The RSDL lotion is pre-impregnated in a 2 x 3.9 x 0.4 inch, or 3.9 x 3.9 x 0.4 inch foam sponge applicator pad. Each applicator pad is packaged as a single unit in a heat-sealed polyethylene-lined aluminum foil pouch. The foil pouch is covered by a kraft paper outer layer to facilitate coloring of the finished package and to make opening the package possible when wearing CW protective clothing.

AI/ML Overview

The provided text describes the Reactive Skin Decontamination Lotion (RSDL) and its premarket notification to the FDA. However, the document does NOT contain the detailed information needed to fill out all requested sections about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert qualifications for an AI/device performance study in the way typically found for diagnostic devices.

The RSDL is a decontamination lotion, and the performance criteria and studies for it are related to its efficacy in removing chemical agents and its safety/biocompatibility, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are common for AI-driven devices.

Based on the provided text, here is what can be extracted and inferred:

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

Acceptance Criteria (Inferred from "Discussion of tests and test results")	Reported Device Performance
Efficacy: Ability to remove and/or neutralize chemical warfare agents and T-2 toxin.	"RSDL performed significantly better than the predicate device against the agents tested."
Biocompatibility/Safety: Safe for intended use (on skin).	"it can be concluded the RSDL is safe for its intended use."
Compatibility: Compatible with other agents military personnel would apply to the skin.	"RSDL was demonstrated to be compatible with all agents tested."

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

Sample size for test set: Not specified in the provided text. The tests conducted were for efficacy, biocompatibility, safety, and compatibility, likely involving chemical agents and potentially biological samples/models, but the exact sample sizes are not given.
Data provenance: Not explicitly stated. Given the applicant is the "U.S. Department of the Army" and the context of chemical warfare agents, the studies were likely conducted in a controlled laboratory or military testing environment, possibly in the USA. It's not specified if data was retrospective or prospective in detail, but implied as a series of tests for regulatory submission.

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

This concept of "experts establishing ground truth" for a diagnostic device test set is not directly applicable to the RSDL's reported tests. The "ground truth" for RSDL would likely be objective measurements of chemical agent reduction/neutralization, and observations of biological responses for safety/biocompatibility, rather than expert consensus on interpretive tasks.
No information on "experts" or their qualifications for establishing ground truth is provided.

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

This is not applicable to the type of product and studies described. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) forms the ground truth or is being evaluated, which is not the case here.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices involving human readers/interpreters, which the RSDL is not.

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

Yes, performance evaluations of the RSDL were conducted as a standalone product. The "device" (RSDL lotion) itself was tested for its direct chemical and biological effects. There is no "algorithm" or "human-in-the-loop" component for this type of product.

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

The ground truth for efficacy would be objective chemical and biological measurements of agent neutralization/removal and biological impact. For safety and biocompatibility, it would be direct experimental observations and measurements of biological responses in test models or subjects (e.g., skin irritation tests, toxicity assays).

8. The sample size for the training set:

This concept is not applicable. The RSDL is a chemical solution device, not an AI model that requires a training set. The "development" would involve chemical formulation and laboratory testing, not machine learning training.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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MAR 2 5 2003

Applicant:
U.S. Department of the Army

Reactive Skin Decontamination Lotion
Traditional 510(k) Premarket Notification

1 of 2

510(k) SUMMARY

Reactive Skin Decontamination Lotion (RSDL)

Submitter Name:	U.S. Department of the Army
Submitter Address:	64 Thomas Johnson DriveFort Detrick, Maryland 21702
Contact Person:	Ronald E. Clawson, Ph.D.
Phone Number:	301-619-2016
Fax Number:	301-619-7230
Date Prepared:	November 22, 2002
Device Trade Name:	Reactive Skin Decontamination Lotion (RSDL)
Device Common Name:	Kit, Decontamination
Classification Name:	MAC
Predicate Device:	K894455, U.S. Department of the Army, Decontaminating Kit,Skin: M291
Device Description:	The RSDL lotion is pre-impregnated in a 2 x 3.9 x 0.4 inch, or 3.9x 3.9 x 0.4 inch foam sponge applicator pad. Each applicator padis packaged as a single unit in a heat-sealed polyethylene-linedaluminum foil pouch. The foil pouch is covered by a kraft paperouter layer to facilitate coloring of the finished package and tomake opening the package possible when wearing CW protectiveclothing.
Intended Use:	The Reactive Skin Decontamination Lotion is intended to removeor neutralize chemical warfare agents and T-2 toxin from the skin.
Discussion of tests andtest results:	The RSDL was subjected to a number of biocompatibility andsafety tests and from the results of those tests, it can beconcluded the RSDL is safe for its intended use.
	The RSDL was also tested for efficacy in removing and/orneutralizing groups of chemical warfare agents and T-2 toxin.RSDL performed significantly better than the predicate deviceagainst the agents tested.
	In tests evaluating the compatibility of RSDL with other agentsmilitary personnel would apply to the skin, RSDL wasdemonstrated to be compatible with all agents tested.
Conclusion:	This device, with respect to material composition, devicecharacteristics and intended use, has been demonstrated to besafe and effective as a skin decontaminant, and is substantiallyequivalent to the 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 above two wavy lines.

MAR 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Department of the Army C/O Mr. Ronald E. Clawson Department of Defense Chemical-Biological Mgt. Office 64 Thomas Johnson Drive Fort Detrick, Maryland 21702

Re: K023969

Trade/Device Name: Reactive Skin Decontamination Lotion Regulatory Class: II Product Code: MAC Dated: November 26, 2002 Received: November 29, 2002

Dear Mr. Clawson:

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.

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Page 2 - Mr. Clawson

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 (OS) 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 marketed predicate device results in a classification for your device and thus, permits vour 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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Panov

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Applicant: U.S. Department of the Army

023969

510(k) Number (if known):

Device Name:

Reactive Skin Decontamination Lotion

Indications for Use:

The Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin.

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

	Concurrence of CDRH; Office of Device Evaluation (ODE)
PrescriptionUse(Per 21 CFR 801.109)	OR	Over-The-CounterUse	X

	(Division Sign-Off)Division of Anesthesiology, General Hospital,Infection Control, Dental Devices		(Optional Format 1-2-96)
510(k) Number:	K023969

Section 4.0

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Regulation Number and Section

§ 878.4014 Nonresorbable gauze/sponge for external use.

(a)
Identification. A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.