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The Reverse Medical Microcatheter is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.

The Reverse Medical Microcatheter is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter dimensions are included on the individual device labels. The Reverse Medical Microcatheter inner lumen can accommodate guidewires up to 0.018 inches in diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization. The Reverse Medical Microcatheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.

The provided text describes the 510(k) submission for the Reverse Medical Microcatheter. Here's a breakdown of the requested information, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally not explicitly stated with specific numerical thresholds (e.g., "flexibility must be X N/m"). Instead, the report indicates that the device "Met established criteria" for each test. This implies qualitative or pre-defined quantitative criteria that were assessed for conformance.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each bench-top or in-vivo test. It states, "All testing was performed on units that were sterilized and met all inspection criteria." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). This is a 510(k) submission, which typically relies on pre-clinical data (bench-top and potentially animal studies for in vivo testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes a medical device's physical, mechanical, and biological performance testing, not an AI or diagnostic device that requires expert-established ground truth.

4. Adjudication method for the test set

Not applicable, as this is not an AI/diagnostic device and does not involve human readers for ground truth establishment.

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

Not applicable. This is a medical device for physical intervention (microcatheter), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device; there is no "algorithm only" performance concept in this context.

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

The "ground truth" for the performance criteria in this context is defined by industry standards, engineering specifications, and established scientific methods for evaluating medical device properties (e.g., ISO standards, USP tests, internal design control procedures). For example, biocompatibility uses established biological assay methods, and mechanical tests rely on engineering principles.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable. There is no training set for this type of medical device submission.

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