Over-The-Counter Indications: For minor burns, abraded skin, irritated areas and minor wounds. Professional Prescription Indications: Wound moistening solution for dermal lesions such as Stage I-IV pressure ulcers, stasis ulcers, foot ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and skin irritations.

Device Description

A buffered ionic silver aqueous wet dressing for external wound management. The product provides a moist environment that aids the body in the healing process. The non-irritating components of Silvion Antibacterial Silver Skin & Wound Moisturizing Solution allow the product to be used on mucous membranes, the skin as well as acute and chronic wounds. The silver provides effective protection of the solution against microbial contamination. The Silvion Antibacterial Silver Skin & Wound Moisturizing Solution is clear, odorless and colorless. The product is available in 2 oz, 4 oz, 8 oz and 16 oz spray bottles.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Silvion™ Antibacterial Silver Skin & Wound Moisturizing Solution." This document is a regulatory submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study designed to establish acceptance criteria for a new device's performance against predefined metrics.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not available in the provided text because this type of detailed performance study is not typically included in a 510(k) summary for a product like this, which relies on demonstrating equivalence rather than establishing new performance benchmarks.

The document primarily focuses on:

Device Description: What the product is and its components.
Intended Use: The conditions it's meant to treat (minor burns, wounds, ulcers, etc.).
Predicate Devices: Other similar products already on the market that it claims to be substantially equivalent to.
Assessment of Performance Data: This section mentions various in vitro and in vivo biocompatibility, cytotoxicity, and antimicrobial tests. These tests are conducted to demonstrate the safety and fundamental antimicrobial properties (as a drug component) and biocompatibility (as a device component) that support its substantial equivalence to other wound care products, not to meet specific performance acceptance criteria against a defined clinical outcome.

To directly answer your request based on the provided text, the specific information regarding acceptance criteria and the detailed study design to prove device performance as typically expected for advanced AI/medical device performance evaluation is not present.

Here's an attempt to fill in the table and explain the missing information based on the presented content:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated, inferred from regulatory context)	Reported Device Performance (As per the document)
Biocompatibility	Device must be safe for contact with breached/compromised skin (e.g., non-toxic, non-irritating, non-sensitizing).	Supported by: ISO Modified Intracutaneous Study, USP and ISO Modified Systemic Toxicity Study, ISO Maximization Sensitization, and Agarose Overlay Method (cytotoxicity).
Antimicrobial Effectiveness	Solution must provide effective protection against microbial contamination (for the drug component).	Assessed by: MIC and MBC Dilution Methods, Zone of Inhibition, USP Antimicrobial Effectiveness Test <51>, USP Microbial Limit Test <61>, Bioburden Aerobic Total Count, and Microbial Challenge Test.
Substantial Equivalence	Device must be substantially equivalent to predicate devices in terms of intended use, technological characteristics, and safety/effectiveness.	Reviewers determined the device is substantially equivalent to legally marketed predicate devices (K063063 letter states this).
Moist Environment (Device Action)	The device components should provide moisture to dermal wounds and inflamed skin.	"The product provides a moist environment that aids the body in the healing process." (No specific quantitative performance metric reported).

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

Sample size for the test set: Not specified in the document. The document refers to various in vitro and in vivo tests, which would have their own sample sizes (e.g., for animal studies in biocompatibility, or microbial cultures for antimicrobial tests). However, these are not detailed.
Data provenance: The studies mentioned (biocompatibility, cytotoxicity, antimicrobial) are typically conducted under controlled laboratory conditions, implying they are proprietary data generated for the submission. The country of origin and whether they are retrospective or prospective are not stated.

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

This information is not applicable and not provided in this type of submission. Ground truth and expert consensus are relevant for AI/diagnostic imaging devices where human interpretation is being compared or augmented. For a topical wound care solution, performance is typically assessed through laboratory tests and animal/human safety studies, not expert consensus on diagnostic images.

4. Adjudication method for the test set

Not applicable and not provided. Adjudication methods (like 2+1) are used to resolve disagreements among human readers in diagnostic studies. This is not relevant to the types of tests described for this wound care solution.

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 was not done. An MRMC study is designed for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images with or without AI assistance). This device is a topical wound care solution with both device and drug components; it is not a diagnostic tool that enhances human reader performance.

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

Not applicable. This device is a physical solution applied to the skin, not an algorithm.

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

For the biocompatibility studies, the "ground truth" would be established by standard ISO and USP guidelines for determining irritation, sensitization, and toxicity. This involves histological examination, clinical observation of reactions, and survival rates in animal models.
For the cytotoxicity testing, the "ground truth" would be the observed cytotoxic effect on cells as measured by the Agarose Overlay Method.
For the antimicrobial testing, the "ground truth" would be the measurable reduction or inhibition of microbial growth according to established microbiologic test methods (e.g., MIC, MBC, Zone of Inhibition, USP tests).
For demonstrating substantial equivalence, the "ground truth" is the performance and safety profile of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms. This device is a chemical formulation, not an AI model.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for a training set.

Summary

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Medical Molecular Therapeutics LLC 510(k) PreMarket Notification K063063 Silvion Antibacterial Silver Skin & Wound Moisturizing Solution Rev 15 May 07

7. 510(k) Summary Information

JUL - 3 2007 In accordance with 21 CFR 807.92, the 510(k) Summary is presented to provide an understanding for the basis of substantial equivalence.

7.1 Submitter's & Owners Name and Address

Arthur B. Flick MD Medical Molecular Therapeutics LLC 36 Lake Rabun Road Lakemont, Georgia 30552

Contact Person: Arthur B. Flick MD Telephone: 706 782 5064 Email: abflick@alltel,net

7.2 Date Prepared

20 September 2006

7.3 Device Name

Trade Name:	Silvion Antibacterial Silver Skin & WoundMoisturizing Solution
Common Name:	Skin & Wound Moisturizing Solution
Classification Name:	Liquid Bandage KMF

7.4 Predicate Devices 807.92(a)(3)

Dermacyn Wound Cleanser	K 042729
Saline Solution (Wound Dressing)	K040683
Restore Wound Cleanser	K022670
Dermacyn Wound Irrigation	K042729

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Medical Molecular Therapeutics LLC 510(k) PreMarket Notification K063063 Rev 15 May 07 Silvion Antibacterial Silver Skin & Wound Moisturizing Solution

X-Static Silverseal Hydrogel Wound Dressing	K040019
Acryderm Silver Antimicrobial Wound Gel	K011994
Antimicrobial Barrier Wound Contact Dressing	K023612

7.5 Device Description

7.6 Assessment of Performance Data

Silvion Antibacterial Silver Skin & Wound Moisturizing Solution has been subject to in vitro and in vivo biocompatibility (ISO Modified Intracutaneous Study, the USP and ISO Modified Systemic Toxicity Study and the ISO Maximization Sensitization) and cytotoxicity testing (Agarose Overlay Method). These tests support the safe use of Silvion Antibacterial Silver Skin & Wound Moisturizing Solution in contact with breached or compromised skin. In vitro antimicrobial testing was assessed by the standard the MIC and MBC Dilution Methods, Zone of Inhibition, USP Antimicrobial Effectiveness Test <51>. USP Microbial Limit Test <61>, Bioburden Aerobic Total Count and Microbial Challenge Test.

7.7 Statement of Intended Use

OTC: Minor burns, abraded skin, irritated areas minor wounds.

Professional: Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and skin irritations.

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510(k) PreMarket Notification K063063 Medical Molecular Therapeutics LLC Rev 15 May 07 Silvion Antibacterial Silver Skin & Wound Moisturizing Solution

7.8 Technological Characteristics and Substantial Equivalence

Silvion Antibacterial Silver Skin & Wound Moisturizing Solution is a combination product within the meaning of section 503(g) of the Federal Food, Drug, and Cosmetic Act (Act) and Title 21 of the Code of Federal Regulations (CFR) section 3.2(e)(1) and (2). In accordance with section 503(g)(1) of the Act and 21 CFR section 3.4, Silvion Antibacterial Silver Skin & Wound Moisturizing Solution had two modes of action. One action of the product is the device components' action to provide moisture to dermal wounds and inflamed skin. Another mode of action of the product is that of the drug component (ionic silver) to act as an antimicrobial agent. The primary mode of action of the combination product is attributable to the device components' action to provide moisture to dermal wounds and inflamed skin.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, superimposed over three horizontal lines that represent waves. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Molecular Therapeutics LLC % Arthur B. Flick, MD 36 Lake Rabun Road Lakemont, Georgia 30552

JUL - 3 2007

Re: K063063

Trade/Device Name: Silvion™ Antibacterial Silver Skin & Wound Moisturizing Solution Regulatory Class: Unclassified Product Code: FRO Dated: May 22, 2007 Received: May 24, 2007

Dear Dr. Flick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 - Arthur B. Flick, MD

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Medical Molecular Therapeutics LLC 510(k) PreMarket Notification K063063 Silvion Antibacterial Silver Skin & Wound Moisturizing Solution Rev 15 May 07

5. INDICATIONS FOR USE

510(k) Number: K063063/S1

Device Name: Silvion™ Antibacterial Silver Skin & Wound Moisturizing Solution

Indications For Use:

Over-The-Counter Indications:

For minor burns, abraded skin, irritated areas and minor wounds.

Professional Prescription Indications:

Wound moistening solution for dermal lesions such as Stage I-IV pressure ulcers, stasis ulcers, foot ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and skin irritations.

Prescription Use	X	AND/OR	Over-The-Counter Use	X
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)

(Division Sign)

Concurrence of CDRH Division of General and Neurologic Office of Device Evaluation (ODE)

12063062

510

Regulation Number and Section

N/A