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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.

Device Description

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.

AI/ML Overview

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.

Performance Aspect	Acceptance Criteria (Implicit)	Reported Device Performance
Material/Composition	Non-cytotoxic, cyanoacrylate-based	Non-cytotoxic, cyanoacrylate-based
Drying Time	Rapid Drying	Within 45 seconds
Adherence	Adheres to contours of skin	Adheres to contours of skin to form a transparent flexible film
Wear-off	Wears off naturally as skin regenerates	Wears off naturally as skin regenerates
Sterilization	Applicator and packaging are sterilized	Applicator and packaging are sterilized
Biocompatibility	Meets ISO 10993-1 standards	Subjected to appropriate biocompatibility testing in accordance with ISO 10993-1, results confirm product is safe for its intended use
MVTR Rates	Substantially equivalent to predicate device	Demonstrated equivalence to the predicate device
Waterproof Properties	Substantially equivalent to predicate device	Demonstrated equivalence to the predicate device
Friction Reduction	Substantially equivalent to predicate device	Demonstrated equivalence to the predicate device
Barrier Film Duration	Substantially equivalent to predicate device	Demonstrated equivalence to the predicate device
Intended Use	Meets stated intended use	Clinical evaluations conducted to demonstrate LiquiShield®-S meets its intended use

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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