Search Results

The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, to maintain patency and reduce the need of post-operative intervention surgery. The composite stent is intended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steady support of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction by adhesions. The stent can be removed at any time within 28 days by cooling and self-crimping.

The subject device is supplied sterile for single use. The composite removable sinus stent provides sinus wall support following functional endoscopic sinus surgery. A delivery system is provided to insert the implant. The system contains the following components: Stent: The stent is balloon expandable and composed of an outer polyurethane and inner Nitinol alloy bodies. The stent is designed to accommodate the size and variability of the post-surgical ethmoid cavity anatomy. Once expanded the stent is designed to support the walls of ethmoid cavity, in order to prevent adhesions and middle turbinate lateralization into the septum. Stent can be removed within 4 weeks by cooling and self-crimping. Delivery System: The delivery system is designed to insert, position and deploy the stent, following functional endoscopic sinus surgery, guided by endoscopic direct vision. The delivery system consists of a water filled syringe connected to high compliance low pressure balloon via rigid shaft. The balloon is supplemented with color marker.

The provided text describes the "Composite Removable Sinus Stent System" and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or study results in the format requested for an AI/CADe device.

This document is a 510(k) summary for a physical medical device (a sinus stent), not an AI/CADe (Computer-Aided Detection/Diagnosis) device. Therefore, the questions related to AI/CADe performance, such as sample sizes for test/training sets, expert consensus for ground truth, or MRMC studies, are not applicable to the information provided.

The document discusses various tests for the sinus stent, including:

• Bench Testing: Covered aspects like stent integrity, dimensions, functional tests, crush resistance, radial strength, corrosion resistance, delivery system integrity, dimensional verification, repeat inflation, crossing profile, and simulated use. It states, "Bench testing met all acceptance criteria of the Design Verification tests and complied with 311001 Composite Removable Stent System Specifications." However, the specific acceptance criteria values and the reported device performance values are not detailed in a table.
• Biocompatibility Testing: Conducted according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, and chemical characterization. It concludes the device is biocompatible.
• Animal Study (GLP): Involved 5 sheep with 10 implanted stents and 10 control sites. Evaluated safety and feasibility through macroscopic and histological analysis after 4 and 6 weeks. Concluded no adverse local tissue effects and safe implantation for up to 28 days.
• First in Man Clinical Study: Involved 15 patients with 29 successfully implanted and removed stents. Evaluated complications, adverse events, inflammatory reaction, healing, adhesion/restenosis rate, pain, discomfort, and SNOT-20 scores. Concluded no complications, lower inflammation, faster healing, lower adhesion/restenosis, and improved patient experience compared to standard of care.
• Sterilization & Shelf Life: Validated according to ISO 11135;2014 for sterilization (SAL 10-6), tested ethylene oxide residuals (met ISO 10993-7:2008), and met Bacterial Endotoxin Test (USP 85). Packaging shelf life established per various ASTM and ISO standards.

Therefore, I cannot populate the requested table or answer the specific AI/CADe related questions based on the provided text. The document focuses on the safety and effectiveness of a physical medical device through traditional engineering and biological evaluations.

Ask a specific question about this device