Search Results

GazelleTM PTFE (polytetrafluroethylene) suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including; cardiovascular, dental, general surgical procedures and repair of the dura mater. Gazelle™PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. GazelleTM PTFE suture and Delivery Device is provided sterile as a single use device.

The Gazelle PTFE surgical sutures are monofilament surgical sutures composed from expanded polytetrafluoroethylene (ePTFE) material. They are attached to a standard stainless steel surgical needle. The Gazelle Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The PTFE suture is loaded into the Gazelle Delivery Device and is delivered to the desired location through the Gazelle device tip by pressing the actuation button on the Gazelle device handle.

The provided document describes the FDA 510(k) premarket notification for the "Gazelle PTFE Suture and Delivery Device." This document details the device's characteristics, intended use, and a summary of performance data to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing AI performance or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria and a study proving a device meets these criteria, specifically in the context of AI performance, human reader improvement, and ground truth establishment, cannot be extracted from this document.

The document does provide information pertinent to medical device approval, such as:

• Device Name: Gazelle PTFE Suture and Delivery Device
• Regulation Number and Name: 21 CFR 878.5035, Nonabsorbable expanded polytetrafluoroethylene surgical suture
• Regulatory Class: Class II
• Product Code: NBY
• Predicate Device: Riverpoint Medical MONOTEX PTFE Suture – K140415
• Indications for Use: General soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures, and repair of the dura mater. Not indicated for microsurgery, ophthalmic procedures, or peripheral neural tissues.
• Performance Data General Statement: "Gazelle PTFE Surgical Sutures meet the requirements specified in FDA's Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA". It also states that "the PTFE suture has passed performance testing, including mechanical testing in accordance to USP for nonabsorbable suture and biocompatibility testing of the suture material in accordance with ISO 10993-1. Packaging and sterilization validation and shelf life testing have been successfully performed. The Gazelle Delivery Device was tested for Button Push Force, Distal Tip / Shaft Pull Force, Handle / Shaft Pull Force, Stylet / Button Pull Force and underwent surgeon evaluation."

However, none of this information relates to an AI/ML-based device or a study involving human readers and ground truth for diagnostic accuracy, which are the prerequisites for answering the specific questions about acceptance criteria and study design for AI-driven technologies.

Ask a specific question about this device