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

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

AI/ML Overview

The provided text describes a 510(k) submission for TAMPAX® Tampons, which is a conventional unscented menstrual tampon. The submission asserts that the device is substantially equivalent to a predicate device (TAMPAX® Tampons, K002096). The acceptance criteria and supporting study details for this type of medical device clearance are generally different from those for AI/ML-powered software devices.

Based on the provided documents, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this conventional medical device are primarily focused on safety and effectiveness as defined by regulatory standards for menstrual tampons.

Acceptance Criteria	Reported Device Performance
Safety:	The results of these safety tests support the conclusion that this 510(k) device is equally as safe as the predicate device.
- Biocompatibility	Conducted. (Implicitly met as part of the safety assessment.)
- In vitro testing	Conducted. (Implicitly met as part of the safety assessment.)
Effectiveness:	The TAMPAX® Tampons 510(k) device complies with the syngyna absorbency requirements of 21 CFR 801.430. Therefore, additional syngyna absorbency testing is not necessary to establish their equivalence to the predicate tampon in terms of effectiveness.
- Syngyna absorbency (compliance with 21 CFR 801.430)	Complies with 21 CFR 801.430.
Substantial Equivalence (Overall):	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. The device is similar to the predicate device in terms of component materials, overall design and labeling. It differs from the predicate device in the composition of the non-woven pledget overwrap material.

Study Details (Based on the provided text, many details specific to AI/ML or complex clinical studies are not applicable or not provided)

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

Test Set Sample Size: Not explicitly stated for specific tests. The safety assessment involved a "battery of safety tests," but the number of units or samples tested for each is not detailed.
Data Provenance: Not specified. Given the nature of in vitro and biocompatibility testing for a medical device like a tampon, the data would likely originate from laboratory settings rather than human subjects/patients or specific geographical regions in the way clinical studies often do. This would be prospective testing done on the device itself.

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

Not applicable in the context typically seen for AI/ML diagnostic devices. "Ground truth" for a tampon's safety and absorbency is established by standardized laboratory methods (e.g., syngyna testing, biocompatibility assays), not expert consensus on interpretations. The evaluation of test results would be performed by qualified laboratory personnel following established protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic imaging or similar scenarios where subjective interpretation might need resolution. For laboratory tests on a physical device, results are typically quantitative and assessed against predefined specifications without this type of 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:

No. An MRMC study is not relevant for this device. This type of study is specifically for evaluating the impact of AI on human readers' diagnostic performance in fields like radiology. This device is a physical product (a tampon), not an AI/ML diagnostic tool.

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

Not applicable. This device is a physical tampon, not an algorithm.

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

For safety: Compliance with established biocompatibility standards and material safety profiles. This is based on validated laboratory test methods.
For effectiveness: Compliance with the syngyna absorbency requirements defined in 21 CFR 801.430. This is a standardized, objective laboratory test.

8. The sample size for the training set:

Not applicable. This is a conventional medical device; there is no "training set" in the machine learning sense. Device design and material selection are based on engineering principles and regulatory requirements, not machine learning training.

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

Not applicable, as there is no training set for this 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).