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The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, footlankle, knee, hand/wrist, and elbow in the following procedures:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
• I Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy.
• I Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 Anchors only).
• . Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
• . Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).

The OSSIOfiber® Suture Anchor consists of an eyelet and anchor body preloaded on an inserter. The anchor body and eyelet are made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.

The OSSIOfiber® Suture Anchors are sterile, single-use, and non-pyrogenic.

The provided text is a 510(k) summary for the OSSIOfiber® Suture Anchor, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device (like an AI model) meets acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement.

Therefore, I cannot provide the information requested in your prompt based on the provided text, as the document describes a mechanical medical device (suture anchor) and its non-clinical testing for substantial equivalence, not a study involving AI or human reader performance.

The request asks for details like:

• A table of acceptance criteria and reported device performance (in terms of AI metrics)
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC comparative effectiveness study results (AI vs. human)
• Standalone algorithm performance
• Type of ground truth used (e.g., pathology, outcomes)
• Training set sample size and ground truth establishment

None of this information is present in the provided 510(k) summary for the OSSIOfiber® Suture Anchor, which is a physical implant, not a diagnostic AI device. The "non-clinical data" section pertains to mechanical tests (static pull-out, cyclic pull-out, torsional strength, driving torque, insertion testing) and biocompatibility, which are relevant for a suture anchor but not for the type of AI-driven diagnostic device your prompt describes.

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