(54 days)
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
The CONMED Argo Knotless® Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
The CONMED Argo Knotless® Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The threaded anchor and the suture eyelet are manufactured of PolyEtherEtherKetone (PEEK) material. Each size features a single use driver, a threaded anchor, suture eyelet, a 1.0mm UHMWPE Hi-FiTM, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. A maximum of six (6) Hi-Fi #2 suture, or 1.3mm Hi-Fi ribbon suture, or (2) two limbs of Hi-Fi tape, or one (1) bioresorbable reinforced implant can be threaded through the eyelet. The repair sutures are then tensioned and cleated on the driver cleat, if deemed necessary by the surgeon. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
Analysis of the Provided Text for Device Acceptance Criteria and Study Details
The provided text from the FDA 510(k) clearance letters for "The Acumed Wrist Fixation System" (K251296) and "CONMED Argo Knotless® Anchor" (K251530) pertains to medical devices that are physical implants, not AI-powered or software-based devices requiring performance studies with human readers or AI algorithms.
Therefore, the information requested in your prompt (e.g., acceptance criteria for AI performance, sample sizes for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance, training set details) is not present in these documents.
These 510(k) summaries describe:
- The Acumed Wrist Fixation System: Metallic bone fixation appliances. Clearance is based on substantial equivalence to pre-1976 devices. Performance data is not detailed in this specific excerpt, as it's a general clearance letter.
- CONMED Argo Knotless® Anchor: An implantable bone anchor made of PEEK. Clearance is based on substantial equivalence to a predicate device (Argo Knotless™ SP Anchor, K220757). The performance testing listed (Insertion, Ultimate Pull Displacement Resistance, Cyclic, User Validation, Packaging, Sterilization, Pyrogen, Biocompatibility, Shelf-life) are all engineering and materials-based tests for a physical implant, not diagnostic accuracy or AI performance evaluations.
Conclusion:
Based on the provided FDA 510(k) clearance letters, it is not possible to answer the questions related to AI device acceptance criteria, study methodologies (like MRMC, human reader studies, or ground truth establishment for AI), or training data for AI models. The devices described are physical orthopedic implants, and their clearance is based on mechanical and material performance, as well as substantial equivalence to previously cleared devices.
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