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The Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. Specially sloped plates can be used in cases when a tibial slope adjustment is needed. This system consists of plates and screws which join together to correct abnormalities or trauma related injuries. It is intended to be used with adequate post-operative immobilization.

The Arthrex Humeral Fracture Plates and Screws are intended to provide internal fixation of proximal fractures of the humerus.

The Arthrex Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition, and stabilize metatarsus primus varus.

The Arthrex Distal Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.

The Arthrex Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand and wrist, such as opening wedge osteotomies of Hallux Valgus.

The Arthrex Distal Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. The system can be used for palmar, dorsal or orthogonal application.

The Arthrex Compression FT Screw is intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Osteochondral fragments (talar vault, femoral condyle)Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)Cancellous fragments (talus)Carpal, metacarpal, and small hand boneTarsal and metatarsalsPhalangesIntra-articular fracturesAnkleProximal and distal humerusProximal and distal radiusProximal and distal ulnaOsteochondral fixation and fracturesOsteochondritis DissecansFixation of fractures and osteotomies about the kneeOblique fractures of the fibulaReconstructive surgeries of the footMalleolar fixation

The Arthrex Plates, Screws, and Staples is a family of plates, screws, and staples manufactured from stainless steel or titanium that will be offered as sterile or non-sterile devices in various sizes for use in orthopedic surgery.

The provided text is a 510(k) summary for the Arthrex Plates, Screws, and Staples. This type of submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a change in sterilization methods. It does not contain information about acceptance criteria or a study proving device performance against specific clinical or algorithm-based metrics as would be typical for AI/ML devices or novel diagnostic tools.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this document does not contain that kind of data.

The "Purpose of Submission" section clearly states: "This special 510(k) premarket notification is intended to address the use of Gamma Irradiation and Ethylene Oxide sterilization on the Arthrex Plates, Screws, and Staples devices, which were originally cleared as non-sterile devices... The intended use, material, and fundamental technological characteristics of the proposed Arthrex Plates, Screws, and Staples are substantially equivalent to the non-sterile predicates."

This indicates that the focus of this particular submission is on sterilization equivalence, not on a performance study against acceptance criteria in the way described in your request.

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