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Synthes Ti. LC-DHS is a sliding hip screw plate device, intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.

Synthes Ti. LC-DHS is a sliding hip screw plate device, intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. The device is manufactured from a Titanium Allov.

This document describes a medical device, the Synthes Titanium Limited Contact-Dynamic Hip Screw Implant (Ti. LC-DHS), and asserts its substantial equivalence to existing Synthes devices (LC-DHS and DHS). However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of AI or algorithm-driven assessment.

The provided text focuses on:

• Device Description: The Ti. LC-DHS is a sliding hip screw plate device made of Titanium Alloy, intended for treating specific hip fractures.
• Comparison: It's compared to existing Synthes DHS and LC-DHS implants, which are made of stainless steel.
• Sterilization: Details on sterilization methods are provided.
• Substantial Equivalence: The key statement is: "Based on mechanical test results, the Ti. LC-DHS design has been found to be substantially equivalent to the DHS design."

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance in the context of an AI or algorithmic medical device, as the provided text pertains to a physical orthopedic implant and its mechanical equivalence, not a software-based or AI-driven system.

If you have a document describing an AI/algorithmic medical device, please provide that, and I would be happy to analyze it according to your requested criteria.

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