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Synthes 5.0/7.3 mm Cannulated Locking screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the femur.

The Synthes 5.0/7.3 mm Cannulated Locking Screws feature self-drilling and self-tapping tips, have a flat head profile with rounded edges with a hex drive recess. They are available in additional lengths ranging from 100 - 145mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed Synthes LCP® plating systems.

The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document is a 510(k) summary for the Synthes 5.0/7.3 mm Cannulated Locking Screws, which primarily focuses on establishing substantial equivalence to a predicate device.

The content includes:

• Device Description: Synthes 5.0/7.3 mm Cannulated Locking Screws are self-drilling, self-tapping, have a flat head with rounded edges and a hex drive recessive, and are available in various lengths.
• Intended Use: For use with existing Synthes LCP® plating systems for the fixation of various long bones, such as the femur.
• Material: Stainless Steel.
• Classification: Class II, 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener.
• Predicate Device: Synthes 5.0/7.3 mm Cannulated Locking Screws (the document states the predicate is the same as the new device, which is unusual for a typical 510(k) summary, often implying a modification or re-submission for the same device type).
• Substantial Equivalence: Stated as supported by comparative information.

It explicitly lacks details regarding:

• Specific acceptance criteria (e.g., performance thresholds for strength, fatigue, biocompatibility, etc.).
• Any study design, methodology, results, or data pertaining to the device's performance against such criteria.
• The elements related to AI/algorithm performance (test set, ground truth, experts, MRMC studies, standalone performance, training set) are entirely irrelevant as this is a physical medical device, not an AI or software-based diagnostic tool.

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