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The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic agents to the peripheral and neurovascular systems. The catheter is also intended for the introduction of therapeutic agents to the peripheral system. The catheter is not intended for use in the coronary vasculature.

The Plato MICROCATH® 27B Microcatheter is a single lumen microcatheter with a flexible polymer shaft of varying stiffness to aid in navigation of the neurovasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire. The proximal end of the catheter has a diameter of 3.4F tapering to a distal OD of 3.2F. The catheter can be inserted into a 5F guide catheter. The inner diameter is constant over the entire length of the catheter shaft and accommodates guidewires up to 0.025" in diameter. The catheter is 150 cm in length with a straight tip configuration which can be shaped, using steam heat and the provided mandrels, to the users' preferred shapes. A steam shaping mandrel is included in the packaging. The microcatheter has a hydrophilic coating on the outer distal shaft to reduce friction during catheter manipulation in the vasculature and has one radiopaque tip marker at its distal tip to facilitate fluoroscopic visualization.

The subject microcatheter is identical with respect to its technological characteristics, design and materials to Scientia's currently marketed Plato MICROCATH 27B Microcatheters cleared under K143398. This 510k was prepared to expand the indications for use of the device to include its use in the neurovasculature.

The provided document describes the acceptance criteria and a study demonstrating that the Plato MICROCATH® 27B Microcatheter meets these criteria.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for each test in a numerical format (e.g., "n=X catheters"). Instead, it generally refers to "all catheters," "all samples," or "test and predicate catheters." The provenance of the data is primarily non-clinical, involving in-vitro testing and simulated use in anatomical models and human cadavers.

• Data Provenance: Predominantly non-clinical laboratory testing (in-vitro) and human cadaver studies.
• Country of Origin: Not specified, but generally assumed to be carried out by the manufacturer (Scientia Vascular LLC) or their contracted labs.
• Retrospective or Prospective: All tests described are prospective, conducted specifically to demonstrate substantial equivalence for this 510(k) submission.

3. 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)

For the human cadaver testing and radiopacity evaluation, "physicians" were used to evaluate the devices. No specific number or qualifications (e.g., years of experience, specialization) of these physicians are provided in the document.

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

The document does not describe any formal adjudication method (like 2+1 or 3+1) for establishing ground truth or evaluating performance, beyond "physicians" performing evaluations in the cadaver study. The non-clinical tests rely on meeting specified standards (e.g., ISO, ASTM, internal specifications).

5. 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

There is no MRMC comparative effectiveness study and no AI component mentioned in this document. This is a traditional medical device (microcatheter) and the testing is purely for physical and functional performance, not diagnostic accuracy with AI.

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

There is no standalone algorithm performance study as this device does not involve any algorithm or AI.

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

For most functional and biocompatibility tests, the ground truth is defined by established industry standards (ISO, ASTM), FDA guidance documents, and internal engineering specifications which are based on acceptable performance limits for medical devices. For the cadaver studies, the "ground truth" for performance was based on physician evaluation and comparison to a predicate device's performance in a similar setting. There is no pathology or patient outcomes data as it's a pre-market submission for a physical device.

8. The sample size for the training set

There is no training set as this device does not incorporate machine learning or AI.

9. How the ground truth for the training set was established

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

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