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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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The Level One Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

The Level One (L1) Hand Plating System includes metallic plates, washers, and screws intended for small bone fixation. Plates are pre-contoured to accommodate patient anatomy, available in various shapes and range in thickness from 0.6mm - 3.0mm, and are compatible with the standard and multidirectional locking screws offered in the system. Screws are self-tapping, available in a standard or multidirectional locking configuration and range in diameter from 1.0mm - 2.7mm with lengths from 2mm - 32mm. Standard screws may be used alone or in conjunction with the washers or plates for small fragment osteosynthesis. Implants are manufactured from CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136). The system includes the necessary instrumentation to facilitate implantation. The purpose of this submission is to offer the previously cleared non-sterile device system in K141489 in sterile packaging via gamma irradiation.

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of device performance, as it is a 510(k) summary for a medical device (Level One Hand Plating System).

The primary purpose of this document is to demonstrate substantial equivalence to a predicate device, focusing on material, design, intended use, and a change in sterilization method (from non-sterile to sterile via gamma irradiation).

Therefore, the requested information regarding acceptance criteria, reported device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this submission.

The document states:

• "Clinical testing was not necessary for the determination of substantial equivalence." This indicates that no clinical performance study, as might be required for new or high-risk devices, was performed or presented.
• The non-clinical performance data section focuses on biocompatibility and bacterial endotoxin testing to support the change to sterile packaging, rather than demonstrating performance against specific clinical or diagnostic acceptance criteria.

In summary, this document is concerned with regulatory approval based on equivalence, not with proving new performance claims against defined acceptance criteria.

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