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LiquiBand Exceed 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 and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand Exceed topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

LiquiBand Exceed 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 Exceed topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand Exceed topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand Exceed topical skin adhesive polymerizes within minutes.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study performed for the LiquiBand Exceed:

Important Note: The provided document is a 510(k) summary for a medical device (LiquiBand Exceed topical skin adhesive). This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical trial with acceptance criteria for device performance. As such, the information you're requesting, especially detailed acceptance criteria with specific performance thresholds and a multi-reader multi-case study, is typically not found in this type of submission. The performance tests listed are primarily to show that the new device performs comparably to or at least as well as the predicate device for relevant characteristics.

Response Based on Provided Document:

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

The document does not explicitly state numerical acceptance criteria or specific reported device performance values in a table format for the LiquiBand Exceed itself. Instead, it states that "Testing was performed in accordance with the FDA special controls guidance document for 'Tissue Adhesive for the Topical Approximation of Skin'" and that the results demonstrated "substantial equivalence to the predicate device."

The tests performed, which would have had associated pass/fail criteria (likely defined by the guidance document or established industry standards), are listed as:

2. Sample sizes 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 any of the performance tests. It also does not provide details on the data provenance, such as country of origin or whether studies were retrospective or prospective. Given the nature of a 510(k) summary and the listed tests (ASTM standards, in-vitro), most of these would be laboratory-based rather than human clinical studies.

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 information is not applicable and not provided in the document. The tests performed are primarily engineering and material science tests (e.g., adhesion strength, polymerization time, sterilization) or laboratory biological tests (biocompatibility, microbial barrier). These types of tests do not typically involve human experts establishing a "ground truth" in the way a diagnostic AI device would.

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

This information is not applicable and not provided. Adjudication methods are relevant for clinical studies where human assessment of outcomes is necessary, particularly with multiple reviewers. The tests described are objective, laboratory-based measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation or AI assistance, which is not the case for a topical skin adhesive.

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

This concept is not applicable to a topical skin adhesive. There is no algorithm or AI component mentioned for the LiquiBand Exceed. The device's performance is standalone in the sense that it's a physical product applied directly.

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

For the in-vitro and ex-vivo performance tests, the "ground truth" would be established by the methods and criteria specified in the referenced ASTM standards and other relevant industry standards (e.g., ISO 10993-1 for biocompatibility). For example, the "ground truth" for wound closure strength would be the measured force required to cause failure, compared against a pre-defined threshold or the predicate device's performance. For shelf-life, it would be the sustained quality metrics over time. Clinical outcomes data are not presented in this 510(k) summary for the LiquiBand Exceed as the primary means of demonstrating substantial equivalence.

8. The sample size for the training set

This information is not applicable and not provided. 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

This information is not applicable as there is no training set for this device.

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Marathon No Sting Liquid Skin Protectant is intended to protect intact or damaged skin from the effects of moisture, friction, (rubbing) or shear (tearing).

Marathon No Sting Liquid Skin Protectant helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage. Marathon No Sting Liquid Skin Protectant can also be used in areas that are exposed to friction and shear from bedding, clothing, shoes, or any material that will rub against the skin. Marathon No Sting Liquid Skin Protectant helps protect the skin against irritation caused by adhesive products.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a premarket notification for a medical device (Marathon No Sting Liquid Skin Protectant). It discusses the regulatory classification and general controls applicable to the device.

However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, or comparative effectiveness studies for an AI/algorithm-based medical device.

Therefore, I cannot fulfill your request for this information based on the provided text.

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Barle Tissue Adhesive 2 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 and simple, thoroughly cleansed, trauma induced lacerations. Barle Tissue Adhesive 2 topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Barle Tissue Adhesive 2 is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure. It is applied to easily approximated skin edges and polymerizes within minutes. Barle Tissue Adhesive 2 is supplied in a single patient use configuration.

The provided text describes a 510(k) summary for a medical device, Barle Tissue Adhesive 2. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, the information provided focuses on demonstrating equivalence rather than establishing novel acceptance criteria and proving performance against them in the same way one would for a new, non-predicate-based device.

Therefore, the document does not contain the acceptance criteria and study details as typically defined for demonstrating the performance of an AI/ML-based device or a novel medical device against specific performance metrics.

Specifically, the document lacks information regarding:

• A table of acceptance criteria and reported device performance because the submission is for substantial equivalence to predicates, not for meeting new performance thresholds.
• Sample sizes used for a test set and data provenance in the context of a performance study.
• Number of experts and their qualifications for establishing ground truth for a test set.
• Adjudication method for a test set.
• MRMC comparative effectiveness study, effect size, or improvement of human readers with AI assistance.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The provided text focuses on the following:

• Device Description: Barle Tissue Adhesive 2 is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure.
• Indications for Use: 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. It may be used in conjunction with, but not in place of, deep dermal stitches.
• Technological Characteristics: Substantially equivalent to predicate devices, with changes being modification of the applicator body design to remove actuation "wings" and addition of a microbial barrier claim.
• Substantial Equivalence Justification: Barle Tissue Adhesive 2 is substantially equivalent to Barle Tissue Adhesive (K123133) and LiquiBand® Flow Control Topical Skin Adhesive (K122446) with regard to Indication For Use, target population, intended application, mechanism of action, and performance. It is also substantially equivalent to LiquiBand® Flow Control regarding the microbial barrier claim.
• Conclusion: Based on extensive design verification, functional, and performance testing conducted in accordance with the "Class II Special Controls Guidance Document: Tissue Adhesive for Topical Approximation of Skin, May 30 2008," Barle Tissue Adhesive 2 is considered safe, effective, and performs as well as the legally marketed predicate devices.

In summary, this document is a 510(k) submission asserting substantial equivalence based on comparable characteristics and adherence to existing guidance documents, not a detailed report of a performance study with specific acceptance criteria and study results against those criteria.

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Barle Tissue Adhesive 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 and simple, thoroughly cleansed, trauma induced lacerations. Barle Tissue Adhesive topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Barle Tissue Adhesive is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure. Barle Tissue Adhesive is supplied in a single patient use configuration. The applicator is composed of a crushable glass ampoule contained within a plastic polypropylene applicator. The ampoule is crushed through force applied by the clinician to the 'wings' of the applicator body. It is applied to easily approximated skin edges and polymerizes within minutes. The device is contained within a PET/tyvek blister.

The provided text describes a 510(k) premarket notification for the Barle Tissue Adhesive, which is a medical device for wound closure. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific, quantitative acceptance criteria through a clinical study. Therefore, some of the requested information, particularly regarding specific numerical performance metrics, sample sizes for test sets in clinical studies, expert involvement in ground truth establishment for a test set, MRMC studies, or standalone algorithm performance, is not available in the provided text.

However, the document does list several nonclinical tests performed to demonstrate substantial equivalence and safety/effectiveness.

Here's the information extracted from the provided text as it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a table format that would typically be seen in a clinical study report for a new AI device. Instead, it refers to a "performance and safety profile" established in accordance with a regulatory guidance document and demonstrates "substantially equivalent performance" through comparative nonclinical testing.

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

The document refers to "nonclinical testing" and "comparative testing" without specifying sample sizes for these tests. For the porcine wound healing study, it's an in vivo animal study, not a human clinical test set. The data provenance is from tests conducted by the manufacturer, Advanced Medical Solutions (Plymouth) Ltd., in the UK, as implied by the submission details. These are pre-market, nonclinical studies, not clinical trials with human patient data.

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

This information is not provided because the reported studies are nonclinical (e.g., in-vitro, animal) and primarily focus on comparative performance to predicate devices and adherence to biocompatibility standards, rather than expert-adjudicated ground truth on human data.

4. Adjudication Method for the Test Set

Not applicable/not provided, as the studies are nonclinical and don't involve expert adjudication of human clinical cases to establish ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technological characteristics and nonclinical performance, primarily comparing the new device to existing predicate devices.

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

Not applicable. This device is a topical tissue adhesive, not an AI algorithm.

7. The Type of Ground Truth Used

For the porcine wound healing study, the "ground truth" would be direct observation of healing outcomes in the animal model, likely assessed by veterinarian scientists or researchers. For other nonclinical tests (tensile strength, degradation, etc.), the "ground truth" is measured physical/chemical properties. For biocompatibility, it's the results of standardized biological tests. This is not "expert consensus," "pathology," or "outcomes data" in the typical clinical AI context, but rather data derived from controlled laboratory and animal studies.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product (tissue adhesive), not an AI model that requires a training set.

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

Not applicable. The device is a physical product, not an AI model.

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LiquiBand Flow Control 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 and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand Flow Control topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

LiquiBand® Flow Control is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate for wound closure. LiquiBand® Flow Control is supplied in a single patient use configuration. The applicator is composed of a crushable glass ampoule contained within a plastic polypropylene applicator. The ampoule is crushed through force applied by the clinician to the 'wings' of the applicator body. It is applied to easily approximated skin edges and polymerizes within 30 seconds. The device is contained within a PET/tyvek blister

The provided text describes the LiquiBand® Flow Control, a topical skin adhesive, and refers to "Microbial barrier testing" studies. However, it does not present specific acceptance criteria in a quantitative format, nor does it detail a study that directly proves the device meets such criteria with reported performance metrics like accuracy, sensitivity, or specificity.

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device and summarizing non-clinical testing. Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the type of testing performed and the conclusion, but does not provide a table with specific numerical acceptance criteria and corresponding device performance data.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Microbial barrier testing was conducted using LiquiBand Flow Control," but not the number of samples or replicate tests.
• Data Provenance: The study was "in vitro," meaning it was conducted in a laboratory setting. The country of origin of the data is not specified, but the submitting company is based in the UK. The study was non-clinical.

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

• Not applicable. This was an in vitro microbial barrier test, not a clinical study requiring expert assessment of outcomes or images. The ground truth would be based on the results of microbiological assays (e.g., presence or absence of microbial penetration).

4. Adjudication Method:

• Not applicable, as this was an in vitro lab test.

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

• No. The document explicitly states: "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 means no human-in-the-loop studies were performed.

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

• Not applicable. This is not an AI/algorithm-based device. The "standalone" performance here refers to the device's inherent physical and chemical properties as a microbial barrier, evaluated in an in vitro setting without human interpretation of results in a clinical context.

7. Type of Ground Truth Used:

• Microbiological Assay Results: The ground truth was established by direct experimental observation of microbial growth or penetration through the adhesive film in an in vitro setting. The test involved challenging the adhesive with "common organisms known to cause infections" at a "minimum concentration of 1 x 10^6 cfu."

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

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