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The AXI+LINE™ Proximal Bunion Correction System is indicated for fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments in the foot and ankle.

The AXI+LINE™ Proximal Bunion Correction System is a plate system made from Titanium alloy. The geometry of the plate is that of a modified semi-tubular bone plate with a correction angle between the proximal and distal plate segments. The system also includes non-locking cortical and locking screws also made from Titanium alloy and necessary surgical site preparation and insertion instruments as a procedure pack.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "AXI+LINE™ Proximal Bunion Correction System."

The information provided does not describe an AI/ML-based device or a study involving human readers or algorithmic performance metrics typical for AI/ML validation. Instead, it describes a traditional orthopedic implant device.

Therefore, I cannot extract the requested information about acceptance criteria for an AI device, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided document.

The "Safety and Performance" section of the 510(k) Summary (page 4) details the mechanical testing performed for this physical device, which involves:

• Finite Element Analysis (FEA): Used to determine the worst-case plate configuration for static and dynamic four-point bend testing.
• Mechanical Testing: Performed according to recognized standards:
  • ASTM F-382: Static and dynamic 4-point bend testing of the AXI+LINE™ Proximal Bunion Correction System plate.
  • ASTM F-543: Axial push-out, insertion torque, and torque to failure testing of the locking and non-locking bone screws.
• Biocompatibility: Not performed, as the device is made from standard medical Titanium alloy (ASTM F136), which has a long history of successful use in similar orthopedic indications and is the same material as a predicate device (Nextremity MSP Metatarsal Shortening System).

The acceptance criteria for such a device would typically be that the device meets or exceeds the mechanical performance requirements defined in the referenced ASTM standards (F-382 and F-543), demonstrating equivalence to predicate devices and being safe and effective for its indicated use. The document states that the testing demonstrated the device to be "substantially equivalent to predicate devices" based on indications for use, technological characteristics, and performance testing.

In summary, the provided document is for a physical medical implant, not an AI/ML software device. The questions relate to AI/ML validation, which is out of scope for this document.

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