(31 days)
The BD ChloraShield IV Dressing with CHG antimicrobial, per K152923, is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.
The BD ChloraShield IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing with integrated Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.
This document is a 510(k) premarket notification for a medical device called the "BD ChloraShield IV Dressing with CHG antimicrobial". It describes a special 510(k) application, which is used for modifications to a previously cleared device where the modification does not affect the indications for use or the fundamental scientific technology of the device.
The core purpose of this document is to demonstrate "substantial equivalence" to a predicate device (K113836, Benehold CHG Transparent Film Dressing) after a specific change: expanding the specification for Chlorhexidine Gluconate (CHG) content in the dressing.
There is no information in this document about the use of AI, machine learning, or any form of algorithmic performance that would necessitate the detailed acceptance criteria and study design requested in the prompt.
The "performance testing" section (Section 7) refers to:
- Antimicrobial efficacy testing to the requirements set forth within USP 51.
- Verification/validation activities confirming that the specification change was "well within the requirements".
- Antimicrobial efficacy test results demonstrating conformance.
This is a chemical/material performance study, not a performance study of an AI/ML diagnostic or assistive device. Therefore, I cannot extract the requested information regarding AI/ML performance, ground truth establishment, expert review, or MRMC studies, as those concepts are irrelevant to this specific device and its regulatory submission.
The prompt asks for acceptance criteria and study details related to an AI/ML device, which this document is clearly not about.
As such, I cannot fulfill the request in the way it is structured. I can only confirm that the document describes a regulatory submission for an IV dressing and indicates that performance testing involved antimicrobial efficacy testing, demonstrating the modified CHG specification still met the requirements of the original submission.
No information regarding AI/ML performance, ground truth, experts, or MRMC studies is present in the provided text.
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