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Antimicrobial Silicone PHMB Foam Wound Dressings are indicated for use in the management of

• · post-surgical incisions,
• · pressure sores,
• · venous stasis ulcers,
• · diabetic ulcers,
• · donor sites.
• · abrasions,
• · lacerations,
• · superficial and partial thickness burns,
• · dermatologic disorders,
• · other wounds inflicted by trauma and,
• · as a secondary dressing or cover dressing for packed wounds.

Antimicrobial Silicone PHMB Foam Wound Dressing, is a polyurethane foam trilaminate dressing impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressing has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.

Based on in vitro performance data, the Antimicrobial Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria, yeast and mold within the dressing for up to 7 days. Antimicrobial Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing.

The perforated wound contact layer contains a gentle silicone adhesive that provides secure, nonirritating adhesion and supports non-traumatic removal during dressing changes.

The device is presented in a border (adhesive) version. The dressing is supplied sterile in a range of sizes between 10.24 in2 (64cm) to 64 in2 (400cm).

The provided text describes a 510(k) submission for a medical device called "Antimicrobial Silicone PHMB Foam Wound Dressing." The submission aims to demonstrate substantial equivalence to a predicate device, "Silicone PHMB Foam Wound Dressing (K190819)." The key difference is the addition of an antimicrobial claim for the subject device.

Here's an analysis of the acceptance criteria and supporting study information based on the provided text:

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

The document does not explicitly state acceptance criteria in the typical numerical performance thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance" is focused on demonstrating substantial equivalence to an existing predicate device, particularly concerning the newly added antimicrobial claim.

Acceptance Criteria (Implicit from the 510(k) submission):

• Antimicrobial Efficacy: The modified device must demonstrate efficacy against gram-positive bacteria, gram-negative bacteria, yeast, and mold within the dressing.
• Identical Design, Materials, and Manufacturing Process: The subject device must be identical to the predicate device in these aspects, except for modifications related to the antimicrobial claim.
• Substantially Equivalent Intended Use and Performance Characteristics: The device's overall intended use and other performance (biocompatibility, absorption, MVTR, waterproofness, peel resistance, bacterial barrier, distribution) must be consistent with the predicate device.
• No New Questions of Safety or Effectiveness: The modifications should not introduce new safety or effectiveness concerns.

Reported Device Performance (from "Performance Testing Summary" and "Comparison of Technological Characteristics"):

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 mentions in-vitro testing for antimicrobial efficacy. It does not provide a specific "sample size" in terms of number of patient cases or imaging data. Instead, it refers to testing against "mold challenge organism," "gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms."

• Sample Size: Not applicable in the context of patient cases or images for this type of in-vitro study. The "sample" would be the wound dressing material itself and the microbiological cultures. Specific numbers of microbial samples or dressing replicates are not provided.
• Data Provenance: In-vitro testing. No country of origin is specified for the testing itself, but the manufacturer is based in the UK. The study is prospective in the sense that the testing was conducted specifically for this submission, although it followed a "well-established modified AATCC TM 100 method previously used for the predicate device."

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 is not applicable to the type of study presented. The ground truth for antimicrobial efficacy is established through standardized objective in-vitro microbiological testing methods (modified AATCC TM 100) using known challenge organisms, not through expert consensus or interpretation of patient data.

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

This is not applicable to the type of study presented. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from human expert interpretations, typically in diagnostic imaging or clinical trials. Here, the ground truth is determined by the results of the specific in-vitro microbiological assay.

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 wound dressing, not an AI-assisted diagnostic tool.

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 (expert consensus, pathology, outcomes data, etc)

For the antimicrobial efficacy claim, the ground truth is established through objective microbiological culture results using a modified AATCC TM 100 method. This method quantifies the reduction or prevention of microbial growth on the dressing.

For the other performance characteristics (Biocompatibility, Absorption, MVTR, Waterproofness, Peel Resistance, Bacterial Barrier, Distribution), the ground truth was established by various standardized test methods (e.g., ISO 10993-1, USP 41-NF36, BS EN 13726 series, ASTM D6282-11, ASTM D4169).

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI device. The testing conducted is for verification of physicochemical and antimicrobial properties.

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

This is not applicable, as there is no training set mentioned or implied for this device.

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LiquiBand® XL is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. LiquiBand® XL should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

LiquiBand® XL is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes.
In vitro studies have shown that LiguiBand® XL acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
LiquiBand® XL also incorporates a self-adhering mesh that is approximated skin edges to provide temporary skin edge alignment to an incision until the liquid adhesive is applied to achieve skin closure.

The device under consideration is the LiquiBand® XL, a tissue adhesive with an adjunct wound closure device for the topical approximation of skin.

Acceptance Criteria and Device Performance:

The document describes performance testing conducted according to the FDA special controls guidance document for "Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin." The table below summarizes the types of tests performed, which inherently represent the acceptance criteria for those specific properties for demonstrating substantial equivalence. The reported device performance is that these tests were performed and the device demonstrated substantial equivalence to the predicate device. Specific numerical acceptance values or performance results are not provided in this summary.

Additional Information:

1. Sample size used for the test set and data provenance: The document does not specify the exact sample sizes for each of the performance tests. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied that these are laboratory and animal studies conducted by the manufacturer to demonstrate performance characteristics.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts: This is not applicable to the type of performance testing described. The tests are physical, chemical, and biological evaluations, not requiring human expert interpretation in the same way clinical imaging studies might.

3. Adjudication method for the test set: Not applicable for these types of performance tests.

4. Multi-reader multi-case (MRMC) comparative effectiveness study: No MRMC or clinical studies were performed. The document explicitly states: "No clinical testing has been submitted, referenced, or relied upon for determining substantial equivalence."

5. Standalone (i.e. algorithm only without human-in-the loop performance) performance: Not applicable as this is a physical medical device, not an AI/algorithm-based device.

6. Type of ground truth used: The ground truth for the performance tests consists of established scientific and engineering standards (e.g., ASTM standards, ISO 10993-1), and the predicate device's performance profile against these standards. The objective is to show that the LiquiBand® XL performs similarly to the predicate.

7. Sample size for the training set: Not applicable as this is not an AI/algorithm-based device that would require a "training set."

8. How the ground truth for the training set was established: Not applicable.

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LiquiBand® Plus is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand® Plus may be used in conjunction with, but not in place of, deep dermal stitches.

LiquiBand® Plus topical skin adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-Octyl-cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single patient use applicator and packaged in a pouch. The LiquiBand® Plus topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand® Plus topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand® Plus topical skin adhesive polymerizes within minutes.

In vitro studies have shown that LiquiBand® Plus topical skin adhesive acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.

The provided text describes the 510(k) summary for the medical device LiquiBand Plus, a topical skin adhesive. It outlines its indications for use, technological characteristics, and performance data from various tests. However, the document does not explicitly state acceptance criteria in a quantitative manner or provide specific performance results against those criteria in a table format. It focuses on demonstrating substantial equivalence to a predicate device through various performance and biocompatibility tests.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance with numerical values, nor can I quantify the sample sizes for test sets, the number or qualifications of experts for ground truth, or an adjudication method. The document does not contain information about multi-reader multi-case studies, standalone algorithm performance, or specific ground truth methodologies for any studies, as the device is a physical medical device (skin adhesive), not an AI/software device that would typically involve such studies.

Here's a breakdown of what can be extracted from the provided text, while acknowledging the limitations regarding the core request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not available in the provided text. The document states that "Testing was performed in accordance with the FDA special controls guidance document for 'Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin'". It lists several tests, but does not provide specific numerical acceptance criteria for these tests or the quantitative performance results achieved by LiquiBand Plus against those criteria. It only states that the testing demonstrated substantial equivalence.

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

Not available in the provided text. The document lists the types of tests performed (e.g., Lap-shear strength, Animal wound healing study) but does not disclose the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable/available in the provided text. This device is a topical skin adhesive, not an AI/software for interpretation. "Ground truth" in the context of expert review for image or data interpretation is not relevant here. The evaluation focuses on physical and biological properties.

4. Adjudication method for the test set:

Not applicable/available in the provided text. As above, adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in expert interpretation, which is not relevant for this device type.

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/available in the provided text. This type of study is for AI-assisted diagnostic or interpretative devices. LiquiBand Plus is a physical medical device.

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

Not applicable/available in the provided text. This is relevant for AI/software and not a physical medical device.

7. The type of ground truth used:

Various methods depending on the test, but not explicitly detailed as "ground truth" in the context of expert review. For a physical device like LiquiBand Plus, the "ground truth" would be established through the methodologies of the specific performance tests listed (e.g., standardized testing protocols for strength, degradation, biocompatibility endpoints like cytotoxicity). The document mentions "in vitro studies" and "animal wound healing study," but details on specific ground truth establishment for these are not provided.

8. The sample size for the training set:

Not applicable/available in the provided text. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable/available in the provided text. There is no "training set" for this device.

In summary, the provided FDA 510(k) summary for LiquiBand Plus details the regulatory classification, indications for use, and a list of performance and biocompatibility tests conducted to demonstrate substantial equivalence to a predicate device. However, it does not provide the quantitative acceptance criteria, specific performance results against those criteria, sample sizes for the studies, or details related to expert ground truth establishment, as these are typically applicable to AI/software devices for diagnostic or interpretative tasks, not physical medical devices like the one described.

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Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:

• Pressure ulcers
• Leg ulcers
• Diabetic ulcers
• Graft and donor sites
• Post-operative surgical wounds
• Trauma wounds (dermal lesions, trauma injuries or incisions)
• 1st and 2nd degree burns
• Abrasions and lacerations

Silver Antimicrobial Wound Gel is an opaque, amorphous hydrogel containing a high (>80%) water content and hydrophilic polymer chains. This formulation increases the moisture within the wound through water donation which makes the gel effective in assisting the debridement and desloughing process in dry necrotic wounds, whilst maintaining a moist wound environment for optimal wound healing. Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel. Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.

The provided text is a 510(k) summary for a medical device modification, specifically for a Silver Antimicrobial Wound Gel. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not include specific acceptance criteria with quantifiable metrics (e.g., "device must achieve X% sensitivity or Y% specificity"). Instead, it focuses on demonstrating performance through qualitative statements and comparisons.

Therefore, for the requested table of acceptance criteria and device performance, I can only extract what is stated. For other sections, the information is largely absent based on a typical AI/software device study description.

Here's the analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a device modification for a wound care product, not an AI software), the "acceptance criteria" are not presented as numerical thresholds for performance metrics like sensitivity or specificity. Instead, the acceptance is based on demonstrating antimicrobial barrier activity and acceptable wound healing performance compared to a predicate device and standard care.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of subjects or wounds for the in-vivo porcine study. It only mentions "an in-vivo porcine study."
• Data Provenance: The in-vivo study was a porcine study (animal model). The country of origin for the data is not specified, but the applicant is based in the United Kingdom. It is a prospective study as it describes an assessment over time ("day 2 & 4 assessment points").

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

• Not applicable/Not mentioned. The in-vivo study involved direct observation and measurement of wound characteristics in a porcine model, rather than expert interpretation of images or clinical data for ground truth establishment in the way an AI medical device would.

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

• Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in clinical image interpretation, not for direct observations in an animal model.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for a wound care gel.

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

• Not applicable. The device is a wound care gel, not an algorithm. Therefore, "standalone" performance in the context of AI is not relevant.

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

• For the in-vivo study, the "ground truth" (or outcome measures) were direct observations of wound closure rate, wound site adherence, peri-wound inflammation/erythema, presence of debris, and adverse effects in a porcine model. These are direct physical measurements and observations.
• For the in-vitro study, the ground truth was based on laboratory testing against specified microorganisms following recognized standards (USP 33 and European Pharmacopoeia Edition 6.6 section 5.1.3).

8. The sample size for the training set

• Not applicable. This is a medical device (wound gel), not a machine learning model. There is no "training set."

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

• Not applicable. There is no "training set" for this device.

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Silver PU Antibacterial Foam Dressings are indicated for the management of light to moderate exuding partial and full thickness wounds, such as: '. - Decubitus (pressure) ulcers - Diabetic ulcers 0 - Leg ulcers . - Graft and donor sites - Lacerations and abrasions 9 - 1st and 2nd degree burns - Trauma wounds (dermal lesions, trauma injuries or incisions) e - Post-operative surgical wounds The Silver PU Antibacterial Foam Dressings are indicated for external use only

The Silver PU Antibacterial Foam Dressings is available in two variants: Silver PU Antimicrobial Foam Dressing - Non-Adherent variant consists of a low friction waterproof polyurethane film, which also provides a bacterial barrier, laminated to hydrophilic absorbent polyurethane foam with a silver coated nylon mesh wound contact layer. Silver PU Antimicrobial Foam Dressing - Island variant consists of a polyurethane waterproof membrane coated with pressure sensitive acrylic adhesive, which also provides a bacterial barrier, with a centrally located hydrophilic absorbent polyurethane foam with a silver coated nylon mesh wound contact layer. Each Silver PU Antibacterial Foam Dressing contains a minimum of 0.26mg/cm² of elemental silver, the antibacterial action of the silver protects the dressing from bacterial contamination and provides an effective barrier to bacterial penetration. The antibacterial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against a broad spectrum of microorganisms associated with wound infection, such as Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Strentococcus pvogenes, Enterococcus faecalis (VRE) and Escherichia coli. Silver Antibacterial Foam Dressings may reduce odour caused by micro-organisms in the wound. Odour reduction results from the antibacterial effect in the dressing. Silver PU Antibacterial Foam Dressings are soft, highly absorbent, conformable and create the ideal environment for moist wound healing. Silver PU Antibacterial Foam Dressings are suitable for use under compression bandaging. Silver PU Antibacterial Foam Dressings are available in various sizes and shapes. The dressings are packaged in individual pouches, then into shelf cartons.

The document describes a 510(k) submission for Silver PU Antibacterial Foam Dressings. The acceptance criteria and supporting studies are presented in the form of performance data demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "antimicrobial, animal and bench testing" but does not specify sample sizes for these tests. Data provenance for these tests is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for the data itself, beyond the manufacturing location of the applicant (United Kingdom) and the predicate device manufacturers (unspecified locations, but common for global medical device companies).

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

Not applicable. This submission focuses on the performance of a wound dressing, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set. The "ground truth" for this type of device lies in objective measurements from laboratory, animal, and bench testing.

4. Adjudication Method for the Test Set:

Not applicable. As above, this type of submission does not involve an adjudication method by human readers for a test set in the same way an AI diagnostic device would.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. This type of study is typically performed for diagnostic devices where human reader performance is a key metric, often with and without AI assistance.

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

Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation is based on:

• In vitro microbiological testing: To demonstrate antibacterial efficacy against specific pathogens.
• Animal testing: Implies studies on living organisms, likely for biocompatibility, wound healing, or safety aspects. The specifics are not detailed.
• Bench testing: Involves laboratory tests to assess physical properties like absorption, integrity, silver release, and barrier functions.
• Biocompatibility testing: Performed according to BS EN ISO 10993-1 standards, which involves a series of tests to determine the biological response of the device material in contact with the body.
• Sterilization validation: To confirm the effectiveness of the sterilization process.

These types of ground truth are objective, measurable outcomes in a laboratory or controlled environment, rather than expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set:

Not applicable. This submission is for a physical medical device (wound dressing), not an AI/machine learning model. Therefore, there is no "training set" in the context of AI.

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

Not applicable. As stated above, there is no training set for this type of device.

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Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as:

• ·Post-operative wounds .
• Trauma wounds (dermal lesions, trauma injuries or incisions)
• Leg ulcers
• Pressure ulcers
• Diabetic ulcers
• Graft and donor sites
• Post-operative surgical wounds
• 1st and 2nd degree burns
• Partial and full thickness wounds

Silver Alginate II Dressing is indicated for external use only

Silver Alginate II Dressing is a sterile, non woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (Silver Sodium Hydrogen Zirconium Phosphate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.

The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to fourteen (14) days, based on in-vitro testing. Odour reduction results from the antibacterial effect in the dressing.

Silver Alginate II Dressing is an effective barrier to bacterial penetration.

Silver Alginate II Dressing protects the wound and aids autolytic debridement therefore facilitating wound healing.

The Silver Alginate II Dressing is available various sizes: 5cm x 5cm (2" x 2"), 10cm x 10cm (4" x 4"). 10cm x 12cm (4" x 4.75"). 15cm x 15cm (6" x 6"). 10cm x 20cm (4" x 8"), 20cm x 30cm (8" x 12") and 2.7cm x 30cm (1" x 12"). The dressings are packaged in foil pouches.

This document describes a Special 510(k) Device Modification for the Advanced Medical Solutions Limited's Silver Alginate II Dressing. The modification aims to demonstrate substantial equivalence to previously cleared devices. The document references performance data but does not explicitly state acceptance criteria or the specifics of a study proving the device meets those criteria in a way that aligns with the detailed requests in the prompt.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "in-vitro testing" and "microbiological assessment" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.

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

Not applicable. The tests described are laboratory/bench tests, not involving expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. The tests described are laboratory/bench tests, not involving adjudication of interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document refers to in-vitro testing and biocompatibility assessments, not studies involving human readers and clinical cases.

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

This question is not applicable as the device is a wound dressing, not an AI algorithm. The performance described is for the physical device itself.

7. The type of ground truth used

For antimicrobial effectiveness, the ground truth appears to be based on direct observation of bacterial inhibition/reduction in in-vitro settings.
For biocompatibility, the ground truth is compliance with the requirements of international standard BS EN ISO 10993-1, which involves various biological tests.
For sterilization, the ground truth is compliance with ISO 11137 standards, which involves validated sterilization processes.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device that requires a training set.

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

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

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Silver Alginate IV Antimicrobial Wound Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as:

• . Post-operative wounds
• Trauma wounds (dermal lesions, trauma injuries or incisions) .
• Leg Ulcers ●
• Pressures Ulcers .
• Diabetic Ulcers .
• Graft and donor sites .
• Post-operative surgical wounds
• 1st and 2nd degree burns
• Partial and Full Thickness wounds

Silver Alginate IV Antimicrobial Wound Dressing is indicated for external use only

Silver Alginate IV Antimicrobial Wound Dressing is a sterile, non woven pad or rope/ribbon/filler composed of a high M (mannuronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (silver carbonate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the dressing forms a gel, which aids autolytic debridement, whilst maintaining a moist environment for optimal wound healing and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms, such as a Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Streptococcus and bw, merceas faecalis (VRE), Pseudomonas aeruginosa, Escherichia Doli, and fungi such as Candida albicans , over a period of up to twenty-one (21) days, based on in-vitro testing, and may reduce odour caused by micro-organisms in the wound. Odour reduction results from the antibacterial effect in the dressing. Silver Alginate IV Antimicrobial Wound Dressing is an effective barrier to bacterial penetration. The dressing has pale golden appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 10cm x 12cm, 15cm, 10cm x 20cm, 20cm x 20cm flat dressings; 2.7cm x 30cm room, 10cm x 12cm, 150m, 150mm x 2g rope dressings). The dressings are packaged in pouches.

The provided text describes a 510(k) notification for a medical device, the Silver Alginate IV Antimicrobial Wound Dressing. This type of submission focuses on establishing substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials to prove efficacy against acceptance criteria. Therefore, the document primarily details the basis for equivalence rather than specific acceptance criteria and a study proving performance against them.

Based on the provided information, I can answer some of your questions and note where the information is not available:

1. Table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. For a 510(k) submission like this, the "acceptance criteria" are generally that the new device performs as well as or substantially equivalently to the predicate device in relevant tests (e.g., biocompatibility, sterilization, antimicrobial activity, absorption). The document states that the testing demonstrated compliance and substantial equivalence to predicate devices, implying these "acceptance criteria" were met.

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. The document mentions "in-vitro testing" for antimicrobial activity, but the specific number of samples or experimental replicates is not detailed.
• Data Provenance: The manufacturing company is Advanced Medical Solutions Limited, located in the United Kingdom. The testing would presumably have been conducted in the UK or by contractors for AMS Ltd. The nature of the tests (biocompatibility, sterilization validation, in-vitro antimicrobial activity) indicates laboratory-based studies rather than human clinical trials. These would generally be considered prospective in design for the specific tests performed.

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 and therefore not provided. The "ground truth" concept is typically used in AI/ML studies where human experts classify data for model training and validation. For a medical device like a wound dressing, the "ground truth" for performance is established through standardized laboratory tests and validated methodologies (e.g., microbiology labs for antimicrobial activity, toxicology labs for biocompatibility). There is no mention of human experts interpreting raw test results as "ground truth" in the way it would be for an image classification task, for example.

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

Not applicable. As noted above, this type of adjudication is relevant for expert-driven tasks, not for standardized laboratory performance testing of a 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

No. This is a medical device (wound dressing), not an AI/ML diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant or discussed. The comparison is against predicate wound dressings to establish substantial equivalence, not against AI.

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

Not applicable. This is not an algorithm or AI product. The device itself is the "standalone" product.

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

As explained in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly applicable here. For the tests cited:

• Biocompatibility: Ground truth is established by adherence to standards like BS EN ISO 10993-1, which involves specific laboratory assays (e.g., cytotoxicity, irritation, sensitization).
• Sterilization Validation: Ground truth is adherence to harmonized standards, ensuring a specified sterility assurance level (SAL).
• Antimicrobial Activity: Ground truth is established by validated in-vitro microbiological test methods demonstrating reduction or inhibition of microbial growth.

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. No training set is used for this type of medical device.

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Non-Adherent Antimicrobial Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.

Non-Adherent Antimicrobial Wound Dressing is indicated for external use only.

Non-Adherent Antimicrobial Alginate Dressing is a sterile, non woven pad composed of a high G (guluronic acid) alginate, carboxymethy)cellulose (CMC) and silver coated nylon fibres, laminated to a perforated, non-adherent ethylene methyl acrylate (EMA) wound contact layer. The dressing absorbs exudate and allows intact removal, whilst maintaining a moist wound environment. A moist wound environment is optimal for wound healing. The silver ions within the dressing protects the dressing from bacterial contamination. Odor reduction results from the antibacterial effect.

This document is a 510(k) premarket notification for a medical device modification, specifically for Advanced Medical Solutions Limited's Non-Adherent Antimicrobial Alginate Dressing. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for de novo acceptance criteria for a new AI/software device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning AI or software performance.

Here's why and what information is available:

• Device Type: The device is a wound dressing, a physical medical product, not an AI or software device.
• Purpose of Submission: This is a 510(k) modification for a PHYSICAL device (adding a perforated, non-adherent wound contact layer). The primary goal is to show "substantial equivalence" to existing, legally marketed predicate devices, not to establish new performance criteria for a novel AI.
• Study Types Mentioned: The document refers to:
  • Biocompatibility testing: In compliance with BS EN ISO 10993-1.
  • Sterilization validation: In compliance with ISO 11137 standards.
  • Performance testing and antimicrobial activity: Stated to be substantially equivalent to predicate devices.
    These are standard tests for physical medical devices and do not involve AI performance metrics, sample sizes for AI test sets, expert ground truth, or MRMC studies.

Based on the provided text, I cannot complete the table or answer the questions regarding acceptance criteria and an AI study.

The prompt's specific questions are geared towards the evaluation of AI/software as a medical device (SaMD) or AI-enabled medical devices, which typically involve metrics like sensitivity, specificity, AUC, human reader improvement, and detailed ground truth establishment. This document does not pertain to such a device or evaluation.

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Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:

• . Pressure ulcers
• Leg ulcers .
• . Diabetic ulcers
• . Graft and donor sites
• . Post-operative surgical wounds
• . Trauma wounds (dermal lesions, trauma injuries or incisions)
• 1st and 2nd degree burns .
• Abrasions and lacerations .

Silver Antimicrobial Wound Gel is an opaque, amorphous hydrogel containing a high (>80%) water content and hydrophilic polymer chains. This formulation increases the moisture within the wound through water donation which makes the gel effective in assisting the debridement and desloughing process in dry necrotic wounds, whilst maintaining a moist wound environment for optimal wound healing.
Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel.
Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Silver Antimicrobial Wound Gel":

The document does not explicitly state numerical acceptance criteria in a table format for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to established in-vitro and in-vivo testing standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (a 510(k) for a wound gel), the "acceptance criteria" are more implicitly derived from demonstrating safety, efficacy, and substantial equivalence to existing predicate devices.

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

The document primarily references two types of testing for device performance:

• In-vitro Testing:

  • Sample Size: Not explicitly stated as a numerical count of "samples" for the antimicrobial tests. It mentions a "seven day log reduction evaluation test and preservative efficacy test in accordance with the requirements of USP 30 (Antimicrobial Effectiveness Testing)." This implies standardized methodology with defined replicates, but not a specific "sample size" in terms of clinical cases.
  • Data Provenance: Not specified, but generally, in-vitro tests are conducted in laboratory settings, likely within the UK or a qualified testing facility.

• In-vivo Testing (Porcine Study):

  • Sample Size: Not explicitly stated as a number of animals or wounds. The wording describes "an in-vivo porcine study" that assessed dressing performance and compared three treatment arms (Silver Antimicrobial Wound Gel, equivalent Hydrogel without silver, and "Wet to Dry" gauze). We cannot determine the exact sample size from the provided text.
  • Data Provenance: The study was "in-vivo," using porcine subjects, implying a controlled animal study. The country of origin for the study is not mentioned. It is a prospective study as it involved applying the treatments and then assessing outcomes.

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

• In-vitro Testing: Not applicable in the context of "experts establishing ground truth." The ground truth for antimicrobial efficacy is derived from standardized laboratory tests with defined protocols (e.g., USP 30 requirements).
• In-vivo Testing (Porcine Study): Not explicitly stated. For animal studies, assessments would typically be performed by trained researchers or veterinary professionals. It does not mention a panel of "experts" in the context of radiologists or similar clinical specialties for establishing ground truth, as this is an animal study evaluating wound healing parameters.

4. Adjudication Method for the Test Set

• In-vitro Testing: Not applicable. Results are quantitative measurements from lab tests.
• In-vivo Testing (Porcine Study): Not specified. The document states "The report findings showed that..." suggesting data collection and analysis, but no explicit adjudication method (like 2+1 or 3+1 consensus) among multiple assessors for qualitative observations is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study typically involves multiple human readers evaluating medical images or cases with and without AI assistance to measure reader improvement. The provided document concerns a wound gel and its performance, not an AI-based diagnostic or assistive device for human readers.

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

No, a standalone study in the context of an algorithm's performance was not conducted. The device is a wound gel, which is a physical product, not a software algorithm. Its performance is intrinsic to its physical and chemical properties and how it interacts with wounds, not through an algorithm operating independently.

7. Type of Ground Truth Used

• In-vitro Testing: Ground truth is established by standardized laboratory test results (e.g., log reduction of microbial counts for antimicrobial efficacy, compliance with ISO standards for biocompatibility).
• In-vivo Testing (Porcine Study): Ground truth is based on direct observation and measurement of wound healing parameters in a controlled animal model. This includes wound closure rate, wound site adherence, peri-wound inflammation/erythema, and general absence of adverse effects.

8. Sample Size for the Training Set

Not applicable. This device is a wound care product, not an AI or machine learning algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

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Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as:

• Post-operative wounds .
• Trauma wounds (dermal lesions, trauma injuries or incisions) .
• Leg Ulcers .
• Pressures Ulcers .
• Diabetic Ulcers ◆
• Graft and donor sites .
• Post-operative surgical wounds .
• 1st and 2nd degree burns .
• Partial and Full Thickness wounds .

Silver Alginate II Dressing is indicated for external use only

Silver Alginate II Dressing is a sterile, non woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (Silver Sodium Hydrogen Zirconium Phosphate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to twenty-one (21) days, based on in-vitro testing. . Odour reduction results from the antibacterial effect in the dressing. Silver Alginate II Dressing is an effective barrier to bacterial penetration. Silver Alginate II Dressing protects the wound and aids autolytic debridement therefore facilitating wound healing. The dressing has an off-white appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm, 20cm x 30cm flat dressings; 2.7cm x 30cm and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat rope dressings are packaged in pouches and the flat rope and rope dressings are packaged in a blister pack.

The provided text describes a 510(k) premarket notification for a medical device called "Silver Alginate II Dressing." This submission is for a device modification and asserts substantial equivalence to previously cleared devices.

The information provided does not include a study that focuses on device performance in the context of acceptance criteria as one would typically find for an AI/ML medical device. Instead, the document discusses the biocompatibility and sterilization validation of the dressing, and its substantial equivalence to predicate devices based on comparable absorbency, silver release profile, and antimicrobial activity. There is no mention of an algorithm, AI, machine learning, or human reader studies.

Therefore, the requested information elements related to AI/ML device performance and associated studies (items 1 through 9) are not present in the provided text.

Here is a summary of what is available in the document, which primarily focuses on regulatory approval based on equivalence for a wound dressing:

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

• Acceptance Criteria (Implicit - based on predicate device equivalence):
  • Biocompatibility in compliance with BS EN ISO 10993-1.
  • Sterilization validation in compliance with harmonized standards.
  • Comparable absorbency to predicate devices.
  • Comparable silver release profile to predicate devices.
  • Comparable antimicrobial activity to predicate devices.
• Reported Device Performance:
  • "The biocompatibility of Advanced Medical Solutions Limited Silver Alginate II Dressing has been demonstrated to be in compliance with the requirements of BS EN ISO 10993-1."
  • "Sterilisation validation has been performed in compliance with harmonised standards."
  • "Comparable absorbency, silver release profile and antimicrobial activity have been demonstrated."
  • "The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to twenty-one (21) days, based on in-vitro testing."
  • "Odour reduction results from the antibacterial effect in the dressing."
  • "Silver Alginate II Dressing is an effective barrier to bacterial penetration."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* This information is not provided in the document. The studies mentioned (biocompatibility, sterilization, absorbency, silver release, antimicrobial activity) are general test types for wound dressings, but specific sample sizes or data provenance are not detailed.

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 as no expert-based ground truth for a test set (like an image review or clinical outcome assessment) is described.

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
* No MRMC study was done, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* For biocompatibility and sterilization, the "ground truth" would be compliance with specified international standards (BS EN ISO 10993-1 and unspecified harmonized standards for sterilization).
* For absorbency, silver release, and antimicrobial activity, the "ground truth" was established through in-vitro laboratory testing, with comparison to predicate devices. The specifics of these tests (e.g., control groups, reference methods) are not detailed but are implied to be standard in-vitro assessments for such dressings.

8. The sample size for the training set
* Not applicable, as this is not an AI/ML device and no training set is described.

9. How the ground truth for the training set was established
* Not applicable, as this is not an AI/ML device and no training set is described.

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