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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

This document is a 510(k) Pre-market Notification for a topical skin adhesive (LiquiBand Flow Control) and as such focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and proving their fulfillment through extensive clinical studies. Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable or detailed in this type of submission.

However, I can extract information related to the comparative testing performed to demonstrate substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The submission demonstrates substantial equivalence based on a comparison to predicate devices rather than specific quantitative acceptance criteria with predefined thresholds for each test. The "acceptance criteria" here are implicitly that the new device performs comparably to the predicate devices in the listed tests.

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

The document does not specify detailed sample sizes for each of the nonclinical tests (tensile strength, set time, etc.). These are typically laboratory-based tests. Data provenance is implied to be from internal testing by the manufacturer (Advanced Medical Solutions (Plymouth) Ltd.), which would generally be considered proprietary and therefore not explicitly detailed in terms of country of origin for each test dataset, nor whether it's retrospective or prospective in the clinical sense.

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

Not applicable. The tests performed are nonclinical, laboratory-based functional and chemical analyses, not requiring expert ground truth in the medical imaging or diagnostic sense.

4. Adjudication method for the test set

Not applicable, as no expert review or adjudication process is described for these nonclinical tests.

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 topical skin adhesive, not an AI or imaging diagnostic device.

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

Not applicable. This device is a topical skin adhesive, not an AI or algorithm-based device.

7. The type of ground truth used

For the nonclinical tests (tensile strength, polymerization time, etc.), the "ground truth" would be the measured physical and chemical properties of the device, assessed against established industry standards (e.g., ASTM standards for tensile strength) and compared to the properties of the predicate devices. For biocompatibility, the ground truth is the successful completion of ISO 10993 tests, demonstrating the absence of adverse biological reactions.

8. The sample size for the training set

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

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

Not applicable. As above, this device does not utilize a training set in the AI context.

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LiquiBand Dual 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. LiguiBand Dual topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

LiquiBand® Dual is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate for initial wound closure and a blend of 30% n-butyl-cyanoacrylate and 70% 2-octyl cyanoacrylate for subsequent over layers . LiquiBand® Dual is supplied in a single patient use dual applicator configuration.

The provided text describes a 510(k) submission for a medical device named LiquiBand® Dual, a topical skin adhesive. The submission aims to demonstrate substantial equivalence to a predicate device, LiquiBand® Ultima (K100284).

However, the document does not provide specific acceptance criteria in terms of performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the device's efficacy. Instead, it outlines comparative testing summary that was performed to demonstrate substantial equivalence to the predicate device.

Given the information, I can construct a table for the "Acceptance Criteria and Reported Device Performance" as it relates to the types of tests performed and the comparative nature of the results, rather than quantitative performance thresholds. The study mentioned is a "Clinical Study" as part of the substantial equivalence testing.

Here's the breakdown of the requested information based on the provided text:

Acceptance Criteria and Study Details for LiquiBand® Dual (K102076)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria are implicitly met by demonstrating "substantially equivalent performance" to the predicate device, LiquiBand® Ultima, across the listed parameters. The document states that the "following comparative testing demonstrated substantially equivalent performance between LiquiBand Dual and LiquiBand Ultima". This means the acceptance criteria were that LiquiBand Dual performed as well as or acceptably close to LiquiBand Ultima in these areas.

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

• Sample Size for Test Set: The document explicitly mentions a "Clinical Study" but does not provide details on the sample size used within this study or for any other comparative tests.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

• This information is not provided in the document. The type of device (topical skin adhesive) and the nature of the “substantially equivalent” claim suggest that ground truth would likely be established through objective physical/chemical testing and clinical outcomes, rather than expert interpretation of complex data (like imaging). If a clinical study involved expert assessment, the details are not included.

4. Adjudication method for the test set

• This information is not provided in the document.

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 comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices and is not applicable to a topical skin adhesive. The LiquiBand® Dual is a physical device, not an AI system.

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

• No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device.

7. The type of ground truth used

• The ground truth for the comparative tests would have been established by:
  • Objective physical and chemical measurements: For tensile strength, set time, heat of polymerization, viscosity, and GC chemical analysis, the ground truth is derived from standardized laboratory measurements according to ASTM or other accepted methodologies.
  • Clinical Outcomes: For the "Clinical Study," the ground truth would typically involve observed clinical outcomes such as wound dehiscence, infection rates, cosmetic results, or other relevant endpoints related to wound closure efficacy and safety. The document does not detail the specific clinical endpoints used.

8. The sample size for the training set

• This concept is not applicable as the LiquiBand® Dual is not an AI/machine learning device that requires a training set.

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

• This question is not applicable as the device is not an AI/machine learning device.

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LiquiBand Ultima 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 Ultima topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

LiquiBand® Ultima is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. LiquiBand® Ultima is supplied in a single patient use dual tip configuration.

The provided document describes the K100284 510(k) premarket notification for the LiquiBand® Ultima topical skin adhesive. It focuses on demonstrating substantial equivalence to a predicate device (LiquiBand® LB 0004, K083531) rather than establishing new performance criteria through a clinical study with acceptance criteria.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not applicable or cannot be extracted directly from this type of regulatory submission. The submission is a "Traditional 510(k)" which typically relies on demonstrating equivalence to an already legally marketed device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define explicit acceptance criteria with specific thresholds for performance metrics. Instead, it states that comparative testing "demonstrated substantially equivalent performance" to the predicate device.

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

The document does not specify the sample sizes for the comparative physical and chemical tests (tensile strength, set time, heat of polymerization, viscosity, GC chemical analysis). There's no information on data provenance (country of origin, retrospective/prospective) for these material and performance characteristic tests, as they are likely lab-based measurements on manufactured product samples.

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

Not applicable. The "ground truth" for demonstrating substantial equivalence here is the established performance of the predicate device, not expert consensus on clinical outcomes. The tests are laboratory-based physical and chemical characterizations.

4. Adjudication Method for the Test Set:

Not applicable. There's no clinical trial or expert review necessitating an adjudication method.

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

No. This is a medical device, specifically a tissue adhesive. MRMC studies are typically for diagnostic imaging devices where human readers interpret results.

6. Standalone (Algorithm Only) Performance:

No. This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used:

The "ground truth" or reference for evaluating LiquiBand® Ultima's performance is the performance characteristics of the predicate device, LiquiBand® LB 0004 (K083531), as measured through various ASTM standards and chemical analyses.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set." The product is manufactured and tested according to specifications.

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

Not applicable, as there is no training set. The "ground truth" for the comparative testing was the pre-existing data and performance profiles of the predicate device.

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LiquiShield™ Liquid Bandage is intended for over the counter (OTC) use to cover minor cuts and scrapes and minor irritations of the skin and help protect them from infection.

LiquiShield™ Liquid Bandage biocompatible cyanoacrylate-based, drying, liquid barrier film for the protection the skin. It is applied as a liquid and dries, within approximately 45 seconds, adhering to the contours of the skin to form a transparent, flexible film. LiquiShield™ Liquid Bandage wears off naturally as the skin regenerates. The applicator and contents are supplied sterile, and the device is, therefore, suitable for aseptic techniques.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the LiquiShield™ Liquid Bandage:

Acceptance Criteria and Study Information for LiquiShield™ Liquid Bandage

This device is not an AI/ML powered device, therefore some sections are not applicable (N/A) as they relate specifically to AI device evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device and meeting intended use requirements through various testing.

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

• Sample Size for Test Set: Not specified in the provided text. The document mentions "appropriate biocompatibility testing" and "mechanical and performance testing" along with "clinical evaluations," but does not detail the sample sizes for these tests.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. This type of device evaluation (for a liquid bandage) typically does not involve expert adjudication in the same way an AI diagnostic device would.

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

• Was an MRMC study done? No. This type of study is typically relevant for diagnostic devices involving interpretation by multiple readers, often with AI assistance. It is not applicable to a liquid bandage.
• Effect Size of AI improvement: N/A, as no AI was involved.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No. This is also not applicable as the device is a physical product (liquid bandage), not a standalone algorithm.

7. Type of Ground Truth Used

The ground truth for this device's evaluation appears to be based on:

• Established Biocompatibility Standards: BSENISO 10993-1.
• Direct Measurement/Observation of Physical Properties: Such as drying time, film formation, adherence, waterproof nature, flexibility, and ability to keep out dirt and germs.
• Clinical Observation: To demonstrate that the product "meets its intended use requirements" for covering minor cuts/scrapes and protecting from infection.
• Comparison to Predicate Device: The predicate device serves as the benchmark for "substantial equivalence" across various performance aspects.

8. Sample Size for the Training Set

• Sample Size for Training Set: N/A. This concept is relevant for AI/ML models that require training data. The LiquiShield™ Liquid Bandage is a conventional medical device and does not have a "training set."

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

• How Ground Truth Was Established: N/A, as there is no training set for this conventional device.

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LiquiShield®-S is intended to protect intact or damaged skin from the effects of moisture, friction (rubbing), or shear (tearing).

LiquiShield®-S helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage.

LiquiShield®-S can also be used in areas that are exposed to friction and shear such as occurs when items, such as bedding, clothing, or shoes, rub against the skin.

LiquiShield®-S helps protect the skin against irritation caused by adhesive products.

LiquiShield®-S is a non-cytotoxic (not harmful to the bodv) cyanoacrylate based, rapid drying, liquid barrier film for the protection of the skin. It is applied as a liquid and dries, within 45 seconds, adhering to the contours of the skin to form a transparent flexible film. LiquiShield®-S will wear off, naturally, as the skin regenerates. The applicator and packaging are sterilized.

This document is a 510(k) summary for a medical device called LiquiShield®-S, a liquid barrier film. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not explicitly addressed or applicable in the provided text.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical "acceptance criteria" for the device, but rather claims substantial equivalence to the predicate device based on several performance aspects.

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

The document mentions "clinical evaluations" but does not specify a sample size for any "test set." No information on data provenance (e.g., country of origin, retrospective/prospective) is provided. The focus is on demonstrating equivalence through mechanical and performance testing and biocompatibility, not a clinical trial with a defined test set for a specific performance metric.

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

Not applicable. The document does not describe a process for establishing ground truth using experts for a test set, as it is a 510(k) submission focused on substantial equivalence rather than a de novo approval requiring extensive clinical validation with expert adjudication.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

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

No MRMC comparative effectiveness study is mentioned. This type of study is typically used for diagnostic devices involving human interpretation of results, which is not the case for a liquid barrier film.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical barrier film, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is implicitly established by:

• Compliance with Standards: Meeting ISO 10993-1 for biocompatibility.
• Equivalence to Predicate Device: Mechanical and performance testing to demonstrate equivalence to the 3M No Sting Barrier Film (K955103) for properties like MVTR, waterproofness, friction reduction, and barrier film duration.
• Clinical Evaluation: Mentioned as being conducted to demonstrate the device meets its intended use, but no specifics on how "ground truth" was established within these evaluations are provided.

8. The 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 above, there is no training set for this type of device.

Summary of Device Performance and Equivalence Claim:

The submission for LiquiShield®-S asserts that the device is substantially equivalent to the predicate device (3M No Sting Barrier Film) based on:

• Intended Use and Application: Both are liquid barrier films for skin protection.
• Product Performance: Testing demonstrated equivalence in MVTR rates, waterproof properties, friction reduction, and barrier film duration.
• Biocompatibility: Conforms to ISO 10993-1, indicating safety.
• Clinical Evaluations: Performed to confirm the device meets its intended use.

The provided document, being a 510(k) summary, focuses on regulatory approval through substantial equivalence rather than detailed clinical trial results for specific performance metrics with defined acceptance criteria.

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