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The HemoDraw™ Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.

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I am sorry, but the provided context does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for the HemoDraw™ Arterial Blood Sampling Set, indicating that the device has been found substantially equivalent to a predicate device. It defines the indications for use of the device but does not include any performance data or study design details.

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The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.

The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system.

I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

The document is an FDA 510(k) clearance letter for the "SECURE® Arterial Blood Sampling Set." This letter primarily:

• Acknowledges the review of the premarket notification.
• States that the device is substantially equivalent to legally marketed predicate devices.
• Outlines general regulatory requirements and responsibilities for the manufacturer.
• Includes the "Indications for Use" statement for the device.

It does not contain:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test or training sets.
• Information about experts used for ground truth or adjudication methods.
• Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or how it was established.

Therefore, I cannot provide the requested information.

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The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.

The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.

The provided text is a 510(k) summary for a medical device called the "ABC In-Line Blood Sampling Kit." This document is a regulatory submission for premarket notification to the FDA, not a study report detailing performance acceptance criteria and validation studies in the way you've requested.

Therefore, I cannot extract the information you've asked for (acceptance criteria, study details, sample sizes, expert qualifications, etc.) for the following reasons:

• Clinical Performance Study Not Described: The document focuses on demonstrating substantial equivalence to a predicate device (Baxter VAMP™ blood sampling system cleared under 510(k) K/885281) for regulatory clearance. It does not describe an independent clinical performance study with acceptance criteria and results.
• Focus on Substantial Equivalence: The primary points made are about the device's function, materials, and substantial equivalence to the predicate, with a brief mention of pressure monitoring frequency response being "essentially equivalent." This is a regulatory comparison, not a detailed performance study with defined metrics.
• No Mention of AI or Algorithm Performance: The device is an "In-Line Blood Sampling Kit," a physical medical device. There is no mention of an algorithm, AI, or software component that would require the kind of performance metrics you've outlined (e.g., standalone performance, MRMC studies, ground truth establishment methods for a machine learning model).

To summarize, the document does not contain the information required to answer your prompt because it is a regulatory submission demonstrating substantial equivalence of a physical medical device, not a report on a clinical or AI performance study.

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