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The ATLAS™ Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bone fragments in adult and pediatric patients.

The ATLAS™ Plating System is a metallic plate and screw system for treatment and fixation of fractures, fusions and osteotomies of bones in the Foot, Ankle, Hand, and Wrist.

The plates are available in different geometries to accommodate different patient and bone anatomies. The plates are made from Titanium alloy (Ti-15Mo Allov per ASTM F2066-18).

The screws are available in different diameters from Ø2.7mm to Ø5.5mm, non-locking or locking configurations with lengths ranging from 8mm to 60mm. All screws are manufactured from Titanium alloy (Ti-6Al-4V ELI per ASTM F136-13).

Implants are single use and the system is provided non-sterile.

The provided text describes a medical device, the ATLAS™ Plating System, and its regulatory clearance. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the context of an AI/ML algorithm.

The document is a 510(k) summary for a metallic bone fixation system, which is a physical implant, not a software or AI/ML device. The "performance data" section (Section IX) refers to mechanical testing of the screws and plates (ASTM F543 and F382) to demonstrate the physical integrity and strength of the hardware. These are standard engineering tests for orthopedic implants.

Therefore, I cannot fulfill the request for information related to AI/ML algorithm acceptance criteria and study details because the provided document is not about an AI/ML device.

Here's why the requested information isn't present:

• No AI/ML Component: The device, "ATLAS™ Plating System," is described as a "metallic plate and screw system." There is no mention of software, artificial intelligence, machine learning, image analysis, or any digital diagnostic component.
• Mechanical Performance Data: The "performance data" cited are ASTM standards for mechanical testing of screws and plates, which are physical tests, not evaluations of an algorithm's accuracy or efficacy.
• Regulatory Pathway: A 510(k) for a traditional hardware device like this focuses on substantial equivalence to existing predicate devices based on materials, design, and physical performance. It does not involve the types of clinical performance studies and ground truth establishment required for AI/ML devices.

If you have a document pertaining to an AI/ML medical device, please provide that, and I would be happy to analyze it against your criteria.

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