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OTC: Anasept™ Antimicrobial Skin and Wound Gel is intended for OTC use for management of skin abrasions, lacerations, minor irritations, cuts, exit sites and intact skin. of being as a long and the Antimicrobial Skin and Wound Gel is intended to be used under the supervision of a healthcare professional in the management of wounds such as stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.

OTC: Anasept™ Antimicrobial Skin and Wound Cleanser is intended for OTC use for mechanical cleansing of dirt and debris form skin abrasions, minor irritations, cuts, exit sites and intact skin.

Professional Use: Anasept™ Antimicrobial Skin and Wound Cleanser is intended for professional use for cleansing and removal of foreign material including micro-organisms and debris from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.

Anasept™ Antimicrobial Skin and Wound Gel is a clear, amorphous, isotonic hydrogel wound I thatept - - Intimerooms in a moist wound environment that is conducive to healing, by either absorbing wound exudate or donating moisture while delivering antimicrobial sodium hypochlorite. This antimicrobial agent inhibits the growth of microorganisms. Anasept™ Antimicrobial Skin and Wound Gel will be supplied in collapsible blind ended, heat-sealed, coextruded tubes fitted with a "flip top" dispenser closure.

Anasept™ Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the mechanical removal of the debris and foreign material from the application site. Dirt, debris and foreign materials are mechanically removed by the action of the fluid (Wound Cleanser) moving across the wound bed or application site. The device also contains an antimicrobial agent that inhibits the growth of microorganisms. Anasept™ Antimicrobial Skin and Wound Cleanser will be supplied in High Density Polyethylene bottles in various packaging configuration: 15 oz in HDPE bottle with dispensing caps and 8, & 12 oz with Trigger sprayer and 8 oz with Finger pump sprayer.

The provided text describes two devices: Anasept™ Antimicrobial Skin and Wound Gel and Anasept™ Antimicrobial Skin and Wound Cleanser. Both are being submitted for 510(k) clearance and claim substantial equivalence to existing predicate devices. The performance testing is focused on demonstrating the antimicrobial efficacy of the active ingredient (sodium hypochlorite) within the respective formulations.

Here's a breakdown of the requested information for both devices based on the provided text, as they underwent very similar testing based on the summaries:

Anasept™ Antimicrobial Skin and Wound Gel & Anasept™ Antimicrobial Skin and Wound Cleanser

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for the "Time/Kill studies" or "biocompatibility studies." It refers to "test organisms prescribed in the USP Antimicrobial Effectiveness Testing " and "additional bacterial strains."
• Data Provenance: The studies are described as "in-vitro and in-vivo biocompatibility studies" and "Time/Kill studies" performed "in accordance with the procedure provided with the original submission." There is no mention of country of origin for the data or if it's retrospective or prospective. Given the nature of these tests, they are likely prospective laboratory studies.

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 text. The antimicrobial efficacy testing is based on established microbiological testing methods (USP ) against known organism concentrations. Biocompatibility studies also follow standard protocols. These types of tests do not typically rely on expert consensus for "ground truth" in the same way clinical diagnostic studies might.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The performance tests described (Time/Kill, biocompatibility, stability) are objective laboratory measurements, not subjective evaluations requiring adjudication.

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 information is not applicable/provided. The devices are antimicrobial gels and cleansers, not AI-powered diagnostic tools or image analysis devices. Therefore, MRMC studies involving human readers and AI assistance are not relevant to these products.

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

• This information is not applicable/provided. The devices are physical products, not algorithms. The "standalone" performance here refers to the product's inherent antimicrobial and physiochemical properties as tested in the laboratory.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the antimicrobial efficacy testing is defined by quantifiable reduction of specified microorganisms (e.g., "reducing high level concentrations (10^7 /gram of product) of microorganisms to undetectable levels" or "Reduction by Log 7"). The specific microorganisms are listed (e.g., Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, MRSA, VRE, etc.).
• For biocompatibility, the ground truth would be the absence of adverse biological reactions in accordance with established safety standards for in-vitro and in-vivo tests.
• For stability, the ground truth is the maintenance of product specifications (e.g., antimicrobial efficacy, physical properties) over time.

8. The Sample Size for the Training Set

• This information is not applicable/provided. These are not machine learning models requiring training sets. The studies involve testing the product against panels of microorganisms or in biocompatibility models.

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

• This information is not applicable/provided for the reasons stated in point 8.

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Silver Shield™ Antimicrobial Skin and Wound Gel is intended for OTC use for Abrasions and lacerations and under the supervision of a health care professional in the management of Stage 1-1V Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Grafted and donor sites,

Silver Shield Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel wound dressing that helps maintain a moist wound environment that is conducive to healing, by either absorbing the wound exudates or donating the moisture while delivering antimicrobial silver. The gel matrix of the Silver Shield™ Antimicrobial Skin and Wound Gel is composed of a silver complex and an inert viscosity-modifying agent that imparts viscous hydrogel properties. Silver Shield™ Antimicrobial Skin and Wound Gel will be supplied in collapsible blind ended, heatsealed, co-extruded tubes fitted with a "flip top" dispenser closure. This reusable tube will be placed in a chipboard dispenser box with a package insert.

This document describes the acceptance criteria and the study that proves the device, Silver Shield™ Antimicrobial Skin and Wound Gel, meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria are Met:

The provided document describes a premarket notification (510(k)) submission for the Silver Shield™ Antimicrobial Skin and Wound Gel. The "study" in this context refers to the performance testing conducted to demonstrate substantial equivalence to a predicate device and to confirm the device's stated characteristics.

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

The document describes "USP preservative efficacy testing" and "Various test models" for determining antimicrobial barrier properties. It does not explicitly state a sample size for these tests in terms of the number of unique wound samples or patients. Instead, the "test set" (in the context of microbiological testing) would refer to the specific bacterial and fungal strains used in the in vitro efficacy tests. These included:

• Standard USP test organisms
• Antibiotic-resistant strains: Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin resistant Enterococcus (VRE).
• Additional common bacteria: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens.
• Fungi: Candida albicans and Aspergillus niger.

The data provenance is from laboratory testing (in vitro) as opposed to clinical data from patients or a specific country of origin. This appears to be a retrospective analysis in terms of comparing the device's performance to the established USP requirements and the predicate device's performance.

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

Not applicable in the typical sense for this type of device. The "ground truth" for the antimicrobial efficacy was established by:

• USP standards and methodologies: The United States Pharmacopeia (USP) provides a compendium of standards for the quality and purity of medicines, including testing methods for antimicrobial efficacy. These standards are developed by scientific experts and consensus.
• Performance of the predicate device (K011994): The performance of an already legally marketed and established device served as a benchmark for substantial equivalence.

There is no mention of individual "experts" establishing a ground truth for individual cases in a test set, as this was not a clinical or diagnostic imaging study.

4. Adjudication Method for the Test Set:

Not applicable. This was not a study involving human interpretation of data requiring adjudication. The results of the laboratory tests (e.g., inhibition zones, microbial counts) would be quantitatively measured and compared against predefined acceptance criteria from the USP.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic imaging devices to evaluate the impact of an AI algorithm on human reader performance. The Silver Shield™ Antimicrobial Skin and Wound Gel is a medical device (wound dressing) where efficacy is determined through laboratory performance tests and biocompatibility, not by human reader interpretation.

6. Standalone (Algorithm Only) Performance:

Not applicable. The Silver Shield™ is a physical medical device (wound gel), not a software algorithm. Its "standalone performance" refers to its intrinsic physical, chemical, and antimicrobial properties demonstrated through in vitro testing. The provided document describes exactly this standalone performance of the device itself.

7. Type of Ground Truth Used:

The ground truth used was primarily:

• Established scientific and regulatory standards: Specifically, the USP (United States Pharmacopeia) preservative efficacy test requirements.
• Benchmark performance of a legally marketed predicate device: The performance of AcryDerm Silver Antimicrobial Wound Gel (K011994).
• Biocompatibility testing standards: Although not detailed, implied by the statement "biocompatibility testing... also demonstrated that the device is safe and effective."

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The development of the gel formulation and manufacturing process would involve internal R&D and optimization, but not in the context of a "training set" for an algorithm.

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

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

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