(52 days)
Scented or scented deodorized tampons for absorption of menstrual fluid. Unscented menstrual tampons for absorption of menstrual fluid.
Scented or scented deodorant and unscented menstrual tampons for the absorption of menstrual fluid.
This document describes the 510(k) submission for "Playtex Tampons," specifically for scented deodorant and unscented varieties. However, it does not contain information about formal acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, sample sizes for training/testing, or expert involvement as typically required for AI/algorithm-based medical devices.
Instead, this submission is centered on demonstrating substantial equivalence to previously cleared predicate devices, a common pathway for medical devices that are similar to devices already on the market. The provided text is a 510(k) summary and the FDA's clearance letter.
Therefore, many of the requested sections about acceptance criteria and study details cannot be filled based on the provided text.
Here's an analysis of what can and cannot be extracted:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics with thresholds (e.g., sensitivity, specificity). The acceptance criteria for a 510(k) submission like this are generally demonstrating substantial equivalence in terms of safety and effectiveness to a predicate device. This is achieved through nonclinical testing and comparison of technological characteristics.
- Reported Device Performance: No quantitative performance metrics (e.g., absorption capacity, leakage rates) are reported in the provided text. The performance is implied to be equivalent to the predicate devices.
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 specified.
- Data Provenance: Not specified.
- The nonclinical testing referenced includes: Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing. These are typically lab-based tests, not clinical studies with "test sets" in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not a study requiring expert-established ground truth for a test set as it's a submission for a physical medical device (tampon) rather than an AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of an algorithm's ground truth. For the physical device, the "ground truth" for safety and effectiveness would be established through standard laboratory testing methods comparing the device's properties (e.g., toxicity, irritation) to established safety standards and the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device and Approval Process from the Provided Text:
- Device Name: Playtex Tampons (Scented Deodorant and Unscented)
- Intended Use: Absorption of menstrual fluid.
- Substantial Equivalence: The device is claimed to be substantially equivalent to previously cleared Playtex Gentle Glide®, Slimfits™, and Soft Comfort™ Tampons. The new tampon has the same technological characteristics and mode of action as the predicate devices.
- Nonclinical Testing: Referenced for substantial equivalence determination. This included tests for human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing. These tests are typically performed to assess the safety of materials and formulations.
- Outcome: The FDA determined the device to be substantially equivalent to predicate devices, thus allowing it to be marketed.
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).