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Playtex® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

Absorbency Ranges:

Absorbs menstrual flow < 6 grams (Slender Light)

Absorbs menstrual flow 6-9 grams (Slender Regular, Regular)

Absorbs menstrual flow 9-12 grams (Super)

Absorbs menstrual flow 12-15 grams (Super Plus)

Absorbs menstrual flow 15-18 grams (Ultra)

Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.

The Playtex® Gentle Glide Scented and Unscented Tampons (K120245) have specific acceptance criteria related to absorbency, which were verified through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device meets these acceptance criteria, as stated in the performance testing section: "Syngyna testing was conducted in accordance to 21 CFR §801.430(f)(2) to verify that the modified tampons met absorbency ranges as specified in the regulation."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size for the "Syngyna testing" (absorbency testing) or the biocompatibility tests. It only mentions that these tests were "conducted." The data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this device is a menstrual tampon and the primary performance testing involves absorbency measurements, there isn't a "ground truth" derived from expert consensus in the same way it would be for a diagnostic AI device. The ground truth for absorbency is established by the standardized Syngyna testing method itself, as defined by 21 CFR §801.430(f)(2).

For the biocompatibility tests (preclinical and clinical), these are standard in vitro and in vivo tests that would be conducted by trained laboratory personnel, but not "experts" in the sense of clinicians establishing ground truth for a diagnostic outcome.

4. Adjudication Method for the Test Set

Not applicable. The absorbency tests are objective measurements, and biocompatibility tests involve standardized protocols and observations. There is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This is a medical device (menstrual tampon), not a diagnostic AI software. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the absorbency performance is based on objective measurements obtained through the standardized Syngyna testing method, as mandated by federal regulation (21 CFR §801.430(f)(2)).

For the biocompatibility tests, the ground truth is established through standard laboratory test results (e.g., cytotoxicity, irritation, sensitization, TSS).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of its development and testing as described in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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