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AcryDerm Silver Antimicrobial Foam Wound Dressing is indicated for the management of 1st and 2nd degree burns, wounds such as venous and arterial ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

AcryDerm Silver Antimicrobial Foam Wound Dressings are sterile, single use hydrophilic polyurethane foam dressings containing antimicrobial silver for use in the management of wounds.

This 510(k) summary for the AcryDerm Silver Antimicrobial Foam Wound Dressing does not describe a study involving device performance metrics, acceptance criteria, or ground truth relevant to AI/ML or diagnostic devices.

The document states:

• "Testing: the new product meets or exceeds safety and biocompatibility assurance guidelines as provided in the guidance of Part-1 of the ANSI/AAMI/ISO standard (10993-1:2003 - Biological Evaluation of Medical Devices - Part I: Evaluation and Testing)"
• "Performance Standards: No performance standards are prescribed for the new product."

This indicates that the submission focuses on safety and biocompatibility testing against established standards for wound dressings, rather than a performance study measuring sensitivity, specificity, accuracy, or similar metrics typically associated with AI/ML diagnostic devices. There is no mention of a "test set" in the context of diagnostic performance, nor are there any reported performance values like sensitivity or specificity.

Therefore, I cannot fill in the requested information as it pertains to a different type of device evaluation, one that is not present in this 510(k) document.

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Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1ª and 2ª degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
OTC: AcryDerm Wound Gel Model #B is indicated for the management of minor abrasions, cuts, lacerations and scalds.

AcryDerm Antimicrobial Silver Gel Model #B is a repeat use, amorphous hydrogel containing antimicrobial silver for use in the management of wounds.

The provided text is a 510(k) summary for the AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B. This type of regulatory submission primarily focuses on establishing substantial equivalence to a predicate device rather than demonstrating performance against specific, quantitative acceptance criteria through clinical or complex technical studies as would be seen for AI/ML devices or novel diagnostic tools.

Therefore, many of the requested categories for a study proving acceptance criteria are not applicable to this document. The device is a wound dressing, and the assessment centers on safety, biocompatibility, and manufacturing practices, not on diagnostic performance or AI model evaluation.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Device Performance

Study Information (as applicable to this type of device)

1. Sample size used for the test set and the data provenance: Not applicable. The testing described (safety, biocompatibility, preservative assurance) would not typically involve a "test set" or "data provenance" in the way it's understood for AI/ML or diagnostic device studies. These are laboratory-based tests on the device materials themselves or microbiological performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as expert consensus is not a concept relevant to the testing methods for this wound dressing.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No 'adjudication' in this sense would be used for the device's stated testing.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests mentioned are:

   • Safety and Biocompatibility: Conformance to established ISO and NIH standards (pre-defined thresholds for toxicological and biological responses).
   • Preservative Assurance: Conformance to USP <25> standards (pre-defined microbial reduction and stability criteria).

7. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of medical device assessment.

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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The new oxygen enriched topical hydrophilic closed cell foam wound dressings are indicated for use in the management of acute and chronic wounds. The products are intended as a primary topical wound contact dressings for use in the management of wound exudates for wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, first and second degree burns, lacerations, puncture wounds, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

Over the Counter Use: AcryDerm Absorbent Oxygen Dressings are intended to be used on minor wounds including lacerations scrapes, skin tears, abrasions, blister wounds, and minor burns.

AcryDerm Absorbent Oxygen Dressing is a single use, sterile, hydrophilic absorbent closed cell foam enriched with gaseous and dissolved oxygen intended for use in the management of wounds. The oxygen enriched product is intended to be used as a topical moisture management wound dressing.

The provided text describes a 510(k) premarket notification for the AcryDerm Absorbent Oxygen Dressing. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a detailed clinical study with performance metrics in the way a clinical trial for a novel AI device might.

Therefore, many of the requested categories for AI device studies are not applicable or cannot be extracted from this document, as the regulatory pathway for this specific wound dressing does not typically involve such studies for its clearance.

Here's a breakdown of what can be extracted and what cannot, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. The document describes a medical device (wound dressing) and its regulatory clearance process, which primarily relies on substantial equivalence to predicate devices and adherence to safety/manufacturing standards, rather than performance evaluation against a "test set" in the context of an AI study. There is no mention of a test set, data provenance, or patient data.

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

• Not Applicable. No test set or ground truth established by experts is mentioned for this device.

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

• Not Applicable. No test set or related adjudication method is mentioned.

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 diagnostic or assistive device for human readers. No MRMC study was conducted.

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

• Not Applicable. This is a physical wound dressing, not an algorithm.

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

• Not Applicable. No ground truth in the context of diagnostic or analytical performance evaluation is relevant or mentioned for this product. The 'ground truth' for this type of device is its ability to meet material specifications, safety, and manufacturing quality.

8. The sample size for the training set

• Not Applicable. This is a physical wound dressing, not an AI model requiring a training set.

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

• Not Applicable. No training set or associated ground truth establishment is relevant or mentioned.

Summary of the Study (as described in the document):

The "study" described in the 510(k) submission is not a clinical trial in the traditional sense of evaluating efficacy or diagnostic accuracy, but rather a demonstration of substantial equivalence to legally marketed predicate devices. The "study" involves:

• Technological Characteristics Comparison: The device's ability to absorb 5 to 10 times its weight in moisture (in vitro absorbency studies) is compared to similar characteristics of predicate devices.
• Safety and Biocompatibility Testing: The product underwent testing to meet or exceed safety and biocompatibility guidelines as provided in the ISO standard (Biological Evaluation of Medical Devices) and NIH Publication 99-4494.
• Sterility Assurance: The product's sterility assurance conforms to AAMI/ANSI/ISO 11137-1994.
• Manufacturing Practices: A commitment to manufacturing according to good manufacturing practices.

The regulatory clearance (K082459) was granted based on these demonstrations, concluding that the AcryDerm Absorbent Oxygen Dressing is "substantially equivalent" to predicate devices without requiring new clinical efficacy studies or performance standards to be met beyond safety and manufacturing quality.

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AcryDerm Silver Antimicrobial OTC Wound Gel is intended for use on intact and broken skin and dermal injuries such as minor laceration, cuts, burns, scrapes and minor surgical procedures wounds.

AcryDerm Silver Antimicrobial OTC Wound Gel is a moist amorphous gel wound filler that contains antimicrobial silver. It is supplied in collapsible blind ended heat sealed co-laminate tubes fitted with screw caps.

The provided text is a 510(k) summary for the AcryDerm Silver Antimicrobial OTC Wound Gel. It discusses the device's characteristics, intended use, and the basis for its substantial equivalence to predicate devices, primarily for a change from prescription to over-the-counter (OTC) status.

However, the document does not describe acceptance criteria or a study designed to prove the device meets specific performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it focuses on demonstrating the device's antimicrobial properties and safety for OTC use based on existing data and standard tests.

Here's an analysis of the provided information in the requested format, with an emphasis on what is not present in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document states that the device conforms or was established by certain tests, implying these tests inherently define the "acceptance criteria" for that type of product (e.g., passing the USP Preservative Challenge Test is the criterion). However, explicit numerical or qualitative cut-offs for these criteria are not mentioned in this summary.

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

• Test Set Sample Size:
  • For the Kirby-Bauer and USP Preservative Challenge Tests: Not explicitly stated. These are in vitro tests typically performed with bacterial/fungal cultures.
  • For the "wound healing study": The sample size is not provided.
• Data Provenance: Not explicitly stated, meaning country of origin is unknown. The Kirby-Bauer and USP tests are standard laboratory methods. The "wound healing study" is likely retrospective, as it refers to performance from a previously cleared product that has been "in continuous distribution since 2002."

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

• This information is not applicable/not provided. The device is an antimicrobial wound gel, not a diagnostic device requiring expert interpretation of results for "ground truth" establishment in the context of image analysis or similar tasks. The "ground truth" for antimicrobial efficacy comes from laboratory assays (Kirby-Bauer, USP Challenge) and clinical observation of safety and performance (wound healing study).

4. Adjudication Method for the Test Set

• Not applicable/not provided. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is not a diagnostic imaging device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

• Not applicable. This product is a medical device (wound gel), not a software algorithm. Its performance is assessed through in vitro and in vivo (human use, though details are scant) studies, not algorithm performance.

7. The Type of Ground Truth Used

• Antimicrobial Efficacy: Laboratory results from standardized tests (Kirby-Bauer, USP Preservative Challenge Test) against known microorganisms.
• Biocompatibility: Results from tests conducted according to ISO standards.
• Safety and Performance in Wound Healing: Clinical outcomes observed during the use of the previously cleared prescription product. The specific nature of "outcomes data" (e.g., wound closure rates, infection rates) is not detailed.

8. The Sample Size for the Training Set

• Not applicable/not provided. This device is not an AI/ML algorithm that requires a "training set." The product's performance is based on intrinsic material properties and biological interactions.

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

• Not applicable/not provided. See point 8.

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To secure devices such as indwelling catheters, drains, monitoring leads and airway management apparatus to patients skin. For use as a cover dressing or in direct contact of wounds such as pressure ulcers, stasis ulcers, sites, davice incention its cond degree burns, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donors sites.

The new product is sterile single use silver antimicrobial adherent transparent film. Sterility assurance will conform to AAMI/ANSI/ISO 11137-1994.

The provided text is a 510(k) summary for the AcryDerm Silver Antimicrobial Thin Film. It describes the device, its intended use, and pre-clinical testing for antimicrobial effectiveness and biocompatibility. However, it does not contain information about specific acceptance criteria or performance studies as typically understood for AI/ML-driven medical devices.

Instead, the document details a regulatory submission process to demonstrate "substantial equivalence" to legally marketed predicate devices, which is a different type of assessment than proving a device meets specific performance criteria through clinical or analytical studies with defined metrics.

Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or detailed device performance metrics in the way one would for an AI/ML diagnostic or predictive device (e.g., sensitivity, specificity, AUC, recall). The primary performance criteria mentioned relate to antimicrobial effectiveness and biocompatibility, which are qualitative or based on standard test methods rather than statistical thresholds from a clinical study.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The document refers to "pre-clinical testing" which typically involves laboratory-based studies (e.g., microbiology cultures, biocompatibility assays) rather than human subject test sets for performance evaluation.
• Data Provenance: The pre-clinical testing describes in vitro studies ("zone of inhibition studies against clinical isolates," "in vitro serial transfer testing"). This data would be generated in a laboratory setting rather than being retrospective or prospective patient data from a specific country.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. Ground truth, in this context, would be determined by laboratory assays (e.g., presence/absence of microbial growth, measurement of zone of inhibition) rather than expert consensus on complex medical images or clinical outcomes.
• Qualifications of Experts: N/A. The "experts" would be laboratory technicians or scientists performing standard microbiological and biocompatibility tests.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., radiology reads) to establish consensus ground truth when individual expert opinions might differ. This document describes laboratory tests.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done, as this is a device for antimicrobial properties and wound dressing, not an AI-assisted diagnostic or decision support system intended to improve human reader performance.

6. Standalone Performance Study

• Standalone Performance Study: The "Pre-Clinical Testing" section describes a form of standalone performance evaluation for the device's antimicrobial properties. This involves direct testing of the film against various microorganisms and for its duration of activity. However, it's not a "standalone algorithm performance" study as would be conducted for AI/ML.

7. Type of Ground Truth Used

• Type of Ground Truth: For antimicrobial efficacy, the ground truth is based on microbiological assays (e.g., inhibition of microbial growth, measured zone of inhibition). For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993 Part-1 standards. For sterility, compliance with AAMI/ANSI/ISO 11137-1994 ensures sterility.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML model that requires a training set. The "training" in manufacturing refers to quality systems and production processes, not data for machine learning.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned for an AI/ML model.

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AcryDerm Silver Antimicrobial Wound Gel is an amorphous wound moisture management gel that is an effective antimicrobial barrier. The antimicrobial barrier function of the dressing may help reduce the incidence of infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds.

AcryDerm Silver Antimicrobial Wound Gel is a line extension of the previously cleared product, AcryDerm Gel Wound Dressing. The new product is a moist amorphous gel wound filler that contains antimicrobial silver that inhibits the growth of microbial contaminants in contact with the dressing. The high moisture content gel contains a base matrix composed of hydrophilic polyacrylate absorbent microspheres that contain a silver complex and stabilizers to prevent discoloration and staining from the dressing. AcryDerm Silver Antimicrobial Wound Gel will be supplied in collapsible blind ended heat sealed co-laminate foil tubes fitted with screw caps. The reusable product primaries will be packed in individual dispenser boxes with a product insert. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).

This looks like a 510(k) premarket notification for a medical device called AcryDerm Silver Antimicrobial Wound Gel. However, the provided text does not contain information about a study with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness as typically associated with clinical performance studies for AI/ML devices.

The document is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, not a performance study report for a novel AI algorithm. Therefore, I cannot extract the requested information like acceptance criteria, study findings, sample sizes for test/training sets, or details about expert adjudication from this specific text.

Here's why the information is not present in the provided text:

• Device Type: This is a wound dressing with antimicrobial properties, not an AI/ML diagnostic or prognostic device. The regulatory submission focuses on its physical characteristics, intended use, and comparison to existing wound dressings.
• Regulatory Pathway: A 510(k) is a premarket notification that demonstrates substantial equivalence to a predicate device. It typically relies on comparisons of technological characteristics and intended use, and sometimes bench testing or minor clinical data to support safety and effectiveness, but not necessarily a large-scale clinical performance study with sophisticated statistical analysis as would be required for an AI device.
• Absence of AI/ML Specifics: There is no mention of algorithms, machine learning, image analysis, diagnostic performance metrics (like sensitivity, specificity, AUC), or human-in-the-loop studies.

In summary, the provided document is not a study report that would contain the information you've requested about acceptance criteria and device performance in the context of an AI/ML device.

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AcryDerm Silver Antimicrobial Perforated Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds.

AcryDerm Silver Antimicrobial Perforated Dressing is a line extension of the previously cleared product, AcryDerm Silver Antimicrobial Strands. The new product is made from the same matrix material, has the same composition and is made using substantially an equivalent manufacturing process as the predicate. The new product is an absorbent, perforated wound dressing that contains antimicrobial silver that minimizes the growth of microbial contaminants in contact with the dressing. AcryDerm Silver Antimicrobial Perforated Dressing will be supplied sterile packaged in single use heat sealed medical grade poly-laminate pouches. The single use primaries will be packed into dispenser boxes for distribution. Biocompatibility has been assessed and it meets the requirements of ISO 10993-1 (Biological Evaluation of Medical Devices).

This document is a 510(k) summary for a medical device called "AcryDerm Silver Antimicrobial Perforated Dressing." It describes the device, its intended use, and its substantial equivalence to a previously cleared product. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria.

This type of submission to the FDA focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate device). This typically involves showing that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

Therefore, I cannot extract the requested information from the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or effect size.
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.

The provided text only addresses the comparison of the new device to a predicate device, focusing on its composition, manufacturing process, and intended use to establish substantial equivalence. It is not a clinical study report or a performance validation document in the context of specific quantitative acceptance criteria.

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Wound cover dressing for the following wounds: Acute Wounds such as: Surgical wounds, Lacerations, Donor site wounds, First and second degree burns, Skin tears, Abrasions. Chronic Wounds such as: Pressure sores, Diabetic ulcers, Venous stasis ulcers, Arterial stasis ulcers.

AcryDerm Silver Antimicrobial Barrier Wound Dressing is a moist sheet wound dressing that contains silver halide that may help to reduce growth of microbial contaminants of the dressing. The base matrix is composed of a hydrophilic polyacrylate absorbent sheet containing silver halide and stabilizers. AcryDerm Silver Antimicrobial Barrier Wound Dressing will be supplied as sterile sheets of 2x2"; 4x4"; 4x8"; of 8x8" sizes, packaged in single use heat sealed medical grade foil pouches.

The provided text describes a 510(k) summary for the AcryDerm Silver Antimicrobial Barrier Wound Dressing, focusing on its substantial equivalence to predicate devices and its intended use. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically performed for AI/ML devices.

The document is a regulatory submission for a medical device (wound dressing) that was prepared in 1999/2000. It is primarily concerned with demonstrating that the new device is "substantially equivalent" to existing legally marketed devices, rather than establishing performance against specific acceptance criteria through clinical trials.

Therefore, I cannot populate the table or answer most of your specific questions related to acceptance criteria, AI performance studies, sample sizes, expert ground truth, or MRMC studies, because this information is not present in the provided text.

Here's a breakdown of what can be extracted and why other questions cannot be answered:

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

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

• Not Applicable. The document describes a physical wound dressing and its composition, an AI/ML device would require a "test set" of data (e.g., images, patient records). This device does not generate or analyze data in that manner. No test set for performance evaluation is mentioned.

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. This is not an AI/ML device. Ground truth, in the context of an AI/ML device, would refer to expert-labeled data used to evaluate algorithm performance. The device is a wound dressing.

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

• Not Applicable. See point 3.

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. See point 3.

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

• Not Applicable. See point 3.

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

• Not Applicable. See point 3. The relevant "ground truth" for a wound dressing would typically involve clinical healing outcomes, but no such study is detailed in this 510(k) summary for performance evaluation.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. See point 8.

In summary: The provided document is a 510(k) premarket notification for a physical medical device (wound dressing) aiming for substantial equivalence to existing products. It does not involve AI/ML technology, and therefore, the concepts of acceptance criteria for AI performance, test sets, training sets, ground truth establishment by experts, or MRMC studies are not applicable to the information contained within these pages.

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