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Synthes LCP Proximal Femur Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.

The LCP Proximal Femur Plates are contoured to match the anatomy of the proximal femur with a limited contact low profile design. The plate has dynamic compression holes combined with conical shaped threaded screw holes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or 5.0 mm locking screws, and 7.3 mm cannulated locking & cannulated conical screws. The plates and screws are available in a various lengths.

The provided submission does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it is a 510(k) premarket notification summary for a medical device (Synthes (USA) LCP Proximal Femur Plate and Screws), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance efficacy data against pre-defined acceptance criteria.

The document discusses:

• Device Description: The physical characteristics and components of the Synthes (USA) LCP Proximal Femur Plate and Screws.
• Intended Use/Indications for Use: The medical conditions and anatomical locations for which the device is designed to be used (various fractures of the proximal femur).
• Predicate Device: The previously cleared device to which the new device is being compared (Synthes 4.5mm Broad Locking Compression Plate (LCP)).
• Substantial Equivalence: A statement indicating that comparative information supports substantial equivalence, which is the core of a 510(k) submission.

Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text.

In a 510(k) submission, the "study" demonstrating that the device meets criteria typically takes the form of comparison to a predicate device, showing that the new device is as safe and effective as a legally marketed device. This often involves:

• Bench testing (mechanical, materials, biocompatibility) to show similar performance characteristics to the predicate.
• Sometimes, a review of clinical literature for similar devices.
• Rarely, in certain 510(k)s, clinical data might be included if there are significant differences from the predicate, but it's not the primary mechanism for clearance.

The provided document summarizes a successful 510(k) submission, indicating the FDA found the device substantially equivalent to its predicate. This implies that the device met the regulatory requirements for clearance without requiring detailed efficacy studies in the way a PMA (Premarket Approval Application) would, where acceptance criteria and comprehensive clinical study results would be mandatory.

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