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The Minjie Catheter System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The Minjie Catheter System consists of the Minjie Catheter, Introducer Peel Away Tool and packaging hoop with Elbow Flush Luer. The Minjie Catheter is a single lumen. flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the catheter is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating, to reduce friction during intravascular use. The Minjie Catheter System dimensions are included in the individual device label. The devices are supplied sterile and are intended for single use only.

The provided FDA 510(k) summary for the Minjie Catheter System does not contain acceptance criteria or reported device performance in the format requested for AI/algorithm-based devices. This document describes a medical device (a catheter system) and its performance through non-clinical (bench and animal) testing to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI algorithm.

Therefore, many of the requested fields related to AI algorithm evaluation (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to the information provided in this document.

However, I can extract information related to the device's non-clinical testing and its conclusions, which serve as the "proof" that the device meets some form of acceptance criteria for medical devices of this type.

Here's a summary based on the provided document, adapting the requested structure where possible for a non-AI device:

Acceptance Criteria and Study for the Minjie Catheter System

The Minjie Catheter System is a physical medical device (catheter) and its performance is evaluated against engineering specifications, biocompatibility standards, and functional capabilities rather than AI algorithm metrics. The studies performed are non-clinical, including bench testing and an animal study, to demonstrate substantial equivalence and safety/effectiveness for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All devices met acceptance criteria" for each bench test, but it does not explicitly define the numeric acceptance criteria themselves. The reported performance is therefore a qualitative statement of compliance.

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

• Bench Testing: The document does not specify the exact sample size for each bench test (e.g., "All devices met acceptance criteria" implies multiple devices were tested). There is no explicit mention of data provenance (e.g., country of origin). This is non-clinical, prospective testing.
• Biocompatibility Testing: Not specified for individual tests.
• Sterilization and Shelf-Life: Not specified, but validation studies would involve multiple units.
• Animal Testing: The document states "An animal study was performed," but does not specify the number of animals used. Data provenance is not specified.

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)

This is not applicable as this is a physical device and not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. Bench testing results are typically objective measurements against engineering specifications. Animal study evaluations would be performed by qualified veterinary and pathology staff, but specific numbers and qualifications are not provided.

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

Not applicable for physical device testing.

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-assisted diagnostic or therapeutic device.

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

Not applicable.

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

For this physical device:

• Bench Testing: Engineering specifications, industry standards (e.g., ISO), and defined performance parameters serve as the "ground truth" or acceptance criteria.
• Biocompatibility Testing: Established biological response parameters outlined in ISO 10993 series and FDA guidance.
• Animal Testing: Angiographic and histological evaluations, which are considered objective medical findings.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

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