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Under the supervision of a healthcare professional, Titan Ag 200 may be used for the management of:

• Wounds with moderate to heavy exudate. ●
• Partial thickness burns. ●
• Leg ulcers, pressure ulcers and diabetic ulcers.
• Surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and ● donor/graft sites).
• . Traumatic wounds (e.g. abrasions and lacerations).
• Wounds prone to bleeding such as wounds that have been mechanically or surgically ● debrided or donor sites .

Titan Ag 200 Wound Dressing is a soft, conformable non-woven fabric made from a blend of cellulose fiber(s) impreqnated with metallic silver (in the form of silver nano-particles), sodium carboxymethyl cellulose fibres and strengthening cellulose fiber(s). The ionic silver released into the wound dressing when in contact with wound exudate or blood has an antibacterial effect on wound bacteria held within the dressing, preventing it from being colonized. The structure of the dressing remains intact through the gel formation. Debris and any bacteria absorbed in the wound exudate and retained within the dressing are removed when the dressing is changed.

The provided text describes the Titan Ag 200 wound dressing and its substantial equivalence to the predicate device, Aquacel Ag Extra (K121275). Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on "Equivalent" and "Similar" in the context of this document: The document explicitly states that "Statistical analysis of the difference in results obtained for silver release over 7 days for the subject and predicate devices was statistically insignificant. Therefore the devices are deemed to have equivalent silver release." This suggests that "similar" or "equivalent" in this context means statistically comparable performance that meets the safety and effectiveness requirements.

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

The document does not explicitly state the sample sizes for the various performance tests (e.g., number of dressings tested for silver release, absorbency, or wet tensile strength).

• Data Provenance: The studies are described as non-clinical performance data, indicating they were conducted in a laboratory setting. There is also mention of a porcine wound healing study, which would be an in vivo animal study. The document does not specify the country of origin for these specific tests, but the submitting company is based in the United Kingdom.

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

This information is not provided in the document. The ground truth for performance testing is typically established by adhering to recognized international standards and test methods (e.g., AATCC 100 for antibacterial efficacy, British Pharmacopoeia for absorbency, ISO 10993 for biocompatibility). These standards define the methodology and acceptance criteria, rather than relying on expert consensus for each individual test result within the submission.

4. Adjudication Method for the Test Set

This information is not applicable in the context of the performance testing described. The tests are objective measurements against established standards, not subjective assessments requiring adjudication by multiple readers.

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

No, an MRMC comparative effectiveness study involving human readers is not described in this document. The studies focus on the physical and biological performance of the wound dressing itself, not on human interpretation or effectiveness with and without AI assistance. This device is a wound dressing, not an AI-powered diagnostic or therapeutic device.

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

No, a standalone algorithm performance study was not done. This document pertains to a physical medical device (wound dressing), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests were based on:

• Standardized test methods and predetermined acceptance criteria: For silver release, absorbency, antibacterial activity, wet tensile strength, sterilization validation, and packaging integrity. These are objective measures against predefined thresholds.
• Biological evaluation standards (ISO 10993 series) and FDA guidance: For biocompatibility. This involves a battery of tests to assess different biological responses.
• Comparison to a legally marketed predicate device: The performance of the Titan Ag 200 was directly compared to the Aquacel Ag Extra (K121275) to demonstrate substantial equivalence.
• Porcine wound healing study: This is an in vivo animal model used to assess the device's effect on the wound healing process.

8. The Sample Size for the Training Set

This information is not applicable as this document describes a physical medical device (wound dressing) and its performance testing, not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable as this document describes a physical medical device (wound dressing) and its performance testing, not a machine learning or AI algorithm that requires a training set.

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Rx: Under the supervision of a healthcare professional, the Stay Fresh Hydrocolloid dressing is intended for use as a primary dressing for exuding wounds that acts as a barrier to bacterial penetration, for use on first and second degree burns, surgical wounds, pressure ulcers, dermal ulcers, as well as minor cuts, abrasions, lacerations.

OTC: The Stay Fresh Hydrocolloid dressing acts as a barrier to bacterial penetration and is indicated for first aid to cover minor cuts, minor abrasions, and minor lacerations.

Sarasota Medical Products hydrocolloid dressing adhesive formulations are composed of naturally occurring substances that turn into a gel when they come into contact with wound fluid. Superabsorbent particles are embedded in an inert polymer matrix that provides the desired level of cohesiveness required to prevent leaving any residue in the wound. The outer most layer of the dressing is covered by a polyurethane film that reinforces the dressing's barrier properties and helps to reduce friction on clothing, bedding, and opposing extremities. When placed over a wound, these dressings create a moist environment. This environment has been shown to help to facilitate the removal of debris and protect the wound against bacteria and other external contaminants.

The Stay Fresh Hydrocolloid includes sequestered hydrogen peroxide (0.2 to 0.35% by weight). The sequestered hydrogen peroxide is an effective and safe antibacterial agent that protects the dressing. The role of antibacterial agents in wound dressings is: 1) to reduce the incidence of bacterial colonization within the dressing and 2) to provide a potential barrier to bacterial entry into the wound. The Stay Fresh Hydrocolloid is effective in controlling growth of bacteria commonly found to populate dressings. The outer thermoplastic layer is effective at providing a physical barrier to bacterial entry into the wound.

The Stay Fresh Hydrocolloid dressing will be supplied sterile. Sterilization will be achieved by gamma radiation at 25 Kgy in accordance with ISO 11137 and ISO 14385.

The provided text describes a 510(k) premarket notification for a medical device called "Stay Fresh Hydrocolloid." It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results similar to a clinical trial efficacy endpoint. Instead, the "Performance Testing" section lists various tests conducted to establish safety and efficacy, implying that meeting the standards for these tests serves as the acceptance criteria. The results are generally described as supporting the safety and efficacy of the device.

Implicit Acceptance Criteria and Reported Device Performance:

The document states, "Non-clinical testing demonstrates substantially equivalent safety and efficacy as compared to the predicate device." This is the overarching "reported device performance."

Study Details:

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

   • Sample Size: The document does not specify exact sample sizes for each test within the "Performance Testing" section. For the Porcine wound healing model, it mentions "Full and partial thickness wounds," but not the number of animals or wounds.
   • Data Provenance: The studies are non-clinical (laboratory and animal studies). The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying adherence to U.S. regulatory standards for such tests. All studies appear to be prospective in nature as they were conducted specifically for this submission.

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

   • Not applicable. This device is not an AI/CADe device where human expert review establishes ground truth for image interpretation. The ground truth for performance tests (e.g., bacterial growth, wound healing, physical properties) is established by the methodologies of the tests themselves (e.g., lab measurements, histological analysis in animal models).

3. Adjudication method for the test set:

   • Not applicable. There is no human interpretation involved that would require an adjudication method like 2+1 or 3+1.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is not an AI/CADe device, and no MRMC study was conducted.

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

   • This is not an AI/CADe device, so the concept of "standalone performance" in that context does not apply. The performance tests conducted are inherently "standalone" in the sense that they evaluate the physical, chemical, and biological properties of the dressing itself.

6. The type of ground truth used:

   • Laboratory Measurements: For physical properties (tack, absorbance, thickness, hydrogen peroxide concentration, etc.), the ground truth is established by standard laboratory measurement techniques.
   • Microbiological Standards: For antibacterial efficacy, the ground truth is based on established microbiological assay standards (e.g., modified ASTM E2180-01) and observed bacterial growth/inhibition.
   • Histopathology/Clinical Observation in Animal Models: For wound healing, the ground truth would be established through histological examination and macroscopic observation of wound closure/healing in the porcine model.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set. The development of the hydrocolloid formulation and design would be based on general scientific principles and material properties, not statistical learning from a "training set."

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

   • Not applicable, as no training set is relevant for this type of device and submission.

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DURAFIBER Ag is an effective antimicrobial dressing that is intended to provide a moist wound environment for use in the management of partial and full thickness wounds including first and second degree burns. Examples of wounds types which indicated are:

• Chronic wounds including diabetic ulcers, leg ulcers, pressure ulcers and . sores (partial & full thickness);
• surgical wounds left to heal by secondary intent; .
• . traumatic wounds;
• wounds that are prone to minor bleeding, such as wounds that have been . mechanically or surgically debrided.

DURAFIBER Ag is a non woven dressing made of cellulose and cellulose ethyl sulphonate with silver. The product is an absorbent fibrous dressing that gels on contact with wound fluid. The device provides effective antimicrobial properties intended to reduce or inhibit microbial colonization of the device.
The silver is present in the device in the form of silver chloride. Upon contact with wound fluid, silver ions are produced from the dissociation of silver and chloride atoms. The ionic form of silver is the active antimicrobial agent.

The provided text describes a 510(k) summary for the DURAFIBER Ag dressing, focusing on its substantial equivalence to predicate devices rather than a direct study proving device performance against acceptance criteria. The document highlights biocompatibility testing and an animal model study, but does not present specific acceptance criteria in a quantifiable manner or a study that directly verifies those criteria with reported performance metrics.

Therefore, the following information is extracted or inferred based on the provided text. Many requested fields cannot be directly answered as the nature of this submission (substantial equivalence for a medical dressing) differs significantly from a device that would require clinical performance metrics like sensitivity, specificity, or AI assistance effect sizes.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a wound dressing, the "acceptance criteria" are primarily related to safety, biocompatibility, and substantial equivalence to legally marketed predicate devices. The document does not specify quantitative performance metrics (like sensitivity, specificity, or error rates) that would typically be found for diagnostic or AI-driven devices.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence Basis):

Study Details

The provided text describes the basis for substantial equivalence for a wound dressing, and the "studies" mentioned are primarily pre-clinical in nature for biocompatibility and an animal model. It does not describe a clinical study in humans designed to meet specific performance criteria often seen in device clearance involving diagnosis or intricate analytical tasks.

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

• Biocompatibility Tests: The text states these were conducted "using product that has been packaged and sterilised." It does not specify a "sample size" in terms of number of samples, but rather mentions the types of tests (cytotoxicity, sensitization, irritation, subchronic toxicity, genotoxicity). The provenance of these tests is not explicitly stated (e.g., country of origin, specific lab data).
• Animal Model Study: "an animal model" was used. The specific number of animals (sample size) is not provided. The provenance (e.g., specific animal species, location of study) is also undefined.

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

• This information is not applicable/provided as the studies described are pre-clinical (biocompatibility, animal model) and do not involve human interpretation or expert ground truth establishment in the diagnostic sense.

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

• This information is not applicable/provided for the types of studies performed (biocompatibility, animal model).

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC study was not done. This device is a medical dressing, not an AI-assisted diagnostic or interpretation device that would involve "human readers" or "AI assistance."

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

• No, this is not applicable. The device is a physical wound dressing and does not involve an algorithm or AI.

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

• Biocompatibility: Ground truth is established by standardized, validated assays and material science principles as per ISO 10993-1:2003, with results indicating "safe for their intended use."
• Animal Model: Ground truth was based on physiological observations and comparisons of "deleterious clinical effects" against "standard treatment." This would likely involve clinical assessment of wound healing parameters in animals.

7. The sample size for the training set:

• This information is not applicable/provided. The submission describes a medical device, not an AI/ML product requiring a training set.

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

• This information is not applicable/provided as there is no training set for this type of device.

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