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

The subject devices, which are modified from the predicate devices, are unscented menstrual tampons consisting of a tampon (pledget with string) and an applicator. The tampons are made of rayon fiber and have absorbency ranges: regular (6-9 grams) and super (9-12 grams). The applicators are made of polyethylene and polypropylene and have four color versions.

The provided text is a 510(k) Summary for the Playtex Stella™ Tampons. It details the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted. However, it does not contain the specific acceptance criteria or the full study details that you requested.

Here's what I can extract and what is missing based on your request:

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

The document mentions "color leaching studies" and their analysis using "Tolerable Intake (TI) analysis of each component in the colorant formulation using ISO 10993-17:2002." This implies that the acceptance criteria for these studies would be that any leached components are within tolerable intake levels as defined by ISO 10993-17:2002. However, the specific quantitative acceptance criteria (e.g., maximum allowable concentration of a leached substance) and the actual reported performance (e.g., the measured concentrations) are not provided in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: The document states "The color leaching studies were conducted for new applicators." It does not specify the number of applicators or samples tested.
• Data provenance: Not specified.

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)

This section is not applicable as the studies described are non-clinical (chemical analysis for leaching, biocompatibility leverage) and do not involve human expert interpretation of data like medical imaging would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the studies described are non-clinical, involving chemical analysis rather than human interpretation requiring adjudication.

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

This section is not applicable. The device is a menstrual tampon, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a menstrual tampon, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the color leaching studies, the "ground truth" would be the established Tolerable Intake (TI) levels for each component, as defined by ISO 10993-17:2002. For the biocompatibility, the ground truth is based on historical data from the predicate device (K132819) which presumably met biocompatibility standards.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This section is not applicable. There is no mention of a "training set."

In summary:

The provided document describes non-clinical testing (color leaching and leveraging biocompatibility data) for a physical medical device (menstrual tampon). It mentions the methodology used (LC-MS, GC-MS, ISO 10993-17:2002 for tolerance) but lacks specific quantitative acceptance criteria or detailed study results and sample sizes that would typically be found in a full study report. The request for information related to AI or expert adjudication is not relevant to this type of device and submission.

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Playtex scented (or scented deodorized) and unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow

Scented (or scented deodorized) and unscented menstrual tampons for the absorption of menstrual fluid. The tampon consists of a pledget, string and applicator (barrel and plunger).

The provided text is related to a 510(k) submission for menstrual tampons, specifically regarding a change in the applicator color. It is not an AI/ML device, and therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.

However, I can extract the relevant "acceptance criteria" and the "study" that proves the device meets them from the document in the context of this specific regulatory submission.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a regulatory submission for a physical medical device (menstrual tampon) with a minor change (applicator color), not an AI/ML device relying on test sets of data. The "tests" mentioned are laboratory tests (Leaching Studies, Syngyna testing) performed on the device itself or its materials, not on a data set.

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)

This information is not applicable. Ground truth, in the context of expert consensus, is relevant for AI/ML diagnostic or measurement devices. For this physical device, "ground truth" refers to established scientific/regulatory standards for material safety and absorbency, measured through laboratory methods, not expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical trials or studies for AI/ML devices or human reader performance. The studies performed here are laboratory tests.

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

This information is not applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a menstrual tampon.

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

This information is not applicable. There is no algorithm involved in the performance or evaluation of this menstrual tampon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is based on established regulatory standards and scientific methodologies for biocompatibility (evaluated through leaching studies, indirectly confirming safety) and absorbency (Syngyna testing against 21 CFR §801.430(f)(2)). It's not based on expert consensus, pathology, or outcomes data in the way these terms are used for AI/ML devices.

8. The sample size for the training set

This information is not applicable. There is no AI/ML algorithm requiring a training set for this device.

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

This information is not applicable. Since there is no training set, there's no ground truth to establish for it.

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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

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.

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