o.b. ® tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies, and in applicator and non-applicator versions. o.b. ® non-applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. o.b. ® applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. The applicator consists of a cardboard laminate with a coating.

AI/ML Overview

The provided text describes the 510(k) submission for o.b.® applicator and non-applicator tampons. This submission concerns a medical device rather than a software or AI-powered solution, so the typical structure for AI/software acceptance criteria and study details (like sample size for test/training sets, expert adjudication, MRMC studies, standalone performance) does not directly apply.

However, I can extract the relevant "acceptance criteria" (performance aspects tested) and the "study" conducted to demonstrate equivalence for this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Aspect)	Reported Device Performance (Study Results)
Biocompatibility	- Cytotoxicity: Conducted on rayon and extracts thereof. - Vaginal Irritation: Conducted in Rabbits on rayon and extracts thereof. - Acute Systemic Toxicity: Conducted on rayon and extracts thereof. - Intracutaneous Toxicity: Conducted on rayon and extracts thereof.
Dermal Irritation/Sensitization	- Repeat Insult Patch Test: Confirmed lack of potential for human dermal irritation and sensitization.
Microbiological Safety	- Microbiological Testing: Conducted on rayon and extracts thereof.
Overall Safety Comparison	- Conclusion: Non-clinical and clinical testing results indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons.

Explanation of Applicability:

For this device (tampons), the "acceptance criteria" are related to its biological and physical safety, as assessed through specific non-clinical (and implicitly "clinical" in the sense of human patch testing) tests. The "reported device performance" is the outcome of these tests, demonstrating that the device meets these safety standards and is comparable to previously marketed devices.

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

Sample Size (Non-clinical): Not explicitly stated with numerical values. For animal studies (Vaginal Irritation in Rabbits), a typical sample size for such tests involves a small group of animals (e.g., 3-6 rabbits per test group), but the exact number is not provided in the document.
Sample Size (Clinical/Human Patch Test): "A Repeat Insult Patch Test" typically involves a moderate number of human subjects (e.g., 50-200) for dermal sensitization testing. The exact number is not specified.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the submission is to the U.S. FDA, implying that the studies would adhere to U.S. regulatory standards. These are considered prospective tests conducted specifically to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts

This section is not applicable in the context of this device and study. The "ground truth" for tampon safety is established through standardized laboratory and animal testing protocols, and sometimes human patch tests, which rely on objective measurements and established scientific methods rather than expert consensus on interpretive data (like in imaging or diagnostics).

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in diagnostic or imaging studies. The safety tests performed for tampons are objective and do not involve such interpretive adjudication.

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

This is not applicable. MRMC studies are specific to evaluating the impact of an assistance (like AI) on human performance in diagnostic tasks. This submission is for a physical medical device (tampon) and does not involve AI or human "readers" interpreting cases.

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

This is not applicable. This question is relevant to AI/software performance. The device is a tampon, which operates "standalone" in the sense that it performs its physical function without a human-in-the-loop interaction in the way AI algorithms do.

7. The Type of Ground Truth Used

The "ground truth" used for non-clinical testing (biocompatibility, toxicity) is based on:

Standardized laboratory assays: Measuring specific biological responses (e.g., cell viability for cytotoxicity).
Animal models: Observing physiological reactions in rabbits for irritation.
Human volunteers: Observing dermal reactions in the Repeat Insult Patch Test.

Essentially, the ground truth is derived from objective biological and toxicological endpoints as defined by established scientific and regulatory testing guidelines.

8. The Sample Size for the Training Set

This is not applicable. "Training set" refers to data used to train machine learning models. This submission is for a physical device, not an AI or software product.

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

This is not applicable for the same reasons as #8.

Summary

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FEB 1 0 1998

K974629
P1072

Appendices

Appendix A - 510(k) Summary

Device Name	Trade name :o.b. ® applicator tampon and non-applicator tampon Classification name: unscented menstrual tampons
Equivalence tolegallymarketeddevice	Modified o.b. ® applicator tampons and non-applicator tampons are substantially equivalent to the current commercial o.b. ® tampons, both applicator and non-applicator versions.
Devicedescription	o.b. ® tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies, and in applicator and non-applicator versions. o.b. ® non-applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. o.b. ® applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. The applicator consists of a cardboard laminate with a coating.
Intended use	o.b. ® tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons.
Technologicalcharacteristics	The only difference between the modified tampons and the predicate device is the rayon component of the absorbent plug. All other technological characteristics are the same for the modified and the predicate device. There is no impact on the function of the device because of the change in the rayon.

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K974629
P202

Performance data Non-clinical testing

Biocompatibility and microbiological testing were conducted on the alternate Blocompatibility and microorologream to and rayon of on extracts thereon " valent to legally marketed tampons. The following tests were conducted:

· Cytotoxicity
Vaginal Irritation in Rabbits
· Microbiological Testing
· Acute Systemic Toxicity
Intracutaneous Toxicity

A Repeat Insult Patch Test was conducted to confirm the lack of the potential Performance for human dermal irritation and sensitization. data Clinical testing

Results of non-clinical and clinical testing indicate that the safety of modified Conclusion tampon is comparable to current legally marketed, commercial tampons.

Contact

Submitted by Personal Products Company 199 Grandview Road Skillman, NJ, 08558-9418

Contact person: Ralph A. Petrone Manager, Regulatory Affairs Personal Products Worldwide 908 874 1214

Date

This Summary was prepared on November 11,1997

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ralph Petrone Manager, Regulatory Affairs Personal Products 199 Grandview Road Skillman, NJ 08558-9418

Re: K974629

FEB 10 1998

o.b.B Tampons Dated: December 10, 1997 Received: December 12, 1997 Regulatory Class: II 21 CFR 884.5470/Procode: 85 HEB

Dear Mr. Petrone:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 misbranion.

If your device is classified (see above) into either class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions. or other Federal laws or regulations.

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 predication 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h. William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix C - Indications for Use Statement

510(k) Number (if known)_K9146 29

Device Name: o.b. Tampons, applicator and non-applicator versions

Indications for Use:

0.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.

(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 V

Robert P. Sathing
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 4629 510(k) Number ﻜﻠ

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).