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The Synthes Ti DFN System is generally intended to stabilize fractures of the distal femur. Specifically, the Ti DFN is intended for supracondylar fractures (including those with intraarticular and/or extra-articular involvement), pathologic fractures, mal-unions, non-unions, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures proximal to a total knee, fractures distal to a total hip, fractures in the multiply injured patient, fractures in the morbidly obese patient, and fractures in osteoporotic bone. The Ti DFN can be used in either reamed or non-reamed applications.

Synthes Ti DFN System is a cannulated and solid locking intramedullary fixation device. The following components make up the DFN system: Transverse Locking Nails, 6.0 mm Ti Locking Screws, 4.9 mm Ti Locking Bolts, and Ti End Caps. Synthes Ti DFN System is manufactured from a titanium alloy. Synthes Ti DFN has various locking options both proximally and distally. The Ti DFN are available in diameters ranging from 9 mm to 13 mm, and lengths ranging from 160 - 460 mm. The 6.0 mm Ti Locking Screws and 4.9 mm Ti Locking Bolts are used to lock the DFN into place. The Ti End Cap locks the distal 6.0 mm Ti Locking Screw to the Ti DFN.

The provided text is a 510(k) Summary for a medical device (Synthes Ti Distal Femoral Nail System). It describes the device, its intended use, and compares it to predicate devices.

However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria in the way you've outlined with performance metrics, sample sizes, ground truth establishment, expert adjudication, or AI performance.

The document is focused on demonstrating substantial equivalence to existing devices, which is the regulatory pathway for 510(k) submissions. This typically involves showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety and effectiveness. This often relies on biomechanical testing or literature review comparing the performance characteristics (e.g., strength, stiffness) of the new device to the predicate devices, rather than clinical studies with "acceptance criteria" and "device performance" in the sense of diagnostic accuracy or clinical outcomes as you might find for a software algorithm or a new drug.

Therefore, I cannot fulfill your request for the specific information points because they are not present in the provided document. The document is about a hardware medical device and its regulatory clearance process, not an AI/software-based diagnostic device or a study with typical clinical trial metrics.

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