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Navigation catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of guidewires and other interventional devices.

The M2 Navigation catheter and GuideLiner Navigation catheter (Navigation catheters) are rapidexchange catheters with a working length of 163 cm. The device is available in eight sizes and is compatible with GuideLiner catheters (GuideLiner Navigation catheter models) and 6F, 7F, and 8F guide catheters (M2 Navigation catheter models).

The distal portion of the device is a 25 cm single-lumen catheter that serves as the guidewire lumen. Portions of the outer diameter (OD) of the lumen are cross shaped to allow blood to flow around the catheter while staying centered within a guide catheter or GuideLiner catheter. The device is compatible with 0.014 inch exchange length or 180 cm guidewires. The catheter lumen is constructed with two durometers of Pebax (polyether block amide) resin over a polyimide-PTFE composite liner. The device has one radiopaque marker band located 2 mm from the distal tip. The OD of the lumen has a silicone wipe to enhance deliverability to the target vasculature. The proximal end of the lumen transitions to a 304V stainless steel pushwire that has non-radiopaque positioning marks located at 95 cm (single mark) and 105 cm (double mark) from the distal tip. A short Pebax hub/sleeve covers the proximal end of the pushwire.

The provided text describes a medical device, the M2 Navigation Catheter and GuideLiner Navigation Catheter, and its clearance through the 510(k) pathway. This pathway establishes substantial equivalence to a predicate device, it does not involve a study of clinical effectiveness with acceptance criteria for device performance as would be seen for AI/ML devices or novel therapies.

Therefore, I cannot provide the detailed information requested in the prompt (acceptance criteria table, sample sizes, expert ground truth, MRMC study details, standalone performance, training set details) because the provided text is for a traditional medical device (catheter) cleared via the 510(k) process, which relies on demonstrating similarity to an already legally marketed device, not on complex performance metrics established through clinical trials or studies like those for AI/ML or drug devices.

The "studies" mentioned in the document are verification tests comparing the new device to its predicate, focusing on physical and material characteristics, rather than clinical performance or diagnostic accuracy.

Here's what can be extracted from the provided text regarding the "study" that proves the device meets "acceptance criteria," interpreted within the context of a 510(k) submission for a catheter:

Acceptance Criteria and Device Performance (for a physical catheter device via 510(k) pathway)

Study Details:

The "study" in this context refers to a series of verification tests performed by the manufacturer, Vascular Solutions, Inc., to demonstrate that the new Navigation Catheters are substantially equivalent to the predicate GuideLiner Catheter (K091750).

• 1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

  • Sample Size: Not specified in the provided text. These would typically be engineering test samples, not human subjects.
  • Data Provenance: Not explicitly stated, but assumed to be internal testing by the manufacturer (Vascular Solutions, Inc.) in the USA. These are engineering studies, not clinical data sets from patients.
  • Retrospective or Prospective: These are prospective engineering tests performed on manufactured devices.

• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

  • Not applicable. For these types of physical/mechanical verification tests, "ground truth" is established by engineering specifications and standards, not by clinical expert consensus. The "experts" would be engineers and quality control personnel performing the tests according to established protocols.

• 3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical interpretations (e.g., image reading) where disagreement among experts might occur. This is not relevant for physical device testing.

• 4. 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:

  • Not applicable. This device is a physical medical instrument (catheter), not an AI-powered diagnostic or assistive tool. No human readers or AI assistance are involved in its primary function or the validation described.

• 5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

  • Not applicable. This is a physical catheter, not an algorithm.

• 6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

  • Engineering specifications and standards. For example, "dimensional verifications" would use established engineering tolerances as their ground truth. "Kink" would have a defined level of acceptable deflection or resistance to kinking.

• 7. The sample size for the training set:

  • Not applicable. There is no "training set" as this is not an AI/ML device.

• 8. How the ground truth for the training set was established:

  • Not applicable. No training set exists.

Summary: The provided document describes the clearance of a medical catheter through the 510(k) pathway. The "studies" and "acceptance criteria" discussed are engineering verification tests designed to demonstrate that the new device is functionally equivalent and as safe as its predicate. This is entirely different from the types of studies and criteria used for AI/ML devices or therapies where clinical performance metrics (like sensitivity, specificity, clinical outcomes, or reader improvement) are the focus.

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