The Acticoat® Calcium Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exudative partial and full thickness wounds including decubitus ulcers, diabetic ulcers, venous stasis ulcers, surgical and traumatic wounds. Acticoat® dressings may be used over debrided and partial thickness wounds.

Device Description

The Acticoat® Calcium Alginate Dressing is a highly absorbent non-woven calcium alginate fabric with an Acticoat® coating applied directly to its surface. It has a light grey appearance. Formatted in various sizes (5cm x 5cm, 10cm x 12.5cm, 15cm x 15cm, and a 2.5cm x 30cm rope) and packaged in Tyvek pouches.

AI/ML Overview

The provided text is a 510(k) summary for the Acticoat® Calcium Alginate Dressing. It details the device's description, indications for use, and a summary of substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria from a performance standpoint.

The "Testing" section broadly states:

"The biocompatability of Acticoat® Calcium Alginate Dressing has been demonstrated in accordance with 1999 ISO 10993-1. In vitro and in vivo testing has demonstrated the characteristics of Acticoat® Calcium Alginate Dressing are substantially equivalent to the predicate devices."

This indicates that biocompatibility testing was performed according to ISO standards, and other in vitro/in vivo testing was done to show equivalence to predicate devices. However, it does not specify what those "characteristics" were, what the acceptance criteria for those characteristics were, or the detailed results of those tests.

Therefore, I cannot fill out the requested table and answer many of the questions as the specific performance study details are not present in the provided document.

Here's an attempt to answer based only on the available information, noting where data is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Specific Performance Metrics)	Reported Device Performance (Specific Results)	Comments
Biocompatibility (as per ISO 10993-1)	Demonstrated in accordance with 1999 ISO 10993-1	Specific tests and results not provided.
Substantial Equivalence to Predicate Devices (K000051 Acticoat® Foam Dressing and K983210 Algisite M Calcium Alginate Dressing) for "characteristics" of dressing	Demonstrated through in vitro and in vivo testing	"Characteristics" are not detailed. Specific tests and results for these characteristics are not provided.

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 for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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 as this is a medical device (dressing) and the testing mentioned is more related to material properties and biological interaction than diagnostic accuracy requiring expert ground truth.

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

Not applicable for the type of testing described (biocompatibility, in vitro/in vivo material characteristics).

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

Not applicable. This is a medical dressing, not an AI diagnostic or assistive device.

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

Not applicable. This is a medical dressing, not an algorithm.

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

For biocompatibility, the ground truth would be established by the ISO 10993-1 standard itself, which defines acceptable biological responses. For in vitro/in vivo "characteristics," the ground truth would likely be defined by established ASTM or other international standards/methods for material properties, absorbency, bacterial barrier properties, etc., which are then compared to the predicate devices. Specific details are not provided.

8. The sample size for the training set

Not applicable in the context of this device and the presented testing summary. No "training set" for an algorithm is mentioned.

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

Not applicable.

Summary

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K002896

Westaim Biomedical Acticoat® Calcium Alginate Dressing Premarket Notification

510(k) Summary

General Information:

This 510(k) is to provide notification of substantial equivalence for the Acticoat® Calcium Alginate Dressing, which is substantially equivalent to previously marketed devices intended for wound care.

Submitted by:	Westaim Biomedical, Inc.One Hampton Road, Suite 320Exeter, NH 03833
Contact Person:	Steven Chartier
Date prepared:	September 15, 2000
Classification:	A final classification for wound/burn dressings has not beenimplemented.
Trade Name:	Acticoat® Calcium Alginate Dressing
Common Name:	Alginate Dressing
Predicate Devices:	K000051 Acticoat® Foam DressingK983210 Algisite M Calcium Alginate Dressing

Indication for Use:

Description:

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As with other Acticoat® dressings, the Alginate dressing is an effective physical and As with other Actional "uressings, the Alginate aresearly of the climity of the climit full thickness wounds.

Testing:

The biocompatability of Acticoat® Calcium Alginate Dressing has been demonstrated in The blocomparabliny of Actional in vitro and in vivo testing has demonstrated accordance with 100 roover ristics of Acticoat® Calcium Alginate Dressing are substantially equivalent to the predicate devices.

Summary of Substantial Equivalence:

The Acticoat® Calcium Alginate Dressing consists of a non-woven calcium alginate The Actional Oalchum Alginato Broosany of the Algisite M Calcium Alginate Dressing dressing, which is substantially oqurvated with nanocrystalline silver in a manner predicate device. This dressing nation of Foam Dressing predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2001

Mr. Steve Chartier Manager, Regulatory and Clinical Affairs Westaim Biomedical, Inc. One Hampton Road, Suite 320 Exeter, New Hampshire 03833

Re: K002896

Trade Name: Acticoat® Calicium Alginate Dressing Regulatory Class: Unclassified Product Code: KMF Dated: December 22, 2000 Received: December 22, 2000

Dear Mr. Chartier:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to use sutted in 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). You may, therefore, market the device, subject to the general controls Cosment for (110). I The general controls provisions of the Act include requirements for provisions or ation, 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 (Premarket Approval), it may be subject to such additional controls. Existing major (1 remarket i fprovial), was device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the rurent Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory sation. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does rodern regions for gour 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.

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Page 2 - Mr. Steve Chartier

This letter will allow you to begin marketing your device as described in your 510(k) Finstitution will and in you've began 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 11 you desire specific and for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and Compliance at (301) 59 m 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 nothroution (21 OF Croom 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 vours,

Miriam C. Provost

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

Enclosure

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ATTACHMENT 7

Westalm Biomedical Acticoat® Calcium Alginate Dressing Premarket Notification

510(k) Number (if known): K002896

Calicium Alginate Device Name:____ Acticoat

Indications For Use:

The Acticoat Calcium Alginate Dressing is an effective barrier The barrier functions of the dressing to bacterial penetration. may help reduce infection in moderate to heavily exudative partial and full thickness wounds including decubitus ulcers, diabetic ulcers, venous stasis ulcers, surgical and traumatic Acticoat dressings may be used over debrided and wounds. 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 OR

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional format 1-2-96)

Miriam C. Provost

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

510(k) Number K002896

Regulation Number and Section

N/A