(69 days)
Sil Tec Medical Grade Silicone Sheeting is suitable for external use or short-term mplantanon (30 days or less). Sil-Tec sheeting is intended for modification with a scalpel or scissors, by the surgeon or medical practical practions patientspecific applicanons. Patient selection and suitability is up to the surgeon/medical practioner user The surgeon/medical practitioner user must rely on his or her own best medical judgment and training as to the use of this device.
The following are some indications where silicone sheeting bas been successfully employed Surgical repairs, anchoring device for hemodialysis shunts; temporary covering for a presentally ruptured omphalocele during staged repair of wethral strictures; protective to help facilitate neural regeneration and tendon healing, surgical repair of fractured orbital floors; to prevent soft tissue fibrosis or bony michlosis following surgical correction of trismus (Waming Note: Not for permanent use in the presence of degenerative bone changes, chronic bruxism, or temporomandibular 1011 applications); other surgical procedures; and as insulating material for recoveramulation.
It is the surgeon/medical practitioner users responsibility to thoroughly test any products made in part or otherwise incorporating Sil-Tec medical grade sheeting to determine the acceptability of the products performance in a specific application.
Sil-Tec Sheeting
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA for a medical device called "Sil-Tec Sheeting" and does not contain the specific information requested about acceptance criteria, device performance, study details, ground truth, or sample sizes.
The document primarily focuses on:
- The FDA's decision of substantial equivalence for the "Sil-Tec Sheeting" device.
- Regulatory classifications and general controls applicable to the device.
- Indications for Use for the device.
Therefore, I cannot extract the requested information from this document.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.