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The Omni Foot and Ankle Plating System is internal fixation of arthrodesis, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

The Omni Foot and Ankle Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths, thickness and number of holes. A locking compression slot is included in the plate to allow use of a locking screw for additional compression if desired by the surgeon. The locking and non-locking plate screws are provided in diameters of 2.3mm, 2.8mm and 3.5mm in lengths ranging from 6mm to 50mm. The System offers 3.5mm headed and headless cannulated screws and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screws can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization. The Omni Foot and Ankle Plating System includes general use and system-specific instrumentation, such as drill bits, drill sleeves and drill guides, depth gauges, targeting guide, drivers, guidewires, and rasps. The system also includes a system-specific sterilization tray.

This document describes the FDA's clearance of the Omni Foot and Ankle Plating System. It does not contain information about an AI/ML medical device, clinical performance studies with human readers, or the establishment of ground truth using experts. Instead, it focuses on the substantial equivalence of a traditional medical device (bone fixation system) to previously cleared predicate devices through engineering analysis and material comparisons.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided text.

The information relevant to the device's acceptance is found in the "Non-clinical Testing" section:

Non-clinical Testing Summary:

• Device Tested: Omni Foot and Ankle Plating System (new plate geometries and 3.5mm headless cannulated screws).
• Comparison:
  • New plate geometries compared to existing Omni Foot and Ankle System plates and ARIX Foot System (2.3/2.8) plates.
  • 3.5mm headless cannulated screws compared to predicate Omni 3.5mm cannulated screws and Extremity Medical Compression Screw.
• Methodology: Engineering analysis and compression testing for the locking compression slot.
• Conclusion: The analysis indicated that the Omni Foot and Ankle Plating System is equivalent to predicate devices and does not introduce new issues of safety or effectiveness.

Key takeaway from the document regarding "acceptance":

The acceptance of this device by the FDA is based on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance data (engineering analysis and mechanical testing), rather than clinical studies or the type of AI/ML performance evaluation described in your prompt.

Specifically, for a non-AI/ML device like this, the "acceptance criteria" revolve around aspects such as:

• Material Equivalence: Meeting ASTM standards (F67 and F136) for unalloyed Titanium and Titanium Alloy (Ti-6AL-4V).
• Design Equivalence: Demonstrating that new geometries, dimensions, and features (like the locking compression slot) are comparable to predicate devices.
• Mechanical Performance Equivalence: Ensuring the device performs similarly to predicates in terms of strength, compression, and stability, as demonstrated through engineering analysis and testing (e.g., compression testing).
• Intended Use Equivalence: The indications for use must be substantially similar to the predicate devices.

Since the request is specific to an AI device and the provided text is for a traditional surgical implant, much of the requested information is not applicable. If you are looking for an example of an AI/ML device approval, this document is not suitable.

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The Omni Foot and Ankle Plating System is intended for use in internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

The Omni Foot and Ankle Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.

The provided text is for a 510(k) premarket notification for a medical device called the "Omni Foot and Ankle Plating System." This document does not describe the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered device. Instead, it details the regulatory process for establishing substantial equivalence to previously cleared devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics for an AI/ML powered device from the provided text.

The document explicitly states: "No clinical testing was performed." and relies on "engineering analysis" for comparison to predicate devices, which is typical for non-AI/ML mechanical devices.

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