(219 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.