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The Lunderquist Extra Stiff Wire Guides are intended to facilitate catherization and/or placement of devices during vascular diagnostic procedures and vascular interventional procedures. The Lunderquist Extra Stiff Wire Guides are intended for use in the major vessels, the aorta and vena cava, including their access vessels and adjacent vessels.

Straight (TSMG-/-LES) and Curved (TSCMG-/-LES) Lunderquist® Extra Stiff Wire Guide. PTFE-coated stainless steel wire guides with lengths ranging from 90 cm to 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil for enhanced visibility. The J-curve radius for the curved wire guides is either 3 mm or 7 mm.

Double curved (TSCMG-/-LESDC) and extended double curved (TSCMG-/-E-LESDC) Lunderquist® Extra Stiff DC Wire Guide. PTFE-coated stainless steel wire guides with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. TSCMG-/-LESDC has a primary/secondary curve radius on 75/15 mm, and TSCMG-/-E-LESDC has an extended primary/secondary curve radius on 55/15 mm.

The Lunderquist® Extra Stiff Wire Guide is used both to assist in anatomical access for other devices (notincluded) and to support the delivery of medical devices. The wire guide is introduced into the target vessel; other devices, such as a sheath, catheter, stent, or endo vascular graft can then be passed over the wire guide to be positioned or manipulated within the vascular system.

The Lunderquist® Extra Stiff Wire Guides are available in different lengths, shapes, etc. to accommodate different anatomical applications.

The provided document, a 510(k) premarket notification for the Lunderquist Extra Stiff Wire Guides, does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.

The document states that the purpose of the submission is to "clarify the intended use statement and update device labeling based on postmarket surveillance information." It explicitly mentions:

"No changes to the design, materials, manufacturing, sterilization, or principles of operation have been introduced with the subject devices. Therefore, performance testing was not warranted, and testing provided for the predicate device (K171513) remains applicable."

This indicates that new performance testing, particularly for the type of criteria and study you're asking about (which are typical for AI/ML device evaluations), was not conducted for this submission because the device itself and its function have not changed. The device is a physical catheter guide wire, not a software algorithm.

Therefore, I cannot provide the requested information based on the given text. The questions you've posed relate to the validation of AI/ML models, which is not applicable to a submission for a physical medical device like a wire guide, especially one where no design changes have been made.

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The device is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide is needed.

The subject device, the Lunderquist Extra Stiff DC Wire Guide with an extended double curved tip, is considered a line extension of the predicate Lunderquist Extra Stiff DC Wire Guides. The subject device is a PTFE-coated 0.035 inch stainless steel wire with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. The length of the device is either 260 cm or 300 cm and the J-curve radius is 15 mm. The devices have the body and stiffness required to control large diameter, stiff devices without causing damage to the patient's anatomy or the lumen of the delivery system.

The provided text describes a 510(k) premarket notification for a medical device, the Lunderquist Extra Stiff Wire Guide. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria in the manner of an AI/software device.

Therefore, the information required to answer your questions regarding acceptance criteria and a study proving device capability, specifically for an AI device, is not present in this document. This document pertains to a traditional medical device (a guide wire), not an AI-powered device.

Here's why the required information is absent:

• Type of Device: The Lunderquist Extra Stiff Wire Guide is a physical medical instrument. The questions you've posed (acceptance criteria for AI, training sets, adjudication, MRMC studies, ground truth establishment) are relevant to the validation of AI/Machine Learning devices.
• Regulatory Pathway: A 510(k) submission for a physical device emphasizes performance data to show the device functions as intended and is as safe and effective as a legally marketed predicate device. This is different from the rigorous clinical validation required for many AI/ML-based medical devices, which would involve the type of studies you're asking about.
• Performance Data Provided: The "Performance data" section (page 5) lists various physical tests (Biocompatibility, Surface test, Tape adhesion, Friction, Flexing, Peak tensile force, Ultrasound test, Simulated Use Test, Torque test). These are standard engineering and material tests for a wire guide, not AI model performance metrics. Each test simply states "The predetermined acceptance criteria were met," without detailing what those criteria were or specific performance values.

In summary, this document does not contain the information needed to answer your questions about acceptance criteria and study data for an AI device.

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