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The CurvaFix® IM System is intended for fixation of fractures of the pelvis.

The CurvaFix IM System is a collection of flexible intramedullary devices for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the IM Implant from a flexible to rigid state after implantation. The IM Implant can be returned to a flexible state should device explant be required. The implants are available in two diameters (7.5mm and 9.5mm) and lengths ranging from 90mm to 180mm to accommodate a variety of anatomic requirements.

The provided text does not contain information about an AI/ML medical device. The document is a 510(k) premarket notification for a medical device called the "CurvaFix IM System," which is a collection of flexible intramedullary devices for pelvic fracture fixation.

Therefore, I cannot provide details on:

• A table of acceptance criteria and reported device performance (for an AI/ML device)
• Sample sizes for test sets or data provenance
• Number of experts or their qualifications for ground truth establishment
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size
• Standalone algorithm performance
• Type of ground truth used
• Training set sample size
• Method for establishing ground truth for the training set

The document primarily focuses on the mechanical performance and substantial equivalence of the CurvaFix IM System to a predicate device, based on non-clinical performance data and simulated use studies in cadaver models. It states that "The worst-case configuration of CurvaFix IM Implant met all established acceptance criteria for mechanical testing that were based upon performance of the primary predicate device." However, these acceptance criteria are related to the physical properties and function of the implant, not the diagnostic performance of an AI/ML algorithm.

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