Search Results

The Mitek Biocryl Rapide Interference Screw is intended for fixation of soft tissue or bone tendon bone grafts during cruciate ligament reconstruction surgeries of the knee.

The Mitek Biocryl Rapide Interference Screw

The provided text describes a 510(k) premarket notification for the Mitek Biocryl Rapide Interference Screw. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than performing a de novo clinical study with acceptance criteria and detailed performance data in the way a new AI/software medical device might.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable to this document.

The document does provide information under "Safety and Performance" but states the determination of substantial equivalence was based on:

1. A detailed device description.
2. Conformance to consensus standards and voluntary standards.
3. Comparison to the predicate device.

It explicitly concludes that "Based on the indications for use, technological characteristics, and comparison to the predicate device, the Mitek Biocryl Rapide Interference Screw has been shown to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act."

No clinical study with acceptance criteria and performance metrics for the device's function (e.g., successful fixation rate, biomechanical strength in vivo, etc.) is described in this 510(k) summary. The FDA's letter confirms substantial equivalence based on the provided information, not on a new clinical trial proving specific performance metrics against pre-defined acceptance criteria.

Ask a specific question about this device