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To allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.

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To allow multiple needleless accesses to an injection vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.

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The provided text is an FDA 510(k) clearance letter for the "FlowArt® Valve for Vial Access". This document does not contain any information about acceptance criteria for an AI/ML device, nor does it describe a study proving such a device meets acceptance criteria.

The 510(k) is for a physical medical device (a valve for vial access), not an AI/ML software device. Therefore, it does not discuss topics such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

To answer your request, I would need a different document that pertains to the clearance of an AI/ML driven medical device. The current document is irrelevant to the specific questions asked as it focuses on the substantial equivalence of a physical medical device to a predicate device, and the general regulatory requirements for marketing such a device.

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FlowArt® Needle-Free Split Septum Valve: Needle-free valve is intended for use as an accessory to a vascular access device used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein.

FlowArt® Needle-Free Split Septum Valve

I am sorry, but the provided text only contains an FDA clearance letter for a medical device called "FlowArt® Needle-Free Split Septum Valve" and its indications for use. It briefly describes the device's purpose as an accessory for vascular access devices in hemodialysis or for administering/withdrawing fluids via an intravascular administration set.

This document does not include information about:

• Acceptance criteria or reported device performance in a table format.
• Details of a study proving the device meets acceptance criteria.
• Sample sizes, data provenance, number of experts, adjudication methods, or ground truth details for any test or training sets.
• Information regarding multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide a detailed response to your request based on the given input. The document is solely an FDA clearance letter confirming substantial equivalence to predicate devices, not a study report.

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Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device.

Needleless valve allows the user to add medication into the without the use of a needle.

Power Injection Rating and Flowrate (400 psi and 10 mL/sec).

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The provided text is related to an FDA 510(k) clearance for a medical device called "FlowArt," an intravascular administration set. This document is a clearance letter and does not contain information about acceptance criteria or specific studies that prove the device meets those criteria.

Therefore, I cannot provide the requested information based on the input text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication methods for a test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
4. Information on standalone algorithm performance.
5. The type of ground truth used.
6. Sample size or ground truth establishment for a training set.

The document primarily focuses on the regulatory clearance process and general controls for medical devices.

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Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device.

Needleless valve allows the user to add medication into the without the use of a needle.

Power Injection Rating and Flowrate (400 psi and 10 mL/sec).

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would enable me to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "NeutrArt," an intravascular administration set. It discusses regulatory matters, indications for use, and administrative information, but it does not include clinical study data or performance metrics.

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Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device.

Stopcocks are intended for use to change the direction of fluids through a tubing set.

Needleless valve allows the user to add medication into the without the use of a needle.

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This document is a 510(k) clearance letter for the NeutrArt device, which is an intravascular administration set. It provides regulatory information and indicates that the device has been found substantially equivalent to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot provide a response based on the input text. Please provide a document that contains information about the device's technical specifications, performance studies, and validation processes.

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Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. Stopcocks are intended for use to change the direction of fluids through a tubing set. Needleless valve allows the user to add medication into the without the use of a needle.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Flowart" and does not contain the detailed information you requested about acceptance criteria and the study proving the device meets them.

The document primarily focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory requirements and guidelines for the manufacturer.
• The indications for use of the Flowart device (extension sets, stopcocks, needleless valve).

It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Information on data provenance, expert qualifications, or adjudication methods.
• Details about MRMC studies, effect sizes, or standalone algorithm performance.
• The type and establishment of ground truth.

Therefore, I cannot fulfill your request with the information provided.

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