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Prescription Use:
Under the supervision of a healthcare professional, the Antimicrobial Gelling Fiber Dressing with PHMB is indicated for the management of:

• · Post-surgical incisions
• Pressure ulcers
• · Diabetic ulcers
• · Venous stasis ulcers
• · Donor sites
• · Abrasions
• · Lacerations
• · Superficial and Partial thickness burns
• · Dermatologic disorders
• · Other wounds inflicted by trauma
  Over-the-Counter Use:
  The Antimicrobial Gelling Fiber Dressing with PHMB may be used for the management of:
• · Minor abrasions
• · Minor lacerations
• Minor cuts
• Minor scalds and bums

Antimicrobial Gelling Fiber Dressing with PHMB, is a sterile, non-woven pad or rope composed of carboxymethylcellulose (CMC) fibers, Polyhexamethylene Biguanide (PHMB), Ethylenediaminetetraacetic acid (EDTA), and a reinforcement layer (nylon) for intact removal. The dressing is soft, conformable, and highly absorbent, making it ideal for use with moderate to heavily exuding chronic and acute wounds. As wound exudate containing microorganisms is absorbed and trapped within the dressing, a gel is formed that conforms to the wound bed and anatomical contours, and aids in maintaining a moist wound environment and removing non-viable tissue and slough (autolytic debridement). This is conducive to the natural healing process.
The dressing contains an active ingredient, PHMB. Based on in vitro performance data, the Antimicrobial Gelling Fiber Dressing with PHMB effectively reduces microbial colonization within the dressing for up to 7 days.
The device is presented in a range of both flat/pad (160 g/m 2 and 200 g/m 2 ) and rope (160 g/m 2 ) dressings. The dressings are manufactured consistently using the same raw materials, the same manufacturing lines, follow a similar manufacturing process and utilize the same sterilization route. The sterile dressings are supplied in a range of sizes between 4in 2 (25cm 2 ) to 96in 2 (600cm 2 ).

This document describes a 510(k) premarket notification for a medical device called "Antimicrobial Gelling Fiber Dressing with PHMB." It asserts substantial equivalence to predicate devices, but does not contain information related to software, algorithms, AI performance, or specific acceptance criteria for such a system.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document details the device's physical properties, indications for use, and a summary of performance testing, which are primarily related to physical characteristics, sterility, biocompatibility, and antimicrobial efficacy of the dressing itself.

Here's the relevant information that is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Performance Testing Summary" but doesn't explicitly list specific acceptance criteria values alongside device performance values in a table format as might be expected for an AI/software device. Instead, it describes general categories of testing and general statements of efficacy.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a study involving a test set for an AI/algorithm. The performance testing is for the physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving human experts establishing ground truth for an AI/algorithm test set.

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 device is a physical wound dressing and does not involve human readers or AI assistance in an interpretive capacity.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/algorithm. For the physical device, efficacy against microorganisms was demonstrated in vitro.

8. The sample size for the training set: Not applicable.

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

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Under the supervision of a healthcare professional, High Performance Antimicrobial Gelling Fiber with Silver can be used in the management of moderate to heavily exuding chronic and acute wounds. The antimicrobial dressing is indicated for use on the following wounds;

• · Pressure ulcers (partial and full thickness)
• · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• · Diabetic foot ulcers
• · Surgical wounds that heal by primary intent such as dermatological and surgical incisions
• · Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites
• Traumatic wounds

High Performance Antimicrobial Gelling Fiber with Silver is an antimicrobial, absorbent gelling fiber dressing comprising of a non-woven pad or ribbon containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. The dressing is sterile, soft and conformable to anatomical contours.
High Performance Antimicrobial Gelling Fiber with Silver manages exudate in moderate to heavily exuding wounds and helps create a favorable environment for moist wound healing. The highly absorbent dressing absorbs exudate from the wound to form a soft gel that intimately conforms to the wound bed and aids in maintaining a moist wound environment, which is conducive to the wound healing environment and aids autolytic debridement (removal of non-viable tissue). The dressing is designed to minimize the risk of maceration and damage to newly formed tissue. High Performance Antimicrobial Gelling Fiber with Silver can be used under compression.
High Performance Antimicrobial Gelling Fiber with Silver contains ionic silver, and effectively manages and suppresses colonization and proliferation of micro-organisms within the dressing for up to 7 days.
High Performance Antimicrobial Gelling Fiber with Silver, when tested in vitro, has been shown to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing.
The dressings are supplied sterile (gamma irradiation) in a range of sizes, ranging in area from 28cm² (4.34 in²) to 650cm² (100.75 in²).
High Performance Antimicrobial Gelling Fiber with Silver is a modification of the predicate device to include updated product labelling in support of an antimicrobial product offering.

This document is a 510(k) premarket notification for a medical device called "High Performance Antimicrobial Gelling Fiber with Silver." It is a regulatory submission to the FDA, not a study report proving the device meets specific performance acceptance criteria through clinical or comparative effectiveness studies in the traditional sense of AI/imaging devices.

Therefore, many of the requested criteria for AI/imaging device studies (like sample size for test sets, number of experts for ground truth, MRMC studies, effect size, etc.) do not apply to this type of medical device clearance.

This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (Silver High Performance Dressing, K183645), primarily by showing that the new device has identical design, materials, and manufacturing processes, and similar performance characteristics. The key modification mentioned is updated product labeling to support an antimicrobial offering, which is backed by in vitro testing.

Here's a breakdown of the relevant information from the document in relation to your request, with an explanation of why other parts are not applicable:

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

The document does not present a formal table of quantitative acceptance criteria for in vivo clinical performance metrics typically seen with AI algorithms (e.g., sensitivity, specificity, AUC). Instead, the "performance" demonstrated is primarily through in vitro testing and claims of substantial equivalence to the predicate.

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

• Not applicable for clinical/human test sets. The performance data mentioned is from in vitro testing against microorganisms. No information is provided about the "sample size" of microorganisms or the specific provenance of the data beyond "in vitro."
• Retrospective/Prospective: The in vitro testing is a laboratory study, not a retrospective or prospective clinical study on human subjects.

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

• Not applicable. Ground truth in this context refers to the identification of microorganisms and their inhibition, which is established through standard microbiological laboratory methods, not expert human readers of medical images.

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

• Not applicable. This relates to human reader consensus in diagnostic studies, which is not relevant here.

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. This device is a wound dressing, not an AI-assisted diagnostic tool for human readers.

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

• The "standalone" performance here is the in vitro antimicrobial efficacy. The document states: "High Performance Antimicrobial Gelling Fiber with Silver, when tested in vitro, has been shown to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing." This is the primary standalone performance claim.

7. The type of ground truth used:

• Microbiological laboratory reference standards/assays for in vitro antimicrobial efficacy. For the wound healing and absorption claims, the ground truth is implied by the physical and chemical properties of the dressing, and its substantial equivalence to the predicate which had its own performance data for those aspects.

8. The sample size for the training set:

• Not applicable. This device is not an AI algorithm that undergoes a "training set" process.

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

• Not applicable. See point 8.

In summary:

This 510(k) submission for an antimicrobial wound dressing clears the device based on substantial equivalence to an existing predicate device and in vitro laboratory testing to support its antimicrobial claims. It does not involve the types of clinical or AI performance studies (e.g., diagnostic accuracy, human reader studies, ground truth established by expert consensus on images) that would require the detailed information requested in points 2-5, 8, and 9.

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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, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma, and as a secondary dressing for packed wounds.

The subject device, Silicone PHMB Foam 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 dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.

Based on in vitro performance data, the Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing for up to 7 days. Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against the following bacteria (MRSA, Streptococcus pyogenes, VRE, Escherichia coli, Klebsiella pneumoniae, Serratia marcescens) and yeast (Candida albicans) challenge organisms within the dressing.

The perforated wound contact layer contains a gentle silicone adhesive that provides secure, non-irritating adhesion and supports nontraumatic 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 to 64 in2.

The provided text describes a 510(k) submission for a medical device, the "Silicone PHMB Foam Wound Dressing." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical outcome studies with specific acceptance criteria as might be seen for novel devices or high-risk applications.

Therefore, the information typically requested in your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, effect sizes, adjudication methods, type of ground truth for training) is not applicable in the context of this 510(k) submission for a wound dressing.

Instead, the submission focuses on performance testing (in-vitro and animal testing) and biological evaluation to demonstrate safety and functional equivalence to the predicate device.

Here's what can be extracted from the document regarding the device's performance and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for a wound dressing, "acceptance criteria" are generally framed as demonstrating equivalence to a predicate device in terms of design, materials, indications for use, and performance characteristics. The specific metrics for "device performance" are primarily related to its physical and antimicrobial properties rather than diagnostic accuracy metrics.

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

• Sample Size: Not specified in terms of "test set" for human performance, as this is a device for physical wound management. The performance data relied on in-vitro and animal testing. Specific numbers of samples or animals are not provided in this summary document.
• Data Provenance: Not explicitly stated but the applicant is based in the UK (Advanced Medical Solutions Ltd, Winsford, Cheshire, CW7 3RT GB). The studies conducted would typically comply with international standards (e.g., ISO for biological evaluation). The document does not specify if the studies were retrospective or prospective, but in-vitro and animal studies are typically prospective experimental designs.

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

• Not Applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Ground truth for in-vitro antimicrobial effectiveness would be based on laboratory microbiological assays, and for physical properties, on engineering and material science standards.

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

• Not Applicable. No human interpretation or adjudication process is described for this device's performance evaluation.

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/diagnostic device.

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

• Not Applicable. This is not an algorithmic device. The "standalone" performance refers to the intrinsic properties of the wound dressing (e.g., absorbency, antimicrobial activity).

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

• For Antimicrobial Efficacy: Ground truth established via
  • In-vitro microbiological assays: (e.g., confirming inhibition of bacterial/yeast growth on/in the dressing).
• For Biocompatibility: Ground truth established via
  • Compliance with International Standard ISO 10993-1: Biological evaluation based on established protocols and endpoints (e.g., cytotoxicity, sensitization, irritation) in animal models or in-vitro tests.
• For Physical Performance: Ground truth established via
  • Standardized physical testing methods: (e.g., for absorbency, fluid handling, peel adhesion), often against industry benchmarks or the predicate device's measured properties.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning/AI device, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML algorithm.

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Under the supervision of a healthcare professional, Silver High Performance Dressing can be used in the management of moderate to heavily exuding chronic and acute wounds. The dressing is indicated for use on the following wounds:

• · Pressure ulcers (partial and full thickness)
• · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• · Diabetic foot ulcers
• · Surgical wounds that heal by primary intent such as dermatological and surgical incisions
• · Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites
• Traumatic wounds

Silver High Performance Dressing is a sterile dressing comprising of an absorbent non-woven fiber pad or ribbon containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. The dressing is soft and conformable to anatomical contours. Silver High Performance Dressing manages exudate in moderate to heavily exuding wounds and helps create a favorable environment for moist wound healing. The highly absorbent dressing absorbs exudate from the wound to form a soft gel that intimately conforms to the wound bed and aids in maintaining a moist wound environment, which is conducive to the wound healing environment and aids autolytic debridement (removal of non-viable tissue). The dressing is designed to minimize the risk of maceration and damage to newly formed tissue. Silver High Performance Dressing can be used under compression. Silver High Performance Dressing contains ionic silver, and effectively manages and suppresses colonization and proliferation of bacteria and yeast within the dressing for up to 7 days. Silver High Performance Dressing , when tested in vitro, has been shown to be effective against the following four gram positive bacteria (Vancomycin- resistant enterococcus (VRE), Streptococcus mutans and Staphylococcus aureus and Methicillin - resistant staphylococcus epidermidis (MRSE)), four gram negative bacteria (Enterobacter cloacae, Klebsiella pneumonia, Serratia marcescens and Escherichia coli (E. coli)), and yeast (Candida albicans) challenge organisms within the dressing. The dressings are supplied sterile (gamma irradiation) in a range of sizes, ranging in area from 28cm² (4.34 in-) to 650cm² (100.75 in4).

The provided document {0-6} is a 510(k) premarket notification for the "Silver High Performance Dressing" by Advanced Medical Solutions Ltd. This document primarily focuses on establishing substantial equivalence to a predicate device (AQUACEL® Ag Hydrofiber Dressing - K080383) rather than detailing clinical study results for novel acceptance criteria of an AI/ML medical device.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves an AI/ML device meets them, specifically:

• No table of acceptance criteria and reported device performance for an AI/ML device.
• No sample size for a test set for an AI/ML device, nor its data provenance.
• No information on experts used for ground truth establishment.
• No adjudication method for a test set.
• No multi-reader multiple-case (MRMC) comparative effectiveness study with human readers.
• No standalone (algorithm only) performance for an AI/ML device.
• No type of ground truth used in the context of an AI/ML device (e.g., expert consensus, pathology, outcomes data).
• No sample size for a training set or how its ground truth was established, as this is not an AI/ML device submission.

The studies described in the document are primarily in vitro and animal studies (porcine model) assessing the physical characteristics (absorbency, wet integrity, tensile strength), antimicrobial efficacy of silver, and biocompatibility/wound healing performance of the dressing itself, in comparison to a predicate device. This is typical for a wound dressing submission, not an AI/ML diagnostic or assistive device.

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Under the supervision of a healthcare professional Surgical Silver Post Operative Dressing may be used in the management of post operative surgical wounds healing by primary intent, and as an effective barrier to bacterial penetration.

The subject device, Surgical Silver Post Operative dressing, is a sterile dressing comprising of an absorbent non woven pad containing an ionic silver. This centered silver pad is secured between two layers of hydrocolloid; the outer hydrocolloid layer incorporates a breathable waterproof film. The inner layer of hydrocolloid forms a windowed self adhesive skin contact layer, which adheres to healthy skin, minimizes trauma on removal and assists in minimizing leakage. As wound fluid is absorbed the dressing forms a gel, this helps maintain a moist environment. A moist wound environment has been shown to be conducive for wound healing. The non-woven pad gelling properties allow intact removal without damage to the closure system e.g. sutures.

Based on in vitro performance data, the Surgical Silver Post Operative dressing provides a barrier to bacterial penetration through the dressing and the silver component prevents colonization and proliferation of bacteria within the dressing for up to 7 days.

Surgical Silver Post Operative dressings, when tested in-vitro have been demonstrated to be efficacious, achieving ≥4 log reduction within the dressing including multiple re-inoculations against three gram positive (MRSA, MRSE, VRE) bacteria, three gram negative bacteria ( Escherichia coli, Klebsiella pneumonia, Pseudomona areuginosa ) and yeast ( Candida albicans ) challenge organisms.

The dressings are supplied sterile (gamma irradiation) in a range of sizes between 14 in 2 to 49 in 2 .

The device, Surgical Silver Post Operative Dressing, is subjected to various performance tests to demonstrate its substantial equivalence to the predicate device, AQUACEL® Ag Surgical dressings (K091034). The studies cited include in-vitro performance data, animal testing, and biological evaluation.

Here's an breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bacterial Barrier / Silver Efficacy: The sample size for the in-vitro tests is not explicitly stated in terms of the number of dressings or repetitions.
• Wound Healing (Porcine Model): The document mentions "test subjects" in the porcine model, implying a number of animals were used, but the specific count is not provided.
• Biocompatibility: The sample size for the various biocompatibility tests is not specified.
• Data Provenance: The studies are described as in-vitro and animal testing, which are implicitly prospective studies designed to evaluate the device. The country of origin for the studies is not explicitly stated, but the manufacturer is Advanced Medical Solutions Ltd, based in the UK, suggesting the studies were likely conducted or overseen in the UK or by a contract research organization.

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

• Bacterial Barrier / Silver Efficacy: The ground truth for bacterial efficacy (in-vitro) is established through standard microbiological testing protocols, which rely on validated laboratory methods and measurements (e.g., colony-forming unit counts). While experts perform these tests, a specific "number of experts" or their qualifications for establishing ground truth as in a clinical consensus review is not applicable in this context.
• Wound Healing (Porcine Model): The evaluation involved "macroscopic and histopathological observations." Histopathological observations typically involve trained veterinary pathologists or equivalent experts. However, the exact number and qualifications of these experts are not provided.
• Biocompatibility: These tests are conducted according to international standards (e.g., ISO 10993-1) by qualified toxicologists and laboratory personnel. The specific number and qualifications of experts are not detailed in this summary.

4. Adjudication method for the test set

• Bacterial Barrier / Silver Efficacy: No explicit adjudication method is mentioned. The results would likely be based on quantitative measurements and statistical analysis against predefined thresholds.
• Wound Healing (Porcine Model): "Macroscopic and histopathological observations" suggest subjective and objective assessments. However, no specific adjudication method like 2+1 or 3+1 for resolving discrepancies is described. Typically, a qualified pathologist's report would constitute the finding.

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 section is not applicable as the device is a medical dressing and not an AI-powered diagnostic or decision support system that would involve human readers or an AI assistance component.

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

This section is not applicable as the device is a medical dressing and not an algorithm. The "standalone" performance here refers to the dressing's intrinsic properties.

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

• Bacterial Barrier / Silver Efficacy: Ground truth is based on quantitative microbiological assays (e.g., direct enumeration of bacterial colonies) performed in-vitro.
• Wound Healing (Porcine Model): Ground truth is established through macroscopic observation of wound healing progression and microscopic histopathological examination of tissue samples.
• Biocompatibility: Ground truth is determined by the results of standardized biological tests according to ISO 10993-1, which assess cellular responses, systemic toxicity, and tissue reactions.

8. The sample size for the training set

This section is not applicable. The device is a medical dressing with performance evaluated through laboratory and animal studies, not a machine learning algorithm that requires a training set.

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

This section is not applicable for the same reasons as point 8.

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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, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing for packed wounds.

The subject device, PHMB Foam Wound Dressing, is a polyurethane foam impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment. Based on in vitro performance data, the PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing for up to 7 days. PHMB Foam dressing, when tested in-vitro has demonstrated to be effective against the following three gram positive bacteria (MRSA, MRSE, VRE), three gram negative bacteria (Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa) and two yeast (Candida albicans, Rhodotorula mucilaginosa) challenge organisms within the dressing. The device is available in Non-border (non-adhesive) and Border (adhesive) versions. The dressing is supplied sterile in a range of sizes between 4 in squared to 64 in squared.

This is a 510(k) premarket notification for a medical device, specifically a PHMB Foam Wound Dressing. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study with acceptance criteria for an AI/algorithm-based diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI device is not applicable to this document.

The document describes the device's in vitro performance against various bacteria and yeast, and biological evaluation, but these are not the type of studies relevant to the detailed AI/algorithm questions.

Here's why each specific point you asked for is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This document describes the performance of the wound dressing in terms of its ability to absorb exudate, maintain a moist environment, and prevent bacterial colonization in vitro. It does not present acceptance criteria for an AI's diagnostic performance (e.g., sensitivity, specificity, AUC).
2. Sample sized used for the test set and the data provenance: The document mentions in vitro performance data and animal testing, but not clinical test sets or data provenance in the context of an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a wound dressing's in vitro or animal testing.
4. Adjudication method for the test set: Not applicable for this type of device submission.
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 relates to AI-assisted human reading, which is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used: For this device, the "ground truth" would be established through laboratory testing (e.g., bacterial inhibition, fluid absorption measurements) and biological evaluation for safety, not expert consensus or pathology on images.
8. The sample size for the training set: Not applicable as there is no AI training.
9. How the ground truth for the training set was established: Not applicable as there is no AI training.

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PHMB Foam Wound Dressings are indicated for use in the temporary management (

The subject device, PHMB Foam Wound Dressing, is a polyurethane foam impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment. Based on in vitro performance data, the PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing while in use (

The provided documentation is a 510(k) Summary Statement for a medical device called "PHMB Foam Wound Dressing." It describes the device, its intended use, claims substantial equivalence to a predicate device, and summarizes performance testing. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

This document describes a conventional wound dressing, not an AI/ML powered device. Therefore, the questions related to AI/ML device performance (like sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance with AI, etc.) are not applicable to this document.

Here's a breakdown of what the document does provide and why it doesn't fit the AI/ML framework:

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

• Acceptance Criteria (Implied/General): The document implies acceptance criteria are met by demonstrating substantial equivalence to a predicate device and by providing in-vitro and animal testing results that show the dressing's functional and biological safety properties. These are not explicitly numerical or threshold-based acceptance criteria for an AI model's performance metrics.
• Reported Device Performance:
  • **Barrier to bacterial penetration and prevention of colonization and proliferation within the dressing (

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Advanced Medical Solutions Ltd's Silver Foam Wound Dressings are indicated for moderately to heavily exuding, partial to full thickness wounds, including: pressure ulcers; leg ulcers; diabetic foot ulcers; graft wounds and donor sites; skin tears; first and second-degree burns; surgical wounds; lacerations and abrasions.

(Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings are sterile, extremely absorbent, conformable, and semi-permeable to moisture vapour, and assist in maintaining a moist environment for optimal wound healing. (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings contain nominally 1% ionic silver (silver sodium hydrogen zirconium phosphate); the action of which protects the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration. The antimicrobial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against bacterial and fungal strains known to be detrimental to wound healing, such as; Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Streptococcus pyogenes, Staphylococcus epidermidis, MRSA (Methicillin resistant Staphylococcus aureus) MRSE (Methicillin resistant Staphylococcus epidermidis), and VRE (Vancomycin resistant Enterococcus faecium). The antibacterial effect in the (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings supports the reduction of odour caused by microorganisms absorbed in wound exudate. (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings may be used with a compression bandage.

This is a 510(k) premarket notification for a medical device (wound dressing), not a study describing AI software. Therefore, the requested information about acceptance criteria, study design, and AI performance metrics is not applicable and cannot be extracted from the provided text.

Specifically:

• No AI component: The device described is a physical wound dressing containing silver, not an AI software or system.
• No clinical study to prove acceptance criteria for AI: The document is a regulatory submission demonstrating substantial equivalence to a predicate device, primarily through comparison of physical characteristics, intended use, and existing in-vitro antimicrobial testing, not a clinical trial evaluating advanced performance metrics for AI.
• No "acceptance criteria" in the context of AI performance: The "acceptance criteria" here refer to regulatory requirements for demonstrating safety and effectiveness of a physical medical device, not performance benchmarks for an AI algorithm.

Therefore, I cannot provide the requested table and information as it pertains to AI performance.

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

• Post-operative wounds .
• . Trauma wounds
• . Leq Ulcers
• Pressure Ulcers .
• Diabetic Ulcers .
• Graft and donor sites .

Silver Alginate II Dressing is indicated for external use only

The dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver, which absorbs wound exudate and releases silver ions in the presence of wound fluid. As wound exudate 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 four (4) days, based on in vitro laboratory testing. Odour reduction results from the antibacterial effect in the dressing.

The dressing is an effective barrier to penetration by microorganisms.

The dressing has a off-white appearance, and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm flat dressings; 2.7cm x 30cm, and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat dressings are packaged in pouches, and the flat rope and rope dressings are packaged in a blister pack.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silver Alginate II Dressing.

This submission is a 510(k) for a medical device (wound dressing), which primarily demonstrates substantial equivalence to existing predicate devices rather than proving a novel therapeutic effect or clinical outcome through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are focused on demonstrating that the new device performs similarly to or meets the established characteristics of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify sample sizes for any of the in vitro tests. The data provenance is stated as "in vitro laboratory testing" conducted by Advanced Medical Solutions Ltd. (England). This indicates the data is from an in vitro (laboratory) setting and not from human clinical trials. It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

This type of information is not applicable to this 510(k) submission. The "ground truth" for demonstrating substantial equivalence of a wound dressing is based on established performance characteristics and standardized in vitro testing methods (e.g., ISO standards, antimicrobial efficacy tests). It does not involve expert consensus on the device's performance in a clinical scenario, as would be the case for a diagnostic AI device.

4. Adjudication Method for the Test Set

This is not applicable. The "adjudication method" refers to how discrepancies in expert opinions are resolved, typically in a clinical study context. Since the testing described is in vitro and based on measurable performance characteristics, there is no expert adjudication process in this context.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Silver Alginate II Dressing is a therapeutic wound dressing, and its performance is evaluated through in vitro tests and comparison to predicate devices, not by human reader interpretation.

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

This question is not applicable as the Silver Alginate II Dressing is a physical medical device (wound dressing), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" doesn't apply.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by:

• Established performance characteristics of predicate devices: The new device's performance (absorbency, silver release, antimicrobial activity) is compared to that of the already legally marketed predicate devices.
• Standardized in vitro testing methodologies: Biocompatibility is assessed against BS EN ISO 10993-1 requirements. Antimicrobial activity and other key performance characteristics would have been evaluated using recognized laboratory methods.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this 510(k) submission for a wound dressing. Training sets are relevant for machine learning algorithms.

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

This question is not applicable for the same reasons as #8.

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Advanced Medical Solutions Ltd's 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.

Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing is a sterile, non-woven pad composed of a high G (quluronic acid) alginate, carboxymethylcellulose (CMC) and silver coated nylon fibres. The sustained release of silver creates a favourable environment by protecting the dressing from bacterial contamination. The dressing absorbs exudate, maintains a moist wound healing environment and allows intact removal. The dressing has a light grey appearance, and is available in various sizes (5cm x 5cm, 11cm x 11cm, 10cm x 20cm flat dressings and 2.5cm x 30.5cm rope). The flat dressings are packaged in pouches, and the rope is packaged in a blister pack.

This document describes the 510(k) summary for Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance metrics (accuracy, sensitivity, specificity, AUC), or details of a study with sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K002896 Acticoat Calcium Alginate Dressing) based on similarities in:

• Materials (calcium alginate and silver)
• Intended use and indications for use
• Product description and functional characteristics (absorbent, sterile, sustained silver release, antimicrobial effect, barrier to bacterial penetration, maintains moist wound environment, intact removal, similar dressing change frequency)
• Biocompatibility (demonstrated in accordance with BSENISO 10993-1)
• Sterilization method (gamma irradiation)
• Contraindications
• Product sizes and variants

The document states: "Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device." However, it does not provide specific performance metrics or detailed results from this in vitro testing, nor does it detail a clinical study with the requested elements.

Therefore, I cannot populate the table or answer most of the questions as the provided text does not contain that specific information.

Summary of available information regarding performance and studies:

1. A table of acceptance criteria and the reported device performance:
   Not provided in the document. The document focuses on demonstrating substantial equivalence rather than reporting specific performance metrics against set acceptance criteria for metrics like accuracy, sensitivity, specificity, or AUC.

2. Sample size used for the test set and the data provenance:
   Not provided. The document mentions "Additional in vitro testing" but does not detail sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no human-in-the-loop study with a test set requiring expert ground truth 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:
   Not applicable. This device is an antimicrobial dressing, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   The document mentions "Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device." This suggests some form of standalone testing was performed to compare its characteristics to the predicate, but no specific performance metrics like those for an algorithm are detailed. The device is a physical dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not explicitly stated for the "in vitro testing." Given the nature of an antimicrobial dressing, ground truth would likely relate to microbiological growth inhibition, fluid absorption, or silver release rates, rather than expert consensus on images or pathology.

8. The sample size for the training set:
   Not applicable, as this is not an AI/ML device with a training set in the conventional sense.

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

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