The provided text is a 510(k) summary for Playtex Tampons, asserting their substantial equivalence to previously cleared Playtex tampons. It does not describe a study involving device performance metrics, acceptance criteria, or a test set as would typically be found for a medical device or AI/software product requiring quantitative performance evaluation.

Instead, the submission focuses on demonstrating that the new Playtex tampons have the same technological characteristics and mode of action as the predicate devices, and that nonclinical testing confirms their safety and effectiveness are substantially equivalent.

Therefore, most of the requested information about acceptance criteria, performance, sample sizes, experts, and adjudication methods is not applicable to this type of submission.

Here's a breakdown based on the information that is present:

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

Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to legally marketed predicate devices. This means the new device must be as safe and effective as the predicate device(s). Specific quantitative performance metrics are not provided here for "device performance."
Reported Device Performance: The submission states: "Playtex tampons are substantially equivalent to the predicate device in terms of safety and effectiveness."

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary)
Safety	As safe as predicate device(s)	Substantially equivalent
Effectiveness	As effective as predicate device(s)	Substantially equivalent
Technological Characteristics	Same or equivalent to predicate device(s)	Same or same mode of action
Materials	Same or equivalent to predicate device(s)	Same or same mode of action

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable. This submission does not describe a "test set" in the context of device performance evaluation with a specific sample size. The substantial equivalence claim is based on nonclinical testing and comparison to predicate devices, not typically involving a test set of human subjects or data for a new performance metric.

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

Not Applicable. There is no "test set" or explicit "ground truth" establishment by external experts described in this submission. The "ground truth" for substantial equivalence is based on regulatory standards and documented safety/effectiveness of predicate devices and nonclinical testing results.

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

Not Applicable. No test set or adjudication method is described.

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 not an AI/software device. No MRMC study was conducted.

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

Not Applicable. This is not an AI/software device. No standalone algorithm performance was assessed.

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

Implied Ground Truth for Substantial Equivalence: The ground truth for this submission is the established safety and effectiveness of the predicate device(s) as determined by prior regulatory clearances and the results of nonclinical testing conforming to recognized standards (e.g., human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, Dioxin analysis and TSST-1 toxin testing).

8. The sample size for the training set

Not Applicable. This is not an AI/software device requiring a training set.

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

Not Applicable. This is not an AI/software device.

Summary

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7 2000 FEB

Kaa3794

ರು 510(k) SUMMARY

SUMMARY OF SAFETY AND EFFECTIVENESS A.

1.	COMPANY NAME	-	Playtex Products Inc.
	ADDRESS	-	75 Commerce DriveAllendale, New Jersey 07401
	TELEPHONE	-	201-785-8000
	CONTACT PERSON	-	M. RosengartenDirector of Regulatory & BiomedicalAffairs
	DATE OF SUMMARY	-	November 5, 1999
2.	DEVICE NAME	-	Playtex Tampons
	CLASSIFICATION NAME	-	Unscented Menstrual Tampons

1. The new Playtex tampons are substantially equivalent to previously cleared Playtex Gentle Glide® and Silk Glide®, Regular, Super and Super Plus tampons, and Slimfits® Regular and Super tampons.
1. The device description is: Unscented menstrual tampons for the absorption of menstrual fluid.
રું Playtex tampons are intended to be used as unscented menstrual tampons for the absorption of menstrual fluid.
1. The new tampon has the same technological characteristics as the predicate device. The fiber, string and materials in contact with the vaginal wall are the same or have the same mode of action.
B. 1. Nonclinical testing referenced for the determination of substantial equivalence includes:

Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, Dioxin analysis and TSST-1 toxin testing.

1. Based on the review of the data referenced in this "510(k) Summary," the Playtex tampons are substantially equivalent to the predicate device in terms of safety and effectiveness.

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Kga3794

CONFIDENTIAL

10. FOR TREATMENT AS REQUEST CONFIDENTIAL COMMERCIAL INFORMATION UNDER 21 C.F.R. 807.95 (b) AND REQUEST FOR CONTINUING CONFIDENTIALITY UNDER 807.95(C)(3).

I, Dr. Irwin Butensky, Sr. Vice President, R&D, Playtex Products, Inc., ("Playtex") certify as follows:

Playtex deems its intent to market Playtex Tampons #30999 to be confidential ( i) commercial information.
To the best of Playtex's knowledge, neither I nor anyone else has disclosed ( ii) Playtex's intent to market the subject device through advertising or any other manner, to scientists, market analysts, exporters, or other individuals or companies, except to employees of or paid consultants to Playtex or to individuals in an advertising firm pursuant to commercial arrangements with appropriate safeguards for secrecy.
(iii) Playtex shall notify the FDA immediately if its intent to market the device is disclosed to anyone, except to its employees, or to its paid consultants or individuals such as in an advertising or law firm, pursuant to commercial arrangements with appropriate safeguards for secrecy.
Playtex has taken precautions to protect the confidentiality of its intent to market ( iv) Playtex tampons #30999.
(v) I understand that submission of false information to the U.S. Government is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(g).

Respectfully submitted.

Irwin Butensky

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17 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark Rosengarten Director Regulatory & Biomedical Affairs Research & Development Playtex Products, Inc. Technical Center 75 Commerce Drive Allendale, NJ 07401-1600

Re: K993794

Playtex Odor Absorbing Gentle Glide® Slimfits® and Silk Glide® Tampons Dated: November 5, 1999 Received: November 9, 1999 Regulatory Class: II 21 CFR §884.5470/Procode: 85 HEB

Dear Mr. Rosengarten:

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 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, 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 vour 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 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) 594-4613. 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS OF USE PAGE

Page 1 of 1

510(k) Number (if known): K 993794

Device Name: __ Playtex Odor Absorbing Gentle Glide . Slimfits® and Silk Glide® Tampons Indications For Use:

Unscented menstrual tampons for absorption of menstrual fluid.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use. √

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 2794 510(k) Number.

Regulation Number and Section

§ 884.5470 Unscented menstrual tampon.

(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).