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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 Outback® Catheter is intended to facilitate placement and positioning of guide wires/ catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.

The Outback catheter is comprised of four primary elements: 1) guide 2) catheter shaft 3) rotating hemostasis valve (RHV) and 4) deployment handle or control knob. The guide is a single-lumen, steel braided polyimide shaft that can be extended or retracted by the control knob. The tubular catheter shaft houses this guide and is also steel braided polyimide in composition. The rotating hemostasis valve (RHV) has two functions: a one way valve allows for flushing of the catheter while a locking hub at the proximal end of the RHV controls the retracted position of the guide. The fourth component is the deployment handle/control knob that is used to extend or retract the guide. This control knob also functions as a port with a luer fitting for flushing of the guide wire lumen.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) summary for a medical device (Outback® Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance study results against specific acceptance criteria.

Therefore, I cannot generate the requested table and study description based on this input.

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The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.

The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest.

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity or specificity thresholds). Instead, the performance claims are qualitative and relate to the device's intended function and safety.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "in-vitro testing and animal studies." It only refers to "results of in-vitro testing and animal studies."
• Data Provenance: The studies mentioned are "in-vitro testing" and "animal studies." No country of origin is specified, and the studies are inherently prospective in nature (designed and conducted to gather specific data).

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

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. Given the nature of "in-vitro testing and animal studies," ground truth would likely be established through direct observation, physiological measurements, or histological analysis, rather than by human expert interpretation in the same way it would be for a diagnostic AI.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method. This type of method (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation of medical images where disagreements need to be resolved. For in-vitro and animal studies, objective measurements or observations form the "ground truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done. The device described (CrossPoint TransAccess Catheter) is a physical medical device (catheter with ultrasound imaging capability), not an AI algorithm intended for diagnostic interpretation to be used with or without human assistance. Therefore, a study comparing human readers with and without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. As noted above, this device is not an AI algorithm. Its performance is related to its physical function and the quality of the ultrasound images it provides, not algorithmic interpretation.

7. The Type of Ground Truth Used

Based on the description of "in-vitro testing and animal studies," the ground truth would likely be established through:

• Direct Observation: For catheter placement and manipulation.
• Physiological Measurements: To assess efficacy and safety in animal models.
• Histological Analysis or Other Pathology: For evaluating tissue effects or confirming findings in animal studies.
• Engineering Measurements/Specifications: For in-vitro performance (e.g., image resolution, catheter flexibility).

8. The Sample Size for the Training Set

The document does not mention a training set. This is because the device is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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