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The CottonDay Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.

CottonDay Tampon will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. 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 two absorbencies: Regular and Super.

The provided text describes a 510(k) premarket notification for a medical device: the CottonDay Tampon. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on a study with a test set, ground truth, and expert evaluation as would be the case for a novel AI/ML device.

Therefore, many of the requested elements for an AI/ML device (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for a tampon.

The "acceptance criteria" in this context are the regulatory requirements for showing substantial equivalence for medical devices like tampons, primarily through non-clinical performance testing and biocompatibility.

Here's how to interpret the information provided in the context of the requested parameters, with explanations for why certain elements are not present:

1. A table of Acceptance Criteria and the Reported Device Performance

For this type of device, "acceptance criteria" are typically defined by recognized standards and FDA guidance for tampons. The document doesn't provide a strict pass/fail table with numerical thresholds for every test, but rather states that tests were performed "in accordance with" guidance and "met the requirements."

• Pledget Length: Regular 38mm (Predicate 43-46mm), Super 47mm (Predicate 48-51mm)
• Pledget Diameter: Regular 12mm (Predicate 11-12mm), Super 12mm (Predicate 12-13mm)
• Applicator Inner Length: Regular 73 ± 5% (Predicate 120 ± 5%), Super 73 ± 5% (Predicate 120 ± 5%)
• Applicator Outer Length: Regular 76.5 ± 5% (Predicate 120 ± 5%), Super 76.5 ± 5% (Predicate 120 ± 5%)
• Applicator Inner Diameter: Regular 11.8 ± 5% (Predicate 13mm), Super 11.8 ± 5% (Predicate 16mm)
• Applicator Outer Diameter: Regular 14.1 ± 5% (Predicate 13mm), Super 14.1 ± 5% (Predicate 16mm)
  Note: "Differences in technological characteristics do not raise different questions of safety and effectiveness." |
  | Absorbency Range (Syngyna Absorbency) | Compared to Predicate:
• Regular: 6.0 - 9.0 (Predicate 6.0)
• Super: 9.0 - 12.0 (Predicate 9.0 - 12.0)
  Note: "Differences in technological characteristics do not raise different questions of safety and effectiveness." |
  | Chemical Residues | Assessed in accordance with guidance; implied to meet requirements. |
  | Withdrawal Cord Strength | Assessed in accordance with guidance; implied to meet requirements. |
  | Fiber Shedding | Assessed in accordance with guidance; implied to meet requirements. |
  | Tampon Integrity | Assessed in accordance with guidance; implied to meet requirements. |
  | Biocompatibility Testing (per ISO 10993-1, 10993-5, 10993-10, 10993-11) | |
  | Cytotoxicity (MEM Elution Test) | Results met the requirements of ISO 10993-5:2009. |
  | Sensitization (Guinea Pig Maximization Test) | Results met the requirements of ISO 10993-10:2010. |
  | Irritation (Vaginal Irritation Test) | Results met the requirements of ISO 10993-10:2010. |
  | Acute Systemic Toxicity | Results met the requirements of ISO 10993-11:2006. |
  | Microbiology Testing (per 2005 FDA Guidance) | |
  | Does not enhance Staphylococcus aureus growth | Conducted; implied to demonstrate no enhancement. |
  | Does not increase TSST-1 production | Conducted; implied to demonstrate no increase. |
  | Does not alter normal vaginal microflora | Conducted; implied to demonstrate no alteration. |

Study to Prove Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is the non-clinical performance, biocompatibility, and microbiology testing summarized in section 9 of the 510(k) summary. These tests are standard for tampons and are designed to address the safety and effectiveness concerns for such a device.

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

• Sample Size for Test Set: Not explicitly stated in the document. For physical and chemical tests on medical devices, sample sizes are typically defined by the relevant standards and validated test procedures. These are not 'datasets' in the AI/ML sense but rather physical units of the product.
• Data Provenance: Not explicitly stated. These tests are typically conducted in accredited labs (often contract research organizations) and are generally prospective, specific to the device being submitted. Country of origin for testing is not provided, but the applicant (Taebong Co., Ltd.) is from Korea.

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

• Not Applicable. For a tampon, "ground truth" as per AI/ML terminology (e.g., annotated images by radiologists) does not apply. The "truth" is established by the results of standardized instrumental and biological tests measured against predefined chemical/physical/biological thresholds. The expertise lies in the certified laboratory personnel performing the tests according to published standards.

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

• Not Applicable. Adjudication is relevant for subjective human interpretation tasks (like image review). These are objective laboratory tests. Results are typically quantitative measurements compared to specified limits.

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. This is not an AI/ML device. MRMC studies are used to evaluate diagnostic accuracy and impact of AI on human performance in diagnostic tasks, which is not relevant for a tampon.

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

• Not Applicable. This is not an AI/ML algorithm.

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

• Not Applicable (in the AI/ML sense). The "ground truth" is defined by the established, scientifically validated standards and guidance documents (e.g., ISO 10993 series, FDA guidance for tampons) that specify acceptable limits for physical, chemical, and biological properties.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set.

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

• Not Applicable. As there is no training set, this question is not relevant.

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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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