Search Results

COHITECH Organic cotton cardboard applicator tampons light are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. It will be provided on light absorbency (6g and under). Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.

This document describes a 510(k) premarket notification for COHITECH Organic Cotton Cardboard Applicator Tampons Light. The submission seeks to add a "light" absorbency version to an existing family of tampons (Regular, Super, and Super Plus) previously cleared under K091084.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a single table with acceptance criteria and reported device performance side-by-side. Instead, it lists the performance characteristics assessed and implies that these assessments met predetermined acceptance criteria based on the 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)".

Performance Characteristics Assessed (Implied Acceptance Criteria Met):

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

• Sample Size: The document does not explicitly state the sample sizes for the performance tests (dimensions, absorbency, withdrawal cord strength, fiber shedding, or microbiology testing). It refers to "verification activities" and "testing on the subject device."
• Data Provenance: The document does not specify the country of origin for the data. The studies appear to be retrospective in the sense that they are conducted to demonstrate equivalence for regulatory approval, rather than being part of an ongoing clinical trial. The microbiology testing includes data on the "subject device," indicating it was specifically tested. For biocompatibility, reliance was placed on prior testing from K091084, with a certification that materials are the same.

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

This information is not applicable to this type of device (menstrual tampons). The "ground truth" here is defined by established engineering and microbiological performance standards and guidance documents (e.g., 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)"). There are no "experts" in the sense of clinical reviewers establishing a diagnostic ground truth, but rather testing engineers and microbiologists performing standardized tests.

4. Adjudication method for the test set:

This is not applicable as it's not a diagnostic device involving human interpretation. The "adjudication" is based on comparing test results against predefined thresholds in established standards.

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 is not an AI/CAD device. It is a physical medical device (menstrual tampon).

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-based device.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on:

• Established industry standards and regulatory guidance: Specifically, the "2005 FDA guidance 'Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)'". This guidance outlines the required performance characteristics and likely specifies the methodology and acceptable ranges for these tests.
• Predicate device characteristics: The subject device is compared to a legally marketed predicate device (Maxim menstrual tampons and Organyc menstrual tampons, K091084). The "ground truth" for the predicate device's safety and effectiveness was established during its own clearance process, and the subject device aims to demonstrate substantial equivalence to this established benchmark.

8. The sample size for the training set:

This is not applicable. This is not a machine learning or AI device that requires a training set.

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

This is not applicable. There is no training set for this device.

Ask a specific question about this device

The device is intended to be inserted into the vagina to absorb menstrual fluid.
Cotton menstrual tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. These tampons will be provided as three absorbencies: regular, super and super plus. Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.

The provided documents describe the regulatory submission for "COTTON MENSTRUAL TAMPONS" (also branded as MAXIM MENSTRUAL TAMPONS and ORGANYC MENSTRUAL TAMPONS) seeking substantial equivalence to existing predicate devices. The evaluation focuses on the technical characteristics and functionality of the tampons, rather than complex AI or medical imaging. As such, many of the requested elements for AI/medical device studies (e.g., sample size for test sets, expert qualifications, MRMC studies, training set details) are not applicable to this submission.

Here is an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the characteristics of the predicate devices. The study aims to demonstrate that the proposed device, COTTON MENSTRUAL TAMPONS, has similar technological features and equivalent performance, particularly in absorbency and dimensions, to the predicate devices.

The reported device performance aligns with or is within acceptable deviations from the predicate devices' characteristics, particularly matching the Natracare Tampon in terms of material composition and overall absorbency ranges.

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

The document indicates "Functional laboratory testing performed in foreseeable operating conditions." This suggests physical testing of the tampons. However, details regarding the specific sample size for these tests (e.g., number of tampons tested for dimensions, absorbency) are not provided in the summary. The data provenance is from the manufacturer, COTTON HIGH TECH SL, located in Spain. The study appears to be part of a prospective evaluation for regulatory 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 to this type of device and study. The "ground truth" (e.g., absorbency, dimensions) is established through standardized laboratory testing methods, not expert consensus in the clinical sense.

4. Adjudication method for the test set

Not applicable. Laboratory test results are typically objective measurements, not subject to adjudication in the way clinical interpretations are.

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 an AI-assisted diagnostic device, and therefore, an MRMC study is not relevant.

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

Not applicable. This is a physical medical device (tampon), not an algorithm or software.

7. The type of ground truth used

The ground truth used for performance evaluation is based on objective laboratory measurements of physical characteristics (dimensions, absorbency) and chemical/biological testing of materials, adhering to relevant standards for menstrual tampons. The "ground truth" for comparison is the established characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device