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The SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, tarsals, metatarsals, phalanges), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Hand System is indicated for fixation of hand (metacarpals, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Wrist System is indicated for fixation of wrist (distal radius, ulna) fractures, fusions, osteotomies, nonunions, malunions and reconstructions.

The SIGNEX Forearm System is indicated for fixation of forearm (radius and ulna) fractures, fusions, osteotomies, nonunions, malunions and reconstructions.

The SIGNEX Elbow System is indicated for fixation of elbow (distal humerus, olecranon, proximal radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Humerus System is indicated for fixation of humerus fractures, fusions, osteotomies, malumions and reconstructions.

The SIGNEX Foot System is indicated for fixation of foot (tarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Fibula System is indicated for fixation of fibula fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Tibia System is indicated for fixation of tibia fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Femur System is indicated for fixation of femur fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Clavicle System is indicated for fixation of clavicle fractures, fusions, osteotomies, non-unions and reconstructions.

The SIGNEX plates and screws are intended for closure /or bone fixation of fractures, fusion, osteotomies, non-union, malunion and reconstruction of hand, wrist, forearm, elbow, humerus, foot, fibia, tibia, femur and clavicle.

This is comprised of plates and screws. The plates are made of Pure Titanium (ASTM F67), Ti-6Al-4V ELI Titanium alloy (ASTM F136), and Screws are made of Ti-6A1-4V ELI Titanium alloy (ASTM F136). The plates and screws are single-use only, non-sterile products. so, those must be sterile before use.

The provided text describes the 510(k) summary for the SIGNEX device, which comprises plates and screws for bone fixation. It details the substantial equivalence comparison to predicate and reference devices, along with performance data. However, it does not describe an AI/ML-based device. The information provided is purely for a mechanical medical device (bone fixation plates and screws). Therefore, I cannot extract information related to AI/ML acceptance criteria or a study proving an AI/ML device meets those criteria from this document.

The document discusses:

• Biocompatibility testing: Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Systemic toxicity, Genotoxicity, Pyrogen testing, Implantation testing, all conforming to ISO 10993 series.
• Mechanical testing: Torsion test (ASTM F543), Axial pullout strength test (ASTM F543), Driving torque test (ASTM F543), 4-Point bending test (ASTM F382).
• Clinical Studies: Explicitly states "No clinical data were necessary for the demonstration of substantial equivalence."

Since the request pertains to "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically for an AI/ML device, and the provided text describes a mechanical bone fixation device, I am unable to fulfill the request as an AI/ML component is not present in the given information.

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