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The NeoSpan® Compression Implant System is a nitinol implant intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

In2Bones NeoSpan® Compression Implant System (CIS) is a product expansion of the existing NeoSpan Compression Staple Implant w/ Instruments (K161426). The NeoSpan® Compression Implant System consists of implants offered in various configurations from 2 and 3 legs with no hole or 1-to-3 holes intended for bone screw assembly for additional fixation. The fixed-leg implants are comprised of Nitinol per ASTM F2063. The devices are sterile implants intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

Bone screw options for the NeoSpan® Compression Implant System are previously cleared 3.0mm and 3.5mm locking and non-locking screws in lengths 10-30mm made from titanium alloy.

The provided text is a 510(k) summary for the NeoSpan® Compression Implant System, describing a medical device used for bone fixation. It does NOT contain any information about a study proving the device meets acceptance criteria for an AI/software-based medical device.

The document primarily focuses on demonstrating substantial equivalence of the physical implant system to previously cleared predicate devices through performance testing related to mechanical properties (e.g., static bending, fatigue bending, pull-out, corrosion) and biological/sterilization properties, not performance of an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study proving an AI device meets those criteria, as the input document is about an implantable hardware device.

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The CoLink® Mfx Plating System is intended for stabilization of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries, in both pediativ and adult patients.

The CoLink® Mfx Plating System is a line extension to the current CoLink® plating system offerings. The CoLink® Mfx Plating System has eight plate styles: 1st TMT Plates, 1st/2nd Lisfranc Plates, 2nd/3rd Lisfranc Plates, an NC Plate, a Medial Column TNC Plate, a Medial Column NCM Plate, and a Medial Column Bridge Plate. The plates and associated screws are manufactured from Titanium Alloy (ASTM F136).

The provided text describes a 510(k) premarket notification for a medical device called the CoLink Mfx Implant System. It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML-driven medical device.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices through engineering analysis and performance testing of a physical implant system. The "performance testing" mentioned is mechanical testing (four-point bend testing per ASTM F382) to compare the subject plates to predicate plates, and also references previous validations for sterilization, biocompatibility, shelf life, and pyrogenicity for the broader CoLink® Afx System.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or studies related to AI/ML performance because the provided text is for a physical orthopedic implant and not an AI/ML-based device.

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