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The Tunnel CC is intended to be used with a guidewire to access discrete regions of the peripheral vasculature and to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

The Tunnel CC is a single lumen, over-the-wire endovascular catheter. The design consists of a layered tubing configuration with a hydrophilic, lubricious coating on the distal end to reduce frictional forces. The center stainless steel (SS) tubing which drives functionality including buckling resistance is cut in a continuous spiral jigsaw pattern along most of the length; it ends with longitudinal laser cuts at the distal end enabling the formation of a smooth, tapered tip that is continuous with the shaft body of the catheter. This center SS tube is sandwiched between two polymer tubes where the inside layer is PTFE and the outside layer is PEBAX. A luer hub at the user end allows flushing of saline solutions or contrast media through the inner lumen and facilitates guidewire exchanges. This device comes in 0.014", 0.018" and 0.035" guidewire compatible sizes and lengths of 90cm, 135-cm, 155-cm and 170-cm for each quidewire size.

The catheters are used to navigate tortuous peripheral vasculature while providing axial stability to enhance guidewire and device crossing of discrete lesions of the peripheral vasculature. The catheters are also used to allow for guidewire exchanges and provide a conduit for delivering saline solutions and contrast media.

The provided document is a 510(k) summary for the Tunnel Crossing Catheter (Tunnel CC). It describes non-clinical performance testing conducted to support substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms with ground truth determination. Therefore, many of the requested categories for a study involving AI performance or human reader analysis are not applicable to this document.

However, I can extract the relevant information regarding acceptance criteria and performance data for this device as it pertains to non-clinical testing.

Here's the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions that the device was evaluated in nonclinical testing "in accordance with FDA's recognized standards and pre-established acceptance criteria" and that "in all instances, the Tunnel CC functioned as intended." Specific quantitative acceptance criteria are not detailed in this summary; rather, it refers to compliance with ISO standards and successful completion of various tests.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for each bench or simulated use test. It refers to "nonclinical performance testing." Data provenance is from internal testing conducted by Tractus Vascular, LLC to support the 510(k) submission. This is retrospective testing performed on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert-established ground truth for a diagnostic task. The testing involved objective physical and performance characteristics of a medical device according to established engineering and medical device standards.

4. Adjudication method for the test set

Not applicable. There was no adjudication process as it was not a diagnostic study requiring interpretation of results by multiple experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. It is a physical medical device.

7. The type of ground truth used

For the non-clinical performance tests, the "ground truth" essentially refers to:

• Compliance with recognized standards: ISO 10993, ISO 10555-1, ISO 594-1.
• Meeting pre-established design specifications: For characteristics like tracking, flexibility, torquability, guidewire exchange, buckling resistance, kink resistance, and ability to cross a mock lesion. This would be determined by objective measurements and functional tests against engineering requirements.
• Equivalency to predicate devices: The primary goal of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate.

8. The sample size for the training set

Not applicable. There is no training set for an algorithm as this is a physical medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

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The Tractus CSC is intended to be used during interventional procedures in the peripheral vasculature to support a guidewire and facilitate access in discrete regions, allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.

The CSC consists of a family of single-lumen, over-the-wire catheters offered in a variety of sizes for compatibility with a range of guidewire and sheath sizes as well as effective lengths. The subject device is a 0.035" guidewire compatible catheter with a 4.5 Fr crossing profile and available effective lengths of 90, 135, 155, and 170 cm. The catheters are used to navigate tortuous peripheral vasculature while providing axial stability to enhance guidewire crossing of discrete lesions of the vasculature. The catheters are also used to allow for quidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.

The CSC consists of an outer, inner, and center tubing configuration. The outer tubing of the CSC consists of Pebax with hydrophilic coating on the distal end of the catheter to reduce frictional forces and enhance tracking. The inner tubing consists of a PTFE liner and Pebax. The center tubing is spiral laser cut stainless steel. This design provides catheter flexibility, kink resistance and torsional strength while also providing axial stability to support a guidewire and allow for quidewire placement across discrete lesions for further percutaneous intervention, such as angioplasty or stent placement. The distal tip of the catheter, which is stainless steel covered with Pebax and is continuous with the stainless steel center tubing of the catheter, has a smooth, rounded, and tapered profile that provides a seamless catheter-to-guidewire transition.

All effective lengths of the CSC include three radiopaque marker bands that are evenly spaced 10cm apart along the distal end of the catheter including one radiopaque marker band within 4mm of the distal end of the catheter for fluoroscopic visualization of the distal tip. In addition to providing hub-to-tip visualization of the catheter, the marker bands assist in catheter positioning and aide in estimating geometry within the vascular system for subsequent therapies, such as PTA and/or stenting. The proximal end of the catheter includes a luer hub to allow for quidewire passage, flushing saline solution or contrast media through the inner lumen of the catheter, and to facilitate guidewire exchanges.

To use the device, the inner lumen of the catheter is flushed with saline until the solution exits the distal end of the device prior to use. The appropriate size quidewire is inserted into the distal end of the catheter and the catheter is advanced over the guidewire and through a sheath using standard interventional techniques. Under fluoroscopic guidance, the catheter is tracked to the target site within the vasculature and utilized to support guidewire access across discrete areas of the vasculature using standard interventional techniques. For guidewire exchanges, standard interventional techniques are used. Saline or contrast media can be infused into the catheter during operation for flushing and fluoroscopic visualization. Once quidewire access across the target lesion is gained, the catheter is withdrawn using standard interventional techniques.

This document is a 510(k) Premarket Notification for a medical device. It focuses on demonstrating "substantially equivalent" to predicate devices, rather than establishing acceptance criteria and providing performance data of a new and novel device in the format of a typical clinical study report for an AI/ML device.

Therefore, the specific information requested in the prompt, such as acceptance criteria in terms of metrics like sensitivity, specificity, or AUC, sample sizes for test and training sets, expert consensus details, or results of MRMC studies, is not present in this document.

This submission relies on nonclinical testing and comparison to predicates to demonstrate substantial equivalence, rather than a clinical performance study with human subjects, especially not one involving AI/ML.

Here's how this document addresses the performance and acceptance criteria, adapted to the context of a 510(k) submission for a non-AI/ML medical device:

Acceptance Criteria and Device Performance (in the context of a 510(k) for a physical device)

The concept of "acceptance criteria" in this document is primarily focused on the device successfully passing various nonclinical (bench and biocompatibility) tests, demonstrating functionality and safety comparable to legally marketed predicate devices. The "performance" is the successful completion of these tests as intended.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of a table with quantitative performance metrics (like those for an AI/ML device), the acceptance criteria here are qualitative (the device functioned as intended) for a series of nonclinical tests.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: For nonclinical bench testing, the "sample size" refers to the number of devices or components tested for each specific test. This information is not explicitly stated in this summary document.
• Data Provenance: The data provenance is from nonclinical bench testing and biocompatibility testing of the Tractus Crossing Support Catheter itself, conducted by the manufacturer, Tractus Vascular LLC. There is no indication of country of origin for data as it's not patient data. It is inherently "prospective" in the sense that the new device was subjected to these tests.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable in the context of this 510(k) submission. Ground truth for these nonclinical tests is established by standardized testing protocols and comparison to engineering specifications or regulatory standards, not by human experts interpreting clinical images.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-in-the-loop assessments, typically in reader studies for diagnostic devices. For bench testing, the results are typically objectively measured and pass/fail criteria are pre-defined.

5. MRMC Comparative Effectiveness Study

• No. An MRMC study is relevant for evaluating the impact of an AI/ML diagnostic tool on human reader performance. This device is a physical medical device (catheter), not an AI/ML diagnostic.

6. Standalone Performance

• This concept is applicable to AI/ML algorithms. For a physical device, its "standalone performance" is demonstrated through the successful completion of the nonclinical tests listed, showing it functions as intended in laboratory settings.

7. Type of Ground Truth Used

• The "ground truth" for the nonclinical testing is based on pre-defined engineering specifications, international/national standards (e.g., ISO, ASTM for material properties, sterility, etc.), and the successful completion of established biocompatibility protocols.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI/ML model that requires training data.

9. How Ground Truth for the Training Set was Established

• Not applicable. As above, no training set for an AI/ML model is involved.

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The Tractus CSC is intended to be used during interventional procedures in the coronary and peripheral vasculatures to support a guidewire and facilitate access in discrete regions, allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.

The CSC consists of a family of single-lumen, over-the-wire catheters offered in a variety of sizes for compatibility with a range of guidewire as well as effective lengths. The catheters are used to navigate tortuous peripheral and coronary vasculatures while providing axial stability to enhance quidewire crossing of discrete lesions of the vasculature. The catheters are also used to allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.

This document concerns a 510(k) premarket notification for a medical device called the Tractus Crossing Support Catheter (CSC). The information provided is for a traditional medical device and not an AI/ML powered device. As such, the requested information about AI model performance, multi-reader multi-case studies, standalone algorithm performance, and training/test set details related to AI/ML are not applicable.

However, I can provide the relevant information for the nonclinical performance testing conducted for this traditional medical device.

1. A table of acceptance criteria and the reported device performance

The document states that "Functional bench testing was conducted (including demonstrated compliance with relevant standards such as ISO 10555-1 and ISO 594-1)" and "Simulated Use Testing was completed to demonstrate functional performance specifications were met." While specific numerical acceptance criteria and performance results are not detailed in this summary, the overall statement is that the device met these specifications and functioned as intended.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for each test. The tests listed are primarily bench tests and an in-vitro animal study (porcine). Data provenance typical for clinical studies (country of origin, retrospective/prospective) is not applicable here as these are nonclinical performance studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device notification is for a traditional catheter, and performance data is based on nonclinical (bench and animal) testing, not on human expert interpretation of diagnostic images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept applies to clinical studies involving human interpretation or consensus, which is not the nature of the tests performed for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the nonclinical tests, the "ground truth" is defined by established engineering and biological standards, measurement methods (e.g., ISO standards), and physical performance specifications. For instance, biocompatibility is assessed against ISO 10993, and functional performance against defined engineering parameters.

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML powered device.

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