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Over the counter: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration in minor cuts, scrapes, burns, skin irritations and abrasions.

Prescription Use: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration for minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.

ALEO liquid bandage is a tough elastic skin protectant for covering minor skin cuts, scrapes, abrasions and cracks. When applied, it rapidly forms water-proof, breathable and transparent protection that forms an effective barrier to prevent microbial penetration from the external environment while the polymeric film remains intact.

The provided text is a 510(k) summary for the Aleo BME Liquid Bandage. It details the device's intended use, regulatory classification, and comparisons to predicate devices. However, it does not contain specific acceptance criteria or the details of a study with reported device performance metrics in the format requested.

It states that "Physical, mechanical and preservative effectiveness testing results confirm that the Aleo BME Liquid Bandage meets the product design specifications" and that "performance testing of the Aleo BME Liquid Bandage was compared to the predicate devices," but it does not provide the actual criteria or results of these tests.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details on sample size, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided document.

The document focuses on the regulatory submission for substantial equivalence based on the device's design, function, and intended use being similar to existing legally marketed devices, rather than a detailed presentation of performance data against specific acceptance criteria.

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KeriCure™ Liquid Bandage and KeriCure Natural Seal™ Liquid Bandage: To help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.

KeriCure™ Advanced Liquid Bandage: To cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.

The KeriCure™ Liquid Bandage family of products is comprised of a protective, elastic polymer film (proprietary polyacrylate polymer). As applied to the skin, the liquid bandage is slightly more viscous than water and sets within minutes to form a clear, breathable and completely transparent film. The Liquid Bandage is capable of adhering to both intact and compromised body tissue. The device is available with either a dropper or spray applicator.

The provided text describes information about the KeriCure™ Advanced Liquid Bandage, a medical device, and its substantial equivalence to predicate devices, focusing on performance and biocompatibility testing. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, human expert involvement, or AI-related effectiveness.

Here's an analysis of what is available vs. what is not:

Information Present in the Document:

• Device Name: KeriCure™ Advanced Liquid Bandage, KeriCure™ Liquid Bandage, KeriCure Natural Seal™ Liquid Bandage.
• Intended Use: To cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions (for Advanced version).
• Product Code: KMF (Liquid bandage)
• Regulatory Class: Class I
• Predicate Devices: K083913 – NUVADERM – Chesson Labs; K991920 – Dermaphylyx Hydrophilic Wound Dressing, Dermaphylyx, Inc.
• Biocompatibility Testing: Passed ISO 10993-10 for irritation and skin sensitization. Cytotoxicity testing performed according to 10993-5, with spray applicator scoring 1.
• Shelf Life Testing: Performed according to ISO11737-1, ASTM F1980, USP-51 and USP-35, indicating a 12-month shelf life.
• Performance Testing (General): "Performance testing for KeriCure™ Liquid Bandages was performed according to the following standards: ASTM 570, ASTM D638-10, ASTM D789, E96/ E96M-10. The applicant device passed all testing requirements with results similar to the predicate devices in terms of performance capabilities."
• Substantial Equivalence: Claimed based on similar fundamental technological characteristics (flexible wound management, moisture barrier, absorptive qualities, infection protection) and verified by test results in design, materials, and intended use.

Information NOT present in the Document (that you requested):

1. A table of acceptance criteria and the reported device performance: While general statements about "passing all testing requirements" are made, specific numerical acceptance criteria (e.g., "tear strength must be > X N/mm") and the device's exact reported performance values are not provided.
2. Sample size used for the test set and the data provenance: The document mentions "testing requirements" and "test results" but does not specify the sample sizes (e.g., number of bandages tested, number of subjects in a trial) or the origin of the data (e.g., country, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This device is a liquid bandage, not typically an AI-driven diagnostic tool that relies on expert interpretation of images or other data for ground truth establishment. Therefore, this information is not relevant or present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device testing.
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: This is explicitly for AI-assisted diagnostic or interpretative devices. The KeriCure™ Advanced Liquid Bandage is a physical wound dressing; it does not involve AI or human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the performance characteristics mentioned (e.g., elasticity, water vapor transmission), the "ground truth" would be established by the defined parameters within the ASTM/ISO standards themselves, rather than expert consensus or pathology data. For biocompatibility, the ground truth is the absence of irritation, sensitization, or cytotoxicity as defined by the ISO standards.
8. The sample size for the training set: Not applicable, as this is not a machine learning/AI device requiring a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary: The provided text details the regulatory clearance for a liquid bandage, including its intended use, predicate devices, and general statements about biocompatibility and performance testing against established standards. However, it lacks the specific quantitative data, study designs, and human expert involvement details that would be found in a submission for an AI-powered diagnostic device or a study designed to evaluate human performance with and without AI assistance.

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[The device] is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. [The device] coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture.

This product for nail dystrophy is a biocompatible, polymeric lacquer that is applied directly to the nail. The product is dispersed in a solution that dries rapidly, adhering to the contours of the nail to form a transparent, colorless, flexible, waterproof barrier.

The provided text is related to a 510(k) summary for a "Liquid Bandage" device intended for nail dystrophy. However, the document does not describe acceptance criteria for software, an AI-powered device, or a study that uses a test set, ground truth, experts, or comparative effectiveness studies.

The document outlines the regulatory submission for a medical device (liquid bandage for nail dystrophy), comparing it to a predicate device (Ecocel®). It discusses general biocompatibility testing, preclinical studies, laboratory studies, and clinical safety studies to demonstrate substantial equivalence to the predicate.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria, as the necessary information regarding software performance, AI, test sets, ground truth establishment, expert involvement, or comparative effectiveness with human readers is not present in the provided text.

The text mentions "clinical studies" for safety but gives no details about their design, sample size, or specific outcomes in relation to predefined performance acceptance criteria for a diagnostic or AI device.

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To cover intact skin or minor cuts, scrapes, burns, and irritations of the skin, to help keep them clean and dry and help protect them from infection

This product is a liguid polymer in a spray format. The solution is topically applied to the affected area and the carrier solvent evaporates allowing polymerization of the remaining constituents to form a non-toxic, hydrophobic, elastomeric polymer coating that provides a barner against moisture but that is permeable to oxygen. The intended use is as a liquid bandage, as this coating is biocompatible and forms a tough yet pliable seal, preventing it from cracking and peeling as the skin heals.

Here's a breakdown of the acceptance criteria and the study that proves the Chesson Labs Liquid Bandage device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set for each specific experiment. However, it mentions:

• Microbial Barrier: Tested with "five species of bacteria." The sample size for the material itself isn't specified, but it implies tests against these five species.
• Biocompatibility: "Twelve different types of tests were run." No specific sample sizes (e.g., number of animals, cell cultures) are provided.
• Bench Testing: "All product lots met specifications." No specific number of lots or samples per lot is given.

The data provenance is retrospective, as this is a 510(k) submission describing tests already conducted to demonstrate substantial equivalence to existing predicate devices. The country of origin of the data is not explicitly stated.

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

This information is not provided in the document. The studies described are primarily laboratory-based performance and safety tests (microbial barrier, biocompatibility, bench testing) and do not involve human evaluation of device efficacy that would require expert-established ground truth in the way a diagnostic imaging study would. The acceptance criteria are based on measurable physical and biological properties.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are not clinical trials or diagnostic studies requiring expert adjudication of results. The "ground truth" for the performance tests (e.g., whether a microbial barrier was effective, whether a material was biocompatible, or whether a property met a specification) would be determined by the results of the specific test methods and their defined pass/fail criteria.

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

An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and the device's impact on their performance is being assessed. The Chesson Labs device is a liquid bandage, and its effectiveness is determined through physical and biological property testing, not through human reader interpretation.

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

A standalone performance study was done, in the sense that the device's performance was evaluated inherently without human-in-the-loop interaction for its primary function. The biocompatibility, microbial barrier, and bench tests are all evaluations of the device's inherent properties and performance when applied appropriately, without requiring a human to interpret an output or act on a recommendation from the device itself.

7. Type of Ground Truth Used:

The ground truth used for these studies is based on:

• Standardized Test Methods: For microbial barrier, it's defined by the modified ASTM F1608. For biocompatibility, it's defined by ISO-10993 guidelines.
• In vitro and In vivo Laboratory Results: Direct measurements and observations from the conducted tests.
• Pre-defined Specifications: For bench testing, the ground truth is whether the measured values for molecular weight, viscosity, etc., fall within the established specifications.
• Comparison to Predicate Devices: The overall "ground truth" for substantial equivalence relies on demonstrating that the new device's performance, safety, and technical characteristics are comparable to legally marketed predicate devices.

8. Sample Size for the Training Set:

This information is not applicable/not provided. The Chesson Labs liquid bandage is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. The "development" process would involve formulation, characterization, and iterative testing, but not a distinct "training set" similar to what's used for AI.

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

This information is not applicable as there is no "training set" in the context of this device.

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ProDerma Liquid Bandage is indicated for over-the-counter (OTC) use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.

ProDerma Liquid Bandage, a formulated Cyanoacrylate adhesive, is a violet tinted, clear liquid topical bandage composed of 2-Octyl and N-Butyl Cyanoacrylate monomers, a plasticizer and D&C violet #2 pigment.

ProDerma is packaged in a single use applicator containing up to 0.5 grams of product. The single use applicator is constructed in the shape of “tear drop” with the flat bottom side made of a flexible laminated film of Pet/AL/Nitrile and a flexible laminate of either Nitrile/PE or Nitrile/PP/PE formed as a blister on the top side with a polyurethane foam sponge for applying the liquid bandage. Each applicator is individually packaged in a blister with a Tyvek backing. The applicators are packaged in a box with a quantity ranging of 6 to 24 per box depending on the customer's requirements. The applicator is opened by folding over the packet at the narrow end under the foam sponge onto itself. The liquid flows into the foam sponge and is control by the user as pressure is applied to the applicator. ProDerma is then applied to the area in need.

Applicators sterilized to a Sterilization Acceptance Level (SAL) of 10° via commercially available irradiation facilities.

The provided text describes the 510(k) summary for the ProDerma Liquid Bandage (K063202). This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the way a medical AI/ML device submission would.

Therefore, the following information is not applicable or not provided in the given text:

• A table of acceptance criteria and the reported device performance: This is a submission for a traditional medical device (liquid bandage) and not an AI/ML device. Performance is assessed through chemical properties and biocompatibility, not statistical metrics like sensitivity/specificity.
• Sample size used for the test set and the data provenance: Not applicable for a chemical product's substantial equivalence review.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For a chemical product, ground truth would relate to material properties and biological response, not diagnostic accuracy.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, based on the provided text, we can infer some information relevant to the device's "performance" and how its safety and effectiveness were evaluated:

Acceptance Criteria (Implied by Substantial Equivalence and Testing Summary):

The acceptance criteria for a Class I general hospital device like a liquid bandage primarily revolve around:

1. Safety (Biocompatibility): The device must not cause adverse biological reactions when in contact with the skin.
2. Sterilization Efficacy: If sterilized, the process must achieve a specified sterility assurance level (SAL).
3. Functional Equivalence: The device must perform its intended function (forming a cover, polymerization time) similarly to its predicate devices.
4. Material Composition: The components should be known and similar to legally marketed devices.

Study that Proves the Device Meets the Acceptance Criteria:

The key study mentioned is the testing summary which supports the substantial equivalence claim.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

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

• Sample Size for Test Set: Not specified in the document. Biocompatibility and sterility testing typically involve specific sample sizes dictated by the standards (ANSI/AAMI/ISO 10993, 11137, 11737) but these are not enumerated here.
• Data Provenance: Not specified, but standard testing is generally conducted in controlled laboratory environments. The document does not indicate retrospective or prospective clinical data for performance evaluation in the context of human use outcomes.

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

• Not applicable / Not specified. The evaluation here relies on standardized laboratory tests and comparisons to predicate devices, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set:

• Not applicable / Not specified.

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

• No. This type of study is relevant for diagnostic imaging or AI devices, not for a liquid bandage.

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

• Biocompatibility Standards: Ground truth is established by adherence to in vitro and in vivo testing protocols defined by international standards (ANSI/AAMI/ISO 10993).
• Sterilization Standards: Ground truth is established by adherence to validation protocols defined by international standards (ANSI/AAMI/ISO 11137 & 11737).
• Predicate Device Characteristics: For functional aspects (like polymerization time), the "ground truth" or benchmark is the performance characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set:

• Not applicable / Not specified. This concept is for AI/ML models, not for a traditional medical device. There is no "training set" in the context of this 510(k) submission.

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

• Not applicable / Not specified.

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The intended use of the BAND-AID® brand solvent based Liquid bandage is for providing a covering over minor cuts and scrapes that are clean and dry.

Solvent based liquid bandages are single- use liquid bandages that have three components: polymer solution, a foam applicator and aluminum foil pouch. Inside pouch, the swab is vertically situated with foam head down and saturated by the polymer solution. The pouch is sealed prior to use. The pouch will be open by tearing the notch. Upon application, the solvents will quickly evaporate and the polymer will form a clear and flexible film to cover skin /wound. The pouches will be sterilized either in bulk or in retail carton.

The provided text describes a 510(k) summary for the Johnson & Johnson Liquid Bandage, which is a Class I medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through standalone studies with acceptance criteria as one might expect for a higher-risk device or an AI/ML powered device.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or explicitly stated in this type of submission.

Here's an analysis based on the provided text:

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

No explicit quantitative acceptance criteria or corresponding reported device performance metrics are provided in this 510(k) summary. The submission focuses on demonstrating substantial equivalence based on material characteristics and intended use.

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

The text mentions a "Scarification study on humans to assess irritation potential." While it states "Both the new and predicate and BAND-AID® Liquid bandage were categorized as being very low for irritation potential," it does not specify the sample size for this study or its provenance. It is a prospective study as it assesses potential for irritation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "Scarification study" likely involved clinical observation and assessment by medical professionals, but the number or qualifications of 'experts' for establishing ground truth are not mentioned in the context of this type of device.

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

Not applicable. This type of device evaluation does not typically involve adjudication methods for a test set in the way a diagnostic imaging device with expert interpretations would. The irritation study would be based on clinical assessment, likely following a standardized scale.

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 is not an AI-powered device, nor is it a diagnostic device where reader performance is the primary measure.

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

Not applicable. This is not an AI-powered device.

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

For the "Scarification study on humans to assess irritation potential," the ground truth would be based on clinical assessment of irritation potential using a standardized scale. This would be a form of expert assessment of clinical outcomes (irritation levels).

8. The sample size for the training set

Not applicable. This is not an AI-powered device that requires a training set.

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

Not applicable. This is not an AI-powered device.

In summary, the provided 510(k) uses a "substantial equivalence" pathway, meaning the primary "study" is a comparison to legally marketed predicate devices. The study mentioned (Scarification study) is used to support safety claims (biocompatibility, irritation potential) rather than performance against defined acceptance criteria for diagnostic accuracy or similar metrics.

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3M™ Liquid Bandage is indicated for use as an over-the-counter (OTC) device for consumer use to cover minor cuts and scrapes that are clean and dry.
3M™ Liquid Bandage is intended to cover minor cuts, scrapes, and skin irritations that are clean and dry.

3M™ Liguid Bandage is a sterile, clear, liquid that covers minor cuts and scrapes that are clean and dry. The device is packaged in an aluminum tube with a reusable cap, a bottle with spray pump, or an individually wrapped swab.

The provided text describes the regulatory filing for the 3M™ Liquid Bandage. It focuses on the substantial equivalence to a predicate device and safety testing, rather than an advanced AI-driven device with detailed acceptance criteria and study results in the format requested.

Therefore, much of the requested information, such as "reported device performance," "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance study," "type of ground truth," and "training set details," is not applicable or available in this document because it pertains to a different type of device and evaluation.

However, I can extract the relevant information from the provided text regarding the closest equivalent to acceptance criteria and the studies conducted for this liquid bandage product.

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

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

• In-Vitro Cytotoxicity Test: Sample size is not specified. Data provenance is in-vitro (lab-based test).
• Human Repeat Insult Patch Test (HRIPT): Sample size is not specified. Data provenance is prospective human clinical study (presumably within the US, as the submitter is a US company).
• Human Cumulative Irritation Patch Test (HCIPT): Sample size is not specified. Data provenance is prospective human clinical study (presumably within the US).

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

Not applicable. The ground truth for safety tests is based on established scientific protocols and observed biological responses, not expert consensus on diagnostic imaging or similar.

4. Adjudication method for the test set

Not applicable. The studies mentioned are primarily laboratory and human patch tests, which rely on direct observation and measurement of biological responses according to set protocols, rather than expert adjudication of interpretations.

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 is not an AI-driven device, so an MRMC study is irrelevant.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

• In-Vitro Cytotoxicity Test: Biological response/reactivity grade.
• Human Repeat Insult Patch Test (HRIPT): Clinical observation of contact sensitization.
• Human Cumulative Irritation Patch Test (HCIPT): Clinical observation of cumulative irritation.
• Substantial Equivalence: Comparison of technological characteristics, function, indications, and claims against a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable.

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DERMA+FLEX™ Gel Adhesive is indicated for OTC use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.

DERMA+FLEX™ Gel Adhesive is a sterile, clear, high viscosity, flexible, liquid topical bandage composed of a blend of 2-Octyl and N-Butyl cyanoacrylate monomers with an octyl cyanoacrylate polymer, tributyl citrate (a plasticizer) and containing D&C violet #2 pigment. DERMA+FLEX™ is supplied in 0.5g single patient use aluminum tubes with (2) self-piercing applicator caps (a dauber cap and a nozzle cap). Each sterile single use aluminum tube is packaged with applicators in individual Tyvek pouches and sterilized by EtO sterilization rendering the exterior of the tube and applicators suitable for dispensing on sterile fields.

The provided text describes the 510(k) summary for the DERMA+FLEX™ Gel Adhesive and the FDA's clearance letter. It focuses on establishing substantial equivalence to predicate devices and provides details on the device description, indications for use, and a summary of biocompatibility testing. It does not contain information about acceptance criteria for performance, a study to demonstrate device performance in terms of efficacy or effectiveness, or details about sample sizes, expert involvement, or adjudication methods for performance studies.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, or details about performance studies, multi-reader multi-case studies, or standalone algorithm performance.

However, I can extract the information related to the biocompatibility testing that was performed:

1. Table of acceptance criteria and the reported device performance (for biocompatibility testing):

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 describes in vitro and in vivo biocompatibility tests using cell lines (L929 agar overlay test) and animal models (Murine Local Lymph Node Assay and Intracutaneous Inject). Specific sample sizes for these tests are not provided in the document.
• Data provenance is not specified. These are standard laboratory tests typically conducted under controlled conditions and would likely be prospective for the purpose of the 510(k) submission.

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 or not provided for biocompatibility testing. Biocompatibility tests rely on established scientific protocols and quantitative measurements, not expert consensus on qualitative data.

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

• This information is not applicable or not provided for biocompatibility testing.

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 MRMC comparative effectiveness study was mentioned or performed. The device is a "Liquid Bandage" and does not involve AI or human image interpretation.

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

• Not applicable. The device is a physical product (liquid bandage), not an algorithm or AI.

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

• For biocompatibility testing, the "ground truth" is established through:
  • Validated biological assays: such as cell viability assays (L929), immune response assays (LLNA), and irritation potential assays (intracutaneous injection).
  • Interpretation against international standards: (e.g., ISO 10993-5, USP 24) and regulatory guidelines.

8. The sample size for the training set:

• Not applicable. This pertains to algorithm development. For a physical medical device, there isn't a "training set" in the computational sense. The "development" would involve formulation and bench testing.

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

• Not applicable. See point 8.

In summary, the provided document details biocompatibility testing results to demonstrate the safety of the DERMA+FLEX™ Gel Adhesive, not its performance in terms of efficacy, which is typically established through clinical studies not present in this 510(k) summary. The focus of the 510(k) was on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (biocompatibility).

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Elastic Skin Liquid Bandage provides a covering over minor cuts and scrapes that are dry and clean.
Elastic Skin Liquid Bandage is indicated for providing a covering over minor wounds and scrapes that are clean and dry.

Elastic Skin is a liquid solution film-forming product. The product solution is packaged in a container with a brush applicator. A thin coating of solution is applied on the wound with the applicator forming a protective clear film in less than one minute. Additional coats may be applied if needed. The film may be removed by peeling away from the skin with the use of mild soap and water.
Elastic Skin Liquid Bandage composition is as follows:
The main component of Elastic Skin is an organic polymer dissolved in an organic solvent.

Here's an analysis of the provided text, focusing on acceptance criteria and study details for the Elastic Skin Liquid Bandage:

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

The provided 510(k) summary does not explicitly state numerical acceptance criteria with pass/fail thresholds for the performance tests. Instead, it states that "All tests gave satisfactory results," implying that the device met the internal criteria used for each study.

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

• Sample Size: The document lists the types of animals used for some tests (Rabbits for skin irritation, Guinea Pigs for sensitization) and specific microorganisms/cell lines, but does not provide the numerical sample size for any of these tests.
• Data Provenance: The studies were conducted as "laboratory tests." There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests, they would inherently be prospective laboratory 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 section is not applicable to the provided information. The studies performed are laboratory-based safety and performance tests (e.g., microbiology, toxicology, biocompatibility), not studies requiring expert interpretation of medical images or clinical outcomes data to establish ground truth.

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

This is not applicable as the studies are laboratory tests, not clinical studies requiring adjudication of outcomes by human experts. The assessment of "satisfactory results" would typically be based on established laboratory protocols and controls, rather than expert adjudication in the context of clinical agreement.

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

This is not applicable. The device is a liquid bandage, not a diagnostic imaging device utilizing AI. Therefore, an MRMC study with human readers and AI assistance is entirely outside the scope of this medical device.

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

This is not applicable. The device is a physical medical product (liquid bandage), not an algorithm or AI system.

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

The concept of "ground truth" as typically discussed in diagnostic AI or clinical studies is not directly applicable here. For these laboratory tests, the "ground truth" is established by:

• Validated laboratory methods and controls: For self-preservation, sterility, mutagenicity, cytotoxicity, and microbial barrier tests, the "ground truth" is determined by whether the test results fall within predefined acceptable ranges or exhibit expected biological responses according to established laboratory standards (e.g., USP for microorganisms).
• Observed biological reactions: For primary skin irritation and dermal sensitization tests, the "ground truth" relates to the absence or presence of specific adverse reactions (e.g., erythema, edema) in the animal models, as assessed by trained laboratory personnel against control groups.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning algorithm that requires a training set. The "training set" concept is irrelevant in this context.

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

This is not applicable for the same reason as point 8.

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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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