(76 days)
Paragon Menstrual Tampons are a plug made of cellulosic or synthetic material that is inserted into the vaginal and used to absorb menstrual or other vaginal discharge.
Paragon Trade Brands Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus. These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord. The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.
The provided text describes a 510(k) summary for "Paragon Trade Brand Tampons" (K981953), which are menstrual tampons used to absorb menstrual fluid. The submission focuses on demonstrating substantial equivalence to legally marketed Tampax tampons with applicators rather than establishing novel acceptance criteria through a specific clinical study with a device performance table.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not directly applicable or explicitly stated in the provided text. However, I can extract the relevant information and indicate where data is not available from the text.
Here's an analysis based on the provided documents:
Acceptance Criteria and Device Performance
The core of this submission is substantial equivalence to a predicate device (Tampax tampons with applicators), not a new set of numerical performance acceptance criteria. The "acceptance criteria" are implicitly met if the device is found to be substantially equivalent in terms of safety and effectiveness to the predicate.
| Acceptance Criteria Category | Reported Device Performance (Paragon Trade Brand Tampons) |
|---|---|
| Material Composition | Made from rayon and cotton and cotton cord. Similar to materials used in other legally marketed tampons. |
| Intended Use | Inserted into the vagina to absorb menstrual fluid. Identical to predicate device. |
| Biocompatibility | Components demonstrated equivalence to legally marketed tampons in terms of safety and effectiveness. |
| Irritation (O-Irritation) | Tested (result implied to be acceptable for substantial equivalence). |
| Sensitization (O-Sensitization) | Tested (result implied to be acceptable for substantial equivalence). |
| Acute Oral Toxicity (O-Acute Oral Toxicity) | Tested (result implied to be acceptable for substantial equivalence). |
| Eye Irritation (O-Eye Irritation) | Tested (result implied to be acceptable for substantial equivalence). |
| Cytotoxicity (O-Cytotoxicity) | Tested (result implied to be acceptable for substantial equivalence). |
| Dioxins and Furans Analysis | Tested (result implied to be acceptable for substantial equivalence). |
| Absorbency (Syngyna Testing) | Confirmed absorbency. Implied to be comparable/equivalent to predicate device for each of the three absorbencies (regular, super, super plus). |
Study Details (Based on available information in the 510(k) Summary)
The "study" described is a non-clinical testing program to support substantial equivalence.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual tests. The text mentions "Biocompatibility testing of the Paragon Trade Brands Tampons components" and "Standard Syngyna testing confirmed the absorbency of these Tampons." The number of samples or items tested for each specific biocompatability assay (irritation, sensitization, etc.) or Syngyna absorbency is not provided.
- Data Provenance: Not explicitly stated, but typically non-clinical testing like this would be conducted in a laboratory setting, likely within the US or by a contracted lab. It is retrospective in the sense that the testing was performed on the completed device design.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical testing like biocompatibility or absorbency is established by the standardized test methods themselves and the quantitative or qualitative results obtained from those tests, not by expert consensus on interpretations of complex data like medical images. For instance, Syngyna testing has a defined protocol for measuring absorbency.
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Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving multiple expert readers interpreting subjective data (like medical images) to establish a consensus ground truth. This submission describes non-clinical laboratory testing. The results of tests like biocompatibility or absorbency are typically numerical or based on predefined pass/fail criteria, not subjective expert judgment requiring adjudication.
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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 device is a menstrual tampon, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI performance metrics are irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. As stated above, this device is not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility tests (irritation, sensitization, toxicity, cytotoxicity, dioxins/furans), the "ground truth" is established by the standardized test methodologies and their direct results (e.g., specific cellular reactions, chemical levels, lack of observed adverse effects). These results are then compared to established safety profiles for similar materials or predicate devices.
- For absorbency, the "ground truth" is established by the quantitative measurement obtained through standard Syngyna testing.
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The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- This is not applicable as there is no training set for this device.
§ 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).