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510(k) Data Aggregation
(219 days)
TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)
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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