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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CM005 Standard Topical Skin Adhesive is indicated 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. CM005 STANDARD Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 STANDARD Topical Skin Adhesive should be applied by trained medical or nursing staff.

CM004 Mini Topical Skin Adhesive is indicated 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. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.

CM005 Standard Topical Skin Adhesive 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 as a single-use applicator in a blister package. The pen style applicator is composed of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes.

CM004 Mini Topical Skin Adhesive 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 singleuse applicator packaged in a blister pack. The applicator is comprised of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes.

This document is a 510(k) summary for medical devices (CM005 Standard and CM004 Mini Topical Skin Adhesives) and as such does not contain a study addressing acceptance criteria in the manner requested (i.e., with statistical performance metrics against a defined ground truth, typical for AI-software devices).

The provided text describes performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study with acceptance criteria against a clinical outcome or expert ground truth for an AI/software device. The devices are topical skin adhesives, not AI/software devices. Therefore, a table of acceptance criteria vs. device performance, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or methods for establishing ground truth for training data are not applicable in the context of this document.

The "acceptance criteria" for these devices are demonstrated through a series of performance tests and biocompatibility assessments, showing that they are substantially equivalent to already cleared predicate devices.

Here's a summary of the type of performance criteria and tests carried out (as described in the document), rather than a direct answer to the prompt's table due to the nature of the device:

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

Since this is not an AI/software device, there aren't explicit numeric "acceptance criteria" in the traditional sense of diagnostic accuracy (e.g., sensitivity, specificity). Instead, substantial equivalence is demonstrated by performing various tests to show that the new devices perform comparably to predicate devices. The document states:

"It was determined through the testing (Bench and Animal) performed in this 510(k) submission, that the subject devices are substantially equivalent to the predicate devices and any minor differences in performance does not affect safety or efficacy."

The specific performance tests conducted were:

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 does not specify sample sizes for each individual test or their provenance. The tests were bench and animal studies (laboratory and pre-clinical, respectively).

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)

This is not applicable to a non-AI/software device submission. Ground truth for these physical and biochemical tests is established by standardized testing protocols (e.g., ASTM standards) and animal study observations.

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

Not applicable for a non-AI/software device. The tests follow established protocols.

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, as this is not an AI-assisted device.

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

Not applicable, as this is not an AI/software device.

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

For the performance tests, the "ground truth" is defined by the accepted results or outcomes of standardized physical, chemical, and biological tests (e.g., tensile strength measurements, viscosity values, lack of cytotoxicity as per ISO 10993-1). For the animal wound healing study, the ground truth would be histological assessment and observation of wound closure and healing characteristics.

8. The sample size for the training set

Not applicable, as this is not an AI/software device.

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

Not applicable, as this is not an AI/software device.

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Exofin® Precision Pen 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. Exofin® Precision Pen may be used in conjunction with, but not in place of, deep dermal sutures.

Exofin® Precision Pen is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. The adhesive is provided in a 1.0g size, single-use, aluminum, collapsible tube that is fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disc and soft elastomeric brush. The aluminum tube is housed within a silicone bulb that is connected to a polypropylene pen body and held by the end user during application. The adhesive, applicator tip, silicone bulb and pen body are packaged together in a (PETG) plastic blister pack and sealed with a labeled Tyvek® blister backer. A total of 12 units are packaged in a tray which is covered by a sleeve. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity assists in the unintended placement of the adhesive during application due to migration of the liguid adhesive from the wound site. The silicone bulb and pen body of the Exofin® Precision Pen were designed to improve ergonomics during application. In-vitro studies have shown that Exofin® Precision Pen acts as a barrier to microbial penetration when the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

The provided document is an FDA 510(k) summary for the Exofin® Precision Pen, a topical skin adhesive. It claims substantial equivalence to a predicate device (Exofin® High Viscosity Topical Skin Adhesive, K200264). This means the submission focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing extensive de novo clinical studies with detailed acceptance criteria and performance metrics for a novel technology.

Therefore, the information required to fully answer your request regarding acceptance criteria, study details, and specific performance metrics for a new device's clinical efficacy, as one might find for an AI medical device, is not present in this document. This document primarily addresses the substantial equivalence of modifications to a previously cleared device.

However, I can extract the available information related to performance testing that was conducted to support this Special 510(k).

Here's a breakdown of what can be gathered from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a specific table of quantitative acceptance criteria for clinical performance (e.g., wound closure rates, dehiscence rates) or quantitative performance metrics for the Exofin Precision Pen in the context of human studies. The performance testing section discusses "Mechanical Applicator Testing" and states it "met all performance criteria," but these criteria are not detailed.

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: Not specified for any human clinical trials. The performance testing mentioned ("Mechanical Applicator Testing") would involve device units, not human subjects.
• Data Provenance: Not applicable for human clinical data, as no new clinical studies were conducted for this Special 510(k). The "in-vitro studies" for microbial barrier properties suggest lab-based testing.

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

• Not applicable as no human clinical test set requiring expert ground truth establishment for a novel device was conducted for this Special 510(k).

4. Adjudication Method for the Test Set

• Not applicable as no human clinical test set requiring adjudication was conducted for this Special 510(k).

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

• No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices, whereas the Exofin Precision Pen is a therapeutic device (tissue adhesive).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. The Exofin Precision Pen is a physical medical device (a topical skin adhesive with an applicator), not an algorithm or AI system.

7. Type of Ground Truth Used

• Not applicable in the context of human clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the mechanical applicator testing would be the engineering specifications and functional requirements for the pen. For the microbial barrier, it would be laboratory culture results.

8. Sample Size for the Training Set

• Not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

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

• Not applicable for the same reason as above.

Summary of Device Rationale for this 510(k):

The Exofin® Precision Pen is presented as a modification to an already cleared device (Exofin® High Viscosity Topical Skin Adhesive, K200264). The changes are specifically:

1. Addition of a pen (silicone bulb and pen body) for improved ergonomics.
2. An increase in blister size to accommodate the pen body.
3. An increase in the number of device units per tray from 10 to 12.

The key claim for substantial equivalence is that the adhesive formulation, aluminum tube, and applicator tip remain unchanged from the predicate device. Therefore, clinical performance related to wound closure, strength, etc., is considered unchanged and relies on the predicate's clearance. The new testing conducted was primarily "Mechanical Applicator Testing" to ensure the new pen component functions as intended, and it reportedly "met all performance criteria." Biocompatibility was deemed unnecessary for the non-patient-contacting pen component, and the adhesive's biocompatibility was already established. Sterilization validation and shelf-life studies were also conducted for the new configuration.

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Exofin® High Viscosity Topical Skin Adhesive 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® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

Exofin® High Viscosity Topical Skin Adhesive is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. It is provided in a single-use, aluminum, collapsible tube fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disk and soft elastomeric brush, used to apply and spread the adhesive evenly. The adhesive and applicator tip are packaged together in a polyethylene terephthalate glycol plastic blister pack and sealed with a labeled Tyvek® blister backer. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity in Exofin® High Viscosity Topical Skin Adhesive is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In-vitro studies have shown that Exofin® High Viscosity Topical Skin Adhesive acts as a barrier to microbial penetration when 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.

The provided text describes a medical device, Exofin® High Viscosity Topical Skin Adhesive, and its review for substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the format requested in the prompt.

Specifically, the document focuses on the regulatory submission (510(k)) and comparison to a predicate device (Exofin® High Viscosity Tissue Adhesive). It lists various performance and biocompatibility tests conducted, and states that the device "met all performance criteria," but it does not specify what those criteria are (e.g., a numerical threshold or range for wound closure strength).

Therefore, for aspects of the prompt related to specific numerical acceptance criteria, reported performance values, sample sizes, expert qualifications, adjudication methods, or MRMC studies, that information is not present in the provided text. The document concerns a Class II medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new clinical efficacy study with defined acceptance criteria and human expert evaluation in the same manner as, for example, an AI diagnostic algorithm.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be created. The document lists the types of performance tests conducted (e.g., Wound Closure Strength, Adhesive Strength in Tension) and states that the device "met all performance criteria." However, it does not specify the actual numerical acceptance criteria or the measured performance values for these tests. For example, it doesn't say "Wound Closure Strength must be > X N/cm" and "Reported Wound Closure Strength was Y N/cm."

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

• Cannot be determined. The document mentions performance and biocompatibility testing but does not provide details on sample sizes used for these tests, nor does it specify the provenance (e.g., country of origin, retrospective/prospective) of any data beyond indicating "In-vitro studies" for microbial barrier properties.

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

• Not applicable / Cannot be determined. This type of information is typically relevant for diagnostic devices, especially those involving image interpretation by human experts. The Exofin® device is a topical skin adhesive. Its evaluation involves laboratory performance tests and biocompatibility, not expert interpretation of diagnostic data to establish a "ground truth" in the requested sense.

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

• Not applicable / Cannot be determined. Similar to point 3, adjudication methods are relevant for studies comparing expert interpretations, often in diagnostic settings. This device's testing does not involve such a process.

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

• No. An MRMC study is not mentioned. This type of study is typically for evaluating diagnostic accuracy, especially of AI/CAD systems that assist human readers. Exofin® is a therapeutic device (a skin adhesive), not a diagnostic AI.

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

• Not applicable. This question pertains to AI algorithms, which Exofin® is not.

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

• Ground truth in the context of device performance testing: For the performance tests listed (e.g., Wound Closure Strength, Adhesive Strength), the "ground truth" would be the objective measurement against established ASTM standards and internal specifications, rather than expert consensus or pathology in a clinical diagnostic sense. For biocompatibility, it's against established biological safety endpoints.
• The document implies that the device "met all performance criteria," meaning its measured performance values conformed to the pre-defined specifications/acceptance criteria for each test (e.g., ISO, ASTM standards).

8. The sample size for the training set

• Not applicable / Cannot be determined. The device is a physical medical product (a skin adhesive), not an AI model that requires a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

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LiquiBand® Plus is intended for topical applications 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. LiquiBand® Plus may be used in conjunction with, but not in place of, deep dermal stitches.

LiquiBand® Plus topical skin adhesive 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 patient use applicator and packaged in a pouch. The LiquiBand® Plus topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand® Plus topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand® Plus topical skin adhesive polymerizes within minutes.

In vitro studies have shown that LiquiBand® Plus topical skin adhesive 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.

The provided text describes the 510(k) summary for the medical device LiquiBand Plus, a topical skin adhesive. It outlines its indications for use, technological characteristics, and performance data from various tests. However, the document does not explicitly state acceptance criteria in a quantitative manner or provide specific performance results against those criteria in a table format. It focuses on demonstrating substantial equivalence to a predicate device through various performance and biocompatibility tests.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance with numerical values, nor can I quantify the sample sizes for test sets, the number or qualifications of experts for ground truth, or an adjudication method. The document does not contain information about multi-reader multi-case studies, standalone algorithm performance, or specific ground truth methodologies for any studies, as the device is a physical medical device (skin adhesive), not an AI/software device that would typically involve such studies.

Here's a breakdown of what can be extracted from the provided text, while acknowledging the limitations regarding the core request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not available in the provided text. 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'". It lists several tests, but does not provide specific numerical acceptance criteria for these tests or the quantitative performance results achieved by LiquiBand Plus against those criteria. It only states that the testing demonstrated substantial equivalence.

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

Not available in the provided text. The document lists the types of tests performed (e.g., Lap-shear strength, Animal wound healing study) but does not disclose the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable/available in the provided text. This device is a topical skin adhesive, not an AI/software for interpretation. "Ground truth" in the context of expert review for image or data interpretation is not relevant here. The evaluation focuses on physical and biological properties.

4. Adjudication method for the test set:

Not applicable/available in the provided text. As above, adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in expert interpretation, which is not relevant for this device type.

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/available in the provided text. This type of study is for AI-assisted diagnostic or interpretative devices. LiquiBand Plus is a physical medical device.

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

Not applicable/available in the provided text. This is relevant for AI/software and not a physical medical device.

7. The type of ground truth used:

Various methods depending on the test, but not explicitly detailed as "ground truth" in the context of expert review. For a physical device like LiquiBand Plus, the "ground truth" would be established through the methodologies of the specific performance tests listed (e.g., standardized testing protocols for strength, degradation, biocompatibility endpoints like cytotoxicity). The document mentions "in vitro studies" and "animal wound healing study," but details on specific ground truth establishment for these are not provided.

8. The sample size for the training set:

Not applicable/available in the provided text. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable/available in the provided text. There is no "training set" for this device.

In summary, the provided FDA 510(k) summary for LiquiBand Plus details the regulatory classification, indications for use, and a list of performance and biocompatibility tests conducted to demonstrate substantial equivalence to a predicate device. However, it does not provide the quantitative acceptance criteria, specific performance results against those criteria, sample sizes for the studies, or details related to expert ground truth establishment, as these are typically applicable to AI/software devices for diagnostic or interpretative tasks, not physical medical devices like the one described.

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derma+flex® QS ™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.

derma+flex® QS ™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

derma+flex® QS™ High Viscosity Tissue Adhesive 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 aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1095B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA 180 applicator tips. The dauber applicator is comprised of a self-puncturing cap and a foam surface, which allows spreading of the adhesive with uniformity.

The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. The increased viscosity of derma+flex® QS™ is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site.

The provided text describes a 510(k) premarket notification for a medical device called derma+flex® QS™ High Viscosity Tissue Adhesive. This type of filing aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a traditional clinical study. Therefore, the information you're looking for, such as a table of acceptance criteria and device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not directly applicable or available in this document.

However, I can extract information about the shelf-life study which included performance testing to demonstrate that changes in the sterilization process did not alter the device's performance over time. This is the closest equivalent to a performance study mentioned in the document.

Here's a breakdown of the relevant information from the document regarding the shelf-life study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantified acceptance criteria and reported performance values. It only lists the types of tests performed to demonstrate that the minor differences in sterilization did not change the performance of the device over time. The implied acceptance criterion would be that the device's performance on these tests remains within pre-defined acceptable ranges or comparable to the predicate for its stated shelf-life.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the document.
• Data Provenance: Not specified in the document. This was a lab-based, pre-clinical study focusing on material and performance characteristics under different sterilization conditions for shelf-life testing. It is not a clinical study involving human patients or data.

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

• Experts: Not applicable. These were laboratory tests against ASTM standards, not expert-adjudicated clinical outcomes.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Lab tests are typically performed according to established protocols and measured objectively, not through human adjudication in this context.

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

• MRMC Study: No. This document describes a 510(k) submission for a tissue adhesive, not an AI or imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. This is a physical medical device (tissue adhesive), not an algorithm or software.

7. Type of Ground Truth Used:

• Ground Truth: For the shelf-life studies, the "ground truth" would be the established performance characteristics of the predicate device and the specified limits/ranges for each material property and mechanical strength test as defined by industry standards (ASTM), against which the performance of the new device was compared.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device. The studies described are for shelf-life validation, where samples of the device are tested over time.

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

• Ground Truth Establishment: Not applicable, as there is no training set. The "ground truth" for showing substantial equivalence relies on comparing the device's characteristics and performance to existing, legally marketed predicate devices and established standards.

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SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures

SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus and Twist applicators contain the identical adhesive formula and incorporate a plastic ampoule, which houses the adhesive, contained within the double longer plastic sleeves with an attached applicator tip. When SURGISEAL is applied to the skin with these applicators, it polymerizes in minutes.

The provided document is a 510(k) premarket notification for topical skin adhesives (Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive). It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or performance study.

Therefore, the information required to populate most of the sections of your request (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document. This document is related to a medical device approval and not a software or AI algorithm approval.

However, I can provide information on acceptance criteria that are implicitly or explicitly mentioned for the biocompatibility and sterilization aspects of the device, which are part of its overall safety and effectiveness.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not provided in the document):

2. Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI/ML algorithm evaluation; for biocompatibility, sample sizes for in vitro or in vivo tests are part of the ISO standards but not detailed here. The studies were previously conducted on predicate devices. Data provenance would be related to the lab conducting the biocompatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biocompatibility and sterilization is based on established scientific methods and standards.
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, as 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, as this is not an AI/ML device.
7. The type of ground truth used:
   • For Biocompatibility: The "ground truth" is defined by the biological response of cells/tissues to the material, as assessed by standardized tests (e.g., cytotoxicity, irritation, sensitization assays) according to ISO-10993.
   • For Sterilization: The "ground truth" is the sterility assurance level (SAL) achieved, verified by validated sterilization cycles and appropriate microbiological testing, according to ISO 11137 and ISO 11135.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The document describes a 510(k) submission for new topical skin adhesive products (Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive). The "study" or rather, the evidence presented to ensure safety and effectiveness and demonstrate substantial equivalence, relies primarily on:

• Identity of Technological Characteristics: The device's formulation (monomeric 2-octyl cyanoacrylate) and mode of action are identical to previously cleared predicate devices.
• Biocompatibility Testing: Prior biocompatibility testing conducted on the predicate devices (SURGISEAL Teardrop (K082993), SURGISEAL Stylus (K130474), and SURGISEAL Twist (K130474)) in accordance with ISO-10993 was leveraged. This testing confirmed the materials were non-toxic, non-irritating, non-sensitizing, and biocompatible. No new biocompatibility testing was required because the subject devices are identical to the predicates in terms of materials.
• Sterilization Validation: Validation of sterilization methods (electron beam and gamma irradiation for Surgiseal, and gamma followed by ethylene oxide for Stylus and Twist) was conducted according to international standards (ISO 11137-2:2006, ISO 11135-1:2008, ISO 11135-2:2008). This ensures the devices are supplied sterile.
• Shelf-Life Determination: A 2-year shelf life was established, implying stability testing was performed, though details of this testing are not provided in this specific document snippet.
• Microbial Barrier Properties (In vitro): In vitro studies showed SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. However, the document explicitly states that clinical studies were not conducted to demonstrate microbial barrier properties, and a correlation between microbial barrier properties and a reduction in infection has not been established.

In essence, the "study" for this 510(k) submission is a demonstration that the new devices are substantially equivalent to already approved predicate devices regarding their materials, design, intended use, and performance characteristics, supported by prior testing data and adherence to recognized standards for biocompatibility and sterilization.

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

ACTABOND Topical Skin Adhesive is a skin closure device that is comprised of a 2-octyl cyanoacrylate liquid adhesive formulation containing D & C Violet #2. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. In vitro studies have shown that following application, ACTABOND Adhesive acts as a barrier to prevent bacterial penetration. The barrier properties of ACTABOND Adhesive have not been studied in clinical or animal models.

This document is a 510(k) premarket notification for the ACTABOND Topical Skin Adhesive. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with strict acceptance criteria and performance metrics for a novel AI or diagnostic device. Therefore, much of the requested information regarding AI-specific assessments (MRMC studies, stand-alone performance, training set details) is not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the performance testing performed to demonstrate equivalence to the predicate device.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria are not explicitly stated in the provided text as this is a substantial equivalence submission rather than a de novo marketing authorization or a clinical trial report with pre-defined endpoints for efficacy. Instead, the performance studies aimed to demonstrate "equivalence to the predicate device." The "acceptance criteria" can be inferred as achieving comparable results to the predicate device in the listed tests.

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

• Bench Studies: Sample sizes for individual bench tests (viscosity, setting time, strength tests, etc.) are not provided.
• Animal Study: The sample size for the porcine study is not explicitly stated. It refers to "a surgically induced, full thickness, linear wound healing model" and "Both groups" (subject and predicate device groups), implying at least two groups of animals, but the number of animals per group is not specified.
• Data Provenance: The studies were conducted by Bergen Medical Products, Inc. (USA) as part of their design control requirements. The porcine study is an animal model, not human data.

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

• Bench Studies: Not applicable. These are objective physical/chemical measurements.
• Animal Study: A "histological evaluation was also performed." This implies expert pathologists were involved, but the number and qualifications are not specified.

4. Adjudication method for the test set

• Bench Studies: Not applicable. These are quantitative measurements.
• Animal Study: Not specified for the histological evaluation.

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 submission is for a medical device (topical skin adhesive), not an AI or diagnostic imaging device that involves human readers.

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

• Not applicable. This submission is for a physical medical device (topical skin adhesive), not a standalone algorithm.

7. The type of ground truth used

• Bench Studies: Objective physical and chemical measurements (e.g., ASTM standards for strength, measured properties like viscosity, purity).
• Animal Study: Clinical observations of wound healing and histological analysis (microscopic examination of tissue by experts) were used as "ground truth" to compare the wound healing outcomes between the subject and predicate devices.
• Biocompatibility: Standardized ISO methods and biological responses (e.g., cytotoxicity, irritation).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set. The device formulation and performance are based on established material science and empirical testing.

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

• Not applicable. As there is no training set mentioned.

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Exofin® High Viscosty Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.

Exofin® High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

Exofin® High Viscosity Tissue Adhesive 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 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® High Viscosity Tissue Adhesive has a syrup-like viscosity. The increased viscosity is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In vitro studies have shown that Exofin®High Viscosity Tissue Adhesive 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.

This document is a 510(k) premarket notification for the Exofin® High Viscosity Tissue Adhesive. It does not describe acceptance criteria or a study proving that an AI-powered device meets acceptance criteria. Instead, it describes performance testing for a medical device (a tissue adhesive) against established ASTM standards and biocompatibility in accordance with ISO 10993-1.

Therefore, I cannot provide the requested information regarding acceptance criteria and an AI study.

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