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Apollo™ Ankle Fracture Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

• · Lateral Malleolar Fractures
• Syndesmosis Injuries
• · Medial Malleolar Fractures
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• · Vertical Shear Fractures of the Medial Malleolus
• Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• Medial Malleolar Avulsion Fractures
• · Lateral Malleolar Avulsion Fractures

Apollo Locking Screws are intended for use with Apollo's Plating Systems.

Apollo non-Locking Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Apollo washer is intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of bone fragments.

Apollo 1/3 tubular plates are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repar, and fracture fixation, appropriate for the size of the device.

ApolloTM Ankle Fracture Plating System consists of implantable components that will be include an array of Titanium alloy Ti-6AL-4V ELI (ASTM F3001) / PEEK plates and locking and non-locking screws.

The screws are offered in configurations that include a range of Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws. A variety of instrumentation is offered as part of the kit to facilitate delivery of the implants. The implantable devices are provided sterile via Gamma irradiation.

The provided text describes a 510(k) premarket notification for a medical device called the "Apollo™ Ankle Fracture Plating System." This document primarily focuses on establishing substantial equivalence to legally marketed predicate devices, rather than an AI/ML-based device requiring extensive clinical validation with specific acceptance criteria related to algorithmic performance.

Therefore, the information required to answer your prompt, such as acceptance criteria for AI performance, details of a study proving device performance against such criteria, sample sizes for test/training sets, expert consensus, and MRMC studies, is not present in the provided document. The document details the physical testing of the device's components (plates and screws) to ensure mechanical equivalence to predicate devices, but does not involve a study for an AI/ML device.

The closest relevant sections in the provided text are:

• Performance Data: This section mentions mechanical testing of the plates and screws (e.g., ASTM F382, ASTM F543, ASTM F1264) to demonstrate equivalence to predicate devices. This is not a study on AI/ML performance.
• Conclusion: States that the device is substantially equivalent based on intended use, indications for use, technological characteristics, materials, and comparison to predicate devices, implying that the performance is considered acceptable through this equivalence.

In summary, the provided document does not contain the information requested in your prompt as it pertains to a mechanical medical device, not an AI/ML diagnostic or assistive device that would have such acceptance criteria and a study design.

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