The provided document is a 510(k) summary for a medical device (TAMPAX® C Plastic™ Tampons, unscented). This type of document is submitted to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, the study design and acceptance criteria differ significantly from what would be expected for a novel AI/software device. The document primarily focuses on non-clinical testing to establish equivalence based on material safety and specific design characteristics, rather than diagnostic performance metrics typical for AI studies.

Here's an analysis of the "acceptance criteria" and "study" described, interpreted within the context of a 510(k) submission for a tampon:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from testing)	Reported Device Performance
Material Safety	Negligible or no tampon pledget exposure to applicator components via extraction.	Extractions of the 510(k) device plastic applicators performed under exaggerated conditions confirmed negligible or no tampon pledget exposure to the applicator components. (Similar to predicate device applicator extracts).
Applicator Expulsion Force	Within acceptable limits for safe and effective use.	Tests showed that the force is within acceptable limits. (Similar to the current applicator of the predicate device).
Wrapper Seal Strength	Within specified limits to maintain integrity.	Thwing-Albert measurement showed that the seal strength is within specified limits. (Similar integrity to the current wrapper of the predicate device).
Wrapper Peel Strength	Within specified limits to allow proper opening while maintaining integrity.	Instron measurement showed that the peel strength is within specified limits. (Similar integrity to the current wrapper of the predicate device).
Pledget Design	Identical to the predicate device pledget design.	The tampon pledget design was not changed from the predicate device.
Fluid Handling Capabilities	Similar to the fluid handling capabilities of the predicate devices.	The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices. (No specific numerical performance provided, but stated as similar to predicate).

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

The document does not explicitly state numerical sample sizes for each test in the way an AI study would. Instead, it mentions "Extractions of the 510(k) device plastic applicators were performed," "Tests of the 510(k) tampon applicator expulsion force showed," "Tests of the seal strength... and peel strength... of the 510(k) modified wrapper showed."

Test Set Sample Size: Not specified quantitatively. The implication is that sufficient units were tested to demonstrate compliance with the criteria and similarity to the predicate.
Data Provenance: This is not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). The data is generated from laboratory testing of the physical device and its components.

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

Number of Experts: Not applicable. For this type of device, "ground truth" is established by direct physical measurements and engineering standards, not by expert interpretation of clinical data.
Qualifications of Experts: Not specified, but implied to be technicians or engineers qualified to perform the described physical and chemical tests (e.g., performing extractions, operating Thwing-Albert and Instron machines).

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no expert adjudication for physical/chemical test results as there would be for medical image interpretation or clinical outcomes. The results are objective measurements against predefined specifications.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and AI assists that interpretation. This is a physical, non-AI medical device.
Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.

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

Standalone Performance: No, a standalone performance study as typically understood for an AI algorithm was not done. This device is not an algorithm. Its "performance" is its physical characteristics and safety, measured directly.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this submission is based on engineering specifications, material science principles, and direct physical/chemical measurements. The primary method for establishing "equivalence" (which is the goal of a 510(k)) is by comparing these measured characteristics to those of the predicate device and established safety standards.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary in the Context of a 510(k) Submission:

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (TAMPAX® Pearl Tampons, unscented, K081555). The "study" conducted for this device is a series of non-clinical, laboratory-based tests. The acceptance criteria essentially boil down to:

The new device (TAMPAX® C Plastic™ Tampons) must exhibit material safety equivalent to or better than the predicate.
Its functional physical characteristics (applicator expulsion force, wrapper integrity, pledget design, fluid handling) must be similar to or within acceptable limits compared to the predicate device.

The study "proves" the device meets these criteria by showing that the results of the specific physical and chemical tests either match the results of the predicate device (where available) or fall within established acceptable ranges for safe and effective use. The changes made (pigment addition, applicator shape, wrapper modification) were assessed to ensure they did not negatively impact the safety or fundamental performance, and the evidence provided supports this conclusion for FDA's substantial equivalence determination.

Summary

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K110669
pg. 1 of 2

JUN - 2 2011

Section 5: 510(k) Summary

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:	1 June 2011
Trade Name:	TAMPAX® C PlasticTM Tampons, unscented
Common Name:	Unscented Tampon
Classification Name:	Unscented menstrual tampon (21 CFR 884.5470)
Predicate Devices:	TAMPAX® Pearl Tampons, unscentedK081555
Device Description:	Unscented menstrual tampons for absorption ofmenstrual fluid
Intended Use:	TAMPAX® C PlasticTM Tampons, unscented, areintended to be inserted into the vagina to absorbmenstrual fluid

Technological Characteristics: The device is similar to the predicate devices in terms of basic component materials, overall design and labeling. The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices. A pigment has been added to the applicator, the applicator shape and the wrapper have been modified.
Nonclinical Testing: Tampon material safety and design have been established in 510(k) submission K081555. Extractions of the 510(k) device plastic applicators were performed under exaggerated conditions to confirm negligible or no tampon pledget exposure to the applicator components. Tests of the 510(k) tampon applicator expulsion force showed that the force is within acceptable limits. Tests of the seal strength (Thwing-Albert measurement) and peel strength (Instron measurement) of the 510(k) modified wrapper showed that the seal and peel strength of the wrapper is within specified limits. The results of these tests support the conclusion that the 510(k) device is equally as safe as the predicate devices.
Conclusions: The tampon pledget design was not changed from the predicate device. Extracts of the proposed and predicate device applicators show similar results. The modified applicator has similar expulsion force as the current applicator. The seal strength and peel strength results show that the modified wrapper has similar

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K110669
Pg. 2 of 2

integrity to the current wrapper. The results of the extraction testing and seal and peel strength testing for this device support the conclusion that it is safe for its intended use and is substantially equivalent to the cited predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

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

JUN - 2 2011

Re: K110669

Trade Name: TAMPAX® C Plastic™ Tampons. unscented Regulation Number: 21 CFR 8884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: May 3, 2011 Received: May 4, 2011

Dear Dr. Blieszner:

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. 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 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); medical device reporting of medical device-related

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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,

Hicker Lemur MD

erbert P. Lerner, M.D., Director (Acting) 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)	K110669
Device Name	TAMPAX® C Plastic™ Tampons, unscented
Indications for Use	The TAMPAX® C Plastic™ 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) Over-The-Counter Use

Signature

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 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).