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The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring, and injection of contrast media.

Vantex central venous catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring, and injection of contrast media. All catheters include a soft tip to reduce the risk of vessel perforation.

Device Description

The Multi-Med CVCs are single use devices available in 7 or 8.5 French outside diameter, 2-4 lumens, 16 or 20 cm length. The catheters may be coated with AMC Thromboshield benzalkonium chloride heparin coating.

AI/ML Overview

The provided document describes a 510(k) Pre-market Notification for Multi-Med Central Venous Catheters and Vantex CVCs. This type of submission is for demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or a specific level of performance against predefined acceptance criteria for AI/ML devices. Therefore, much of the requested information (such as sample sizes for test/training sets, ground truth establishment, MRMC studies, and standalone performance) is not applicable or not detailed in this type of regulatory filing.

Here's an analysis of the available information based on the prompt's categories:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated as such in a traditional AI/ML sense)	Reported Device Performance
Safety and Effectiveness (implicitly): Must be as safe and effective as predicate devices.	"The Multi-Med CVCs have been demonstrated to be as safe and effective as the predicate devices for their intended use."
Functional Equivalence: Must perform comparably to predicate devices in functional tests.	"The Multi-Med CVCs have successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices."
Material Equivalence: Consistent with accepted materials for such devices.	(Implied by substantial equivalence to predicate devices which use accepted materials, but not explicitly stated as a performance metric.)
Intended Use: Able to fulfill the same indications as predicate devices.	The Multi-Med CVCs are indicated for "access to the central venous system, infusion of solutions, blood sampling, and central venous pressure monitoring." This matches the intended use of similar CVCs. Vantex CVCs also have similar indications and include a soft tip to reduce risk.

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

Not Applicable. This is a medical device submission, not a study involving AI/ML models with distinct test and training datasets. The "testing" refers to functional and safety testing of the physical catheter, not algorithmic performance. The document does not specify sample sizes for these functional/safety tests.

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

Not Applicable. This submission does not involve AI/ML performance evaluation requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not Applicable. This submission does not involve AI/ML performance evaluation requiring an adjudication method for a test set.

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

No. This type of study is not relevant for a physical medical device like a central venous catheter. MRMC studies are typically used to assess the impact of AI/ML tools on human reader performance, which is not the subject of this 510(k).

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

No. This is a physical medical device, not an algorithm. Standalone performance studies are for AI/ML algorithms.

7. Type of Ground Truth Used

Not Applicable. The concept of "ground truth" as it applies to AI/ML model performance is not relevant here. The device's "ground truth" is its physical characteristics, functional performance, and biological compatibility, which are assessed through standard engineering, material, and biocompatibility tests.

8. Sample Size for the Training Set

Not Applicable. As this is not an AI/ML device, there's no "training set" in the context of machine learning.

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

Not Applicable.

Summary of the Study (510(k) Process for Medical Devices):

The "study" in this context is the 510(k) premarket notification process, which aims to demonstrate substantial equivalence to legally marketed predicate devices.

Objective: To show that the Multi-Med CVCs and Vantex CVCs are as safe and effective as their predicate devices and have the same intended use.
Methodology:
- Comparative Analysis: The submitter compared the Multi-Med CVCs to predicate devices (Multi-Med CVC cleared under K955839 and ArrowG+Ard, Arrow G+ Blue Plus Pressure Injectable CVC cleared under K071538) to demonstrate equivalence.
- Functional/Safety Testing: The device underwent functional testing to ensure it performs as intended and is safe. The specific details or results of these tests (e.g., burst pressure, flow rates, biocompatibility, etc.) are not provided in this summary but would be part of the full 510(k) submission.
Conclusion: Based on the comparative analysis and functional/safety testing, Edwards Lifesciences concluded that the proposed Multi-Med CVCs are substantially equivalent to the predicate devices. The FDA concurred with this determination, allowing the device to be marketed.

Data Provenance: The document does not specify the country of origin for any testing data, nor does it classify the data as retrospective or prospective, as these terms are usually applied to clinical studies involving human patient data or AI/ML model development. The focus here is on the device's physical and functional properties.

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