TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS by PROCTER & GAMBLE CO.

The absorbent pledget consists of a scented pad of cotton and/or rayon . fibers overwrapped with a non-woven fabric. A cotton withdrawal cord with absorbent rayon fibers adjacent to the pad is sewn to the pad, and the pad is compressed into a traditional bullet-shaped pledget.
The formed pledget is inserted into a plastic applicator consisting of an . inner pusher tube and an outer insertion tube with a closed, rounded tip.
Each tampon is wrapped in an individual plastic film wrapper and ● packaged in sealed multi-unit containers for retail sale.

AI/ML Overview

The provided text describes a 510(k) submission for TAMPAX® Pearl Scented Tampons. This is a conventional medical device, not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, F1-score, etc.) and ground truth establishment is not applicable here.

However, I can extract the relevant information regarding the safety and effectiveness assessment as presented in the document, which serves a similar purpose in conventional medical device regulation.

Here's a breakdown of the information that can be extracted, framed as closely as possible to your requested structure, but adapted for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	Equivalence to predicate device in terms of safety. (Implied: device should not pose new or increased risks compared to the predicate, and should meet established safety standards for menstrual tampons.)	"This 510(k) device was subjected to an extensive battery of safety tests, including in vitro microbiological testing, biocompatibility testing, and safety-in-use clinical testing of the finished product. The results of these safety tests support the conclusion that this 510(k) device is equally as safe as the predicate device."
Effectiveness	Compliance with syngyna absorbency requirements as per 21 CFR 801.430. (Implied: device should effectively absorb menstrual fluid to a similar standard as the predicate and regulatory requirements.)	"TAMPAX® Pearl Scented Tampons comply with the syngyna absorbency requirements of 21 CFR 801.430. Therefore, additional testing of these tampons is not necessary to establish their equivalence to the predicate tampon in terms of effectiveness."
Technological Characteristics	Similar to the predicate devices in terms of component materials, overall design, and labeling. (Implied: deviations should not negatively impact safety or effectiveness, and differences, if any, should be well-justified). Specific differences noted: fragrance used and composition of the plastic applicator.	"The device is similar to the predicate devices in terms of component materials, overall design and labeling. This device differs from the predicate device in the fragrance used and in the composition of the plastic applicator." (The successful 510(k) clearance implies these differences were deemed acceptable and did not preclude substantial equivalence.)
Intended Use	The device is intended to be inserted into the vagina to absorb menstrual fluid.	"TAMPAX® Pearl Scented Tampons are scented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid." (Matches the stated indications for use.)
Substantial Equivalence	The device should be substantially equivalent to a legally marketed predicate device with regard to safety and effectiveness.	"The results of evaluations of this device support the conclusions that it is safe for its intended use and that it is substantially equivalent to the cited predicate device with regard to safety and effectiveness." (This is the ultimate conclusion of the submission, affirmed by FDA clearance.)

Since this is not an AI/ML device, the following points are not directly applicable or are interpreted within the context of a conventional medical device submission:

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

The document mentions "safety-in-use clinical testing of the finished product" but does not specify sample size, study design (retrospective/prospective), or data provenance. For conventional devices like tampons, such details might not be explicitly required in a 510(k) summary if the testing is standard and considered sufficient for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as "ground truth" in the AI sense is not relevant here. Safety and effectiveness evaluations would be based on established laboratory tests and clinical protocols, not expert consensus on image interpretation.

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

Not applicable.

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, as this is not an AI-assisted diagnostic device.

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

Not applicable.

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

For safety, "ground truth" would be established through:
- In vitro microbiological testing: Laboratory protocols and established standards for microbial assessment.
- Biocompatibility testing: Compliance with ISO standards for medical devices (e.g., cytotoxicity, sensitization, irritation).
- Safety-in-use clinical testing: Clinical observations and self-reported outcomes by participants.
For effectiveness, "ground truth" is compliance with:
- Syngyna absorbency requirements (21 CFR 801.430): This is a standardized laboratory test for measuring absorbency.

8. The sample size for the training set

Not applicable. There is no AI model being "trained."

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

Not applicable.

Summary

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Page 1 of 2

K040312

4. 510(k) Summary

Submitted by:	The Procter & Gamble Company6110 Center Hill AvenueCincinnati, OH 45224
Contact Person:	Mark M. Anderson, Regulatory Affairs Manager(513) 634-5196 (voice) (513) 634-7364 (FAX)
Date Summary Prepared:	January 30, 2004
Trade Name:	TAMPAX® Pearl Scented Tampons
Common Name:	Scented Menstrual Tampon
Classification Name:	Scented or Scented Deodorized Menstrual Tampon(per 21 CFR 884.5460)
Predicate Device:	TAMPAX® Pearl Scented Tampons,Procter & Gamble, K011996

Device Description: The device is a conventional scented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator.

The absorbent pledget consists of a scented pad of cotton and/or rayon . fibers overwrapped with a non-woven fabric. A cotton withdrawal cord with absorbent rayon fibers adjacent to the pad is sewn to the pad, and the pad is compressed into a traditional bullet-shaped pledget.
The formed pledget is inserted into a plastic applicator consisting of an . inner pusher tube and an outer insertion tube with a closed, rounded tip.
Each tampon is wrapped in an individual plastic film wrapper and ● packaged in sealed multi-unit containers for retail sale.

Intended Uses: The device is intended to be inserted into the vagina to absorb menstrual fluid.

Technological Characteristics: The device is similar to the predicate devices in terms of component materials, overall design and labeling. This device differs from the predicate device in the fragrance used and in the composition of the plastic applicator.
Safety Assessment: This 510(k) device was subjected to an extensive battery of safety tests, including in vitro microbiological testing, biocompatibility testing, and safety-in-use clinical testing of the finished product. The results of these

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K04032

Saye 202

safety tests support the conclusion that this 510(k) device is equally as safe as the predicate device.

Effectiveness: TAMPAX® Pearl Scented Tampons comply with the syngyna absorbency requirements of 21 CFR 801.430. Therefore, additional testing i of these tampons is not necessary to establish their equivalence to the predicate tampon in terms of effectiveness.
Conclusions: The results of evaluations of this device support the conclusions that it is safe for its intended use and that it is substantially equivalent to the cited predicate device with regard to safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, stacked on top of each other. To the left of the profiles, the text "DEPARTMENT OF HEALTH & HUMAN" is vertically oriented.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 3 2004

Mark M. Anderson, Ph.D. Regulatory Affairs Manager The Procter & Gamble Company Winton Hill Technical Center 6110 Center Hill CINCINNATI OH 45224-1789

Re: K040312 Trade/Device Name: TAMPAX® Pearl Scented Tampons Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: 85 HIL Dated: January 30, 2004

Received: February 9, 2004

Dear Dr. Anderson:

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 such 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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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3. Statement of Indications for Use

510(k) Number (if known): K040312

Device Name: TAMPAX® Pearl Scented Tampons

Indications for Use:

TAMPAX® Pearl Scented Tampons are scented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Prescription Use (Part 21 CFR 801 Supbart D) AND/OR

Over-The-Counter Use _ X (21 CFR Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Lagan
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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).