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The intended use of the I.T.S. Straight Plate with Angular Stability is to stabilize an osteotomy or fracture of small bones, long bones, the pelvis and the calcaneus in an adult or pediatric patient.

Indications for use include comminuted fractures, supercondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. And, as well, a fracture or osteotomy of the tibia, fibula, femoral condyle, acetabulum, humerus, ulna, middle hand and middle foot bones: treatment of the calcaneus; hip arthrodesis, and provisional hole fixation. The 3.5mm Cortical and Cancellous Angle Stable Screws used in conjunction with the Straight Plate may be used only on small bones.

The intended use of the I.T.S. Screw System is for corrective osteotomy or internal fracture fixation of the patella, pelvis, ankle, and long bones in an adult or pediatric patient.

For the 4.0mm Cannulated Cancellous Screw, indications for use are for radial and ulnar fractures, fractures of the proximal/distal humerus and of the patella, and for tendon fixation, maisonneuve injuries and disruption of the syndesmosis with bimalleolar or supermalleolar fractures and the instability of the talus centering. For the 6.5mm Cannulated Cancellous Screw, indications for use are for fractures of the femoral neck, tibiaplateau, of the sacrum and the articular cavity of the hip joint, and the metaphyseal fractures of the distal femur and distal tibia, fixation of the Ileosacral joint, and fusion of the foot and ankle.

For the 7.3mm Cannulated Cancellous Screw, indications for use are for fractures of the calcaneus, femoral neck, tibiaplateau, and of the sacrum and the articular cavity of the hip joint, fusion of the foot and ankle, fixation of the Ileosacral joint, and metaphyseal fractures of the distal femur and distal tibia.

The system (s) is not intended for spinal use.

The I.T.S. Straight Plate with Angular Stability is a low-profile 4, 6, or 8 hole plate with various length cortical and/or cancellous self-tapping stabilization locking and/or compression screws. The Straight Plate is made from CP titanium according to ASTM F 67-00 and all screws are made from 6-4 Alloyed Titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The I.T.S. Screw System is a group of cannulated fracture fixation screws in various diameters of 4.0mm, 6.5mm, and 7.3mm and lengths. A complement of flat and spherical Washers are available with the system. All screws and washers are made from 6-4 Alloyed Titanium according to ASTM F 136-02 and are surface conditioned with a TIODIZE, Type II preparation.

The provided text is a 510(k) Summary for a medical device (Straight Plate with Angular Stability & Screw System). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document states: "The I.T.S. Straight Plate with Angular Stability and Screw System is shown to be safe and effective for use in fracture fixation of small and long bones in the body." This is a general statement of conclusion and not a detailed report of how safety and effectiveness were demonstrated against specific acceptance criteria through a study.

Therefore, I cannot provide a response filling in the requested table and details because the necessary information is not present in the provided text.

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