Search Results

The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures:

• Hip: acetabular labral repair
• Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair

The SnugFit All-Suture Anchor is an implantable device indicated for the treatment of hip and shoulder instability (Size 1) and shoulder rotator cuff repair and biceps tenodesis (Size 2).
The SnugFit All-Suture Anchor is a knotted device composed entirely of sutures, made of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET) specifically arranged and braided to create an anchoring point within the bone after its deployment. The sutures that compose the anchor, are also used to secure soft tissues to a supporting structure (i.e. bone).
The SnugFit All-Suture Anchors are provided EtO sterile with a 5 years shelf life. The sterile, individually packaged, devices consist of the all-suture anchor and a disposable stainless steel driver with a plastic handle. The all-suture anchor is provided pre-loaded on the disposable driver.
The SnugFit All-Suture Anchors are available in six (6) different configurations depending on anchor size (size 1 and size 2), driver length (long and short), and typology of preloaded sutures.

The provided FDA 510(k) summary for the Medacta International SA SnugFit All-Suture Anchor does not contain information regarding acceptance criteria or a study proving the device meets said criteria in the context of diagnostic accuracy or AI performance.

This document is a premarket notification for a medical device (an all-suture anchor for soft tissue fixation to bone), not a diagnostic algorithm or AI-powered device that would typically involve acceptance criteria related to sensitivity, specificity, accuracy, or human reader performance.

The "Performance Data" section lists non-clinical studies related to the physical performance and safety of the implantable device. These studies are mechanical evaluations, biocompatibility tests, and sterilization validations, which are standard for orthopedic implants.

Here's why the requested information cannot be extracted from this document:

• Type of Device: The SnugFit All-Suture Anchor is a physical implant used in surgery, not a diagnostic imaging tool, AI algorithm, or device that performs an analytical function.
• Performance Data focus: The performance data described (design validation, cyclic and load-to-failure properties, pyrogenicity, biocompatibility) are all related to the mechanical properties, material safety, and physical integrity of the anchor, not diagnostic accuracy.
• Absence of AI/Diagnostic Context: There is no mention of AI, diagnostic imaging, disease detection, or human reader studies.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information contained in the provided FDA submission for this particular device.

Ask a specific question about this device