AcryDerm Silver Antimicrobial Wound Gel is an amorphous wound moisture management gel that is an effective antimicrobial barrier. The antimicrobial barrier function of the dressing may help reduce the incidence of infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds.

Device Description

AcryDerm Silver Antimicrobial Wound Gel is a line extension of the previously cleared product, AcryDerm Gel Wound Dressing. The new product is a moist amorphous gel wound filler that contains antimicrobial silver that inhibits the growth of microbial contaminants in contact with the dressing. The high moisture content gel contains a base matrix composed of hydrophilic polyacrylate absorbent microspheres that contain a silver complex and stabilizers to prevent discoloration and staining from the dressing. AcryDerm Silver Antimicrobial Wound Gel will be supplied in collapsible blind ended heat sealed co-laminate foil tubes fitted with screw caps. The reusable product primaries will be packed in individual dispenser boxes with a product insert. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called AcryDerm Silver Antimicrobial Wound Gel. However, the provided text does not contain information about a study with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness as typically associated with clinical performance studies for AI/ML devices.

The document is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, not a performance study report for a novel AI algorithm. Therefore, I cannot extract the requested information like acceptance criteria, study findings, sample sizes for test/training sets, or details about expert adjudication from this specific text.

Here's why the information is not present in the provided text:

Device Type: This is a wound dressing with antimicrobial properties, not an AI/ML diagnostic or prognostic device. The regulatory submission focuses on its physical characteristics, intended use, and comparison to existing wound dressings.
Regulatory Pathway: A 510(k) is a premarket notification that demonstrates substantial equivalence to a predicate device. It typically relies on comparisons of technological characteristics and intended use, and sometimes bench testing or minor clinical data to support safety and effectiveness, but not necessarily a large-scale clinical performance study with sophisticated statistical analysis as would be required for an AI device.
Absence of AI/ML Specifics: There is no mention of algorithms, machine learning, image analysis, diagnostic performance metrics (like sensitivity, specificity, AUC), or human-in-the-loop studies.

In summary, the provided document is not a study report that would contain the information you've requested about acceptance criteria and device performance in the context of an AI/ML device.

Summary

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KO1 1994

NOV 0 8 2001

510(k) Summery

Contact Person:	Dr. Bruce L. Gibbins, Chairman & CTO
Date of preparation:	June 22, 2001
Device Name (proprietary):	AcryDerm Silver Antimicrobial Wound Gel
Common Name:	Moist antimicrobial wound filler
Classification Name:	Amorphous Hydrogel Wound Dressing
Classification:	Unclassified

Legally marketed device(s) for substantial equivalence comparison:

AcryDerm Silver Antimicrobial Wound Dressing (AcryMed, Inc., OR) AcryDerm Gel Wound Dressing (AcryMed, Inc., OR)

Description of Device: AcryDerm Silver Antimicrobial Wound Gel is a line extension of the previously cleared product, AcryDerm Gel Wound Dressing. The new product is a moist amorphous gel wound filler that contains antimicrobial silver that inhibits the growth of microbial contaminants in contact with the dressing. The high moisture content gel contains a base matrix composed of hydrophilic polyacrylate absorbent microspheres that contain a silver complex and stabilizers to prevent discoloration and staining from the dressing. AcryDerm Silver Antimicrobial Wound Gel will be supplied in collapsible blind ended heat sealed co-laminate foil tubes fitted with screw caps. The reusable product primaries will be packed in individual dispenser boxes with a product insert. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).

Intended Use of the Device: AcryDerm Silver Antimicrobial Wound Gel is an amorphous wound moisture management gel that is an effective antimierobial barrier. The antimicrobial barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds.

Technological Characteristics: AcryDerm Silver Antimicrobial Wound Gel is an amorphous gel wound filler that controls wound moisture levels through dual function and absorption. Antimicrobial action is content of stabilized antimicrobial silver. The product carries the general classification name, "Amorphous hydrogel wound dressing". The composition of AcryDerm Silver Antimicrobial Wound Gel is identical to the predicate device, AcryDerm Gel Wound Dressing except that its preservatives have been replaced by silver technology which is in the predicate, AcryDerm Silver Antimicrobial Wound Dressing. AcryDerm Silver Antimicrobial Wound Gel contains silver that may control microbial contamination of the dressing.

Manufacturing: AcryDerm Silver Antimicrobial Wound Gel will be manufactured according to the product specifications and under good manufacturing practices that ensure the device is safe and effective antimicrobial barrier.

AcryDerm Silver Antimicrobial Wound Gel AcryMed, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 82001

Bruce Gibbins, Ph.D Chief Technical Officer AcryMed, Inc. 12232 SW Garden Place Portland, Oregon 97223

Re: K011994

Trade/Device Name: AcryDerm Silver Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: MGQ Dated: August 28, 2001 Received: August 29, 2001

Dear Dr. Gibbins:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for as sured in the enalousal 976, the enactment date of the Medical Device Amendments, or to commerce prior to may 20, 2017 11:51 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). and Cosmotion i tor (10) that to hevice, subject to the general controls provisions of the Act. The I ou may, dictively, mains of the Act include requirements for annual registration, listing of general volurous provincition 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 If your device 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.

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Page 2 - Bruce Gibbins, Ph.D

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you to begin mainenes of your device of your device to a legally premaired notification. The PDF intelligent on 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 II you desire specific advice to: your sovitro diagnostic devices), please contact the Office of additionally 21 CFR Far 007.10 Additionally, for questions on the promotion and advertising of Compilance at (301) 591 1057. Thereof Compliance at (301) 594-4639. Also, please note the your doveo, product of instrance to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on your and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Sincerely yours,
Mark N. Millikan

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

Enclosure

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NOV 0 8 2001

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510(k) NUMBER (IF KNOWN):	K011994
DEVICE NAME:	AcryDerm Silver Antimicrobial Wound Gel
INDICATIONS FOR USE:

AcryDerm Silver Antimicrobial Wound Gel is an amorphous wound moisture management gel that is an effective antimicrobial barrier. The antimicrobial barrier function of the dressing may that is an enective and reduce the incidence of infection in partial and full thickness wounds nelp control blooding ulcers, venous stasis ulcers, diabetic ulcers, first and second depress were haves and Including decubitus theors, venous saiss and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

× Prescription use Use (Per 21 CFR 801.109) 1)

Over-The-Counter-

(Optional Format

Suas Walke
Fiddler, S.C. 29633

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

AcryDerm Silver Antimicrobial Wound Gel AcryMed. Inc.

510(k) Number

Regulation Number and Section

N/A