(24 days)
Paragon Trade Brands Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470)
Paragon Trade Brands Digital Tampons are made of a plug of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Paragon Trade Brands Digital 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 the 510(k) summary for "Paragon Trade Brand Digital Tampons." However, the device is not an AI/ML device, but rather a traditional medical device (menstrual tampons). Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.
Here's the relevant information that can be extracted from the provided text, structured according to your request, with "Not Applicable" for AI/ML specific criteria:
Acceptance Criteria and Device Performance for Paragon Trade Brand Digital Tampons
This submission describes a traditional medical device (menstrual tampons), not an AI/ML device. Therefore, the acceptance criteria and study details are focused on traditional medical device safety and performance, primarily demonstrating substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Material Safety | Biocompatibility | "equivalent in terms of safety and effectiveness to legally marketed tampons" |
| Irritation Testing | Not explicitly reported for this device, but "Relevant Studies from the literature include" irritation testing. | |
| Sensitization Testing | Not explicitly reported for this device, but "Relevant Studies from the literature include" sensitization testing. | |
| Acute Oral Toxicity | Not explicitly reported for this device, but "Relevant Studies from the literature include" acute oral toxicity. | |
| Eye Irritation Testing | Not explicitly reported for this device, but "Relevant Studies from the literature include" eye irritation testing. | |
| Gene Toxicology Studies | Not explicitly reported for this device, but "Relevant Studies from the literature include" gene toxicology studies. | |
| Chronic Studies | Not explicitly reported for this device, but "Relevant Studies from the literature include" chronic studies. | |
| Reproductive Studies | Not explicitly reported for this device, but "Relevant Studies from the literature include" reproductive studies. | |
| Cytotoxicity Testing | Conducted for Paragon Trade Brands Components. Implied compliance with safety standards. | |
| Dioxins and Furans Analysis | Conducted for Paragon Trade Brands Components. Implied compliance with safety standards. | |
| Functional Performance | Absorbency (Syngyna Test) | "Standard Syngyna testing confirmed the absorbency of these Tampons." |
| Substantial Equivalence | Comparison to Predicate Device (Tampax) | Deemed "substantially equivalent" to legally marketed Tampax tampons with applicators. Materials and intended use are similar. |
2. Sample size used for the test set and the data provenance
Not Applicable (N/A) for AI/ML test sets. The non-clinical testing involved material characterization and absorbency testing (Syngyna testing). The text does not specify the sample sizes for these tests, nor the "country of origin of the data" in a way relevant to clinical data. The studies performed were non-clinical bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A for AI/ML-style ground truth. The "ground truth" here is based on chemical and physical testing standards for biocompatibility and absorbency, not expert human interpretation of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This concept applies to expert consensus in AI/ML performance evaluation, which is not relevant here.
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
N/A. This device is a tampon, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a tampon, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established through standardized non-clinical laboratory testing (e.g., biocompatibility assays, Syngyna absorbency testing) and comparison to the known safety and performance of legally marketed predicate devices (Tampax tampons).
8. The sample size for the training set
N/A. This device is not an AI/ML model and does not have a "training set."
9. How the ground truth for the training set was established
N/A. This device is not an AI/ML model and does not have a "training set" with associated ground truth.
§ 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).