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

The subject devices are conventional unscented menstrual tampons consisting of an absorbent pledget, an overwrap, a withdrawal string, and a plastic applicator. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal string is placed on the ribbon and the ribbon is radially wound, then compressed into a traditional eight-groove bulletshaped pledget, overwrapped with a non-woven cover material. The tampon component is inserted into a three-piece plastic applicator consisting of an inner tube (plunger), a clear middle telescopic tube (telescope), and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon component with applicator is wrapped in an individual plastic film wrapper, and packaged in a sealed multi-unit container for retail sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.

AI/ML Overview

The document you provided is a 510(k) Premarket Notification from the FDA for a menstrual tampon. This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. It doesn't typically contain detailed clinical study reports for AI algorithms.

However, I can extract the acceptance criteria and the self-reported study details regarding the performance testing of the U by Kotex® Click® Unscented Menstrual Tampons as described in the document.

Please note: The requested information regarding sample sizes for training/test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth for training data was established are not applicable in this context, as the device is a physical menstrual tampon, not an AI/software device. The "studies" referenced are laboratory performance tests for physical and chemical properties and biocompatibility.

Here's the information extracted from your document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	- Non-cytotoxic (per ISO 10993-5:2009)

Non-sensitizing (per ISO 10993-10:2010)
Non-irritating (per ISO 10993-10:2010)
Non-toxic (Acute Systemic Toxicity per ISO 10993-11:2006) | - The pledget was demonstrated to be non-cytotoxic.
The pledget was demonstrated to be non-sensitizing.
The pledget was demonstrated to be non-irritating.
The pledget was demonstrated to be non-toxic. |
| Performance Testing (Syngyna Absorbency) | Absorbency range meets requirements of 21 CFR §801.430(f)(2) for each absorbency level (Regular, Super, Super Plus) - Specific numerical ranges are not provided in this document, but implied by regulatory compliance. | The subject tampons met the requirements of 21 CFR §801.430(f)(2) for each absorbency level. |
| Chemical Residues | - No detectable 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)
No detectable 2,3,7,8-tetrachlorofuran dioxin (TCDF)
No detectable pesticide residues
No detectable herbicide residues | There were no detectable 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD); 2,3,7,8-tetrachlorofuran dioxin (TCDF); or any pesticide and herbicide residues. |
| Mechanical Performance | - String strength: ≥ 10 lb force
Fiber shedding: ≤ 2 mg/tampon
Tampon integrity (dry): ≥ 20 daN
Tampon integrity (wet): ≥ 15 daN | - The subject tampons met the string strength specification of ≥ 10 lb force.
The subject tampons met the fiber shedding specification of ≤ 2 mg/tampon.
The subject tampons met the tampon integrity (dry) specification of ≥ 20 daN.
The subject tampons met the tampon integrity (wet) specification of ≥ 15 daN. |
| Microbiology Testing | - Bioburden: Total Aerobic Microbial Count (TAMC) ≤ 200 cfu/g (per USP )
Bioburden: Total Yeast/Mold Count (TYMC) ≤ 20 cfu/g (per USP )
Absence of pathogenic organisms (S. aureus, E. coli, P. aeruginosa, Salmonella species, C. albicans, C. sakazakii) (per USP )
No alteration of normal vaginal microflora growth
No increase in production of Toxic Shock Syndrome Toxin-1 (TSST-1)
No enhancement of S. aureus growth | - The subject tampons passed the Bioburden test with TAMC ≤ 200 cfu/g and TYMC ≤ 20 cfu/g.
The subject tampons passed the test for absence of pathogenic organisms (S. aureus; E. coli; P. aeruginosa; Salmonella species; C. albicans; and C. sakazakii).
The subject tampons did not alter growth of normal vaginal microflora.
The subject tampons did not increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1).
The subject tampons did not enhance the growth of S. aureus. |

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in the document for each test. The document mentions "The following studies have been performed..." and refers to compliance with ISO standards and FDA guidance, which would typically involve specific sample sizes per test methodology, but these are not detailed in this summary.
Data Provenance: The studies were performed by Kimberly-Clark Corporation to support the substantial equivalence of their device. The exact country of origin for the data generation process is not specified beyond Kimberly-Clark having their main address in Neenah, WI, USA. The studies are prospective in the sense that they are laboratory tests performed on the new device to demonstrate its properties.

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

Not Applicable. This is a physical medical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established analytical and biological methodologies (e.g., ISO standards, USP chapters).

4. Adjudication method for the test set:

Not Applicable. As this is not an AI algorithm or clinical trial with subjective assessments, there is no adjudication method by experts. The results are based on objective laboratory measurements against predefined thresholds.

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 a physical medical device (menstrual tampon), not an AI-assisted diagnostic or imaging device.

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

Not Applicable. This refers to a physical product, not an AI algorithm.

7. The type of ground truth used:

For biocompatibility: Ground truth is established by the specified ISO 10993 standards.
For performance testing (Syngyna absorbency): Ground truth is established by the FDA Guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions" issued July 27, 2005, and specifically 21 CFR §801.430(f)(2).
For chemical residues: Ground truth is established by analytical chemistry methods for detecting specific compounds.
For mechanical performance: Ground truth is established by design specifications (e.g., ≥ 10 lb force, ≤ 2 mg/tampon) based on industry standards and safety considerations.
For microbiology testing: Ground truth is established by reference to USP and , as well as established microbiological methods for assessing impact on microflora and toxin production.

8. The sample size for the training set:

Not Applicable. This is a physical product, not an AI product that requires a training set.

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

Not Applicable. As above, no training set for this type of device.

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).