(57 days)
Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central ridence obsphagetee trachea and main bronchus), and arrways (Such as trictures due to tumors (Trachea and main bronchus) .
Compression or strictures due to tumors (trachea and main bronchus) Stenosis of the central airways (such as trachea and main bronchus) Tracheo Esophageal fistula
Airway complications such as-anastomosis and stenosis
The Rusch Polyflex Stent Kit consists of a medical silicone file Rusch folyrica beene core along with the components Suppored by insert the device into the human body. These required to inocre one he Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper.
This amendment changes the material of the Insertion ffirs amending to adds indicator markings to the stent and provides for a non-sterile version.
The provided text is a 510(k) summary for the Rusch Polyflex Stent Kit. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study demonstrating that the device meets specific acceptance criteria through clinical trials and data analysis.
Therefore, the input does not contain information about:
- Acceptance criteria in the context of a clinical performance study.
- A study proving the device meets acceptance criteria.
- Reported device performance against acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established.
The prompt asks for details that are typically found in clinical evaluation reports or performance studies, which are not present in this 510(k) summary. A 510(k) is primarily focused on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety/effectiveness based on comparison to existing predicate devices, rather than presenting a detailed clinical performance study with acceptance criteria.
Therefore, it is impossible to extract the requested information from the provided text.
§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”