Silverlon™ Contact Wound Dressings are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).

Device Description

Silverlon™ Contact Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in Silverlon™ Contact Wound Dressings consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination. Silverlon™ Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide.

AI/ML Overview

The provided text describes the 510(k) Premarket Notification for the Silverlon™ Contact Wound Dressing. However, it does not contain specific acceptance criteria, a detailed study report comparing device performance against those criteria, or the methodology typically associated with AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and biocompatibility.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will answer what can be extracted and clearly state what information is missing.

Request Analysis and Information Extraction

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

Acceptance Criteria: Not explicitly stated in the document. The submission is focused on demonstrating "substantial equivalence" to existing predicate devices (Arglac, Acticoat, Tegapore) rather than meeting specific quantifiable performance targets. The "acceptance" by the FDA is based on this finding of substantial equivalence and adherence to general controls and specific labeling limitations.
Reported Device Performance: Biocompatibility test results are described.

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: Not specified. The document mentions "standard in vitro and in vivo biocompatibility tests" but does not detail the number of samples or subjects used in these tests.
Data Provenance: Not specified, although the testing was conducted by North American Science Associates, Inc. (NAMSA), Northwood, Ohio, USA. The study type (retrospective/prospective) is not indicated, but given it's biocompatibility testing for a medical device, it would typically be prospective pre-clinical testing.

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: This type of information is typically relevant for studies involving subjective human assessment or diagnostic accuracy, often with AI. The provided document details biocompatibility testing, which relies on standardized lab methods rather than expert consensus on ground truth in the way a diagnostic AI would.

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

Not Applicable: Similar to point 3, adjudication methods are used to establish ground truth in subjective assessments. Biocompatibility testing results are typically objective measurements.

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: The device described (Silverlon™ Contact Wound Dressing) is a physical wound dressing, not an AI/ML diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this product.

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

No: As stated above, this is a physical medical device, not an algorithm.

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

Ground Truth for Biocompatibility: The "ground truth" for the performance claims (safety and substantial equivalence) relies on the results of the "standard in vitro and in vivo biocompatibility tests including cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation study)." These tests follow ISO 10993 standards and represent scientifically established methods to determine biological responses to medical devices. The "ground truth" is therefore derived from standardized biological and chemical assays.

8. The sample size for the training set

Not Applicable: This concept applies to AI/ML models, not physical medical devices.

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

Not Applicable: This concept applies to AI/ML models, not physical medical devices.

Summary Table: Acceptance Criteria and Device Performance

Since explicit acceptance criteria are not provided, I will interpret "acceptance criteria" here as the general requirements for substantial equivalence and safety for a wound dressing, and "reported device performance" as the outcomes of the tests conducted.

Category	Acceptance Criteria (Implied / General Requirements for Substantial Equivalence)	Reported Device Performance (as per submission)
Biocompatibility / Safety	Device must be safe for its intended use, demonstrating no unacceptable biological risks (cytotoxicity, sensitization, irritation, systemic toxicity, tissue compatibility).	"All tests were performed in accordance with Part-10993 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices)."
		"The studies indicated that Silverlon™ 1-Layer and 4-Layer Contact Wound Dressings are safe for their intended use."
	Specific tests: cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation study).	The device underwent and presumably passed all these specific tests.
Functional Equivalence	Device characteristics (flexible primary contact wound dressing, permeability to oxygen and fluids, protection against microbial contamination of the dressing) must be comparable to predicate devices.	"The technological characteristics of the device... are substantially equivalent to the predicate devices cited." (Arglac, Acticoat, Tegapore)
Labeling / Intended Use Restrictions	No claims for use on third-degree burns, accelerating wound healing, long-term/permanent dressing, artificial skin, or as a treatment/cure for wounds. These would require further review.	The FDA letter (K981299) explicitly states these limitations. The 510(k) was accepted with these conditions on labeling.

Missing Information (as per original request and not present in document):

Specific quantitative acceptance criteria (e.g., "cytotoxicity index must be < X").
Quantitative results of the biocompatibility tests.
Sample sizes for the biocompatibility tests (e.g., number of animals, cell cultures).
Details about the experts, adjudication, or ground truth establishment relevant to AI/ML devices.
Any MRMC or standalone performance data, as the device is not AI-based.

Summary

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SEP 25 1998

FAX NO.: 2028334157

09-23-98 03 : 4 4 P P.03

Argentum International LLC

510(k) Premarket Notification Silverlon™ Contact Wound Dressing K981299

September 23, 1998

10. 510(K) SUMMARY

Summary Information 10.1

: . . ...

10.1.1 Submitter's Name and Address

Argentum International LLC Post Office Box 429 Lakemont, GA 30552

Contact person and telephone number:

A. Bart Flick, M.D., Research Director Telephone: (706) 782-6700 Telefax: (706) 782-3903

Date summary was prepared:

September 23, 1998

10.1.2 Name of Device

Trade Name:

Common Name: Classification Name: Silverlon™ Contact Wound Dressing (1- and 4-Layer) Silver-nylon contact wound dressing Contact wound dressing

10.1.3 Identification of predicate device to which substantial equivalence is being claimed

Silverlon™ Contact Wound Dressings are substantially equivalent in function and intended use to the following cleared contact wound dressings: Arglacs Filt11 Dressing (K970566), Acticoat Silver Coated Dressing (K955453), and Tegapore™ Wound Contact Material (K890354).

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Argentum International LLC

510(k) Premarket Notification Silverlon™ Contact Wound Dressing K981299

September 4, 1998

10.1.4 Device Description

Explanation of how the device functions: Silverlon™ Contact Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination.

Basic scientific concepts that form the basis for the device: The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in Silverlon™ Contact Wound Dressings consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination.

Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: Silverlon™ Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide.

10.1.5 Statement of the intended use of the device, including general description of the conditions the device will mitigate and the patient population for which the device is intended

Silverlon™ Contact Wound Dressings are external wound dressings that are designed as an interface between the wound and a conventional occlusive dressing. Silverlon™ Contact Wound Dressings are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).

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Argentum International LLC

510(k) Premarket Notification Silverlon™ Contact Wound Dressing K981299

September 4, 1998

10.1.6 Statement of how the technological characteristics of the device compare to those of the predicate device

The technological characteristics of the device such as flexible primary contact wound dressing, permeability to oxygen and fluids, and protection against microbial contamination of the dressing that are substantially equivalent to the predicate devices cited.

Assessment of Performance Data 10.2

Silverlon™ I-Layer and 4-Layer Contact Wound Dressings were subjected to standard in vitro and in vivo biocompatibility tests including cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation study). All tests were performed in accordance with Part-10993 of the International Standard Organization (JSO) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAmSA), Northwood, Ohio. The studies indicated that Silverlon™ I-1.ayer and 4-Layer Contact Wound Dressings are safe for their intended use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three heads, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

SEP 2 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A. Bart Flick, M.D. Argentum International, LLC P.O. Box 429 Lakemont, Georgia 30552

K981299 Re:

Trade Name: Silverlon™ Contact Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: July 8, 1998 Received: July 8, 1998

Dear Dr. Flick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

This device may not be labeled for use on third degree burns. 1.
1. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Dr. A. Bart Flick

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP

regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation ------------Center for Devices and Radiological Health

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Argentum International LLC

510(k) Premarket Notification Silverlon™ Contact Wound Dressing K981299

August 10, 1998

2. INDICATIONS FOR USE

510(k) Number (if known):

K981299

Device Name:

Silverlon™ Contact Wound Dressing

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter Use

(Division Sign-Off)
Division of General Restorative Devices
K90

Regulation Number and Section

N/A