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The JACE Medical Thoracic Plating System is indicated for use in the stabilization and fixation of fractures of the chest wall including sternal fixation following stemotomy and sternal reconstructive surgical procedures, trauma, or planned osteotomies.

The JACE Medical Thoracic Plating System consists of plates and accessories designed to provide fixation following sternotomy and sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system includes instrumentation which has been specifically designed for use with this system of implant. The system is comprised of an assortment of various plate configurations, locking screws, and accompanying instrumentation. Variants of the plates include flat and pre-contoured concave and convex plates. Plates may be bent to fit patient anatomy. Plates are secured using previously cleared JACE self-drilling locking bone screws (K142484), which are offered in a single diameter of 3.5mm and have a range of lengths from 10mm to 20mm. There are no changes to the screws and they are not within the scope of this 510(k). Like the predicate device, all implant components are manufactured from titanium alloy (Ti-6-Al-4 ELI) per ASTM F136. All implants in the JACE Medical Thoracic Plating System are intended for single use only. The plates, screws, and all associated instrumentation will be provided nonsterile, to be steam sterilized by the end user. MR compatibility has been established.

The provided text is a 510(k) summary for the JACE Medical Thoracic Plating System, a metallic bone fixation device. This document does not describe the acceptance criteria and study proving performance for an AI/ML-driven device. Instead, it details the substantial equivalence review process for a medical implant, focusing on its design, materials, and mechanical performance compared to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device. The document explicitly states:

• "No clinical studies were conducted." This implies that there were no studies performed to demonstrate the device's clinical performance in a human population.
• Performance Testing: The "Performance Testing" section focuses on biocompatibility, magnetic resonance testing, and bench tests (theoretical stress analysis, longitudinal shear-static, lateral distraction-static and cyclic, four-point bending). These are engineering and material science tests, not AI/ML performance evaluations.

The device in question, the JACE Medical Thoracic Plating System, is a physical implant designed for stabilizing and fixing chest wall fractures. It is not an AI/ML diagnostic or therapeutic device, and thus the acceptance criteria and study types applicable to AI/ML would not be relevant to this submission.

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