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unscented menstrual tampons used to absorb menstrual fluid.

TAMPAX Tampons, Plastic Applicator will be provided in three absorbencies, regular, super and super plus. TAMPAX Tampons, Plastic Applicator have a colored plastic applicator. TAMPAX Tampons, Plastic Applicator are made of rayon fibers and overwrap, a cotton withdrawal cord, and a colored plastic applicator.

This device is a medical device, but not one that typically utilizes the types of acceptance criteria and studies you've requested (e.g., related to algorithms, expert consensus, or specific performance metrics like sensitivity/specificity). The provided text is for a menstrual tampon, and the assessment is focused on safety and equivalence to a predicate device, particularly regarding the addition of a colored applicator.

Therefore, many of the requested fields are not applicable in the context of this 510(k) summary. I will fill in the relevant information and indicate "N/A" (Not Applicable) for those that don't fit this type of device submission.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

• "The results of these tests demonstrate that TAMPAX Tampons, Plastic Applicator are equivalent in terms of their safety and effectiveness to legally marketed tampons." |
  | - Biocompatibility: No significant leaching of substances (extraction). | |
  | Clinical: | |
  | - Safety: No increased product-related irritation compared to control. | - Clinical study showed "no differences in product related irritation or comfort between TAMPAX Tampons, Plastic Applicator and the control product." |
  | - Safety: No significant or unexpected adverse events. | - "No significant or unexpected adverse events were observed during the study." |
  | - Effectiveness: Equivalent to predicate (implied by safety and "substantially equivalent" claims). | The study focused on safety, and the conclusion states "the addition of colorant to the Plastic Applicator does not alter the safety or effectiveness of the device and that TAMPAX Tampons, Plastic Applicator are as safe and as effective as predicate, legally marketed tampons." This implies equivalence in effectiveness as well, primarily by not diminishing the existing effectiveness of the tampon design due to the colorant. |

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

• Sample Size (Clinical Test Set): 57 women
• Data Provenance: Not explicitly stated (e.g., country of origin). It was a prospective clinical study.

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

• N/A. Ground truth in this context is self-reported irritation/comfort by the study participants and observation of adverse events by clinical staff, rather than expert interpretation of data.

4. Adjudication method for the test set

• N/A. Not applicable for this type of self-reported outcome and safety observation study.

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/imaging device, so an MRMC study is not relevant.

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

• No. This is not an algorithmic device.

7. The type of ground truth used

• Clinical Endpoints: Patient-reported comfort and irritation, observation of adverse events during clinical study.
• Bench/Lab Endpoints: Results from irritation, sensitization, cytotoxicity, and extraction assays for biocompatibility.

8. The sample size for the training set

• N/A. There is no "training set" in the context of this type of traditional device submission. The study itself is an evaluation of the finished product.

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

• N/A. Not applicable.

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Tampax Tampons with Additive are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Tampons with Additive are menstrual tampons used to absorb menstrual fluid. Tampax Tampons with Additive will be provided in 4 absorbencies, junior, regular, super and super plus. Tampax Tampons with Additive are made of cotton and/or rayon fibers and overwrap, cotton cord, and an additive. The applicator used in Tampax tampons with Additive is flushable and biodegradable. Except for the additive, the materials used in Tampons with Additive are identical to those used in other legally marketed Tampax tampons. This additive has been adequately characterized and evaluated using scientifically valid safety tests.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Tampax Tampons with Additive," structured according to your request.

It's important to note that the provided text describes a medical device (tampons) and not an AI/software device. Therefore, some of your requested categories (like "MRMC comparative effectiveness study," "standalone algorithm performance," "sample size for training set," and "ground truth for training set") are not applicable in this context and will be marked as such.

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: Not explicitly stated for the clinical study. The text mentions "A clinical study was done" and "The study compared Tampax Tampons with Additive to a control tampon," indicating a comparative study, but the specific number of participants is not provided.
   • Data Provenance: Not specified (e.g., country of origin). The study was conducted as a "clinical study" to evaluate safety and compare it to predicates, implying a prospective design.

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

   • This question is not applicable to this type of device and study. The "ground truth" for tampon safety and effectiveness is established through clinical observation, patient reported outcomes, and laboratory testing rather than expert-labeled image data.

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

   • This question is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in image interpretation or diagnostic tasks. In this clinical study, safety endpoints would likely be assessed by investigators and reported (e.g., through adverse event reporting, physical examinations, and patient questionnaires).

4. 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 question is not applicable. This is not an AI-assisted device.

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

   • This question is not applicable. This is not an algorithm-driven device. The "device performance" refers to the physical product itself.

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

   • The "ground truth" for the non-clinical testing was established through laboratory testing (biocompatibility, microbiology).
   • For the clinical testing, the "ground truth" for safety and effectiveness was established through clinical observation, patient feedback (comfort, irritation), and assessment of adverse events, which can be considered a form of outcomes data and clinical endpoints. The comparison was against a "control tampon."

7. The sample size for the training set:

   • This question is not applicable. This is not an AI/machine learning device that requires a training set.

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

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

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