Search Results

The IVT 0.014" PTFE-Coated Trackwire is indicated for use in coronary and peripheral vessels to facilitate the navigation and placement of angioplasty interventional catheters. The 0.014" Trackwire is not indicated for cerebrovascular use.

The IVT 0.014" PTFE-Coated Trackwires have a nominal diameter of 0.014 inches and nominal lengths from 175 to 300 centimeters. The distal 1-3 centimeters of the Trackwire is shapeable. The distal 2-6 centimeters contains a radiopaque coil. The proximal section of the Trackwire is coated with a fluorinated polymer.

The provided document is a 510(k) summary for a medical device, the IVT 0.014" PTFE-Coated Trackwire. It relates to a premarket notification to the FDA for a medical device and not an AI/ML powered device. This type of document is about demonstrating substantial equivalence to existing predicate devices, primarily through physical performance testing and biocompatibility. As such, it does not contain the information requested in your prompt regarding acceptance criteria and studies that prove an AI/ML device meets them.

Specifically, the document does not contain any of the following information:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample size used for the test set or data provenance for an AI/ML model.
• Number of experts used to establish ground truth or their qualifications for an AI/ML model.
• Adjudication method for an AI/ML model test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
• Sample size for the training set of an AI/ML model.
• How the ground truth for an AI/ML training set was established.

The document details the device's description, intended use, and substantial equivalence to physical predicate devices, based on physical performance testing and biocompatibility. It's a regulatory submission for a physical medical product, not a software or AI/ML algorithm.

Ask a specific question about this device

The IVT 11F Guiding Catheter is a standard quiding catheter intended for use in the coronary vasculature as a conduit for other medical devices such as diagnostic and therapeutic catheters and quidewires. Thus, the IVT 11F Guiding Catheter acts to facilitate access for these other medical devices. This device is intended for single use only.

IVT's 11F Guiding Catheter is indicated for use during interventional diagnostic cardiovascular procedures in hospital settings which are appropriate for these types of procedures.

The IVT 11F Guiding Catheter is a series of standard cardiovascular guiding catheters with models corresponding to standard catheter curvature types.

The IVT 11F Guiding Catheter contains a single lumen which acts as a conduit to provide access for other medical devices to the coronary vasculature. The device's proximal end contains a polycarbonate female luer fitting which can be connected to other equipment used in cardiovascular procedures. The 11F Guiding Catheter device is offered in a catheter working length of 94 cm. The shaft is designed with a braided wire reinforcement and can include side holes to enable vessel perfusion during placement. The 11F Guiding Catheter's distal end is shaped to accommodate various anatomic configurations. The 11F Guiding Catheter curvatures include the FL 3.5, FL 4.0, FL 5.0, FR 3.5, FR 4.0, FR 5.0, Multi-purpose Graft, Modified Amplatz, Left Amplatz, Right Coronary Bypass, and Hockey Stick standard catheter shape types. The distal tip of the device is a "soft" tip design.

All IVT 11F Guiding Catheter device packaging configurations are supplied as sterile devices and intended for single use only.

This looks like a 510(k) premarket notification for a guiding catheter, not a study describing the acceptance criteria and performance of an AI/ML device.

Therefore, the requested information fields (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training) are not applicable to the provided text.

The document discusses substantial equivalence to predicate devices based on:

• Intended Use, Indications for Use: Similar to predicate devices.
• Materials and Design: Similar to predicate devices.
• Technical Characteristics: Do not introduce new questions regarding safety or effectiveness.
• Labeling: Similar to predicate devices.
• Biocompatibility and Physical Performance Testing: These tests demonstrate the device to be safe and effective, though specific acceptance criteria and results are not detailed in this summary.

In summary, there is no AI/ML device described in this document, and thus no AI/ML performance study to analyze for acceptance criteria.

Ask a specific question about this device

The IVT 0.014" TRACK is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.

The IVT 0.014" TRACK is constructed from Aermet 100 steel core wire that is distally tapered and fitted with a gold alloy coil. To minimize blood vessel trauma and to facilitate maneuverability, the distal tip is extremely flexible. The core is nominally 0.0136" in diameter. The coil, approximately 1.2" in length with a nominal diameter of 0.0136", is made from a single continuous radiopaque gold alloy wire that has two different wind spacings. The core is inserted into the coil lumen and attached at the distal end utilizing a plasma arc technology that brazes the end of the gold alloy coil to the cylindrical bulb. This special process results in the formation of a gold alloy sphere. The proximal end of the coil is secured to the stainless steel core using a silver alloy solder. The IVT 0.014" TRACK will be manufactured in various lengths ranging from 100 to 300 cms. All IVT 0.014" TRACKs will receive a final parylene (poly-para-xylyene) coating prior to packaging and sterilization. Steering or guidance of the wire is achieved by shaping the tip and rotating the proximal end of the wire, thereby transmitting torque along the axis of the core to the flexible tip. This redirects the shaped tip of the IVT 0.014" TRACK allowing selection or avoidance of branch vessels, thus facilitating navigation in tortuous vessels.

This document concerns a medical device (guidewire) and does not contain information about an AI/ML powered device, a study that uses a test set, or human/expert evaluations. Therefore, I cannot provide the requested information about acceptance criteria and study details.

Ask a specific question about this device

The IVT 0.014" Railwire™ is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.

The IVT 0.014" Railwire™ is constructed from a stainless steel core wire that is distally tapered and fitted with a gold alloy coil. To minimize blood vessel trauma and to facilitate maneuverability, the distal tip is extremely flexible. The core is nominally 0.0136" in diameter. The coil, approximately 1.2 * in length with a nominal diameter of 0.0136", is made from a single continuous radiopaque gold alloy wire that has two different wind spacings. Both the core and coil are single continuous pieces that are secured together at two points. The core is inserted into the coil lumen and attached at the distal end utilizing a plasma arc technology that brazes the end of the gold alloy coil to the cylindrical bulb. This special process results in the formation of a gold alloy sphere. The proximal end of the coil is secured to the stainless steel core using a silver alloy solder. This design provides both unibody integrity and flexibility. The IVT Railwire™ will be manufactured in various lengths ranging from 100 to 300 cms. All Railwire™s will receive a final parylene (polypara-xylyene) coating prior to packaging and sterilization. Steering or guidance of the wire is achieved by shaping the tip and rotating the proximal end of the wire, thereby transmitting torque along the axis of the core to the flexible tip. This redirects the shaped tip of the Railwire™ allowing selection or avoidance of branch vessels, thus facilitating navigation in tortuous vessels.

This document describes a medical device, the IVT 0.014" Railwire™, a guidewire. It does not contain information about studies related to AI/ML device performance, acceptance criteria, or ground truth establishment as it predates modern AI/ML medical device evaluations. The request for information such as "acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are all related to the evaluation of AI/ML-driven devices.

Therefore, since the provided text describes a physical medical device (a guidewire) and not an AI/ML-driven device, the requested information (acceptance criteria, study details, expert involvement, and ground truth for AI/ML evaluation) is not applicable or available within the given document.

The document discusses:

• Device Description: Construction materials (stainless steel, gold alloy coil), dimensions, coating (parylene), and mechanism of steering.
• Intended Use: To facilitate navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.
• Substantial Equivalence: Comparison to predicate guidewire devices (IVT 0.014" Guidewire, IVT 0.014" Peripheral Guidewire, Cook Family of Guidewires) based on intended use, materials, design, technical characteristics, labeling, biocompatibility, and physical performance testing.

It concludes that the device is safe, effective, and substantially equivalent to similar marketed devices based on these traditional medical device evaluation standards.

Ask a specific question about this device