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The MAGIC Infusion Catheter is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The MAGIC Infusion Catheter may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

The MAGIC Infusion Catheters are microcatheters designed with progressive suppleness and a rigid proximal shaft to allow control and navigability in the vascular system. By their diameter and progressive suppleness features, these catheters are specifically designed for catheterization of small diameter, sinuous distal vessels. The catheter body and its distal tip (ring) are radiopaque to provide visibility under fluoroscopy. The MAGIC Infusion Catheter has an external hydrophilic coating which provides a lubricious surface during use. A PTFE coated mandrel is included inside the MAGIC Infusion Catheter to provide support during product preparation and insertion through the guide catheter. The MAGIC Infusion Catheters and accompanying support mandrels are provided sterile, non-pyrogenic, and intended for single use only.

The provided document describes the MAGIC Infusion Catheter and its 510(k) summary. The study is a bench and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample sizes for each specific bench test. It generally refers to "the 1.2F MAGIC Infusion Catheter (subject device)" as being tested. For biocompatibility, it states "The 1.2F MAGIC Infusion Catheter was assessed for biocompatibility."

The provenance of the data is retrospective, as it refers to testing conducted on the subject device to demonstrate substantial equivalence to a previously cleared predicate device. The document does not specify the country of origin of the data beyond the applicant "Balt USA, LLC" being located in Irvine, CA, USA.

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

This information is not applicable to this type of device submission. The study describes physical and biological bench testing of a medical device, not a diagnostic or AI-powered device that requires expert-established ground truth from a test set of clinical images or data. The "ground truth" for these tests is defined by established engineering standards and biological testing protocols (e.g., ISO standards, ASTM standards, USP criteria).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving expert readers for diagnostic accuracy. This submission relies on objective physical and biological measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This submission is for a physical medical device (infusion catheter) and does not involve AI or human readers for diagnostic interpretation.

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

This information is not applicable. This is not an AI-powered device.

7. The Type of Ground Truth Used

The ground truth for the bench tests is based on established engineering specifications, international standards (ISO 105551-1, ASTM F640-12, USP ), and biological testing protocols (ISO 10993-series, ASTM F756, ASTM F2382-18, ASTM F2888-19). These standards define the acceptable performance characteristics and biological response for such medical devices.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device, so there is no "training set."

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

This information is not applicable as there is no training set for this type of device.

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The Magic Infusion Catheter is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The Magic Infusion Catheter may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

The subject device is intended to operate for regional infusion of contrast materials into selected vessels in the neurovasculature. Magic Infusion Catheters are intended to facilitate access through distant, tortuous vasculature. Progressive suppleness ranging from a highly flexible tip to a semi-rigid proximal section allows the catheter to be advanced by the physician. It is not intended for use in the coronary vasculature. Magic catheters are available in 1.8 and 1.5Fr and 165 and 155 cm in length and are available with an "olive" tip configuration.

This document is a 510(k) summary for the Magic® Infusion Catheter, indicating its substantial equivalence to a predicate device. It primarily focuses on demonstrating that changes to materials and coating do not affect safety and effectiveness. As such, the information typically found in studies for AI/ML devices or diagnostic tools (like acceptance criteria tables, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) is not applicable here.

Here's a breakdown of the available information based on your request, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance:

The document describes several tests performed on the Magic Infusion Catheter, particularly regarding the changes to its materials and coating. It states that these tests demonstrate biocompatibility and material integrity.

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

• Sample Size: Not specified. The document refers to "Testing" but does not detail the number of units or samples used for each test.
• Data Provenance: Not specified. This is a technical performance study, not a clinical data study, so "country of origin" of data or "retrospective/prospective" does not apply in the typical sense for medical imaging or diagnostic devices.

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):

• Not Applicable. This is a physical device testing summary, not a study involving expert readers or ground truth in the context of diagnoses or image interpretation. The "ground truth" here is based on laboratory test results and material properties.

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

• Not Applicable. No human adjudication method is described as this is not a study assessing diagnostic performance or subjective interpretations.

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 not an AI/ML device or a diagnostic device where MRMC studies would be relevant.

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

• Not Applicable. This is not an AI/ML device.

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

• Laboratory Test Results and Material Properties. The "ground truth" for the device's performance is derived from standardized laboratory tests for biocompatibility, material strength, flexibility, rupture strength, and flow rate, as well as the known properties of the materials used (e.g., platinum).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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