(15 days)
Maxim Hygiene Organically Grown Cotton Tampon is a tampon used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.
A tampon is used for internally absorbing menstrual flow during a period. A range of absorbencies are available designed to cope with various menstrual flows which differ not only from woman to woman, but also during a woman's menstrual life and during each period.
The provided text describes a 510(k) submission for the Maxim Hygiene Organically Grown Cotton Tampon. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving human subjects or AI algorithms. As such, many of the requested elements for an AI/device performance study are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on physicochemical properties and dimensions matching those of predicate devices. The "reported device performance" is effectively the measured values for the Maxim Hygiene tampon, which are shown to be within the ranges of the predicate devices.
| Parameters | Acceptance Criteria (Predicate Devices' Range) | Maxim Hygiene Products (Reported Performance) |
|---|---|---|
| Applicator Tampon Super with Crown End | ||
| Total Weight | 5.0-5.9g | 5.0-5.9g |
| Weight without applicator | 2.7-3.2g | 2.7-3.2g |
| Withdrawal Cord | 115-175 mm | 115-175 mm |
| Length with Applicator | 120-125 mm | 120-125 mm |
| Length without Applicator | 45-50 mm | 45-50 mm |
| Diameter with Applicator | 15.9-16.1g | 15.9-16.1g |
| Diameter without Applicator | 14.2-15.7g | 14.2-15.7g |
| Syngina Absorption | 9.0-12.0g | 9.0-12.0g |
| Wadding Material | 100% organic cotton | 100% organic cotton |
| Non Woven Material | 100% organic cotton | 100% organic cotton |
| Withdrawal Cord Material | 100% organic cotton | 100% organic cotton |
| Applicator Material | Cardboard | Cardboard |
| Digital Tampon Regular | ||
| Weight with Single Packaging | 2.1-2.5g | 2.1-2.5g |
| Weight Tampon | 2.0-2.4g | 2.0-2.4g |
| Length with Single Packaging | 42-26 mm | 42-26 mm |
| Diameter with Single Packaging | 11.8-12.2 mm | 11.8-12.2 mm |
| Withdrawal Cord | 130-160 mm | 130-160 mm |
| Syngina Absorption | 6.0-9.0g | 6.0-9.0g |
| Wadding Material | 100% organic cotton | 100% organic cotton |
| Withdrawal Cord Material | 100% organic cotton | 100% organic cotton |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI or clinical study. The testing performed ("Determination of Absorbency Rate of Tampons - Syngina Test", "Expulsion Force Applicator Tampons", "Fiber Loss ATS Testing Method", "Stability Check on Digital Tampons") would have involved a sample of tampons for physical and absorption testing. The sample size for these specific tests is not provided.
Data provenance is not applicable in the sense of patient data; it refers to the physical tampons manufactured by Maxim Hygiene.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as there is no "ground truth" derived from expert review in this type of submission. The ground truth for physical properties is derived from standardized testing methods.
4. Adjudication method 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. This is a medical device for menstrual fluid absorption, not a diagnostic AI device requiring human reader performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The "ground truth" for this device is based on physical and chemical properties measured against established standards and validated by comparison to legally marketed predicate devices. This includes:
- Syngina Absorption: A standardized laboratory test to measure absorbency.
- Dimensions and Weight: Direct physical measurements.
- Material Composition: Stated as 100% organic cotton, assumed to be verified through material analysis.
- Biocompatibility: Demonstrated by reference to predicate devices (K983478 and K914430), implying that the materials used are biocompatible as per those previous clearances.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 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).