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Amecath Peripheral Inserted Central Venous Catheter Sets are intended for use in attaining access to the central venous system for short or long-term use for venous pressure monitoring, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is indicated for multiple injections of contrast media through a power injector. The maximum pressure linetors used with the catheter may not exceed 300 psi and the flow rate may not exceed the maximum flow rate indicated.

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This document (K152819) is a 510(k) premarket notification for a medical device called "Amecath Peripheral Inserted Central Venous Catheter Sets." It is a regulatory clearance letter and does not contain details of a study with acceptance criteria and reported device performance related to an AI/Software as a Medical Device (SaMD) product.

The content describes the device's indications for use and confirms its substantial equivalence to legally marketed predicate devices, allowing its commercialization. There is no information provided about:

• Acceptance criteria for performance metrics
• Reported device performance against such criteria
• Sample sizes for test or training sets
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type or establishment of ground truth

Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document is for a physical medical device (catheter sets), not a software or AI product that would typically involve the detailed study characteristics you've requested.

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The Percutaneous sheath introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth for a medical device. The document is an FDA 510(k) clearance letter for an "Ameco Sheath Introducer" and primarily addresses its regulatory status and substantial equivalence to predicate devices. It outlines general controls, regulations, and contact information, but it does not include any performance study data or detailed information that would allow me to answer your questions.

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"Amecath Dual Lumen Implanted Hemodialysis Catheter" is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown.

Repair Kit is designed to replace worn or damaged extension connector adapters on the all catheter models:

• . PDLC
• . PYDLC
• P2TC
• . PXDLC

Catheters are not intended for pediatric use.

"Amecath Dual Lumen Implanted Hemodialysis Catheter" is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown.

This is a 510(k) premarket notification for a medical device (Amecath Dual Lumen Implanted Hemodialysis Catheter and Repair Kit), not a study report or clinical trial. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The provided text is an FDA approval letter, an "Indications for Use" statement, and references to regulatory information. It confirms that the device has been found substantially equivalent to legally marketed predicate devices.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Details of a multi-reader, multi-case comparative effectiveness study or its effect size.
• Standalone (algorithm-only) performance data.
• The type of ground truth used in a study.
• Sample size for training sets.
• How ground truth for a training set was established.

This type of FDA letter focuses on regulatory clearance based on substantial equivalence, not on providing detailed study outcomes for a new device's performance against specific acceptance criteria in the manner one would find in a clinical study report or a publication describing AI algorithm performance.

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"Amecath Dual Lumen Implanted Hemodialysis Catheter" is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown.

Repair Kit is designed to replace worn or damaged extension connector adapters on the all catheter models:

• . PDLC
• PYDLC .
• P2TC .
• PXDLC .

Catheters are not intended for pediatric use.

"Amecath Dual Lumen Implanted Hemodialysis Catheter and Repair Kit"

This is a letter for the clearance of an Amended Dual Lumen Implanted Hemodialysis Catheter and Repair Kit. We can't determine the acceptance criteria and study from this document. This kind of information is usually located in the 510(k) summary document, which is not provided.

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Indicated to permit short-term (

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The provided text is a 510(k) premarket notification letter from the FDA to Ameco Medical Industries for their "Amecath CVC" and "Amecath Pressure CVC" short-term single and multi-lumen catheterization kits.

This document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria for a device's performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval, classification, and general responsibilities under the Federal Food, Drug, and Cosmetic Act.

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Indicated for acute hemodialysis and apheresis. They may be inserted perculaneously and are idealy placed in the internal jugularyon and apricless. They may be inserted percuraneously and an the internal jugular is the preferred site the preferred site.

"Amecath" and "Amecath UniQath Soft" short term dual hemodialysis catheterization kits

The provided text is related to a 510(k) premarket notification for "Amecath" and "Amecath UniQath Soft" short term dual hemodialysis catheterization kits. It includes details about the device's indications for use and classification.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input.

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