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To be used only for blood withdrawal.

The blood sampling system is indicated for use on patients requiring periodic withdrawal of blood samples from arterial and central line catheters, including peripherally inserted central venous catheters, which are attached to pressure monitoring lines.

The Edwards Venous/Arterial Blood Management Protection (VAMP) Systems are sterile, single use devices that provide a safe and convenient method for the withdrawal of blood samples when attached to pressure monitoring lines. The VAMP Plus device is a needleless closed blood sampling system designed to reduce infection, needle sticks, and blood waste associated with blood sampling. One family of VAMP product line, the VAMP Plus blood sampling system, is the subject of this submission. The VAMP Plus Venous/Arterial Blood Management Protection System (VAMP Plus) is designed for use with disposable and reusable pressure transducers and for connection to central line catheters (inclusive of peripherally inserted central catheters and central venous catheters) and arterial catheters where the system can be flushed clear after sampling. The VAMP Plus blood sampling system is used for the drawing and retention of heparinized/diluted blood (or clearing volume) from the catheter or cannula within the line, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of the sample draw, the mixed heparin and blood solution (clearing volume) is reinfused into the patient to reduce fluid loss to the patient.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VAMP Plus Venous/Arterial Blood Management Protection System:

This document is a 510(k) summary for a medical device cleared by the FDA. It outlines the regulatory process for the device, including its intended use, classification, and a comparison to predicate devices. However, this is NOT a study report for an AI/ML medical device. The VAMP Plus system is a physical blood sampling system, not an AI-powered one. Therefore, many of the requested categories in your prompt (such as AI-specific performance metrics, ground truth establishment, expert adjudication, MRMC studies, and training set details) are not applicable to this device or document.

The "study that proves the device meets the acceptance criteria" in this context refers to the functional and safety testing described.

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

The document does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for each criterion. It broadly states that the device successfully passed various tests.

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

The document does not specify the sample size for any of the tests. Given it's a physical device and not a data-driven model, concepts like "country of origin for data" or "retrospective/prospective" studies for data provenance are not directly applicable in the same way they would be for an AI/ML device. The testing would have been conducted in a laboratory or simulated environment, likely at the manufacturer's facility.

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 information is not provided. For physical device testing, "ground truth" is typically established by engineering specifications, validated test methods, and compliance with recognized standards, rather than expert human interpretation in the way it's done for diagnostic AI.

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

Not applicable. Adjudication methods are relevant for subjective interpretations, often in diagnostic imaging by multiple human readers. For the physical device testing described, the "passing" or "failing" of a test is based on objective measurements against pre-defined engineering criteria.

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 device is not an AI system, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the device's performance is established by engineering specifications, validated test methods, and compliance with relevant industry standards (e.g., for biocompatibility, sterility, leak integrity). This is not equivalent to clinical ground truth like pathology or outcomes data, which would be relevant for diagnostic devices or treatments.

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 for this physical device.

Summary of what the document does provide:

• Device: VAMP Plus Venous/Arterial Blood Management Protection System
• Intended Use: For blood withdrawal, specifically periodic withdrawal of blood samples from arterial and central line catheters, including peripherally inserted central venous catheters, attached to pressure monitoring lines.
• Regulatory Pathway: 510(k) premarket notification.
• Predicate Devices: K161962 (VAMP Plus) and K173586 (VAMP Adult).
• Changes from Predicate:
  • Change of sterilization method (Ethylene Oxide to E-beam radiation).
  • Change in PVC plasticizer (DEHP to DINCH®).
  • Update of product labeling.
  • Introduction of an additional sampling site (Luer Activated Sampling Site) to replace the Z-site in some models.
• Proof of Equivalence: The manufacturer asserts that the changes did not alter the performance and that the device successfully passed various functional and safety tests.
• Testing Categories: Functional and performance, packaging, shelf life, sterilization, biocompatibility, chemical characterization, and bench testing (overpressure leak, negative leak, pressure tubing pull, frequency response).

In conclusion: The provided text describes the regulatory clearance of a physical medical device (a blood sampling system) and details the non-clinical testing performed to demonstrate its safety and effectiveness. It is not about an AI/ML medical device, and therefore, many of your specific questions related to AI acceptance criteria, ground truth, and study designs are not addressed or applicable.

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