Search Results

The VASSALLO GT EXT guide wire accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure. This device is intended for peripheral vascular use only.

The VASSALLO GT EXT Guide Wire Extension accessory is used to elongate the working length of compatible peripheral extendable wires. The stainless-steel guide wire extension has an outer diameter of 0.014" (0.36 mm) and a length of 165 cm. The distal end consists of a pipe shaped nitinol-titanium connection port (extension tube). The straight stainless steel wire surface is coated with PTFE. The extension wire is intended to connect with a FILMECC peripheral guide wire shorter than 300 cm. The total length of the system after connection will be 300 cm to 400 cm.

The provided text describes the 510(k) premarket notification for the FILMECC VASSALLO GT EXT guide wire extension. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on performance against specific acceptance criteria for an AI/ML-driven diagnostic or prediction system.

Therefore, the information required to populate the fields related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size, expert ground truth, MRMC study, standalone performance) is not present in the provided document.

The document states:

• Non-clinical testing/performance data: "Non-clinical laboratory testing was performed on the VASSALLO GT EXT to determine substantial equivalence. Testing involved evaluating the joint strength of the extension tube and core wire of extension wire in addition to the joint strength of the extension tube and the core extension wire. The in vitro bench tests demonstrated that the VASSALLO GT EXT met all acceptance criteria and that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device."

This indicates that the acceptance criteria are related to physical performance characteristics (like joint strength) of the guide wire extension and that in vitro bench tests were conducted to demonstrate these. However, the specific quantitative acceptance criteria or the detailed results of these tests (e.g., numerical values for joint strength, performance vs. predicate) are not detailed in this summary.

Given the nature of the device (a guide wire extension, not an AI/ML diagnostic tool), the typical questions about AI/ML device evaluation (like expert readers, MRMC studies, training/test set ground truth for algorithms) are not applicable to this submission.

In summary, based only on the provided text, I cannot complete the requested tables and information fields because:

• The device is a physical medical device (guide wire extension), not an AI/ML or diagnostic device that would involve typical "acceptance criteria" in terms of classification performance (e.g., sensitivity, specificity, AUC) or human reader performance.
• The "acceptance criteria" mentioned are for engineering/performance bench tests (e.g., joint strength), not diagnostic accuracy.
• The document states "in vitro bench tests demonstrated that the VASSALLO GT EXT met all acceptance criteria," but it does not specify what those criteria are or provide the results of those tests.
• There is no mention of a test set, expert ground truth, MRMC study, or training set in the context of an AI/ML system.

To provide the requested information, the 510(k) submission's detailed test reports for the physical properties of the guide wire extension would be needed, not just this summary.

Ask a specific question about this device