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The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. It is not intended for use in peripheral or coronary vasculature.

The pNOVUS 21 Microcatheter (pNOVUS 21) is a single use microcatheter, supplied sterile using ethylene oxide (EtO), in a packing hoop, within a sealed pouch and shelf carton configuration. An introducer sheath and shaping mandrel are supplied on a backing card inside the pouch. The packaging is designed to facilitate ease of handling and aseptic presentation of the device.

The pNOVUS 21 Microcatheter is a variable stiffness single lumen catheter. The pNOVUS 21 has a radiopaque marker on the distal end to facilitate fluoroscopic visualization, and a luer hub on the proximal end to facilitate the infusion of diagnostic agents and the smooth transfer of other devices (e.g., guidewires) into the inner lumen of the microcatheter. The distal end of the microcatheter's external surface has a hydrophilic coating applied for increased lubricity during use. The pNOVUS 21 has a straight tip. Steam shaping of the distal tip allows for one-time customizing of the tip shape. There are two models of the pNOVUS 21 Microcatheter, the device model # are:

• PNOV-21-160
• PNOV-21-150

The pNOVUS 21 Microcatheter is intended for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. pNOVUS 21 is generally inserted either through a sheath or guide-catheter.

The provided text is a 510(k) summary for the pNOVUS 21 Microcatheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing and biocompatibility), rather than a study involving an AI/software component with specific acceptance criteria related to accuracy, sensitivity, or human-in-the-loop performance.

Therefore, many of the requested elements for describing the acceptance criteria and study that prove an AI/software device meets acceptance criteria are not present in this document. This document describes a traditional medical device (microcatheter), not an AI-powered diagnostic or therapeutic software.

However, I can extract the general "acceptance criteria" and "reported device performance" in the context of this traditional device clearance, which are primarily based on meeting defined specifications and demonstrating comparable performance to a predicate device through bench testing.

Here's an attempt to answer the prompt based on the provided text, acknowledging the limitations due to the nature of the device:

This document describes the 510(k) clearance for the pNOVUS 21 Microcatheter, which is a physical medical device, not an AI software. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating the device's physical and functional performance and biocompatibility through non-clinical testing, rather than metrics like sensitivity, specificity, mAP, FROC, or human reader improvement with AI assistance.

The overarching acceptance criterion for substantial equivalence for this device is that it performs as intended and is as safe and effective as a legally marketed predicate device. This is demonstrated through a comprehensive suite of bench tests and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes numerous bench tests conducted to ensure the pNOVUS 21 Microcatheter performs as intended and is substantially equivalent to its predicate. The "acceptance criteria" for each test are typically that "All samples met the acceptance criteria," "performance is comparable to the predicate," or "conforming to specifications." The "reported device performance" is essentially that these criteria were met.

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

The document does not explicitly state the numerical sample size for each specific non-clinical bench test. It consistently reports "All samples met the acceptance criteria," indicating that a sufficient number of devices were tested to provide statistical confidence for the relevant acceptance criteria and demonstrate performance.

• Data Provenance: The tests were conducted internally by phenox Ltd or by their designated testing partners (e.g., sterilization in Trier, Germany by Rose GmbH). The data is prospective in the sense that it was generated specifically for this regulatory submission through controlled bench testing and laboratory studies.

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

This section is not applicable as this submission is for a physical medical device (microcatheter) and does not involve AI software requiring expert-established ground truth for image interpretation or similar diagnostic tasks. The "ground truth" for these tests are objective, measurable physical properties and performance characteristics (e.g., leak/no leak, pass/fail for specific forces, material properties).

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described because the testing involves objective measurements against predefined specifications, not subjective interpretations requiring consensus from adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement

No MRMC study was done. This is a physical medical device, not an AI software intended to assist human readers. Therefore, there is no discussion of human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective physical and functional measurements and performance specifications, as defined by relevant ISO standards, ASTM standards, and FDA guidance documents. Examples include:

• Absence of cytotoxic effect, sensitization, irritation, systemic toxicity.
• Measured burst pressure, friction force, particulate count, torque strength, flow rate.
• Visual inspection for defects, kinks, or damage.
• Confirmation of specific dimensions (ID, OD, length).
• Compliance with standard requirements for luer fittings, packaging, etc.

These are not "expert consensus" or "pathology" in the sense of a diagnostic interpretation, nor are they "outcomes data" from clinical trials, as clinical trials were not deemed necessary.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. As this is not an AI model, there is no training set or ground truth in that context.

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