FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, an overwrap, a withdrawal cord, an absorbent braid, and an applicator.

AI/ML Overview

This document provides a 510(k) summary for the TAMPAX® Pearl Plastic Applicator Unscented Tampons. The purpose of this summary is to demonstrate the device's substantial equivalence to predicate devices, focusing on safety and effectiveness.

Here’s an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description of Acceptance Criteria	Reported Device Performance
Safety - Toxicology	Compliance with FDA guidance and applicable standards for irritation testing, sensitization testing, acute toxicity, and cytotoxicity.	Favorable safety outcomes reported from preclinical toxicology testing. Specific results (e.g., irritation score thresholds) are not provided, but the conclusion is that the device met the safety requirements in these areas.
Safety - Microbiology	No impact on the growth of Staphylococcus aureus; no impact on normal vaginal microflora; no increase in the production of TSST-1 (Toxic Shock Syndrome Toxin-1).	Preclinical microbiology testing confirmed that the device "does not impact the growth of Staphylococcus aureus or the normal vaginal microflora, nor does it increase the production of TSST-1."
Safety - Clinical Adverse Events	Absence of adverse events related to the test products during clinical trials.	"In the clinical trials that were performed, no adverse events related to the test products were reported."
Effectiveness - Absorbency	Compliance with the syngyna absorbency requirements of 21 CFR 801.430. This regulation defines the standard laboratory test for determining the absorbency of menstrual tampons.	"TAMPAX® Pearl Plastic Applicator Unscented Tampons comply with the syngyna absorbency requirements of 21 CFR 801.430." The report explicitly states, "Therefore, additional testing of these tampons is not necessary to establish their equivalence to the predicate tampons in terms of effectiveness." This indicates that the device met the regulatory absorbency standard.
Substantial Equivalence (Overall)	The device is equally as safe and effective as the predicate devices in terms of component materials, overall design, intended use, labeling, and performance. The primary change in the 510(k) device is the incorporation of a process aid to decrease microwave setting time for the pledget, which should not affect safety or effectiveness.	The submission concludes that "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 devices with regard to safety and effectiveness." The FDA's 510(k) clearance letter confirms this substantial equivalence determination.

Since this is a 510(k) summary for a menstrual tampon, the "AI" related questions are not applicable to this type of medical device submission. The device described does not involve AI, image analysis, or expert-driven diagnostic interpretations. Therefore, sections 2-6 and 8-9 are specifically tailored to human-read diagnostic studies or AI-driven medical devices and cannot be fully answered or are entirely irrelevant for this tampon submission.

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

Test Set (Clinical Trials): The exact sample size for the clinical trials is not specified in the provided text. The document states "In the clinical trials that were performed..." but does not give numerical details about participants.
Data Provenance: The document does not specify the country of origin of the data. It implies prospective clinical evaluations ("clinical trials that were performed").
Preclinical Testing: No sample sizes are provided for the preclinical toxicology or microbiology testing.

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

Not Applicable. This is a physical medical device (tampon), not a diagnostic device requiring expert interpretation or ground truth establishment in the traditional sense of image analysis or diagnostic studies. The safety and effectiveness are assessed through laboratory tests and clinical observations rather than expert consensus on a diagnostic output.

4. Adjudication Method for the Test Set

Not Applicable. As above, this is not a diagnostic study requiring adjudication of expert opinions. Clinical observations were made during trials, and laboratory tests were conducted, but an adjudication method for a "test set" in the context of interpretation is not relevant here.

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 a diagnostic device, and therefore neither an MRMC study nor AI assistance is relevant.

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

Not Applicable. This device does not involve an algorithm or AI.

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

For this device, "ground truth" is established through:

Standardized Laboratory Testing: For absorbency, the syngyna absorbency test (21 CFR 801.430) serves as the defined standard. For toxicology and microbiology, standard methods are used to determine parameters like irritation, sensitization, and microbial growth/toxin production. These are objective measures against predefined criteria.
Clinical Observation: Absence of adverse events in clinical trials serves as "ground truth" for clinical safety, relying on participant reporting and investigator observation.
Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is that the new device performs equivalently to the legally marketed predicate devices, as demonstrated by the above tests.

8. The sample size for the training set

Not Applicable. This device does not involve an algorithm or AI, so there is no "training set."

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

Not Applicable. This device does not involve an algorithm or AI, so there is no "training set" and therefore no ground truth established for it.

Summary

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).