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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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