This document is a 510(k) summary for a menstrual tampon, not a medical device that uses AI or complex algorithms. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth is not applicable. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through nonclinical testing, rather than performance against specific numerical acceptance criteria for diagnostic or algorithmic accuracy.

Here is an analysis based on the provided text, highlighting what is and isn't applicable:

Understanding the Device and Context:

The device is "Playtex Tampons" (specifically “Scented, Deodorized Menstrual Tampons”). This is a Class II medical device, but its evaluation is based on substantial equivalence to existing tampons, not on algorithmic performance or diagnostic accuracy. Therefore, many standard AI/ML device evaluation criteria do not apply.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a tampon and not an AI/ML diagnostic or assistive device, there are no specific numerical performance metrics like sensitivity, specificity, or accuracy that are typically used as acceptance criteria for AI devices. The "acceptance criteria" here are implicitly related to demonstrating safety and effectiveness comparable to predicate devices through nonclinical biological and chemical testing.

Acceptance Criteria (Implicit from Substantial Equivalence to Predicate)	Reported Device Performance (Summary of Nonclinical Testing)
Safety and effectiveness (non-toxic, non-irritating, non-sensitizing, not promoting TSST-1 toxin production) equivalent to predicate tampons.	Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing were referenced. The submission states the device is "substantially equivalent to the predicate device in terms of safety and effectiveness."

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

Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The provided document refers to "nonclinical testing" related to biological safety. The exact sample sizes for each type of nonclinical test (e.g., number of animals for toxicity, number of human subjects for sensitization) are not detailed in this 510(k) summary.
Data Provenance: Not applicable for an AI/ML context. The testing is described as "nonclinical testing" which typically refers to laboratory or animal studies, and possibly human volunteer patch tests for sensitization, rather than clinical patient data. The country of origin for these nonclinical tests is not specified, but usually presumed to be where the manufacturer's testing facilities are located or contracted.

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

Number of Experts: Not applicable. For biological safety testing of tampons, "ground truth" is established through standardized laboratory assays and protocols (e.g., toxicity assays, irritation studies), not through expert clinical consensus on images or diagnostic outcomes.
Qualifications of Experts: Not applicable. The "experts" involved would be toxicologists, microbiologists, and other laboratory scientists conducting the nonclinical tests, but their role is not to establish "ground truth" in the diagnostic sense.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of clinical data, which is not the type of data or evaluation performed for a tampon's biological safety and substantial equivalence.

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:

MRMC Study: No. This is not an AI/ML device; it's a tampon. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Standalone Performance: No. This is not an algorithm.

7. The type of ground truth used:

Type of Ground Truth: For the purpose of establishing substantial equivalence for a tampon, the "ground truth" for safety and effectiveness is established through:
- Standardized Biological Assays: Measuring cytotoxicity, irritation, sensitization, and specific toxin production (TSST-1) against established safety thresholds and in comparison to predicate devices.
- Material Characterization: Ensuring the fiber, string, and materials in contact with the vaginal wall are the same or have the same mode of action as legally marketed predicate devices.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI/ML device.

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

Ground Truth for Training Set: Not applicable. There is no training set for this type of device.

Conclusion Note:

This 510(k) document is a classic example of a "substantial equivalence" submission for a relatively low-risk medical device (Class II tampon). The evaluation focuses on demonstrating that the new device is as safe and effective as existing, legally marketed predicate devices, primarily through comparison of materials and nonclinical biological testing, rather than through complex clinical trials or performance assessments against AI-specific metrics.

Summary

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K020 202

MAR 1 2 2002

SUMMARY OF SAFETY AND EFFECTIVENESS A.

510(k) SUMMAR Y

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
DEVICE NAME	-	Playtex Tampons
CLASSIFICATION NAME	-	Scented, Deodorized MenstrualTampons

1. The new Playtex tampons are substantially equivalent to the following 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
1. The device description is: Scented, deodorized menstrual tampons for the absorption of menstrual fluid.
న. Playtex tampons are intended to be used as scented, deodorized menstrual 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.
B. 1. 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.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2002

Mr. Mark Rosengarten Director, Safety & International & International Development Playtex Products. Inc. Technical Center, 75 Commerce Dr. ALLENDALE NJ 07401-1600

Re: K020202

Trade/Device Name: Playtex Deodorant Tampons # 34702 Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II

Product Code: 85 HIL Dated: January 18, 2002 Received: January 22, 2002

Dear Mr. Rosengarden:

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. Iisting 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 (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.

Image /page/1/Picture/12 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 seal is a stylized symbol resembling a caduceus or a bird-like figure, composed of three curved lines.

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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, 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.

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): K CaoaO

Device Name: Playtex Deodorant Gentle Glide, Playtex Deodorant Portables, Playeex Deodorant Gentle Gide® Multipack and Playtex Deodorant Slimfits® Tampons Model #34702

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

David A. Ingram

(Optional Format 1-2-96)

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).