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SECUREPORTIV® ADVANCED 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 a moisture barrier. SECUREPORTIV® ADVANCED is intended to be used with a transparent film dressing for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.

SecurePortIV Advanced Catheter Adhesive is a sterile, professional liquid cyanoacrylatebased adhesive containing a monomeric formulation (2-octyl 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 Advanced liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes.

The SecurePortIV Advanced Catheter Securement Adhesive underwent various tests to demonstrate its safety and effectiveness, leading to its clearance based on substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

• Quantitative measurements: For securement time, a specific time (14 seconds) was measured and reported.

8. Sample Size for the Training Set

This question is not applicable as the device is a physical medical product, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is a physical medical product, not an AI algorithm.

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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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Flora Seal™ Microbial Sealant is intended for use after topical operative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of the skin flora contamination throughout a surgical procedure.

Flora Seal Microbial Sealant is a film forming, cyanoacrylate based microbial sealant provided in a ready to use applicator. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.

The provided text describes the FloraSeal Microbial Sealant and its substantial equivalence to the predicate device, InteguSeal. Since this is a 510(k) summary for a medical device (microbial sealant) rather than an AI/ML powered device, many of the requested categories in the prompt relate specifically to AI/ML studies and are not applicable here.

Here's an analysis based on the provided text:

FloraSeal Microbial Sealant

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: The clinical test involved "volunteer subjects." The exact number of subjects is not specified.
• Data Provenance: The study was a clinical test on human subjects. The country of origin is not specified, but given the FDA 510(k) submission, it is likely that the data was generated in the US or under US regulatory standards. It was a prospective study, as subjects participated in a washout period prior to evaluation for stabilization of skin bacterial flora.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This device is a microbial sealant, and its performance (microbial reduction) would be assessed through microbiological laboratory analysis and clinical observation, not by human experts establishing ground truth for image interpretation or similar AI/ML tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. As above, this concept is not relevant for the evaluation of a microbial sealant.

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:

• Not Applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an AI/ML device. The device (sealant) performs its function directly.

7. The type of ground truth used:

• For microbial reduction: Microbiological assays/measurements (e.g., bacterial counts from skin samples) to quantify the reduction in microbial colonization.
• For bench tests: Engineering and material science measurements for various properties like wound closure strength, film integrity, flexibility, MVTR, setting time, surface coverage, hydrostatic pressure, and water impact penetration.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant.

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Integuseal Microbial Sealant is intended for use after typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure.

INTEGUSEAL Microbial Sealant is a film-forming cyanoacrylate-based product provided in a ready-to-use applicator. The Sealant is intended to be applied on the skin over commonly used surgical skin preparation products with standard surgical draping prior to a surgical incision. Upon polymerization, INTEGUSEAL bonds to the skin, immobilizing the bacteria and thereby reducing the risk of skin flora contamination throughout a surgical procedure.

The provided text describes the INTEGUSEAL Microbial Sealant, a device intended to reduce the risk of skin flora contamination during surgical procedures. The submission details a summary of the device, its intended use, and substantial equivalence to a predicate device, as well as the testing conducted.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The provided text does not explicitly state numerical or specific performance acceptance criteria in a table format. However, it indicates the device was tested to demonstrate "substantial equivalence" to the predicate device, ACTI-Gard Antimicrobial Film, based on its ability to reduce the risk of skin flora contamination.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "in vivo surgical incision microbial contamination testing" as part of the substantial equivalence testing. However, it does not specify the sample size used for this test set nor the country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The testing appears to be primarily laboratory-based (in vitro) and clinical performance-based (in vivo microbial contamination) rather than subjective expert assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication method. It describes testing and comparison to a predicate device, not a process involving multiple human evaluators making judgments that would require adjudication.

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

The device is a "Microbial Sealant," a physical product, not an AI or imaging diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance would not be applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a physical product, not an algorithm. Therefore, a standalone (algorithm only) performance study would not be applicable and was not performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the "in vivo surgical incision microbial contamination testing" would likely involve microbiological culture results quantifying the presence and levels of skin flora contamination, possibly compared to a control or the predicate device. This is a direct measurement of the biological outcome the device is designed to affect.

8. The sample size for the training set

The device is a physical product and does not involve machine learning or AI. Therefore, there is no training set in the context of AI/ML models.

9. How the ground truth for the training set was established

As there is no training set for this device, this question is not applicable.

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