(273 days)
Ontex Tampon is a tampon that is inserted into the vagina and used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.
The tampons to be marketed are conventional unscented menstrual tampons consisting of an absorbent pledget, with and without applicator.
This document describes comparative testing to demonstrate substantial equivalence between the Ontex Tampon (Unscented) and the predicate device, the Maxim Hygeine Organically Grown Cotton Tampon. It does not describe a study involving human readers or AI.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a comparison of parameters between the applicant's device (Ontex International) and the predicate device (Maxim Hygiene Products). The "acceptance criteria" are implied to be that the Ontex Tampon's performance for each parameter should fall within the range or match the characteristic of the predicate device.
| Parameters | Acceptance Criteria (Predicate Device K090098) | Reported Device Performance (Ontex International) |
|---|---|---|
| Applicator Tampon | ||
| 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 | 15.9-16.1 mm | 15.9-16.1 mm |
| Diameter without Applicator | 14.2-15.7 mm | 14.2-15.7 mm |
| Syngina Absorption | 9.0-12.0g | 9.0-12.0g |
| Wadding | 100% organic cotton | 100% organic cotton |
| Non Woven | 100% organic cotton | 100% organic cotton |
| Withdrawal Cord Material | 100% organic cotton | 100% organic cotton |
| Applicator Material | Cardboard | Cardboard |
| Digital Tampon | ||
| 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 (likely 26-42mm, discrepancy in text) | 42-26 mm (likely 26-42mm, discrepancy in text) |
| Diameter with Single Packaging | 11.8-12.2 mm | 11.8-12.2 mm |
| Withdrawal Cord (Digital) | 130-160 mm | 130-160 mm |
| Syngina Absorption (Digital) | 6.0-9.0g | 6.0-9.0g |
| Wadding (Digital) | 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:
- Sample Size: The document does not specify the precise sample sizes for each test performed (e.g., number of tampons tested for Syngina absorption, expulsion force, fiber loss, or stability checks). It only lists the types of tests.
- Data Provenance: The data is generated from laboratory testing performed by Ontex International NV in Zele, Belgium. This is prospective testing to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The study is a comparative laboratory performance study of a medical device (tampons) against a predicate device, focusing on physical and absorbent properties. It does not involve interpretation of data by human experts to establish ground truth in the way medical imaging or diagnostic studies do.
4. Adjudication method for the test set:
This is not applicable. There is no human adjudication process described, as the tests are objective measurements of physical properties.
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. This submission is for a menstrual tampon, not an AI-powered diagnostic or screening tool. There are no human readers or AI involved in this type of device comparison.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
The "ground truth" here is the established and measured performance characteristics of the legally marketed predicate device (Maxim Hygeine Organically Grown Cotton Tampon, K090098). The Ontex device's performance is compared directly against these values, and against standardized test methods (e.g., "Syngina Test," "ATS Testing Method").
8. The sample size for the training set:
This is not applicable. There is no "training set" in this context, as it is not a machine learning or AI algorithm.
9. How the ground truth for the training set was established:
This is not applicable. As stated above, there is no training set for this device submission.
§ 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).