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The Reverse Medical RePort™ Guide Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

The RePort™ Guide Catheter System is a two-catheter system comprised of the RePort™ Sheath and the RePort™ Dilator. The RePort™ Sheath has a distal region which expands when the RePort™ Dilator is advanced. The RePort™ Guide Catheter System can be used with hydrophilic guidewires up to.038 inches in diameter to access the desired anatomy. The proximal ends of the RePort™ Sheath and the RePort™ Dilator have a luer fitting to allow attachment of accessories and infusion of liquids through the catheter is offered in various sizes to accommodate physician preferences and patient anatomy. A split sheath is provided in the package to provide support and facilitate the introduction of the RePort™ Sheath's distal expandable region into the catheter introducer sheath. The System is provided sterile, non-pyrogenic, and is intended for single use only.

The provided document describes the RePort™ Guide Catheter System and its substantial equivalence to predicate devices, rather than an AI/ML device. Therefore, the questions related to AI/ML specific aspects like AI assistance effect size, standalone algorithm performance, training set, and AI specific ground truth are not applicable.

However, the document does contain information about the acceptance criteria and the studies performed to demonstrate the device meets these criteria in the context of a medical device submission.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device "Met established criteria" for all tests, indicating that the acceptance criteria for each test were successfully achieved. The specific numerical values or ranges for these criteria are not provided, only the outcome.

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

• Test Set Sample Size: The document does not explicitly state the specific number of units or samples used for each test. It generally states that "All testing was performed on units which were twice sterilized."
• Data Provenance: The tests are described as "bench-top testing" and "in vivo tests," implying some animal or cadaveric testing for the in vivo portion. There is no mention of human clinical trial data for this 510(k) submission for the RePort™ Guide Catheter System. The document focuses on demonstrating substantial equivalence through non-clinical data. The country of origin for the data is not specified, but the applicant is Reverse Medical Corporation, Irvine, CA, suggesting the testing was likely conducted in the US or by US-based contractors/labs. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.

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

• This question is not applicable as the document describes physical, mechanical, and biological testing of a medical device, not an AI/ML system requiring expert-established ground truth from images or other data. The "ground truth" for these tests would be the measured physical properties or biological responses against established engineering and biological standards.

4. Adjudication Method for the Test Set

• Not applicable for this type of medical device testing. Adjudication methods like 2+1 or 3+1 are used for reviewing ambiguous cases or discrepancies in image interpretation or diagnosis, which is not relevant here. The results of the tests were compared against "established criteria."

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 describes a non-AI/ML medical device. No human reader studies with or without AI assistance are mentioned.

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

• Not applicable. This pertains to an AI/ML algorithm, which is not the subject of this document.

7. The Type of Ground Truth Used

• For the bench tests, the "ground truth" was defined by established engineering standards and specifications (e.g., dimensional tolerances, strength requirements, leak rates).
• For the biocompatibility tests, the "ground truth" was established by international biological evaluation standards (ISO 10993-1), with the results compared against acceptable biological responses.
• For the in vivo tests, the "ground truth" would be direct observation of performance (e.g., deliverability, compatibility, visibility, aspiration performance) and histopathological examination of treated vessels, assessed against pre-defined safety and performance parameters.

8. The Sample Size for the Training Set

• Not applicable. This refers to an AI/ML device. The RePort™ Guide Catheter System is a physical medical device and does not involve a training set.

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

• Not applicable. This refers to an AI/ML device.

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