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SecurePortIV™ catheter securement adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while also providing a moisture barrier. SecurePortV™ is intended to be used with a transparent film dressing on short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.

SecurePortIV Catheter Adhesive is a sterile, professional liquid cyanoacrylate-based adhesive containing a two monomeric formulation (2-octyl cyanoacrylate and butyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube.

The SecurePortIV liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes. It is intended to be used in conjunction with a transparent film dressing.

This document describes the premarket notification for the "SecurePortIV Catheter Securement Adhesive" (K170505). However, the document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report demonstrating the device meets specific acceptance criteria. The information provided is descriptive of the device and comparative to predicates.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not explicitly present in the provided text. I will extract what I can and note where information is missing.

Here's an attempt to answer your questions based on the provided text, with clear indications where the information is not available:

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

The document does not present explicit "acceptance criteria" in the format of defined metrics and thresholds that the SecurePortIV device must pass. Instead, it presents a comparison table (Table 1) against predicate and reference devices, aiming to show comparable or superior performance to establish substantial equivalence. The "Acceptance Criteria" here are implicitly that the SecurePortIV performs "as well or better than" the legally marketed predicate/reference devices across various characteristics.

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MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination.

MediClear™ PreOp can be left on the preoperative incision site for up to 7 days.

MediClear™ PreOp is intended to be used on intact skin and for external use only.

MediClear™ PreOp consists of a clear polyurethane film coated with an antimicrobial silicone adhesive containing 3% w/w chlorhexidine and 0.5% w/w silver salts and is intended to cover and protect skin from the risk of contamination prior to an invasive procedure (i.e. incision or insertion). The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while the polyurethane barrier film acts as a protective patient covering to isolate a procedural site from microbial and other contamination.

MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear. * In vitro effectiveness does not predict clinical performance.

MediClear™ PreOp is a breathable, transparent, self-adhesive silicone film that conforms to the contours of the body.

The document describes the acceptance criteria for the MediClear™ PreOp device and the studies performed to demonstrate that it meets these criteria.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: The document explicitly states: "In vitro effectiveness does not predict clinical performance." This is an important disclaimer for the antimicrobial activity results.

2. Sample Size Used for the Test Set and the Data Provenance:
The document does not provide specific sample sizes for any of the non-clinical tests mentioned. All tests listed are in vitro or bench tests conducted in a laboratory setting. There is no indication of human or animal data provenance (e.g., country of origin, retrospective/prospective) for these non-clinical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable as the studies described are non-clinical bench and in vitro tests. Ground truth in this context would typically refer to the reference standards or control groups used in the laboratory experiments, as well as the expertise of the scientists performing and interpreting the tests according to the cited ISO and ASTM standards. The document does not specify the number or qualifications of these scientific personnel.

4. Adjudication Method for the Test Set:
This information is not applicable as the studies described are non-clinical bench and in vitro tests. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies or studies involving human readers/interpreters where disagreements need to be resolved.

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:
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The device is a physical surgical drape, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone algorithm-only performance study was not performed. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the antimicrobial activity, the "ground truth" or reference for evaluating reduction would be the initial microbial counts before exposure to the device, as measured by standard microbiological assays. For biocompatibility tests, the ground truth refers to established biological responses to control materials or the absence of adverse effects as defined by the ISO 10993 series. For barrier performance, it's the ability to prevent penetration under defined conditions specified by ASTM/AAMI standards. These are laboratory-based ground truths derived from scientific standards and experimental controls.

8. The sample size for the training set:
This information is not applicable. The device is a physical medical device and does not involve AI or machine learning algorithms that require a training set.

9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.

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