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4.5mm Cortex Screw

The 4.5 mm Cortical Screw is intended for use only in conjunction with compatible plates of the APS Osteotomy Fixation System. It is indicated for fixation of long bone fractures and bone fissures where high-strength cortical fixation is required as part of the plate-and-screw construct. The screw provides stable support at the fixation site when used as a component of the APS Osteotomy Fixation System. This screw is not intended for standalone use.

5.0mm Locking Screw

The 5.0 mm Locking Screw is intended for use only with compatible locking plates of the APS Osteotomy Fixation System. It is indicated for fixation of long bone fractures requiring angular stability and reliable screw-plate interface fixation as part of the system construct. The locking mechanism is designed to reduce screw loosening and enhance stability at the fixation site. This screw is not intended for standalone use.

Proximal Medial Tibial Osteotomy Locking Plate

The Proximal Medial Tibial Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy procedures, providing fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures on the proximal medial tibia.

Proximal Medial Tibial Osteotomy Locking Plate, Small

The "Proximal Medial Tibial Osteotomy Locking Plate, Small" is designed for high tibial osteotomy. It is indicated for use in deformity correction and osteotomy, providing fixation in general and reconstructive surgeries, as well as bone fusion or osteotomy procedures.

Proximal Lateral Tibial Osteotomy Locking Plate

The Proximal Lateral Tibial Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the proximal lateral tibia, offering fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures.

Distal Medial Femoral Osteotomy Locking Plate

The Distal Medial Femoral Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the distal medial femur. It provides fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures.

Distal Lateral Femoral Osteotomy Locking Plate

The Distal Lateral Femoral Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the distal lateral femur. It provides fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures.

The APS Osteotomy Fixation System is made of titanium and includes fixation plates designed for both the medial and lateral sides of the distal femur and the proximal tibia.

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Locking Screw: The locking screws, in combination with the appropriate locking plate, are indicated for fixation of fractures, non-unions, replantations, and fusions of small bone fragments, particularly in osteopenic bone of the hand, wrist, foot, and ankle.
Cortex Screw: The Cortex Screw is indicated to be used with the APS Metal Plate & Screw System for the fixatures, osteotomies, non-unions, replantations, and fusions involving small bone fragments, especially in osteopenic conditions. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
Star Cancellous Screw: The Star Cancellous Screw is indicated for the fixation of fractures, and non-unions involving the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, and distal tibia, fibula, particularly in osteopenic bone.
APS HLR Screw: The APS HLR Screw is indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments, including joint fusions (arthrodesis) in the foot and fixation of intra-articular fractures of the humerus, femur, and tibia.
Distal CAS Locking Plate: The Distal CAS Locking Plate is indicated for fixation of fractures, malunions, and osteotomies of the distal (lateral) clavicle.
Distal Clavicle Hook Locking Plate | Clavicle Anatomical Midshaft Locking Plate: The Distal Clavicle Hook Locking Plate and Clavicle Anatomical Midshaft Locking Plate are indicated for the fixation of distal (lateral) clavicle fractures, mid-shaft clavicle fractures, and dislocations of the acromioclavicular joint.
Distal Medial Humeral Locking Plate | Proximal Humeral Locking Plate: The Distal Medial Humeral Locking Plate and Proximal Humeral Locking Plate are indicated for fracture dislocations, osteotomies, and non-unions of the distal (medial) and proximal humerus, particularly in osteopenic bone.
Small ABS Locking Plate | Dynamic Compression Locking Plate: The Small ABS Locking Plate and Dynamic Compression Locking Plate are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
Distal Radial Locking Plate | Trident Distal Radial Locking Plate: The Distal Radial Locking Plate and Trident Distal Radial Locking Plate are indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
Distal Lateral Femoral Locking Plate: The Distal Lateral Femoral Locking Plate is indicated for buttressing distal femur fractures, including supracondylar, intra-articular and extra-articular condylar, peri-prosthetic fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Large ABS Locking Plate: The Large ABS Locking Plate is indicated for fixation of various lones, such as the humerus, femur, and tibia. It is also for use in the fixation of osteopenic bone and fixation of non-unions or mal-unions.
Distal FDH Locking Plate: The Distal FDH Locking Plate is indicated for fractures, osteotomies, and non-unions of the metaphyseal region of the distal fibula, especially in osteopenic bone.
Distal Tibia Locking Plate System (Antero Lateral Distal Tibial Locking Plate, Distal Medial Tibial Locking Plate): The Distal Tibia Locking Plate System is indicated for fractures, and non-unions of the distal tibia, especially in osteopenic bone.
Proximal Medial Tibial Locking Plate: The Proximal Medial Tibial Locking Plate is indicated for buttressing metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, and medial split fractures with associated depression fractures of the medial tibial plateau.
Calcaneal Locking Plate: The Calcaneal Locking Plate is indicated for addressing complex of the calcaneus, including, but not limited to, extra-articular, joint depression, tongue-type, and severely comminuted fractures.
Distal RAF Locking Plate: The Distal RAF Locking Plate is indicated for fixation of complex intra- and extra-articular fractures of the distal radius and other small bones.
Mini Locking Plate System: The Mini Locking Plate System is indicated for fixation of fractures, non-unions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

The APS Metal Plate & Screw System provides anatomically contoured plates designed for use with both non-locking and locking screws. These plates are equipped with locking holes as well as holes for cortex screws, enhancing compression pressure. The combination of locking and compression technologies ensures the implants provide sufficient stability. The system is provided non-sterile and is sterilized in the user facility.

The provided text is a 510(k) summary for the APS Metal Plate & Screw System, a medical device for bone fixation. It focuses on demonstrating substantial equivalence to predicate devices, primarily through materials and mechanical performance testing, rather than clinical performance based on AI or diagnostic capabilities.

Therefore, the document does not contain the information requested regarding acceptance criteria and study details for an AI-powered device, specifically:

• No acceptance criteria table: There's no mention of performance metrics like sensitivity, specificity, or AUC for a diagnostic or AI device.
• No study proving device meets acceptance criteria for AI: The "Performance Data" section discusses biocompatibility and mechanical testing (ASTM F543 and ASTM F382) to establish equivalence for the physical hardware, not the performance of a diagnostic algorithm or AI.
• No sample sizes, data provenance, expert numbers, adjudication methods, MRMC studies, standalone performance, or ground truth details: These are all concepts relevant to the evaluation of AI models or diagnostic devices, which are not discussed in this 510(k) summary.

In summary, the provided document describes a traditional medical device (metal plates and screws) and its evaluation through material and mechanical testing, not a device involving Artificial Intelligence or diagnostic capabilities that would require the typical performance study details asked in the prompt.

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