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Replens is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.

Replens Vaginal Moisturizer is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining vaginal gel delivered in single-use, pre-filled applicators as a long-lasting moisturizer for vaginal dryness. The use of prefilled applicators provides less mess in application. Replens Vaginal Moisturizer is intended for ongoing use, not exclusively for use during intimate sexual activity.

The provided document is a 510(k) Summary for Replens Long-Lasting Vaginal Moisturizer (in pre-filled applicators). It primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than establishing a new device's performance against explicit acceptance criteria in a typical clinical study format for novel devices.

Therefore, the requested information, particularly regarding specific acceptance criteria, comprehensive effect sizes, and detailed ground truth establishment methods for a standalone AI algorithm, is largely not applicable or not explicitly stated in this type of regulatory submission. The document outlines safety and performance data in relation to its intended use and comparison to a predicate device.

However, I can extract and infer some information based on what is provided:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a personal lubricant, the "acceptance criteria" are generally tied to demonstrating safety, intended use (moisturizing and lubrication), and compatibility with condoms, rather than a quantifiable performance metric (like accuracy or sensitivity) typically seen in AI or diagnostic devices. The acceptance is implied by successfully passing various tests.

2. Sample Sizes and Data Provenance for Test Set (Clinical Studies)

The "test set" in this context refers to the clinical studies used to support the safety and efficacy of the Replens device.

• Whitehead (1991): 32 patients enrolled (Replens group)
• Nachtigall (1994): 15 patients enrolled
• Gelfand and Wendman (1994): 25 patients enrolled
• Bachmann et al. (1991): 89 patients enrolled (Replens group)
• Bachmann et al. (1992): 54 patients enrolled
• Zinny and Lee (1991): 26 patients enrolled
• Young et al. (1991): 30 patients enrolled
• Nakamura (1991): 10 patients enrolled

Data Provenance: The document does not explicitly state the country of origin for each study. However, authors like Bachmann, Nachtigall, Gelfand, and Wendman are typically associated with studies conducted in North America (primarily the US). Retrospective or Prospective: The study designs (double-blind, cross-over, open, parallel) indicate these were prospective clinical trials.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the summary. For a medical device like Replens, "ground truth" would be established through patient-reported outcomes, clinical assessments (e.g., pH measurements, vaginal dryness index assessment by a clinician), and potentially histological examination (as mentioned for subacute vaginal irritation). The specific number and qualifications of experts involved in these assessments are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Clinical studies typically have methods for assessing patient outcomes and safety events, but a specific "adjudication method" in the context of diagnostic agreement (like for imaging AI) is not relevant or described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed as this device is a personal lubricant, not an AI diagnostic tool. The concept of "human readers improving with AI vs. without AI assistance" is not applicable here.

6. Standalone Performance Study

Yes, the clinical studies listed (Bachmann et al., Nachtigall, Gelfand and Wendman, Zinny and Lee, Young et al., Nakamura) represent standalone performance studies for the Replens device. They assess its effects, safety, and patient-reported outcomes without "human-in-the-loop" interaction in the sense of an AI algorithm enhancing human decision-making.

7. Type of Ground Truth Used

The ground truth used in the clinical studies for Replens appears to be a combination of:

• Clinical Assessments: Vaginal pH determination, vaginal mucosa observations, vaginal dryness index.
• Patient-Reported Outcomes: Relief of patient's symptoms (vaginal dryness), completion of diary cards.
• Pathology: Histological examination (for subacute vaginal irritation testing).
• Safety Data: Adverse event reporting and tolerability assessments.

8. Sample Size for the Training Set

This information is not applicable. Replens is a medical device (personal lubricant), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical studies mentioned serve as the evidence base for its safety and efficacy.

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

This information is not applicable as there is no training set for an AI algorithm.

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