Search Results

The Contour Forehead/Browlift Thread™ is indicated for use in browplasty surgery. The Contour Forehead/ Browlift Thread™ is indicated for use to fixate the subdermis to the periosteum of the Cranium in browplasty.

The Contour Forehead/Browlift Threads™ are a clear, nonabsorbable, sterile, surgical strand of polypropylene. The base product is USP size 2-0 polypropylene suture material. The 20 centimeter length incorporates a unidirectional-cogged section 10 centimeters long from the distal end. The 12 centimeter length incorporates a bi-directional design from the center. Both Unidirectional and Bidirectional Threads will have a 4 inch needle attached to the distal ends, with a 26 mm curved needle attached to the proximal end of the Unidirectional Thread and a 1 1/2 inch straight needle attached to the proximal end of the Bidirectional Threads. The threads are supplied sterile for single use.

The provided text is a 510(k) summary for a medical device called "Contour Forehead/Browlift Threads™". This document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device, rather than a report detailing acceptance criteria and performance from an independent study.

Therefore, the following information about acceptance criteria and study details cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a study
• Sample size for the training set
• How the ground truth for the training set was established

What can be extracted from the document:

The document primarily focuses on establishing "substantial equivalence" of the "Contour Forehead/Browlift Threads™" to existing, legally marketed predicate devices. This involves demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Key statements related to "performance" and "evaluation" are:

• "Bench and animal evaluations have demonstrated the device to be safe and effective."
• "It is equivalent to other 510 (k) approved surgical sutures and identical to Surgical Specialties' Polypropylene Surgical Sutures, PMA 870064."

This implies that standard biocompatibility and performance testing (likely mechanical strength, material integrity, etc., typical for sutures) was conducted, and the results were found to be comparable to the predicate devices. However, specific numerical acceptance criteria or performance metrics are not detailed in this summary. The FDA's letter states that they reviewed the submission and found the device "substantially equivalent."

Ask a specific question about this device