Search Results

The Fiber System is a single use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

The Fiber Locker System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.

The FiberLocker System is comprised of two components: (1) the FiberLocker Implant (SpeedPatch PET) and (2) an instrument (FiberLocker Instrument) for fixation of said implant. The implant, a needled textile felt is made out of polyester staple fibers and is non-degradable. The FiberLocker Instrument, a surgical micro-stapling or felting device, is a sterile, single use device designed for the fixation of medical felt patches in soft tissue.

The provided FDA 510(k) summary (K241219) for the FiberLocker System does not contain any information about acceptance criteria or a study design for evaluating software or AI performance.

This document describes a medical device called the "FiberLocker System," which is a surgical mesh primarily intended for rotator cuff reinforcement. The performance data presented focuses on the physical and biological characteristics of the implant and its fixation instrument, primarily through bench testing and animal studies.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for AI/software performance. The provided text does not describe an AI or software component for which such criteria and studies would be relevant.

Here's a breakdown of why this information is not present in the document:

1. Nature of the Device: The FiberLocker System is a physical medical device (surgical mesh and instrument), not a software or AI-driven diagnostic or treatment tool.
2. Type of Performance Data: The "Performance Data" section details mechanical properties (tensile strength, suture pull-out, tear testing, corrosion), biocompatibility, and fixation performance in an ex-vivo animal model. These are standard tests for physical implants and surgical instruments.
3. Animal Studies: The animal study described assesses the biological response and biomechanical equivalence of the FiberLocker Implant compared to a predicate device, which is typical for implantable materials.
4. No Mention of Software/AI: The entire document focuses on the hardware aspects of the device. There is no mention of an algorithm, image analysis, diagnostic capabilities, or any form of artificial intelligence.

If this document were for an AI/software device, I would look for keywords like:

• Accuracy, sensitivity, specificity, AUC
• Ground truth, expert consensus, pathology
• Training set, test set, validation set
• Reader study, MRMC study
• FROC, ROC curves
• Algorithm performance, decision support

Since these terms and concepts are entirely absent, it confirms that the provided text does not relate to an AI-enabled medical device performance study.

Ask a specific question about this device