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The Rebar™ Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.

The Rebar" Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.

The provided text does not describe a study involving a device that uses AI or machine learning. Instead, it describes a 510(k) premarket notification for a medical device called the "Rebar™ Micro Catheter." This submission is focused on demonstrating substantial equivalence to an existing predicate device based on material changes (e.g., to the hub material and adhesive) and associated non-clinical bench testing.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided document pertains to a traditional, non-AI medical device clearance.

The document discusses:

• Device: Rebar™ Micro Catheter (a vascular microcatheter)
• Purpose: Delivery of interventional devices or contrast media into the vasculature.
• Regulatory Pathway: 510(k) premarket notification, aiming for substantial equivalence to a previously cleared Rebar™ Micro Catheter (K093750).
• Changes: Primarily changes to the material of the catheter hub (from Polypropylene to Trogamid) and the adhesive used.
• Proof of Equivalence: Non-clinical bench testing and biocompatibility data, rather than clinical trials or AI/ML performance studies.

The acceptance criteria listed are for physical and functional properties of the catheter (e.g., hub integrity, pressurization, tensile strength) and not related to AI/ML performance metrics like accuracy, sensitivity, or specificity. There is no mention of a test set, ground truth acquisition involving experts, MRMC studies, or training sets, as these concepts are not applicable to the type of device and study described.

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Ask a specific question about this device

The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.

The Rebar Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire into the distal vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which tapers into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter has a lubricious hydrophilic coating. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. Select catheter models (.0165" lumen) have a secondary marker 3 cm proximal of the distal tip marker.

The provided text describes the 510(k) summary for the Rebar™ Micro Catheter, which is an infusion catheter, and the FDA's clearance letter for the device. The information focuses on the device's substantial equivalence to a predicate device and its biocompatibility and performance testing against industry standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the sample size used for the test set for any of the performance or biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable to the type of device and studies described. The studies are engineering tests (biocompatibility, mechanical performance) against international standards, not diagnostic performance studies requiring expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are engineering tests, not clinical studies requiring adjudication of outcomes or interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is a key component, which is not the case for an infusion catheter.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of an algorithm or AI was not done. The studies mentioned are for the physical properties and biocompatibility of the catheter itself, not for an algorithm.

7. Type of Ground Truth Used

For biocompatibility, the ground truth would be the results relative to ISO 10993-1 standards (e.g., absence of cytotoxicity, irritation, etc.). For performance testing, the ground truth would be the established requirements and specifications outlined in ISO 10555 (e.g., minimum tensile strength, maximum burst pressure, acceptable flexibility range). These are objective, measurable criteria from recognized standards.

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is a physical medical instrument, not an AI or machine learning model.

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

This information is not applicable as there is no training set for an AI or machine learning model. The "ground truth" for the device's physical and biological properties is established by adherence to recognized international standards (ISO 10993-1 and ISO 10555) for medical device evaluation.

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