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The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 Jugular Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous (Seldinger type) vascular access methods. The introducer is designed to follow a prepositioned standard guide wire (not included) or obturator (blunt end closed tip introducer) when following a surgical placement. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. These catheters are provided in a variety of sizes ranging from 13Fr (8.9 cm insertable length) to 32Fr (34 cm insertable length).

This document is a 510(k) Summary for the MC3 Crescent™ Jugular Dual Lumen Catheter. It outlines the device's indications for use, description, comparison to a predicate device, and how it conforms to Class II Special Controls.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the way one might expect for diagnostic accuracy or clinical outcomes. Instead, it discusses conformance to "Special Controls" and mentions various types of testing to demonstrate "substantial equivalence."

Based on the information provided, the "acceptance criteria" can be inferred from the "Class II Special Controls" and the general requirements for substantial equivalence. The "device performance" is described qualitatively as meeting these controls.

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device (Jugular Dual Lumen Catheter K180151) rather than proving novel clinical efficacy or diagnostic accuracy as might be seen for AI-driven diagnostic devices. The performance metrics are related to safety, material compatibility, and engineering design rather than clinical outcome improvements attributable to the device itself beyond its function in ECMO.

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

The document describes various types of testing but does not provide specific sample sizes for each test mentioned (e.g., "non-clinical performance," "in vivo evaluation," "biocompatibility").

• Non-clinical Performance: Mentions "bench" testing, "mechanical integrity," and "30-day durability." No specific sample size is given.
• In vivo Evaluation: Mentions "7-day in vivo thrombogenicity evaluation." No specific sample size is given, nor is the species used.
• Biocompatibility: Refers to ISO 10993-1:2009 and GLP (21 CFR 58). These are standards for testing, but they don't specify the sample size used in this particular submission.

Data Provenance: The data is generated from various tests (bench, in vivo, etc.) conducted by the manufacturer (MC3 Incorporated). The document does not specify the country of origin for the data or if it's retrospective or prospective, as these are typically controlled laboratory and animal studies, not patient data in the context of this device.

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

This information is not provided in the document. The tests described are laboratory and animal studies, not typically involving human expert adjudication for "ground truth" in the way a diagnostic AI would.

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

This information is not provided and is not applicable to the types of engineering and biocompatibility tests described for this medical device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, not for a physical medical device like a catheter.

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

This question is not applicable as the device is a physical catheter, not an algorithm or AI system.

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

The concept of "ground truth" in the context of diagnostic accuracy is not directly applicable here. For the various tests performed, the "truth" is established through:

• Bench Test Results: Measured physical and mechanical properties against pre-defined specifications.
• Biocompatibility Standards: Adherence to established ISO and GLP guidelines.
• In vivo Evaluation: Biological responses (e.g., thrombogenicity) observed in an animal model, measured against expected safety profiles.

8. The sample size for the training set

This is not applicable. The MC3 Crescent™ Jugular Dual Lumen Catheter is a physical medical device, not an AI/ML algorithm that requires a training set.

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

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

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