Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (TAMPAX® V Plastic Applicator Tampons, unscented) and not a study assessing an AI/ML powered device. As such, most of the requested information (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set size, etc.) is not applicable to this document.

However, I can extract the acceptance criteria and reported device performance based on the information provided regarding the nonclinical tests and consumer preference testing.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Nonclinical Safety	Syngyna	No change from predicate device; within acceptable limits.	Results show no change from the predicate device. Results are within acceptable limits and similar to the predicate device.
	Expulsion Force	No change from predicate device; within acceptable limits.	Results show no change from the predicate device. Results are within acceptable limits and similar to the predicate device.
	Tampon Withdrawal Cord Anchor Strength	No change from predicate device; within acceptable limits.	Results show no change from the predicate device. Results are within acceptable limits and similar to the predicate device.
	S. aureus Growth and TSST-1 Production	No adverse impact of modifications; within acceptable limits.	No adverse impact of the modifications on S. aureus growth and TSST-1 toxin production. Results are within acceptable limits and similar to the predicate device.
User Preference/Safety	Consumer Preference In-use (Comfort)	Tampon and applicator are comfortable to use (no specific quantitative criteria given, implied positive user experience).	Confirmed that the tampon and applicator are comfortable to use.
	Consumer Preference In-use (Adverse Events)	No reports of adverse events.	There were no reports of adverse events.
General Equivalence	Material Safety and Design	Established in predicate 510(k) K061486.	Established in 510(k) submission K061486.
	Biocompatibility	Completed in previously cleared similar 510(k) devices. Relevant for each material.	Biocompatibility testing of each material in the tampon has been completed in previously cleared similar 510(k) devices.
	Fluid Handling Capabilities	Similar to predicate device.	The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate device. (This is a design statement, performance is implied to result in similarity as per other tests).

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: Not explicitly stated for any of the nonclinical tests. For "Consumer Preference In-use Testing," the sample size is not provided, only the outcome.
Data Provenance: Not explicitly stated. The studies were conducted by The Procter & Gamble Company. Given the typical regulatory context for US FDA submissions, these tests would likely have been conducted in a controlled laboratory setting (for nonclinical) and with a consumer panel (for in-use testing), presumably within the US or compliant with international standards, but no country of origin is specified. The studies appear to be prospective for the current device's evaluation.

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

This is not applicable as the device is a physical medical device, not an AI model requiring expert-established ground truth. The "ground truth" for the nonclinical tests is based on established scientific measurement standards for features like strength, fluid absorption, and microbial growth, and for in-use testing, it's based on user feedback.

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

Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI model ground truth.

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-powered device.

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

Not applicable. This is not an AI-powered device.

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

The "ground truth" for this device's performance evaluation includes:

Established scientific/engineering measurements: For nonclinical tests like Syngyna, expulsion force, and withdrawal cord strength, the "ground truth" is derived from standardized physical and chemical testing methods.
Microbiological assays: For S. aureus growth and TSST-1 production, the "ground truth" comes from controlled laboratory experiments measuring bacterial growth and toxin levels.
Consumer self-reporting/feedback: For consumer preference in-use testing, the "ground truth" is based on the subjective experiences and reports of the participants regarding comfort and adverse events.

8. The sample size for the training set

Not applicable. There is no AI model or training set involved.

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

Not applicable. There is no AI model or training set involved.

Summary

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K 113699

JAN 1 2 2012

Submitted by:	The Procter & Gamble Company6110 Center Hill AvenueCincinnati, OH 45224
Contact Person:	Kathleen Blieszner, Ph.D.Regulatory Affairs Manager(513) 634-3168 (voice)(513) 277-2931 (FAX)
Date Summary Prepared:	10 January 2012
Trade Name:	TAMPAX® V Plastic Applicator Tampons,unscented
Common Name:	Unscented Tampon
Classification Name:	Unscented menstrual tampon (21 CFR 884.5470)
Predicate Devices:	TAMPAX® Tampons, unscentedK061486
Device Description:	Unscented menstrual tampons for absorption ofmenstrual fluid. The tampon is a conventionaldesign consisting of an absorbent pledget, anoverwrap, a withdrawal cord and an applicator. Thematerials of construction are cotton, rayon,polypropylene and polyester. The device functionsby absorbing menstrual fluid after being insertedinto the vagina.
Intended Use:	TAMPAX® V Plastic Applicator Tampons,unscented are intended to be inserted into the vaginato absorb menstrual fluid.

Section 5: 510(k) Summary

Technological Characteristics: The device is similar to the predicate devices in terms of basic component materials, overall design and labeling. Both the predicate and the 510(k) device have an absorbent pledget with a non-woven overwrap and a withdrawal cord. The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate device. In the subject device, the overwrap has been extended at the withdrawal end of the tampon. The absorbent pledget has a rounded tip. Minor material changes have been made to the overwrap, the withdrawal cord and the sewing thread. In addition, a plastic applicator will be used. The subject device and the predicate device have the same performance characteristics and equivalent safety and efficacy profiles.

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Safety Assessment: Tampon material safety and design have been established in 510(k) submission K061486. Biocompatibility testing of each material in the tampon has been completed in previously cleared similar 510(k) devices.
Nonclinical Tests: Results of the Syngyna, expulsion force, and tampon withdrawal cord anchor strength testing show no change from the predicate device and confirm that the material changes do not impact safety of the device. There was no adverse impact of the modifications of the 510(k) device on S. aureus growth and TSST-1 toxin production.
Consumer Preference In-use Testing: Consumer preference in-use testing confirmed that the tampon and applicator are comfortable to use. There were no reports of adverse events.
Conclusions: The results of evaluations of both the nonclinical and the consumer preference in-use testing for this device support the conclusions that the subject device is safe for its intended use and is substantially equivalent to the cited predicate device. Syngyna, expulsion force, tampon withdrawal cord anchor strength. S. aureus growth and TSST-1 production, and consumer preference inuse testing results are within acceptable limits and similar to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 1 2 2012

Kathleen Blieszner, Ph.D. Regulatory Affairs Manager The Procter & Gamble Company 6110 Center Hill Avenue CINCINNATI OH 45224

Re: K113699

Trade/Device Name: TAMPAX® V Plastic Applicator Tampons, unscented Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: December 15, 2011 Received: December 16, 2011

Dear Dr. Blieszner:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave 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 for are candine 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 1 ou mayy atterest provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your de 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 r leave or acterination 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known)	K 113699
Device Name	TAMPAX® V Plastic Applicator Tampons, unscented
Indications for Use	The TAMPAX® V Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb 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	X
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, andUrological Devices
510(k) Number	K113699

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).