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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.

The Upstream GoBack Crossing Catheter is a sterile, single-use, single lumen crossing catheter. The Upstream GoBack Crossing Catheter is intended for use with 0.014" coated or noncoated guidewires. The effective length of the GoBack Crossing Catheter is 80 cm or 120 cm with an outer diameter of either 0.96 mm (2.9 Fr) or 1.4 mm. (4.0 Fr). The GoBack Crossing Catheter is made from three lavers; a reinforced polyimide shaft with stainless steel distal tip (in the 2.9 Fr device) or stainless steel and Nylon 12 distal tip (in the 4.0 Fr device), nitinol hypotube, and PTFE polymer sleeve over the nitinol hypotube inside the shaft. The nitinol hypotube has a pre-shaped curved lancet tip at the distal end and a hub at the proximal end for guidewire access. The nitinol tube / needle can move at limited displacement inside the shaft by moving a sliding knob in the catheter handle. The nitinol tube (with the PTFE sleeve) and the polyimide shaft may rotate together using a rotation knob on the catheter handle.

The provided text describes a 510(k) premarket notification for a medical device called the "Upstream GoBack Crossing Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for a novel AI or diagnostic algorithm.

Therefore, the information required to answer the prompt (acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/diagnostic algorithms) is not present in the provided text.

The text details the following regarding performance testing and a clinical study, but these are geared towards demonstrating equivalence, not proving a device meets a pre-defined acceptance criterion for an AI/diagnostic system:

Performance Testing Summary (Non-Clinical):

• Biocompatibility Testing: Performed per ISO 10993-1:2018 and FDA guidance, including cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity (acute), hemocompatibility (hemolysis, complement activation and thromboresistance), LAL, and Material Mediated pyrogenicity.
• Device Dimensional and Functional Testing:
  • Performed on sterile 2.9 Fr and 4 Fr models: Particulates, Torque (at break and transfer), Force at break, Delivery, Radio-opacity, Surface, Needle tip protrusion, Catheter dimensions.
  • Performed on a sterile 2.9 Fr model: Air leakage, Liquid leakage, Force at break, Radio-opaque, RO marker movement, Bend to kink, Needle penetration, Transfer torsional forces.
• Other Performance Testing:
  • Demonstrated no coating abrasion or peeling when polymer-coated guidewires were passed through the catheter.
  • Established a 2-year shelf life.

Clinical Testing Summary:

• Study Design: Retrospective data.
• Sample Size: 151 patients.
• Data Provenance: Not specified (e.g., country of origin).
• Purpose: Demonstrated that the GoBack Crossing Catheter performed equivalently to the predicate in subintimal re-entry procedures. It also validated that the device can be used for both intraluminal lesion crossing and subintimal re-entry.
• Reported Performance:
  • Intraluminal crossing (62 subjects): Technical success rate of 88.7%.
  • Subintimal re-entry crossing (89 subjects): Technical success rate of 88.8%.
  • Major Adverse Event (MAE) rate across all procedures: 0%.
• Ground Truth: Implied clinical outcomes/procedural success, but not explicitly defined with expert consensus, pathology, or adjudication.
• Experts/Adjudication: Not mentioned.
• MRMC Study: Not applicable/not performed for this type of device submission.
• Standalone Performance: Not applicable/not performed.
• Training Set: Not applicable, as this is a medical device, not an algorithm requiring a training set.

In summary, the provided document does not contain the information required to populate the fields of the request, as it pertains to a traditional medical device (catheter) rather than an AI/diagnostic algorithm.

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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.

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.

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.

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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