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The Upstream GoBack Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires.

The Upstream GoBack Crossing Catheter is not intended for use in the coronary, cerebral or carotid vasculature.

Device Description

The Upstream GoBack Crossing Catheter is a sterile, single lumen support catheter, that consists of a reinforced polyimide shaft with a stainless steel tip, and PTFE polymer coated nitinol hypotube inside the shaft. The nitinol tube has a pre-shaped lancet tip at the distal end and a hub at the proximal end for guidewire access. The nitinol tube can move at limited displacement inside the shaft, by moving a sliding knob in the catheter handle.

The Upstream GoBack Crossing Catheter is intended for use with 0.014" and 0.018" non-coated quidewires and the effective length of the catheter is 120 cm with an outer diameter of 1.4 mm.

AI/ML Overview

The medical device described in the document is the Upstream GoBack Crossing Catheter.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance tests conducted on the Upstream GoBack Crossing Catheter. The "acceptance criteria" for these non-clinical tests are generally implied to be that the device "functioned as intended" and "meets its intended design and performance specifications." For the clinical study, the acceptance criteria are clearly defined as primary safety and effectiveness endpoints.

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Sterilization Validation: Established in accordance with ISO 11135 and EN 868-5	Successfully validated.
Packaging Integrity & Accelerated Aging: Completed in accordance with ISO 11607-1, ISO 11607-2, ASTM F1980-07, and ASTM F1929	Successfully completed.
Biocompatibility: Established in accordance with ISO 10993-1, including cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity (acute), hemocompatibility (hemolysis & thromboresistance), pyrogenicity, and complement activation	Successfully established; materials are biocompatible.
Functional Bench Testing (various): Air leakage, liquid leakage, force at break, surface test, catheter dimensions, catheter delivery and kink, catheter torque, needle tip protrusion, marker movement, torque at break, bending to kink, transfer of torsional force, needle penetration force, catheter radio-opaque, corrosion, catheter hydration, catheter environmental, and packaging sealing testing	"In all instances, the Upstream GoBack Crossing Catheter functioned as intended," and "meets all design specifications with respect to its mechanical and handling characteristics."
Clinical Study - Primary Safety Endpoint: Composite rate of major adverse events (MAEs) related to the GoBack Catheter through 24 hours post index procedure, including: death, perforation requiring intervention, and clinically significant peripheral embolism.	No device-related adverse event was seen during the procedures or at 24 hours post procedure.
Clinical Study - Primary Effectiveness Endpoint: Device technical success, defined as the placement of a guidewire in the true lumen distal to a CTO as confirmed by angiography core lab.	92% (23/25) technical success rate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Test Set: 25 subjects.
Data Provenance: Retrospective evaluation of clinical cases.
Country of Origin: Leipzig University Medical Center and Bad-Krozingen Heart-Center, both in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document mentions that the primary effectiveness endpoint (placement of a guidewire in the true lumen distal to a CTO) was "confirmed by the angiography core lab." It does not specify the number of experts, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the term "core lab" implies a specialized group responsible for blinded and standardized evaluation.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). It states that the effectiveness endpoint was "confirmed by the angiography core lab," suggesting a standard review process by the lab, but the specifics of how discrepancies among reviewers (if any) were handled are not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a physical medical device (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance does not apply here.

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

No, a standalone algorithm performance test was not done. As mentioned, this is a physical medical device.

7. The Type of Ground Truth Used

For the clinical study:

Technical Success (Effectiveness): Angiography core lab confirmation.
Safety (MAEs): Clinical observation and assessment by medical professionals during and 24 hours post-procedure; likely based on standard clinical diagnostic criteria for adverse events.

8. The Sample Size for the Training Set

The document describes a retrospective clinical evaluation to support substantial equivalence. This is not a study to train an algorithm. Therefore, there is no training set used in the context of an AI/algorithm study. The 25 subjects were part of the clinical test set designed to evaluate the physical device's performance.

9. How the Ground Truth for the Training Set Was Established

As there was no training set for an algorithm, this question is not applicable.

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