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Synthes 3.5 mm Locking Compression Plate (LCP) System:
The Synthes 3.5 mm LCP is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients.
These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
Synthes 4.5 mm Locking Compression Plate (LCP) System:
The Synthes 4.5 mm LCP is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.
These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications consist of 3.5 mm LCP plates, 4.5 mm Narrow LCP Plates, 4.5 mm Broad LCP plates and 4.5 mm Curved Broad LCP Plates for fracture fixation in adults and pediatric patients. These plates accept locking, cortex and cancellous screws.

The provided document is a 510(k) premarket notification letter for a medical device: Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications.

This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, the document does not contain the detailed information typically found in a clinical study report that would establish acceptance criteria and show the device meets them.

Specifically, the document does not provide any of the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set and data provenance.
• Number of experts and their qualifications used to establish ground truth.
• Adjudication method for a test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone algorithm-only performance study.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on:

• Device Name: Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications.
• Regulation Number and Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories.
• Predicate Devices:
  • Smith & Nephew Locking Bone Plate System (K033669)
  • Smith & Nephew Bone Plate System (K993106)
  • Synthes Locking Compression Plates (K000682, K000684, K041911)
• Device Description: Consists of 3.5 mm LCP plates, 4.5 mm Narrow LCP Plates, 4.5 mm Broad LCP plates, and 4.5 mm Curved Broad LCP Plates for fracture fixation in adults and pediatric patients. These plates accept locking, cortex, and cancellous screws.
• Intended Use/Indications for Use:
  • 3.5 mm LCP System: Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients. Also for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
  • 4.5 mm LCP System: Fixation of various long bones (humerus, femur, tibia) and for use in fixation of peri-prosthetic fractures, osteopenic bone, and fixation of non-unions or malunions in adult patients. Also for fracture fixation of diaphyseal areas of long bones in pediatric patients.
• Substantial Equivalence: The document states, "Information presented supports substantial equivalence." This is the primary "proof" in a 510(k) submission, meaning the device is as safe and effective as a legally marketed predicate device.

To obtain the kind of detailed performance data requested, one would typically need to refer to a premarket approval (PMA) submission, a De Novo classification request, or a clinical trial report for a device that has undergone a more rigorous pathway for demonstrating safety and effectiveness.

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