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The Minimally Invasive Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

The Minimally Invasive Bunion Plating System consists of left and right plates composed of implant grade titanium intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. The system will incorporate both locking and non-locking screws, cannulated screws, and the necessary instruments to facilitate the placement of these implants.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the "Minimally Invasive Bunion Plating System". It aims to establish substantial equivalence to a legally marketed predicate device, not to prove the device meets specific acceptance criteria through a study demonstrating performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document for the following reasons:

• No Acceptance Criteria or Performance Study: This document does not describe acceptance criteria related to a specific performance study (e.g., accuracy, sensitivity, specificity, or clinical outcomes) for the device's function in terms of an AI/algorithm. This is a traditional medical device (bunion plating system), not an AI/algorithm device. The "acceptance criteria" here are the FDA's regulatory criteria for market clearance (substantial equivalence), not performance metrics against a clinical ground truth.
• No Clinical Study Performed: The document explicitly states under Section V. "Clinical Test Summary": "No clinical studies were performed." This means there is no study data to report for points 1, 5, 6, 7, 8, or 9.
• Focus on Substantial Equivalence: The entire submission is built on demonstrating substantial equivalence to a predicate device based on similarities in intended use, design, materials, and mechanical safety/performance, supported by non-clinical (mechanical) testing. It does not involve a study of an AI/algorithm's performance against a human expert's assessment or a defined ground truth.

Therefore, I cannot populate the requested table or answer the specific questions about AI/algorithm performance studies. The information provided is for a physical medical device (bone plates and screws), not a software/AI device.

The "Non-Clinical Test Summary" section mentions:

• Non-Clinical Test Summary:
  • Single Cycle Bend Testing referencing ASTM F382
  • Dynamic Bend Testing referencing ASTM F382
  • "The results of these evaluations indicate that the Minimally Invasive Bunion Plating System is equivalent to the predicate devices."

This is the extent of "testing" mentioned, and it pertains to mechanical properties, not an AI's diagnostic or predictive performance.

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