(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.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized image of a person's head inside of a circle. To the right of the word is a small circle with an R inside, indicating that the word is a registered trademark.
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
(610) 647-9700 Contact: Angela J. Silvestri August 1, 1995
Synthes Titanium Limited Contact-Dynamic Hip Screw Implant (Ti. LC-DHS) is compared to Synthes Limited Contact Dynamic Hip Screw (LC-DHS) Implant and Synthes Dynamic Hip Screw (DHS) Implant.
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.
Synthes DHS is 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 stainless steel.
Synthes will provide the Ti. LC-DHS sterile or non-sterile. Sterile devices will be gamma radiated. Of course, non-sterile devices must be sterilized prior to use, Recommended Sterilization parameters are:
| Method | Cycle | Temperature | Time |
|---|---|---|---|
| Steam | Pre-vacuum | 132° C - 135° C | 6 min. |
| Steam | GravityDisplacement | 132° C - 135° C | 15 min. |
Based on mechanical test results, the Ti. LC-DHS design has been found to be substantially equivalent to the DHS design.
||dt
N/A