is a 510(k) summary that focuses on:

• Submission Information: Submitter's contact details, FDA registration, date of submission.
• Device Classification and Naming: Classification name, common name, proprietary name.
• Predicate Devices: A list of previously cleared devices to which the IMTEC/TitaniumMesh is substantially equivalent.
• Device Description: A brief physical description of the IMTEC/TitaniumMesh (laser cut, expanded, flattened, annealed titanium mesh of specific size/pore, marketed sterile).

Therefore, I cannot fulfill your request for the detailed information asked in your prompt based on the provided text. To answer your questions, I would need a section of the 510(k) addressing performance data, clinical testing, or evidence of substantial equivalence based on performance.

Ask a specific question about this device