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ACTICOAT FLEX 7 is indicated for use on partial and full-thickness wounds for up to 7 days.

This includes:

First and second-degree burns,

To cover grafts, Surgical sites, Venous ulcers, Pressure ulcers

Diabetic ulcers.

The ACTICOAT FLEX 7 dressing consists of a flexible, low adherent polyester layer coated with nanocrystalline silver.

The ACTICOAT FLEX 7 is a highly conformable dressing, nanocrystalline silver provides an effective barrier to microbial contamination The antimicrobial barrier properties of the ACTICOAT FLEX 7 dressings remain effective for up to 7 days. The antimicrobial barrier properties and the ability of the dressing to allow fluid to pass through without impairment, (in-vitro data) has shown ACTICOAT FLEX 7 to be compatible with negative pressure wound therapy (NPWT) for a period of up to 3 days.

The dressing is low adherent, which helps to minimise wound trauma at dressing changes.

The silver coating is derived from a silver target which 99.99% silver. The coating which is applied to the dressing is predominantly silver with a small number of oxygen atoms trapped within the coating structure. The coatings are highly porous and consist of equiaxed nanocrystals organised into coarse columnar structures. These unique physical structures, in combination with the oxygen atoms/molecules that are trapped in the crystal lattice, contribute to the enhanced solubility of the films.

The provided text does not contain any information about acceptance criteria or a study proving device performance against such criteria for the ACTICOAT FLEX 7 Dressing.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data or acceptance criteria from a clinical study.

Here's a breakdown of why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: The document states that "No applicable performance standards have been established under Section 514 of the FD&C Act." It mentions biocompatibility tests in conformance with AAMI/ISO-10993 and an animal model study to show "no deleterious effects on wound healing," but these are not presented as acceptance criteria with specific performance metrics.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of these details are present in the provided text. The document describes the device, declares its substantial equivalence, lists predicate devices, and outlines its intended use. There is no description of a clinical study or performance study that would involve these elements.

The text primarily focuses on:

• Device identification and contact information.
• Device classification and predicate devices.
• A brief description of the device's mechanism (nanocrystalline silver as an antimicrobial barrier).
• Biocompatibility testing results (indicating safety, but not specific performance metrics against acceptance criteria).
• A statement of substantial equivalence to predicate devices, implying similar performance rather than proving new performance against defined criteria.
• The FDA's decision letter based on the 510(k) submission.

Therefore, I cannot populate the table or answer the specific questions because the necessary information is not within the provided document.

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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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The Triosyn T40™ Antimicrobial Dressing is designed for use in partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. The Triosyn T40™ Antimicrobial Dressing may be used over debrided and grafted partial thickness wounds.

The Triosyn T40'''' Antimicrobial Wound Dressing is a sterile, primary wound dressing. It is a multi-layer composite dressing consisting of an absorbent polycster non-woven pad, a permeable adhesive, a single layer of Triosyn iodinated resin beads, and a non-adherent high-density polyethylene mesh (HDPE). This non-adhesive composite dressing is designed to be used as a barrier against microbial penetrations and as a method to reduce the microbial load in partial and full thickness wounds'.

The provided text describes the Triosyn T40™ Antimicrobial Wound Dressing and its substantial equivalence to predicate devices, but it does not include a detailed study with specific acceptance criteria and performance metrics in the format requested. The document focuses on the device description, intended use, technological characteristics, and biocompatibility, stating that the device "functioned as intended" based on "laboratory tests."

Therefore, I cannot populate most of the requested fields directly from the provided text. I will indicate where information is missing or inferred.

Acceptance Criteria and Device Performance

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

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 for Test Set: Not specified for any of the "laboratory tests."
• Data Provenance: The document states "Data on file" for in vitro testing. No country of origin is specified, but the applicant is based in Vermont, USA. The nature of the tests (laboratory/in vitro) suggests they were conducted in a controlled environment as opposed to clinical trials. The data would be considered prospective in the sense that the tests were carried out specifically to evaluate the device for this submission, rather than retrospective analysis of existing data.

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)

• Number of Experts: Not applicable/not specified. The "effectiveness" claims are based on in vitro laboratory test results against defined microbial strains and simulated exudates, and biocompatibility testing according to ISO standards, not on expert interpretations of clinical cases.

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

• Adjudication Method: Not applicable/not specified. The assessments are based on laboratory measurements and standards, which typically do not involve human adjudication in the way clinical studies or image interpretation tasks do.

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

• MRMC Study: No. This device is a wound dressing, not an AI-assisted diagnostic tool or imaging device that would typically undergo an MRMC study with human readers.

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

• Standalone Performance: Not applicable. This is a medical device (wound dressing), not an algorithm or AI system. The performance evaluated is the direct physical/chemical action of the dressing.

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

• Type of Ground Truth:
  • Antimicrobial Effectiveness: Defined microbial strains (e.g., ATCC 33591 for MRSA, ATCC 51575 for VRE) and standardized laboratory methods for evaluating microbial reduction.
  • Iodine Release: Simulated wound exudates and analytical methods for measuring iodine concentration.
  • Biocompatibility: ISO 10993 standards and specified toxicity, irritation, and sensitization tests.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning model that requires a training set. The "laboratory tests" described are for performance evaluation, not model training.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device type.

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Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penetration. The dressing may be use for partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Silver Glucan dressings may be used over partial thickness wounds, debrided wounds, and as a temporary covering for full thickness and grafted wounds.

Silver Glucan dressing consists of a nylon mesh coated with silver and oat glucan. The glucan facilitates the placement of the mesh and the silver protects the wound site from bacterial and yeast contamination.

The sterile, single use dressing will be sold in a variety of sizes ranging from 4" x 4" to 16" x 16" and rolls of 4" x 48".

This premarket notification (K050086) for Brennen Medical, Inc.'s Silver Glucan Wound Dressing does not contain detailed acceptance criteria or a dedicated study report proving the device meets specific performance metrics in the way modern medical device submissions typically do for AI/ML devices.

Instead, this 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, and intended use, and presents a list of general performance tests conducted. The "acceptance criteria" here are implied by the successful completion of these tests and the determination of substantial equivalence (rather than specific quantitative thresholds).

Therefore, I will extract the information available and note where specific details are not provided in this document format.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative thresholds for "acceptance criteria" (e.g., minimum tensile strength in Newtons, specific cytotoxicity scores, exact zone of inhibition measurements) are not detailed in this summary. The summary broadly states that the device "is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."

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

This 510(k) summary does not describe specific "test sets" in the context of an algorithm or AI model evaluation. The "studies" mentioned (Biocompatability, Animal Wound Healing, Silver Dissolution, Tensile Strength, Barrier Efficacy, Zone of Inhibition, Stability) are laboratory or animal-based performance tests, not clinical evaluations with human patient data or AI algorithm testing with a specific test set.

• Sample Size for Test Set: Not applicable/not specified for a "test set" in the context of an AI/ML device. The underlying details of the sample sizes for each specific performance study (e.g., number of animals in the wound healing study, number of samples for tensile strength) are not provided in this summary.
• Data Provenance: Not applicable/not specified for an AI/ML device test set. The provenance of the data for the performance studies (e.g., which lab conducted the tests, what species for animal studies) is not detailed.

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

This information is not applicable. This 510(k) pertains to a wound dressing, not an AI/ML diagnostic or prognostic device that would require expert-established ground truth on a test set. The listed studies are laboratory and preclinical performance tests.

4. Adjudication Method for the Test Set

This information is not applicable. There is no AI/ML test set requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not an imaging or diagnostic AI/ML system that would typically undergo such a study.

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

No, a standalone performance study (in the context of an algorithm) was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies refers to the direct measurement or observation of the physical, chemical, or biological properties and effects of the wound dressing.

• Biocompatibility: In-vitro (cytotoxicity, sensitization assays) and in-vivo (irritation, sensitization on animals/humans) test results.
• Wound Healing: Clinical and histological assessment of wound closure, tissue regeneration, inflammation in an animal model.
• Silver Dissolution: Analytical chemistry measurements of silver release.
• Tensile Strength: Physical testing measurements of material strength.
• Barrier Efficacy: Microbiological challenge tests demonstrating reduction of bacterial/fungal penetration.
• Zone of Inhibition: Microbiological growth assays on agar plates.
• Stability Testing: Comparison of pre- and post-aging performance characteristics.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that is "trained."

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

Not applicable. This device is not an AI/ML algorithm that is "trained."

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The Acticoat® Moisture Control dressing, an addition to the Acticoat® Dressing line of products is intended as an absorbent dressing which provides an effective barrier to bacterial penetration. Acticoat® Moisture Control Dressing is indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1st and 2nd degree burns, and donor sites. Acticoat® Moisture control may be used over debrided and partial thickness wounds.

The absorbent, antimicrobial barrier dressing consists of three layers. An outer blue polyurethane film layer, a central polyurethane foam layer and a nanocrystalline silver coated polyurethane film wound contact layer. The layers are heat laminated together to form a single dressing. The dressing can be cut to size and maintains its antimicrobial activity for up to 7 days.

This 510(k) premarket notification for K050030, the Acticoat® Moisture Control Dressing, is for a wound dressing and as such, does not involve the typical software-driven device acceptance criteria and studies you might expect for an AI/ML product. The submission is focused on demonstrating substantial equivalence to a predicate device, which means proving that the new device is as safe and effective as a legally marketed device.

Therefore, the requested information about acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not applicable to this type of device submission.

Instead, the "acceptance criteria" for this submission are met by demonstrating the following:

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

Regarding the specific questions which are NOT applicable to this 510(k) submission for a wound dressing:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a wound dressing substantial equivalence submission. Performance data for a direct animal or human study for this specific claim of equivalence is not detailed in the summary.
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. "Ground truth" in the context of AI/ML models is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device.
8. The sample size for the training set: Not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) document demonstrates substantial equivalence by comparing the new device's intended use, technological characteristics (materials, design, manufacturing), and biocompatibility to a predicate device (Acticoat® Foam Dressing K000051) which has already been deemed safe and effective. The FDA's acceptance of this submission means they agreed that the Acticoat® Moisture Control Dressing is substantially equivalent to the predicate and does not raise new questions of safety or effectiveness.

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