(160 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.