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Urgoclean Ag. Antibacterial Absorbent Wound Dressing with Silver is indicated to manage exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, dermatological); partial thickness burns; traumatic wounds; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided. The dressing also provides an antibiotic barrier for bacterial penetration of the dressing, which may help reduce infection.

Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver is a sterile nonwoven highly absorbent pad coated with a silver containing soft-adherent lipido-colloid layer on the dressing/wound interface.

In contact with body fluids (exudates, slough) it forms a gel creating a moist environment, which allows for an easy removal of the dressing with little or no damage to healing tissues, leading to no or minor pain.

It is supplied sterile in an individual pouch.

The provided document is a 510(k) premarket notification for a medical device (wound dressing) and outlines its substantial equivalence to a predicate device. It does not describe an AI medical device study with performance criteria and ground truth establishment in the way requested.

The document focuses on demonstrating that the Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver is substantially equivalent to a legally marketed predicate device (Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing) based on similar technology, indications, and safety. There is no mention of an algorithm or AI.

Therefore, I cannot extract the information required to fill out the table and answer the questions about AI performance, sample sizes, expert qualifications, or ground truth establishment. This document is about a physical wound dressing, not an AI-driven medical device.

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Urgoclean Absorbent Wound Dressing is indicated to manage all exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological); partial thickness burns; management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided.

Urgoclean Absorbent Wound Dressing is a sterile non-woven highly absorbent pad coated with a soft-adherent lipido-colloid layer on the dressing/wound interface. In contact with body fluids (exudates, slough) it forms a gel creating a moist environment, allowing a one piece and painless removal. It is supplied sterile in an individual pouch.

This 510(k) summary (K123219) describes a wound dressing and focuses on establishing substantial equivalence to existing predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics for a novel medical device. Therefore, many of the requested categories related to a clinical performance study with AI assistance, expert ground truth, and specific statistical analyses are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are implicitly met if the new device demonstrates similar safety and effectiveness to a legally marketed predicate device. This is primarily shown through:

• Compliance with recognized standards (e.g., ISO 10993 for biocompatibility).
• Demonstration of comparable technological characteristics and performance (e.g., absorption, gelling, non-sticking).
• Alignment of intended use and indications.

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

• Sample Size for Test Set: Not applicable. This document describes biocompatibility testing and a comparison of physical properties, not a clinical trial with a "test set" of patients or data in the typical sense.
• Data Provenance: The biocompatibility tests would have been performed in a laboratory setting, likely in France (where the sponsor is located) or a contracted lab. The comparative properties are based on laboratory analysis and comparison to the predicate device specifications, not on clinical patient data.

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

• Not applicable. There is no "ground truth" derived from expert consensus on a test set of patient cases described in this document. The "truth" for biocompatibility is whether the tests meet ISO standards. The "truth" for substantial equivalence is the demonstration of comparable properties.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method for a test set of data is mentioned.

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

• No. This document does not describe an MRMC comparative effectiveness study, nor does it involve AI assistance.

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

• No. This device is a physical wound dressing, not an algorithm or AI product.

7. The Type of Ground Truth Used

• For Biocompatibility: The "ground truth" is established by adherence to the criteria set forth in ISO 10993 standards. These standards define acceptable levels for cytotoxicity, irritation, sensitization, genotoxicity, and systemic toxicity based on established scientific principles.
• For Substantial Equivalence: The "ground truth" is the established safety and effectiveness profile of the predicate device (Aquacel® Hydrofiber® Wound Dressing), against which Urgoclean Absorbent Wound Dressing is compared based on its materials, design, and performance characteristics.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device, so there is no training set in that context. The "training" here would be the development and testing performed during the device's design phase to ensure it functions as intended, which isn't quantified by a "training set" size in this type of document.

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

• Not applicable. See point 8.

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The barrier functions of Urgocell Ag, antimicrobial wound dressing with silver, may help reduce infection in moderately to high exuding partial and full thickness wounds, including decubitus ulcers, venous static ulcers, diabetic ulcer, first and second degree burns, donor and graft sites.

Urgocell® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial absorbent dressing, composed of 3 layers:

• in contact with the wound, a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver sulphate (3.22 mg/sq.in)
• a non-sensitising, super-absorbent polyurethane foam pad,
• a protective, semi-permeable polyurethane backing.

The provided text describes a 510(k) premarket notification for a medical device called Urgocell® Ag Antimicrobial Wound Dressing with Silver. The focus of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (Urgocell Ag K062559).

The document does not describe a study that uses acceptance criteria in the traditional sense of a clinical trial proving specific performance metrics with statistical significance. Instead, it relies on demonstrating equivalence through various comparisons, primarily related to antimicrobial activity and safety.

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

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

The concept of "acceptance criteria" for a new, modified device in a 510(k) submission is typically focused on demonstrating that the modified device is as safe and effective as the predicate device. For this submission, the key acceptance criteria revolve around antimicrobial activity and safety.

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

• Antimicrobial Activity Studies: The text only states "Studies of antimicrobial activity were previously conducted" and "data was submitted concerning the antimicrobial activity of Urgocell® Ag on three new strains." It does not specify the sample size (e.g., number of replicates or experiments) for these in-vitro tests, nor does it explicitly state the data provenance (country or retrospective/prospective). These are typically laboratory-based, prospective studies.
• Safety Studies (Cytotoxicity, Irritation, Sensitization): These are standard biocompatibility tests, likely conducted in a preclinical (animal or in-vitro) setting. The sample sizes (e.g., number of rabbits, guinea pigs, or cell cultures) are not specified in this summary. The text implies these were "previously conducted," suggesting prospective 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 type of information is not applicable to this submission. The "ground truth" (e.g., presence or absence of infection) for efficacy is not established by expert review of patient data, but rather through in vitro microbiological testing (for antimicrobial activity) and preclinical safety studies. There's no human diagnostic component that would require expert consensus for ground truth.

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

This is not applicable as there is no human interpretation or diagnostic task involved that would require adjudication.

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. This submission is for a wound dressing, not an AI-powered diagnostic device or a system that involves human readers interpreting images.

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

This is not applicable. The device is a wound dressing, not an algorithm.

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

• Antimicrobial Activity: The "ground truth" for antimicrobial activity is established through direct laboratory microbiological assays (e.g., measuring zones of inhibition, reduction in bacterial count).
• Safety Studies: The "ground truth" for safety (cytotoxicity, irritation, sensitization) is established through standardized preclinical testing protocols (e.g., observing cellular viability, skin reactions, immune responses) as defined by ISO standards and regulatory guidelines.

8. The sample size for the training set

This is not applicable. The device is a physical wound dressing; it does not involve machine learning or a "training set."

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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The barrier functions of Urgotul Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.

Urgotul® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial hydrocolloid wound contact dressing, composed of a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver (2.25 mq/sq.inch).

The provided text describes Urgotul Ag, an antimicrobial wound dressing with silver, and its substantial equivalence to a predicate device (Urgotul Ag K061220). The document is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. As such, it primarily details comparative characteristics and safety studies rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically found in efficacy trials for novel devices or AI algorithms.

However, based on the provided text, we can extract the information related to antimicrobial activity studies, which serve as the "performance" data for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The document describes an antimicrobial activity study that was conducted to support the substantial equivalence claim.

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

• Sample Size: Not explicitly stated as a number of "samples" in a clinical trial sense. For the antimicrobial activity study, the "test set" consists of three new bacterial/fungal strains: Enterococcus faecalis, Escherichia coli, and Candida albicans.
• Data Provenance: The document does not specify the country of origin for the antimicrobial activity study. Given the sponsor is Laboratories URGO in France, it is plausible the studies were conducted in France or a European lab. The study appears to be retrospective in the sense that it builds upon previously conducted studies for K061220 and K062559, explicitly stating "data was submitted concerning the antimicrobial activity of Urgocell® Ag on three new strains" with this submission, implying these were studies already performed.

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

This information is not provided in the document. For antimicrobial studies, "ground truth" would typically be established by laboratory culturing and identification methods, not by expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are relevant for clinical trials where human experts evaluate patient data (e.g., medical images). For laboratory-based antimicrobial activity testing, the results are typically determined by standard microbiological assays.

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 an antimicrobial wound dressing, not an AI algorithm for medical image interpretation or diagnosis. Therefore, no MRMC study or AI assistance comparison was performed.

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 wound dressing, not an algorithm.

7. The type of ground truth used:

For the antimicrobial activity study, the "ground truth" would be the laboratory results from standardized microbiological assays. These assays directly measure the device's ability to inhibit or kill specific microorganisms.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not an AI algorithm that requires a training set. The safety and antimicrobial activity studies are product evaluations, not machine learning model training.

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

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

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The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.

Urgocell® Ag wound dressing is a sterile, antimicrobial absorbent wound contact dressing with silver.

Urgocell® Ag wound dressing is non-occlusive and non-adhesive for painless removal.

Urgocell® Ag is composed of three layers :

• in contact with the wound, a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver,
• a non-sensitising, super-absorbent polyurethane foam pad, -
• a protective, semi-permeable polyurethane backing. -

The provided text describes the 510(k) premarket notification for Urgocell® Ag, an antimicrobial wound dressing. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving device performance through a clinical or standalone study as one might expect for a novel AI/software device.

Therefore, many of the requested points regarding AI/algorithm performance and study design are not applicable to this 510(k) submission for a wound dressing.

Here's an analysis based on the provided text, addressing the applicable points and noting where information is not available or relevant:

Description of Acceptance Criteria and Study for Urgocell® Ag Antimicrobial Wound Dressing

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. The submission describes in vitro (biocompatibility and antimicrobial) and comparative design studies, not a clinical "test set" in the context of an AI/software device. The biological studies would have used laboratory samples (e.g., cell cultures, animal models for irritation/sensitization, bacterial cultures). Specific sample sizes for these in vitro and animal studies are not provided in this summary.
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective for these general safety and antimicrobial tests. These are typically standard laboratory tests.

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

• Not Applicable. This is not an AI/software device requiring expert ground truth for image or diagnostic interpretation. The "ground truth" for the safety and antimicrobial studies would be laboratory measurements and established biological responses.

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

• Not Applicable. This type of adjudication is relevant for human expert review in diagnostic studies, not for the in vitro and animal safety/efficacy tests described for this wound dressing.

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 a wound dressing, not an AI or imaging device with human reader interaction.

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

• Not Applicable. This is a medical device (wound dressing), not an algorithm.

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

• For Safety Studies (Cytotoxicity, Irritation, Sensitization): Ground truth would be established by standard biological assays and the observed cellular or animal responses according to scientific protocols (e.g., cell viability, erythema scores, immune responses).
• For Antimicrobial Activity Studies: Ground truth would be established by microbiological methods measuring bacterial growth inhibition or reduction, typically compared against control groups and predicate devices.
• For Substantial Equivalence: The ground truth for substantial equivalence is the demonstration of comparable characteristics (material, function, indications for use, safety, and effectiveness) to already legally marketed predicate devices, assessed by FDA.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device. The studies described are for physical and biological properties of a wound dressing.

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

• Not Applicable. See point 8.

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The barrier functions of Urgotul® Ag Antimicrobial Wound Dressing may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.

Urgotul® Ag wound dressing is a sterile, antimicrobial hydrocolloid wound contact dressing with silver. Urgotul® Ag wound dressing is non-occlusive and non-adhesive for painless removal. Urgotul® Ag is composed of a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver.

The provided text [0-3] does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. This document is a 510(k) summary for a medical device (Urgotul® Ag Antimicrobial Wound Dressing) and primarily focuses on device description, indications for use, and a substantial equivalence determination to predicate devices. It does not include details on performance studies with specific statistical metrics that would define acceptance criteria or demonstrate compliance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Algoplaque Film Extra Thin Hydrocolloid Dressing is a topical wound dressing that is intended for the local management of superficial, dry to lightly-exudating wounds, including pressure sores, dermal ulcers, post-operative wounds or suture sites, and abrasions and lacerations.

Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings.

Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.

ALGOPLAQUE FILM is a flexible, semiocclusive, topical wound dressing that consists of a polyurethane backing sheet and a hydrocolloid layer. The hydrocolloid layer interacts with wound exudate - liquifying into a soft gel. This gel enables the dressing to be removed with minimal trauma to the underlying tissues.

The provided text describes a 510(k) summary for a medical device called "ALGOPLAQUE FILM Extra Thin Hydrocolloid Dressing." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for a novel AI/software medical device. Instead, it focuses on demonstrating safety, effectiveness, and substantial equivalence to existing hydrocolloid dressings already on the market.

Therefore, many of the requested sections about specific types of studies (MRMC, standalone algorithm performance, training/test set details, expert ground truth) are not applicable to this type of traditional medical device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific quantitative acceptance criteria or detailed performance metrics as you would see for a diagnostic device. Instead, the "acceptance criteria" are implied by compliance with safety tests and equivalence to predicate devices.

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

• Sample Size: Not explicitly stated for specific in-vivo animal tests (e.g., number of mice, rabbits, guinea pigs).
• Data Provenance: The studies are described as "in vitro tests and animal safety studies." Given the submitter (Laboratoires URGO) is in France, it's reasonable to infer these studies were conducted by or for them, likely in Europe, though specific country details are not provided. The studies are retrospective in the sense that they were completed before submission.

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

• Not applicable. For these types of safety tests (cytotoxicity, hemolysis, irritation, sensitization), the "ground truth" is established by standard biological assays and the observed physiological responses in animal models, not by human expert consensus or interpretation of complex medical images.

4. Adjudication Method for the Test Set:

• Not applicable. The safety tests described involve objective measurements and observations in laboratory and animal settings, not a review of cases by multiple human readers requiring adjudication.

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

• No, an MRMC study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a wound dressing.

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

• No, a standalone algorithm performance study was not done. This device is a physical wound dressing and does not involve AI algorithms.

7. The Type of Ground Truth Used:

• For the safety studies, the ground truth was based on:
  • Biological assay results: Compliance with USP standards for cytotoxicity, non-hemolytic status.
  • In-vivo physiological responses: Observation of lack of primary irritation, corrosivity, systemic toxicity, and sensitization in animal models (mice, rabbits, guinea pigs).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of this device. It is not an AI/ML algorithm that learns from data. Its performance is based on its physical and chemical properties and biological interactions, as demonstrated by the safety tests.

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

• Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in this manner.

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