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The Tosama Biobased Applicator Tube Menstrual Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.

The device will be offered as a traditional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator comprised of biobased plastic. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.

This document is a 510(k) premarket notification for a medical device (a menstrual tampon) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of a novel AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically involve acceptance criteria related to accuracy, sensitivity, and specificity, and the elements of an MRMC study.

Therefore, the requested information regarding AI/SaMD performance metrics (such as a table of acceptance criteria for device performance, ground truth establishment, expert adjudication, MRMC studies, training/test set details, etc.) is not applicable to this document.

However, the document does contain "acceptance criteria" in the context of non-clinical testing for the physical and biological properties of the tampon. I can extract that information.

Here's a breakdown of the information that is available in the provided text, adapted to the closest relevant sections of your request:

Study on Device Meeting Acceptance Criteria (Non-Clinical)

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

The document states: "The results of these tests met pre-defined acceptance criteria as applicable and are acceptable." It does not provide the specific numerical acceptance criteria or the numerical results for each test. However, it lists the types of tests performed.

Note: The specific numerical "pre-defined acceptance criteria" for each test (e.g., minimum pull-out strength, maximum microbial counts) are not provided in this document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test. The testing was conducted on "All materials used in the construction of Tosama Biobased Applicator Tube Menstrual Tampons as well as complete devices" and "each absorbency level of the complete finished device." This implies a sufficient number of samples were tested to demonstrate compliance, but the exact number isn't quantified.
• Data Provenance: Not explicitly stated, but given the company (Tosama, d.o.o.) is based in Slovenia, EU, it's highly probable the testing was conducted in Europe. The data refers to non-clinical lab testing. These would be prospective experimental tests conducted 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 as this is a physical/biological product validation, not a diagnostic device involving expert human interpretation for "ground truth." The ground truth for these tests is established by quantifiable physical, chemical, and biological measurements following established standards (e.g., ISO, FDA guidance).

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

• Not applicable for non-clinical lab testing. The results are based on objective measurements against pre-defined 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

• Not applicable. This is not an AI/SaMD device.

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

• Not applicable. This is not an AI/SaMD device.

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

• The "ground truth" for the non-clinical tests is established by objective laboratory measurements against recognized international standards and FDA guidance. Examples include:
  • Quantifiable values from biocompatibility assays (e.g., cell viability).
  • Microbial counts from culture methods.
  • Measured absorbency in grams.
  • Physical dimensions in millimeters/grams.
  • Measured force for withdrawal cord pull-out strength.

8. The sample size for the training set

• Not applicable. This is not an AI/SaMD device requiring a training set.

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

• Not applicable. This is not an AI/SaMD device requiring a training set.

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