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The Guidezilla II Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

The Boston Scientific Guidezilla™ II and Guidezilla™ II LONG Guide Extension Catheters act as extensions to traditional guide catheters. The Guidezilla II Guide Extension Catheter enters through the parent guide catheter and extends an additional 15 cm out the distal end of the parent guide catheter, providing physicians with additional support to advance interventional devices into the vasculature. The Guidezilla II Guide Extension Catheter consists of a proximal stainless steel hypotube, which includes a handle used for device identification, and a distal guide catheter segment (25 cm or 40 cm) through which interventional devices may be delivered. The proximal hypotube is connected to the distal guide catheter segment by a small collar. The collar is made of radiopaque platinum iridium material that provides support and a smooth transition from the offset hypotube to the distal guide catheter segment. The distal quide catheter segment incorporates one radiopaque marker band located 2 mm from the distal tip of the device. The radiopaque collar and marker band aid in positioning the device during the procedure. A hydrophilic coating is applied to the distal 20 cm of the device.

The provided text is a 510(k) summary for the Guidezilla™ II and Guidezilla™ II LONG Guide Extension Catheters. It describes the device, its intended use, and a comparison to a predicate device. However, it does not describe an AI/ML-driven device or study that provides acceptance criteria and performance metrics for such a device. The document details performance testing for a physical medical device (catheter) to establish substantial equivalence to a predicate device, as required for FDA clearance.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, or ground truth details) because the document does not pertain to an AI/ML device study.

The document indicates:

• Clinical Testing: "Clinical evaluation was not required for this device." This further confirms that no study of the type requested (MRMC, standalone AI performance, etc.) was conducted or is applicable here.
• Performance Data: The performance data section lists various device performance tests (e.g., Corrosion Resistance, Deliverability, Radiopacity), package performance tests (e.g., Pouch Seal Strength, Sterile Barrier Integrity), and biocompatibility tests (e.g., Cytotoxicity, Sensitization). These are physical and biological tests of the catheter itself, not evaluations of an AI algorithm.
• Ground Truth: The concept of "ground truth" as it relates to expert consensus or pathology for an AI model is not relevant to this document. The "truth" for this device is its physical and biological performance against established engineering and medical device standards.
• Sample Size: Sample sizes are not explicitly mentioned for these physical/biological tests, but they would refer to the number of catheters tested, not patient data.

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