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The Arthrex 3.5 mm Locking Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.

The Arthrex 3.5 mm Locking Compression Plates consists of a series of varying lengths. The Arthrex 3.5 mm Locking Compression Plates range from 70 mm to 278 mm in length and 3.5 mm in thickness. Each plate provides locking screw fixation. The proposed plates are manufactured from Titanium Alloy (ASTM F136) and Stainless Steel (ASTM F138). The proposed plates are sold as sterile (Gamma), single-use, and non-sterile, single-use.

The provided document is a 510(k) premarket notification for a medical device: Arthrex 3.5 mm Locking Compression Plates (K222244). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a new AI-powered diagnostic device meets specific performance criteria.

Therefore, the information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies, is not present in this document. This is because the device described is a physical implant (bone fixation plates), not an AI/medical imaging diagnostic system.

The document describes material testing and mechanical performance to demonstrate equivalence between the new plates and existing predicate devices.

Here's a breakdown of the relevant information provided in the document:

• Device Type: Arthrex 3.5 mm Locking Compression Plates – a physical metallic implant for bone fixation.
• Purpose of Submission: To obtain 510(k) clearance for the new plates by demonstrating substantial equivalence to a predicate device (K123241: Arthrex Fracture Plates).
• Performance Data: The document mentions physical and mechanical testing, not AI model performance.
  • 4-Point Bend Testing (ASTM F382-17): Conducted to demonstrate statistical equivalence in strength to the predicate device.
  • MRI Force, Torque, and Image Artifact Testing: Performed in accordance with FDA guidance and ASTM standards (e.g., ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213) to evaluate MR compatibility.
  • Bacterial Endotoxins Test (BET): Utilizes the Kinetic Chromogenic Method (ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14) to confirm pyrogen limit specifications for sterile devices.
• No AI, Machine Learning, or Diagnostic Study Details: The document does not contain any information about the acceptance criteria or studies typically associated with AI/ML-driven diagnostic devices. There is no mention of:
  • Sensitivity, Specificity, AUC, or other diagnostic performance metrics.
  • Test/training data sets, their sizes, or provenance.
  • Expert involvement in establishing ground truth for diagnostic purposes.
  • Adjudication methods.
  • MRMC studies.
  • Standalone algorithm performance.

In summary, the provided document relates to the 510(k) clearance of a physical medical device (bone plates) and therefore does not contain the information required to answer the prompt regarding AI device acceptance criteria and studies.

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