The provided text is a 510(k) Summary for Playtex Tampons, specifically a submission for new scented, deodorized menstrual tampons. It primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested categories (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document, as it describes a regulatory submission focused on product characteristics and non-clinical testing for equivalence.

Here's a breakdown of the information that can be extracted, and an explanation for why other information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or detailed reported device performance data in a structured table. Instead, it relies on demonstrating substantial equivalence to already cleared devices.

Acceptance Criterion (Implicit)	Reported Device Performance (as stated in document)
Substantial equivalence to predicate devices (safety & effectiveness)	"The new Playtex tampons are substantially equivalent to the following tampons that have been previously cleared... 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."
No significant difference in non-clinical safety aspects	"Nonclinical testing referenced for the determination of substantial equivalence includes: Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion and TSST-1 toxin testing." (Results are summarized as meeting equivalence, not detailed)

2. Sample Size Used for the Test Set and Data Provenance

This document describes non-clinical testing and equivalence to existing products, not a study involving a "test set" in the context of an AI or diagnostic device. Therefore, sample sizes for a test set and data provenance (country, retrospective/prospective) are not applicable and not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Given that this is a 510(k) submission for tampons focused on equivalence and non-clinical safety, there is no mention of experts establishing ground truth for a test set. This type of analysis is typically for diagnostic devices or AI algorithms.

4. Adjudication Method for the Test Set

As there is no "test set" in the context of data for an algorithm or diagnostic device, adjudication methods are not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

An MRMC study is relevant for diagnostic devices where human readers interpret cases, often with and without AI assistance. This document describes a medical device (tampons) that does not involve human interpretation in this manner. Therefore, an MRMC study was not done and effect size is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This document pertains to a physical medical device (tampons) and not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology, outcomes data, or expert consensus is typically associated with diagnostic or AI device evaluations. For this device, the "ground truth" for demonstrating safety and effectiveness relies on:

Established performance of predicate devices: The "ground truth" is that the predicate devices are already deemed safe and effective.
Non-clinical testing outcomes: The results of the non-clinical tests (sensitization, irritation, toxicity, TSST-1) serve as the "truth" for safety aspects, demonstrating that the new device does not pose new or increased risks.

8. The Sample Size for the Training Set

There is no training set in the context of this 510(k) submission as it is for a physical medical device, not an AI or machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this information is not applicable.

In summary: The provided document is a regulatory submission for a physical medical product (tampons) seeking substantial equivalence to existing products. It details the product, its intended use, and indicates non-clinical testing was performed to support safety and equivalence. It does not contain the detailed study design, performance metrics, and data analysis typically found in documentation for diagnostic devices or AI-based solutions, which would address many of the questions posed.

Summary

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9. 510(k) SUMMAR Y

MAR 1 3 2002

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, Regulatory, Safety &International Development
	DATE OF SUMMARY	-	January 18, 2002
2.	DEVICE NAME	-	Playtex Tampons
	CLASSIFICATION NAME	-	Scented, Deodorized MenstrualTampons

The new Playtex tampons are substantially equivalent to the following 3. tampons that have been previously cleared:
- a. Playtex Deodorant Gentle Glide® in Regular, Super and Super Plus absorbencies
- b. Playtex Deodorant Portables® in Regular and Super absorbencies
- c. Playtex Deodorant Gentle Glide Multipack in Regular and Super absorbencies
- d. Deodorant Slimfits® in Regular absorbency
The device description is: Scented, deodorized menstrual tampons for the 4. absorption of menstrual fluid.
Playtex tampons are intended to be used as scented, deodorized menstrual న. tampons for the absorption of menstrual fluid.
The new tampon has the same technological characteristics as the 6. The fiber, string and materials in contact with the predicate device. vaginal wall are the same or have the same mode of action.
Nonclinical testing referenced for the determination of substantial B. 1. equivalence includes:

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

Based on the review of the data referenced in this "510(k) Summary," the 2. Playtex tampons are substantially equivalent to the predicate device in terms of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three heads or faces, with wavy lines below the heads.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2002

Mr. Mark E. Rosengarten Director, Regulatory, Safety & International Development Playtex Products, Inc. Technical Center 75 Commerce Dr. ALLENDALE NJ 07401-1600 Re: K020200 Trade/Device Name: Playtex Deodorant Tampons

Model 34802 Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HIL and HEB Dated: January 18, 2002 Received: January 22, 2002

Dear Mr. Rosengarten:

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 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, Jour responsible in 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,

Nancy C. Brogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, 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): KOマO200

Device Name: Playtex Deodorant Gentle Glide®, Playtex Deodorant Portables®, Playtex Deodorant Gentle Glide® Multipack and Playtex Deodorant Slimfits® Tampons Model #34802

Indications For Use:

Scented or scented, deodorized menstrual tampon for the 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) OR

Over-The-Counter Use/

(Optional Format 1-2-96)

David H. Beynon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020200

Regulation Number and Section

§ 884.5460 Scented or scented deodorized menstrual tampon.

(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).