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CUTIVA™ Topical Skin Adhesive (RM1700) is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. CUTIVA™ Topical Skin Adhesive (RM1700) should be used in conjunction with, but not in place of, deep dermal stitches.

The CUTIVA™ PLUS Skin Closure System (RM1739) is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CUTIVA™ PLUS Skin Closure System (RM1739) should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during the application of the liquid adhesive.

CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) are skin closure devices that are comprised of a 2-octyl cyanoacrylate liquid adhesive formulation. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. The CUTIVA™ PLUS Skin Closure System (RM1739) also incorporates a self-adhering mesh component that is applied to the wound prior to the application of the liquid adhesive to align the skin edges. The liquid adhesive is then applied to the mesh with the adhesive applicator to complete the device application.

Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) provide a physical barrier to microbial penetration as long as the adhesive film remains intact. In vitro studies have been performed to demonstrate the microbial barrier properties of CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) for 72 hours after device application. No clinical studies have been performed and no clinical benefit associated with the in vitro microbial barrier performance of the device has been demonstrated.

This FDA 510(k) clearance letter pertains to a topical skin adhesive, not an AI/ML medical device. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) is not applicable or cannot be extracted from this document, as these concepts are specific to the validation of AI/ML algorithms, not traditional medical devices like skin adhesives.

However, I can provide the available information regarding acceptance criteria and the study that supports the device, focusing on what is relevant for a non-AI/ML medical device.

Device Name: CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for a traditional medical device (topical skin adhesive) and not an AI/ML algorithm, the "acceptance criteria" discussed are typically related to biocompatibility, physical properties, and safety, assessed against recognized standards. The document primarily focuses on biocompatibility testing as a "performance data" highlight for the labeling change.

• No evidence of systemic toxicity.
• Microscopically, the test article caused a minimal or no reaction.
• Worst-case exposure conditions were created by implanting the maximum dose. |
  | Biocompatibility (Reaction) | Minimal or no local reaction at the implantation site. | Microscopically, the test article was classified as causing a minimal or no reaction. |
  | Substantial Equivalence | The device is substantially equivalent to a legally marketed predicate device. | Both CUTIVA™ Topical Skin Adhesive (RM1700) and CUTIVA™ PLUS Skin Closure System (RM1739) were found substantially equivalent to their respective predicate devices (K234114) since they are the same devices with only packaging insert modifications. |

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of human subjects or a "test set" for performance evaluation in the context of an AI/ML algorithm. For the biocompatibility study, it involved "test animals" (rats), but the exact number is not provided.
• Data Provenance: The biocompatibility study was performed in accordance with ISO 10993-11:2017 standards, implying a controlled laboratory study. The country of origin is not specified, but the study method adheres to international standards. It is a prospective animal study for biocompatibility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable in the context of this device. The ground truth for biocompatibility studies is typically derived from established biological assays and pathological analysis by trained professionals (e.g., toxicologists, histopathologists), not from "experts" establishing ground truth in an image-reading or diagnostic context.

4. Adjudication Method for the Test Set

• Not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used for human reader consensus in diagnostic studies, which is not relevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is a traditional medical device (skin adhesive), not an AI/ML algorithm requiring an MRMC study to assess human reader improvement.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This is a traditional medical device, not an algorithm.

7. Type of Ground Truth Used

• For Microbial Barrier Properties: In vitro laboratory testing results, comparing microbial penetration with and without the adhesive.
• For Biocompatibility: Histological examination and physiological observations on test animals (rats) to determine systemic toxicity and local tissue reaction, based on the criteria of ISO 10993-11:2017.

8. Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As there is no AI/ML algorithm, there is no training set and thus no ground truth to establish for it.

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CUTIVA™ Topical Skin Adhesive (RM1700) is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. CUTIVA™ Topical Skin Adhesive (RM1700) should be used in conjunction with, but not in place of, deep dermal stitches.

The CUTIVA™ PLUS Skin Closure System (RM1739) is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CUTIVA™ PLUS Skin Closure System (RM1739) should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the application of the liquid adhesive.

CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) are skin closure devices that are comprised of a 2-octyl cyanoacrylate liquid adhesive formulation. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. The CUTIVA™ PLUS Skin Closure System (RM1739) also incorporates a self-adhering mesh component that is applied to the wound prior to the application of the liquid adhesive to align the skin edges. The liquid adhesive is then applied to the mesh with the adhesive applicator to complete the device application.

Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) provide a physical barrier to microbial penetration as long as the adhesive film remains intact. In vitro studies have been performed to demonstrate the microbial barrier properties of CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) for 72 hours after device application. No clinical studies have been performed and no clinical benefit associated with the in vitro microbial barrier performance of the device has been demonstrated.

The provided text is a 510(k) summary for medical devices (Topical Skin Adhesives and Skin Closure Systems), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for AI/ML performance, such as sample sizes for test/training sets, expert qualifications, and human-in-the-loop studies, is not contained within this document.

The document discusses the substantial equivalence of the new devices (CUTIVA™ Topical Skin Adhesive and CUTIVA™ PLUS Skin Closure System) to legally marketed predicate devices, focusing on:

• Device Description: What the devices are made of (2-octyl cyanoacrylate liquid adhesive, with an additional mesh component for the PLUS system).
• Indications for Use: What the devices are intended for (holding closed easily approximated skin edges of wounds).
• Comparison of Technological Characteristics: A table comparing features of the new devices to predicates (e.g., sterilization method, applicator style, polymerization initiating agent).
• Performance Data: This section details bench studies (viscosity, setting time, strength tests like wound closure strength, tensile strength, lap shear strength, heat of polymerization, applicator functionality, microbial barrier), animal studies (porcine study evaluating safety and effectiveness comparably to predicate devices), and biocompatibility testing (cytotoxicity, sensitization, irritation, pyrogenicity, systemic injection, subcutaneous implantation, systemic toxicity) to demonstrate substantial equivalence.
• Sterilization and Shelf-Life: Details on the sterilization processes and shelf-life confirmation.

Therefore, I cannot provide the requested table and information as it specifically pertains to the evaluation of AI/ML device performance, which is not described in this regulatory submission for a topical skin adhesive.

The acceptance criteria mentioned in the document relate to the successful completion of various physical, chemical, and biological tests for the adhesive devices, and where applicable, demonstration of comparable performance to predicate devices. For example, "All success criteria were met for Endpoint 1 (overall animal health), Endpoint 2 (test article performance), and Endpoint 3 (local tissue response to the test article)" in the porcine study. These are not acceptance criteria for AI/ML model performance metrics.

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The Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple thoroughly cleansed, trauma- induced lacerations. The Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

CM00622 Skin Wound Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampoule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that following polymerization, CM00622 LINC acts as a physical barrier (for up to 7 days) to microbial penetration as long as the polymerized liquid topical skin adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.

CM00622 LINC also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liguid topical skin adhesive is applied to achieve skin closure.

The provided text is a 510(k) Summary for the CM00622 LINC Skin Closure System. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study describing the device performance against specific acceptance criteria in a clinical or standalone setting as would be applicable to AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in this document.

However, I can extract information related to performance testing conducted to support the claim of substantial equivalence.

Here's a summary based on the provided text:

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

The document states that "Testing was performed in accordance with the FDA special controls guidance document for 'Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin' Issued on: November 10, 2010" and that "Performance testing found that the subject device is substantially equivalent to the predicate device and these differences do not affect safety or efficacy."

While specific numerical acceptance criteria and reported performance values are not provided in this summary, the general acceptance criterion is substantial equivalence to the predicate device (DERMABOND™ PRINEO™ Skin Closure System) based on various performance tests. The reported performance is that the device met this criterion, indicating that results from the tests were comparable to the predicate within acceptable limits.

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

This information is not provided in the document. The performance tests listed are bench and animal studies (pre-clinical), not clinical studies with a human test set.

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

Not applicable, as this is not a study assessing diagnostic performance against a ground truth established by experts. The performance tests are largely objective physical and biological tests.

4. Adjudication method for the test set:

Not applicable.

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 device is a medical product (skin closure system), not an AI/ML diagnostic or assistive device.

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

Not applicable. This device is a medical product, not an algorithm.

7. The type of ground truth used:

For the performance tests, the "ground truth" (or reference standard) would be the established methods and expected performance characteristics for such devices, as outlined in the FDA guidance and industry standards (e.g., ASTM standards). For the animal study, the ground truth would be observed wound healing outcomes compared to a control or predicate.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of what was included:

The document lists the following performance tests conducted to demonstrate substantial equivalence:

• Peel Adhesion of Pressure-Sensitive Tape (ASTM D3330/D3330M-04)
• Shear Adhesion of Pressure-Sensitive Tapes (ASTM D3654/D3654M-06)
• Tensile Properties of Thin Plastic Sheeting (ASTM D882-12)
• Lap-shear strength (ASTM F2255-05)
• T-peel adhesion strength(ASTM F2256-05)
• Adhesive strength in tension (ASTM F2258-05)
• Wound closure strength(ASTM F2458-05)
• Adhesive degradation study
• Heat of polymerization
• Viscosity
• Dry time
• Microbial barrier testing (Note: Clinical studies were not conducted to demonstrate microbial barrier properties, and a correlation between these properties and infection reduction has not been established.)
• Device Yield and Quality of Film
• Flow Control
• Animal wound healing study

Biocompatibility tests:

• Physical and/or chemical information: Solvent compatibility, Chemical characterization and Toxicological risk assessment.
• Cytotoxicity.
• Sensitization.
• Intracutaneous reactivity.
• Material mediated pyrogenicity.
• Endotoxin mediated pyrogenicity.
• Acute systemic toxicity.
• Implantation (including sub-acute toxicity).

The conclusion states that based on these tests, the CM00622 LINC Skin Closure System has been demonstrated to be substantially equivalent to the predicate device.

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LiquiBand® XL is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. LiquiBand® XL should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

LiquiBand® XL is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes.
In vitro studies have shown that LiguiBand® XL acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
LiquiBand® XL also incorporates a self-adhering mesh that is approximated skin edges to provide temporary skin edge alignment to an incision until the liquid adhesive is applied to achieve skin closure.

The device under consideration is the LiquiBand® XL, a tissue adhesive with an adjunct wound closure device for the topical approximation of skin.

Acceptance Criteria and Device Performance:

The document describes performance testing conducted according to the FDA special controls guidance document for "Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin." The table below summarizes the types of tests performed, which inherently represent the acceptance criteria for those specific properties for demonstrating substantial equivalence. The reported device performance is that these tests were performed and the device demonstrated substantial equivalence to the predicate device. Specific numerical acceptance values or performance results are not provided in this summary.

Additional Information:

1. Sample size used for the test set and data provenance: The document does not specify the exact sample sizes for each of the performance tests. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied that these are laboratory and animal studies conducted by the manufacturer to demonstrate performance characteristics.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts: This is not applicable to the type of performance testing described. The tests are physical, chemical, and biological evaluations, not requiring human expert interpretation in the same way clinical imaging studies might.

3. Adjudication method for the test set: Not applicable for these types of performance tests.

4. Multi-reader multi-case (MRMC) comparative effectiveness study: No MRMC or clinical studies were performed. The document explicitly states: "No clinical testing has been submitted, referenced, or relied upon for determining substantial equivalence."

5. Standalone (i.e. algorithm only without human-in-the loop performance) performance: Not applicable as this is a physical medical device, not an AI/algorithm-based device.

6. Type of ground truth used: The ground truth for the performance tests consists of established scientific and engineering standards (e.g., ASTM standards, ISO 10993-1), and the predicate device's performance profile against these standards. The objective is to show that the LiquiBand® XL performs similarly to the predicate.

7. Sample size for the training set: Not applicable as this is not an AI/algorithm-based device that would require a "training set."

8. How the ground truth for the training set was established: Not applicable.

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DERMABOND™ PRINEO™ System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND™ PRINEO™ System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND PRINEO System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

DERMABOND PRINEO also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liquid topical skin adhesive is applied to achieve skin closure.

This is a 510(k) premarket notification for a medical device (DERMABOND™ PRINEO™ Skin Closure System) applying for clearance from the FDA. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a de novo study with detailed acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new device cannot be fully extracted from this document in the manner typically expected for a new device submission.

Here's a breakdown of why and what can be extracted:

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

• Not Applicable in the traditional sense. This document explicitly states: "This section is not applicable, as both nonclinical testing are not necessary to support substantial equivalence since there have been no changes to the technological characteristics of the devices, including the adhesive formulation, design, material and performance; this change is only to reduce adhesive volume for subject device."
• Since there were no new non-clinical or clinical studies conducted to demonstrate performance against new acceptance criteria, such a table cannot be created from this document. The submission is based on the premise that the modified device (reduced adhesive volume) performs equivalently to the predicate, which has already met its acceptance criteria.

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

• Not Applicable. No new test set data is presented for performance evaluation because no new studies were deemed necessary. The assessment hinges on the predicate device's existing data and the argument that a reduced adhesive volume does not alter the fundamental safety or effectiveness.

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)

• Not Applicable. No new test set requiring expert ground truth establishment was conducted.

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

• Not Applicable. No new test set requiring adjudication was conducted.

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 device is a physical medical device (skin closure system), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human "readers" or AI assistance are irrelevant to this submission.

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

• Not Applicable. As above, this is not an algorithm-based device.

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

• Not Applicable. No new ground truth for performance evaluation was established for this submission. The "ground truth" for demonstrating substantial equivalence relies on the established performance and safety of the predicate device.

8. The sample size for the training set

• Not Applicable. This document does not pertain to the development of a predictive model or AI, so there is no "training set."

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

• Not Applicable. As above, there is no training set.

Summary based on the provided document:

The core of this 510(k) submission is to demonstrate substantial equivalence of the modified DERMABOND™ PRINEO™ Skin Closure System (with reduced adhesive volume) to its predicate device (K133864).

The document explicitly states that non-clinical and clinical testing were not necessary to support substantial equivalence because "there have been no changes to the technological characteristics of the devices, including the adhesive formulation, design, material and performance; this change is only to reduce adhesive volume for subject device."

Therefore, the "proof" that the device meets acceptance criteria implicitly relies on:

• The predicate device (K133864) having already met its acceptance criteria through its original clearance.
• The argument that a reduction in adhesive volume does not compromise the fundamental safety and effectiveness of the device, given that all other technological characteristics, materials, design, intended use, and manufacturing processes remain identical to the cleared predicate.

In a situation like this, the "acceptance criteria" are effectively met by demonstrating that the changes are minor and do not affect the established performance characteristics of the predicate device. No new study data is presented to prove independent performance against new acceptance criteria.

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Exofin Fusion Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin Fusion Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

Exofin® Fusion Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2- octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single-use applicator packaged in a rigid blister. As applied to skin, the liquid is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that Exofin® Fusion Skin Closure System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established. Exofin Fusion Skin Closure System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm each in length until the liquid adhesive is applied to achieve skin closure.

The provided text is a 510(k) Summary for the Exofin® Fusion Skin Closure System. It details the device, its intended use, and comparison to predicate devices, along with non-clinical testing performed to demonstrate substantial equivalence. However, it does not contain the specific information required to address the request regarding acceptance criteria, study details, expert involvement, or AI-related metrics.

Specifically, the document states: "No clinical testing has been submitted, referenced, or relied upon for Clinical Testing: determining substantial equivalence." This means there are no clinical study results to describe in terms of direct clinical performance, acceptance criteria, or human reader improvement with AI.

Therefore, I cannot fulfill the request for information on the study that proves the device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or details about the training set, as these aspects are not present in the provided 510(k) summary.

The document focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, as outlined in the "Non-clinical Testing" section:

• Acceptance Criteria and Reported Performance (based on non-clinical testing available):

Remaining requested information, not found in the provided text:

• Sample size used for the test set and the data provenance: Not provided, as clinical testing was not relied upon. The non-clinical tests would have their own sample sizes, but these are not detailed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth established or relied upon.
• Adjudication method for the test set: Not applicable.
• 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 device is not an AI-based diagnostic device where human-in-the-loop performance with AI assistance would be relevant.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For non-clinical tests, the "ground truth" would be the established testing parameters and results as per ASTM and ISO standards, demonstrating compliance. Clinical or expert consensus ground truth is not reported.
• The sample size for the training set: Not applicable, as there is no mention of an algorithm or AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

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Exofin® Fusion Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin Fusion Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

Exofin® Fusion Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch containing an applicator. The applicator is comprised of a self-puncturing cap and a soft elastomeric brush, which allows the adhesive to spread uniformly. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Exofin® Fusion Skin Closure System has a low viscosity. In vitro studies have shown that Exofin® Fusion Skin Closure System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established. Exofin Fusion Skin Closure System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of two incisions up to 20 cm each in length until the liquid adhesive is applied to achieve skin closure.

The provided document describes the Exofin® Fusion Skin Closure System and its substantial equivalence to the predicate device, Dermabond™ Prineo™ Skin Closure System. However, it does not contain information on acceptance criteria or a study proving the device meets an algorithm's acceptance criteria.

The document outlines a 510(k) submission for a medical device (a skin closure system), not an AI/ML powered device. The "Performance Data" section details several physical and biological tests conducted on the device components, such as wound closure strength, adhesive strength, biocompatibility, and a porcine wound healing study, to demonstrate its safety and effectiveness. These tests are relevant for a physical medical device.

Therefore, I cannot fulfill the request as it pertains to AI/ML specific acceptance criteria, test set sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as this information is not present in the provided text.

The closest information provided is:

• Type of Ground Truth Used (for the animal study): Histological analysis (for the porcine wound healing study).
• Sample size for the training set: Not applicable/not mentioned, as it's not a machine learning study.
• How the ground truth for the training set was established: Not applicable/not mentioned.

Essentially, the device in question is a physical tissue adhesive system, not an AI software.

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DERMABOND™ PRINEO™ System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND™ PRINEO™ System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octylcyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND™ PRINEO™ System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

DERMABOND™ PRINEOTM System also incorporates 2 self-adhering meshes that are applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 40 cm in length until the liquid adhesive is applied to achieve skin closure.

The provided text describes a 510(k) premarket notification for a medical device, the Dermabond Prineo Skin Closure System. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a clinical study involving human-in-the-loop performance, expert ground truth establishment, or MRMC studies.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. This submission relies on non-clinical design verification and comparison to a predicate device.

Here's an attempt to extract relevant information and note what is not available based on the provided text:

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

The document lists various tests performed to demonstrate safety and effectiveness for the Dermabond Prineo Skin Closure System (42cm) and its substantial equivalence to the predicate device (22cm). However, it does not provide specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it states that "No new safety or performance issues were raised during the testing." and "The additional size meets the same requirements as the current FDA cleared K133864 device."

Here's a table of the types of tests performed, as listed in the document. The "Reported Device Performance" column reflects the general statement provided in the document.

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

• Sample Size for Test Set: The document mentions a "14 day Porcine Effectiveness Study" and various bench tests. However, it does not specify the sample sizes for these tests.
• Data Provenance: Not specified. The studies were non-clinical design verification.

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

• Not Applicable. This document describes a 510(k) submission based on non-clinical testing and substantial equivalence, not a clinical study involving experts establishing ground truth for a test set.

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

• Not Applicable. As above, this was not a clinical study with image interpretation requiring 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

• Not Applicable. This device is a skin closure system, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device or this submission.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• For the non-clinical tests, the "ground truth" would be established by the engineering specifications, material properties, and biological compatibility standards (e.g., ISO 10993). For the porcine effectiveness study, the "effectiveness" would be assessed based on observed outcomes relevant to wound closure. However, specific definitions and methodologies for establishing this "ground truth" (e.g., how "effectiveness" was quantified and assessed in the porcine study) are not detailed in this document.

8. The sample size for the training set

• Not Applicable. This device is not an AI/machine learning algorithm that requires a training set. The submission focuses on non-clinical "design verification."

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

• Not Applicable. (See point 8).

In Summary:

The provided FDA document is a 510(k) clearance letter for a medical device (Dermabond Prineo Skin Closure System). It outlines the device details and the basis for its substantial equivalence to a predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to a series of non-clinical design verification tests (biocompatibility and bench testing) and a 14-day porcine effectiveness study. The document asserts these tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised during the testing." It does not provide the granular details of acceptance criteria, specific numerical results, sample sizes for all tests, or the methodology for ground truth establishment that would be present in a submission for an AI/ML-based diagnostic device or a comprehensive clinical trial report.

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DERMABOND™ PRINEO™ System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND™ PRINEO™ System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with attached applicator tip. As applied to skin, the liquid adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND™ PRINEO™ System acts as a barrier to microbial penetration as long as the liquid adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

DERMABOND™ PRINEO™ System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment until the liquid adhesive is applied to achieve skin closure.

This document is a 510(k) premarket notification for the DERMABOND™ PRINEO™ Skin Closure System, seeking clearance for a new revision of the device's labeling. The document explicitly states that the device itself has not changed in any material, construction, specification, manufacturing, or sterilization process. Therefore, it does not contain a study demonstrating new device performance against acceptance criteria.

The submission claims substantial equivalence to previously cleared DERMABOND™ PRINEO™ devices (K082289/DEN090005 and K133864). Since the device itself is identical to a previously cleared predicate and the changes are only to labeling (adding a contraindication and other clarifications), no new performance data or studies are presented in this document to demonstrate the device meets acceptance criteria. The document relies on the substantial equivalence of the unchanged device to the predicate device.

Therefore, I cannot provide the requested information from this document, as the core of the submission is about labeling changes to an already cleared and unchanged device, not a new study proving performance against acceptance criteria for the device itself.

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DERMABOND PRINEO Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, traumainduced lacerations. DERMABOND PRINEO should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND PRINEO acts as a barrier to microbial penetration as long as the liquid topical skin adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

DERMABOND PRINEO also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liquid topical skin adhesive is applied to achieve skin closure.

The provided text describes the DERMABOND™ PRINEO™ Skin Closure System, a topical skin adhesive. However, it does not contain a typical acceptance criteria table with performance metrics that would be applicable to an AI/ML device or diagnostic tools in the requested format. Instead, it details the regulatory submission and the overall safety and effectiveness assessment for a medical device.

Therefore, many of the requested sections related to traditional diagnostic performance studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and ground truth establishment methods) are not explicitly present in the provided documentation for this specific device. The information focuses on bench testing, biocompatibility, and substantial equivalence to a predicate device, rather than diagnostic accuracy or AI performance.

Here's an attempt to extract and interpret the information based on the provided text, primarily focusing on the type of study conducted for this specific medical device rather than an AI/ML diagnostic:

Acceptance Criteria and Study for DERMABOND™ PRINEO™ Skin Closure System

Given that this is a 510(k) summary for a topical skin adhesive, the "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to a predicate device and ensuring the safety and effectiveness of the new size variant (up to 20 cm incision length) through nonclinical design verification and biocompatibility testing. There are no explicit performance metrics in the format of "acceptance criteria" with numerical targets and "reported device performance" against those targets as would be expected for a diagnostic device. Instead, the "acceptance criteria" can be inferred as successful completion of various bench and in-vivo tests, demonstrating equivalence and meeting established safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit numerical acceptance criteria were not listed, this table reflects the types of tests performed and the general outcome of demonstrating conformance and substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of tensile strength tests, number of peel tests). For the "14 day Porcine Effectiveness Study," the sample size is not stated.
• Data Provenance: The studies are described as "nonclinical design verification" and "in vivo" (porcine model). These are likely conducted internally by Ethicon or contract labs. The "Biocompatibility/In vivo" tests are standard regulatory tests. There is no information regarding country of origin for the data (other than Ethicon being a US company) or whether it was retrospective or prospective in the sense of human clinical trials. The porcine study would be prospective in its design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable (N/A) as the submission details bench and animal (porcine) studies, not studies involving human expert interpretation for ground truth, which is typical for AI/ML diagnostic devices. The "ground truth" for these tests would be the measured physical properties or biological responses against established material and biological safety standards.

4. Adjudication Method for the Test Set

N/A. This is not a human interpretation study requiring adjudication. The results of the physical and biological tests are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

N/A. This device is a topical skin adhesive, not an AI/ML diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

N/A. This device is not an algorithm or AI. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's testing is best described as:

• Physical and Mechanical Measurement Standards: For tests like Peel, Tensile Strength, Viscosity, Creep, etc., the ground truth corresponds to accepted engineering and material science standards and specifications for performance.
• Biological Safety Standards: For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization, etc.), the ground truth relies on established ISO 10993 standards for biological evaluation of medical devices.
• Animal Model Observations: For the "14 day Porcine Effectiveness Study," the ground truth would be direct observation of wound approximation and healing in the animal model, assessed by researchers or veterinarians against clinical endpoints (e.g., wound integrity, closure success).

8. The Sample Size for the Training Set

N/A. This device does not involve a "training set" in the context of AI/ML or a diagnostic model that learns from data.

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

N/A. As there is no training set, this question is not applicable.

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