(53 days)
Argo Knotless® GENESYS™ SP Anchor
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ SP 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 damaqed soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
Argo Knotless® GENESYS™ Anchor
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ 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 soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
Argo Knotless® GENESYS ™ SP Anchor: The Self-Punching (SP) Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied for single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the broaching tip (suture eyelet) is manufactured of titanium material. Each size features a single-use driver, the threaded anchor, a Titanium suture eyelet, a UHMWPE 1.0mm non-absorbable retention suture, and loader tab. The retention suture holds the titanium eyelet in place on the driver assembly and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures.
Argo Knotless® GENESYS ™ Anchor: The Non-Self-Punching Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The anchor configuration requires a pre-prepared bone hole. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. Each size features a single use driver, a threaded anchor, a PEEK suture eyelet, a #2 UHMWPE, 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. The suture eyelet can hold up to six (6) sutures. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
Argo Knotless® GENESYS ™ Anchor: The Preloaded Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. The eyelet is held on with a #2 UHMWPE, nonabsorbable retention suture and supplied with either a white/black or blue/blue colored non-absorbable Hi-Fi suture tape, a retention suture, and loader tab. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
Principle of Operation - soft tissue to bone fixation
This document is an FDA 510(k) clearance letter and summary for a medical device (Argo Knotless GENESYS Anchor). It does not describe a study involving an AI/software as a medical device (SaMD) or diagnostic imaging. Therefore, the requested information about acceptance criteria, study design, ground truth establishment, and human-in-the-loop performance is not applicable to this document.
The document focuses on demonstrating substantial equivalence of a physical medical device (suture anchor) to a previously cleared predicate device. The "Performance Data" section lists various engineering and material tests conducted on the physical device, not clinical performance or diagnostic accuracy studies.
Here's why the questions are not applicable:
- No AI/Software Component: The device described is a physical implantable suture anchor, not an AI or software-based diagnostic tool.
- No Diagnostic Performance: The performance data mentioned (e.g., "Performance Testing," "Magnetic Resonance," "Transportation," "Corrosion Susceptibility") relate to the mechanical, material, and sterility aspects of the anchor, not its diagnostic accuracy in interpreting images or data.
- No Human Reader Interaction: There's no scenario where human readers (like radiologists) would "improve with AI vs. without AI assistance" as this is not an imaging or diagnostic AI product.
- No Ground Truth for AI: Ground truth for a physical device like a suture anchor is typically established through engineering specifications, material properties, and in-vitro or in-vivo (animal or human cadaver) biomechanical testing, not through expert consensus on images or pathology.
Therefore, I cannot populate the table or answer the specific questions related to AI/SaMD performance criteria, study design, and ground truth. The provided text simply doesn't contain that type of information.
§ 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.