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The Boss Crossing Support Catheter (Boss CSC) is indicated to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The proposed device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018" and 0.035" guidewires, respectively. Both catheter shafts are composed of a high modulus thermoplastic material in a monolithic single layer construction. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. Like the predicate, Terumo NaviCross Support catheters, the distal end of the Boss CSC catheter is equipped with an RO marker band to enable visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity.

The 2.4Fand 3.9F catheters are packaged together in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. There are two versions of the device offered:

1. 3.9F/90cm length catheter packaged with a 2.4F/135cm length catheter
2. 3.9F/90cm length catheter packaged with a 2.4F /150cm length catheter

As stated, the 2.4F and 3.9F catheters are packaged together. Each catheter is individually inserted into a spiral HDPE protective hoop which is then secured to an HDPE backer card. The two catheter hoops and backer card are inserted into a Tyvek/Mylar pouch that is then placed into a cardboard outer shelf box. Five (5) individual pouches are then placed in a cardboard shelf box.

The provided text describes a medical device, the Boss Crossing Support Catheter (Boss CSC), and the testing conducted to support its substantial equivalence to predicate devices. However, it does not include the specific details you've requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.

The document discusses various bench tests and biocompatibility tests to demonstrate the device's physical performance, material safety, and sterility. These tests are conducted to ensure the device performs as intended and is safe for use, but they are not related to the performance of an AI/ML diagnostic or assistive device that would have metrics like sensitivity, specificity, or reader improvement.

Below is a breakdown of why this document cannot provide the information you're looking for, and where such information would typically be found for an AI/ML device:

Reason for lack of requested information:

This 510(k) submission is for a physical medical device (a catheter), not an AI/ML-driven diagnostic or assistive technology. Therefore, the concepts of "acceptance criteria" as you've defined them (e.g., sensitivity, specificity, human reader improvement), "test set sample size," "ground truth establishment," or "multi-reader multi-case studies" are not applicable to this particular submission.

What is included (and would be equivalent for a physical device):

• Acceptance Criteria & Reported Performance: The document lists various performance tests (e.g., Kink Resistance, Tensile Strength, Flow Rate, Leak Test, Hydrophilic Coating Integrity, etc.). For each of these, the "acceptance criteria" would be defined in the test protocols (e.g., "no kinks observed under X force," "tensile strength > Y N," "flow rate within Z ml/min"). The "reported device performance" would be the actual measured values from these bench tests. The document states "The Boss CSC catheters submitted in this 510(k) have demonstrated similar performance characteristics to the predicate devices" and "The performance of the Boss CSC Catheters demonstrates substantial equivalence to the performance of the predicate devices," implying these criteria were met.
• Sample Size for Test Set: For physical devices, this would refer to the number of catheters tested for each performance characteristic. The document doesn't specify the exact number of devices tested for each bench test, but it notes "Testing was performed on aged and non-aged Boss CSC catheters."
• Data Provenance: Not applicable in the AI/ML sense. Data comes from bench testing of the manufactured device.
• Experts / Ground Truth: Not applicable for physical device performance. The "ground truth" is the physical measurement itself. For example, a "kink" is a directly observable physical event.
• Adjudication Method: Not applicable.
• MRMC Study: Not applicable.
• Standalone Performance: The "standalone" performance for a physical device refers to its ability to meet its functional specifications directly, which is what the bench tests evaluate.
• Type of Ground Truth: Direct physical measurements and observations from bench testing.
• Sample Size for Training Set: Not applicable (no AI/ML model to train).
• How Ground Truth for Training Set was Established: Not applicable.

Hypothetical Example (if this were an AI/ML device):

If the Boss Crossing Support Catheter were, for instance, an AI-powered system designed to detect potential anatomical blockages during catheter insertion by analyzing real-time imaging, the requested information would look something like this:

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

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

• Sample Size: 500 patient cases (250 with blockages, 250 without), comprising 1500 image frames.
• Data Provenance: A multi-center retrospective dataset collected from hospitals in the United States (70%), Germany (20%), and Japan (10%).

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

• Number of Experts: 3
• Qualifications:
  • Expert 1: Interventional Radiologist, 15 years experience in peripheral vascular interventions, board certified.
  • Expert 2: Vascular Surgeon, 12 years experience, specializes in complex peripheral revascularization.
  • Expert 3: Interventional Cardiologist, 10 years experience, with a focus on peripheral artery disease.

4. Adjudication method for the test set

• Adjudication Method: 2+1 (Two experts independently reviewed each case. If they agreed, that was the ground truth. If they disagreed, a third senior expert was brought in to make the final decision).

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

• MRMC Study Done: Yes
• Effect Size: Average increase of 0.07 in ROC AUC (from 0.81 without AI to 0.88 with AI assistance) across all readers for detecting blockages, and a 15% reduction in reading time without compromising accuracy.

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

• Standalone Performance Done: Yes, as reported in the table above (Sensitivity 92.5%, Specificity 84.1%).

7. The type of ground truth used

• Type of Ground Truth: Expert Consensus (adjudicated by 3 experts based on angiographic images and clinical reports).

8. The sample size for the training set

• Training Set Sample Size: 10,000 patient cases (approximately 30,000 image frames).

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

• Ground Truth for Training Set: Established by a team of 5 clinical residents and 2 junior interventional radiologists, with periodic audits and quality checks performed by a senior interventional radiologist. Cases flagged for ambiguity were escalated for consensus review by senior staff. Pathology reports and outcomes data were sometimes used as secondary confirmation where available for specific types of blockages.

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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.

Ask a specific question about this device

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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The Seeker™ Crossing Support Catheters are recommended for guidewire exchange and infusion devices designed for use in the peripheral vascular system. The catheters are intended to support a guidewire during access into the vasculature, allow for guidewire exchanges, and provide a passage for delivery of saline solutions and/or diagnostic contrast agents.

Not Found

This document is a 510(k) premarket notification decision letter for the Seeker Crossing Support Catheter, a medical device. It does not contain information about acceptance criteria, device performance, or study details.

Therefore, I cannot provide the requested information. The document primarily confirms that the FDA has found the device substantially equivalent to pre-existing legally marketed devices.

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