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The SimpliFix Hip System is intended for fracture fixation of large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to a dynamic hip screw (DHS) in basilar neck fractures.

The SimpliFix Hip System is designed for angular and rotational stability when used for fracture fixation of large bones and large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to DHS in basilar neck fractures.

The system is comprised of Cannulated and Cross Screws that are used together to aid fracture fixation.

I'm sorry, but this document does not contain the information required to answer your request. The provided text is an FDA 510(k) clearance letter for a medical device called the "SimpliFix Hip System."

The document focuses on:

• The FDA's determination of substantial equivalence for the SimpliFix Hip System to legally marketed predicate devices.
• The intended uses (indications for use) of the device.
• A brief device description.
• A summary of performance testing conducted (dynamic screw construct testing, screw performance testing per ASTM F543 and F1264, pyrogenicity testing). This is mechanical performance testing, not clinical/AI model performance.
• Regulatory information about FDA requirements.

There is no mention of:

• Any AI/algorithm component of the device.
• Clinical study data related to acceptance criteria for an AI model.
• Sample sizes for test or training sets for an AI model.
• Expert involvement for ground truth or adjudication methods for AI.
• MRMC studies for AI.
• Stand-alone AI performance.

Therefore, I cannot provide a table of acceptance criteria and device performance for an AI model, nor can I answer the specific questions about the study that proves an AI device meets acceptance criteria, as the document does not relate to an AI device.

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