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Scented, Scented Deodorant and Unscented menstrual tampons for absorption of menstrual fluid: Part 21 C. F. R., Section 884.5460 and Section 884.5470 respectively.

Scented or scented deodorant and unscented menstrual tampons for the absorption of menstrual fluid.

The provided document is a 510(k) summary for Playtex Tampons, seeking substantial equivalence to previously cleared devices. It describes the device, its intended use, and the nonclinical testing performed. However, it does not contain the detailed information necessary to complete a table of acceptance criteria, reported device performance, or elaborate on a specific study as requested.

Here's a breakdown of why the requested information cannot be fully provided from the text:

• Acceptance Criteria & Device Performance: The document states that the new Playtex tampons are "substantially equivalent" to predicate devices. This implies that the performance of the new tampons is expected to be comparable to the predicate devices and meet established safety standards. However, it does not explicitly list specific acceptance criteria (e.g., absorbency rates, leakage rates, or specific irritation scores) nor does it provide quantified reported device performance metrics against those criteria. The "nonclinical testing" listed (human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion and TSST-1 toxin testing) are the types of tests conducted, but not the results or the thresholds for acceptance.
• Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): The document focuses on regulatory submission and a declaration of substantial equivalence based on nonclinical testing referenced. It does not describe a clinical study with a detailed methodology, sample sizes, ground truth establishment, or expert involvement in the way a diagnostic device study would. The "study" here refers to the overall assessment of the device's characteristics against known safety and performance data for similar devices.

Given the limitations of the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Note: The performance is reported as "substantially equivalent" to predicate devices, rather than specific quantitative metrics. The acceptance criteria are inferred from the types of nonclinical tests performed and the claim of substantial equivalence to previously cleared devices.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified in the document. The nonclinical tests listed typically involve in-vitro assays or animal studies, and potentially human patch tests for sensitization/irritation, but the sample sizes for these are not provided.
• Data Provenance: Not explicitly stated. The tests are general nonclinical tests. It's likely these were conducted in a controlled lab environment. The country of origin of the data is not mentioned, but the submitting company is Playtex Products Inc., based in Paramus, New Jersey, USA. The studies are retrospective in the sense that they are supporting a premarket notification for a device that is compared to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided. For nonclinical tests like those listed, "ground truth" typically refers to established scientific methodologies and thresholds in toxicology and material science, rather than expert consensus on diagnostic images or clinical outcomes. The studies are likely interpreted by relevant toxicologists, microbiologists, and material scientists within the company or at contracted labs.

4. Adjudication method for the test set

• Not applicable/not specified. Adjudication methods like "2+1" are relevant for clinical studies, especially those involving multiple readers interpreting data where consensus or tie-breaking is needed. For the nonclinical tests mentioned, results are typically objective measurements against a standard.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (MRMC, AI assistance) is completely irrelevant to the context of a menstrual tampon and a 510(k) submission based on substantial equivalence through nonclinical testing. This category of study is specific to diagnostic imaging devices or AI-powered clinical decision support systems.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No, this is not applicable. The device is a physical product (menstrual tampon), not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for the nonclinical tests is based on established scientific standards, toxicological profiles, and material science specifications for analogous predicate devices and general safety requirements for medical devices. For example, a "dermal irritation" test would have an objective scoring system based on visual assessment by trained personnel (e.g., Draize scale) or instrumental measurements, compared against predefined thresholds for what constitutes an acceptable level of irritation. Similarly, TSST-1 toxin testing would involve laboratory culture methods and quantitative analysis against recognized safety limits.

8. The sample size for the training set

• Not applicable. The concept of a "training set" is relevant for machine learning algorithms. For a physical medical device submitted via 510(k), testing (nonclinical) is performed to demonstrate substantial equivalence to predicate devices, not to "train" an algorithm.

9. How the ground truth for the training set was established

• Not applicable, as there is no "training set" in this context.

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