(233 days)
Playtex scented or scented deodorized menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid; Playtex unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
This document describes the regulatory submission for Playtex Sport Tampons with OdorShield™, not a medical device that uses artificial intelligence or requires a clinical study with image data. Therefore, many of the requested categories for AI/clinical study information are not applicable.
Here's an analysis based on the provided text:
Device: Playtex Sport (Unscented/Scented) Tampons with OdorShield™
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | - Cytotoxicity: ISO Agar Overlay | - Evaluated according to FDA guidance and applicable standards. Results indicate compliance. |
| - Sensitization: Human Repeat Insult Patch Test | - Test articles (polar and non-polar extracts) evaluated for sensitization potential under occlusion (9 patch induction, 2-week rest, challenge, 72-hour monitoring) on a panel of women. Results indicate compliance. | |
| - Irritation & Acute Systemic Toxicity: Human Vaginal Irritation Study | - Both scented and unscented tampons provided to a panel of women over 2 menstrual cycles in a randomized double-blind study. Expert assessments (colposcopy) made at baseline, midpoint, and termination indicated compliance. | |
| Microbiology | - Zone of Inhibition | - Testing conducted. Results indicate compliance. |
| - TSST-1 Testing | - Results indicate compliance. | |
| Odor Absorption | - Testing to demonstrate effectiveness of OdorShield™ Technology | - Expert panel assessment on OdorShield™ Technology performed. |
| - Validated in consumer testing. (Specific quantitative results not provided in the summary, but implied to meet acceptance.) | ||
| Absorbency (Syngyna Testing per 21 CFR 801.430(f)(2)) | - Regular: Absorbs 6-9 grams of menstrual flow | - Syngyna testing conducted. Playtex Sport Regular tampons met the absorbency range of 6-9 grams. The tampons are labeled in accordance with these ranges. |
| - Super: Absorbs 9-12 grams of menstrual flow | - Syngyna testing conducted. Playtex Sport Super tampons met the absorbency range of 9-12 grams. The tampons are labeled in accordance with these ranges. | |
| - Super Plus: Absorbs 12-15 grams of menstrual flow | - Syngyna testing conducted. Playtex Sport Super Plus tampons met the absorbency range of 12-15 grams. The tampons are labeled in accordance with these ranges. | |
| Overall Substantial Equivalence | - The new tampon has the same technological characteristics as the predicate device (K060981) and the odor absorbing technology is already used in a currently marketed device (K070745). The only difference is the modified use of the odor absorbing technology. | - "Results of performance testing indicate that the subject tampon is substantially equivalent to the predicate devices." (Implied that all characteristics, including the modified odor absorbing technology, demonstrate equivalence or acceptable performance for safe and effective use.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Biocompatibility (Sensitization): A panel of women was used for the Human Repeat Insult Patch Test. Specific number not provided, but the description implies a prospective study involving human subjects.
- Biocompatibility (Irritation & Acute Systemic Toxicity): A panel of women of appropriate age was provided with tampons over 2 menstrual cycles. Specific number not provided. This was a randomized double-blind study, indicating a prospective design.
- Odor Absorption: An "expert panel" was used, followed by "consumer testing." Specific sample sizes for both are not provided. The study design (expert panel, consumer testing) suggests prospective data collection.
- Syngyna Testing: This is an in vitro laboratory test, not involving human subjects. The sample size would refer to the number of tampons tested, which is not specified. Data provenance would be laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Biocompatibility (Irritation & Acute Systemic Toxicity): "Expert assessments were made at baseline, midpoint and termination of study by colposcopy." The number of experts is not specified, but they are implied to be medical professionals capable of performing and interpreting colposcopic exams.
- Odor Absorption: An "expert panel" was used for assessment. The number of experts and their specific qualifications are not provided beyond being an "expert panel."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method like 2+1 or 3+1 for resolving discrepancies in expert assessments. It only mentions "expert assessments" and "expert panel assessment."
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 a physical product (tampon) and not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical product and does not involve any algorithms or standalone AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Biocompatibility:
- Sensitization: Human physiological response (skin reaction/sensitization).
- Irritation & Acute Systemic Toxicity: Medical expert (colposcopy) assessment of vaginal health, and implied absence of acute systemic toxicity symptoms.
- Microbiology: Laboratory results (Zone of Inhibition, TSST-1 detection thresholds).
- Odor Absorption: Expert panel consensus and consumer perception.
- Absorbency (Syngyna): Gravimetric measurements of liquid absorption against established regulatory standards.
8. The sample size for the training set
Not Applicable. This is a physical product, not an AI model, 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.
§ 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).