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Replens Long-Lasting Vaginal Moisturizer is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Replens Long-Lasting Vaginal Moisturizer is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. It is a smooth, white, homogenous vaginal gel packaged with a reusable applicator. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water, Glycerin, Mineral Oil, Polycarbophil, Carbomer Homopolymer Type B, Hydrogenated Palm Oil Glyceride, Sorbic Acid, Benzyl Alcohol, Ethylhexylglycerin, tocopherol, and Sodium Hydroxide. Replens Long-Lasting Vaginal Moisturizer is packaged in a 35g aluminum tube (14 applications), with a reusable two-piece, blue translucent, polyethylene applicator designed to dispense 2.5g of lubricant.

The reusable applicator is packaged with an over-wrap in clear, biaxially oriented polypropylene film. The subject device and applicator are packaged together in a carton with a consumer leaflet.

The provided document is a 510(k) Pre-market Notification from the FDA regarding a medical device, the Replens Long-Lasting Vaginal Moisturizer. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with a test set, expert ground truth, or MRMC studies.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) are not applicable to this type of regulatory submission. The goal here is to show that the new device is as safe and effective as the predicate device, primarily through non-clinical performance testing and comparison of technological characteristics.

However, I can extract information related to what is presented as "acceptance criteria" in the context of this submission, which are primarily product specifications and performance testing results.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents product specifications as the "acceptance criteria" for the device itself, rather than acceptance criteria for a diagnostic algorithm's performance. The "reported device performance" is essentially that the device meets these specifications.

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

• Sample Size: Not applicable in the traditional sense of a "test set" for an AI or diagnostic algorithm. The testing described is primarily laboratory-based (e.g., chemical properties, microbial testing, biocompatibility).
• Data Provenance: Not explicitly stated regarding country of origin for the non-clinical tests. The tests themselves are laboratory tests following ISO and USP standards. All testing appears to be "prospective" in the sense that it was conducted specifically for this submission.

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

• Not applicable. This submission is for a personal lubricant, not a diagnostic device requiring expert interpretation of images or other clinical data to establish ground truth. Ground truth for the reported properties (e.g., pH, viscosity, microbial counts) is established by analytical methods and laboratory equipment.

4. Adjudication Method for the Test Set

• Not applicable. There is no human interpretation or adjudication involved in the type of laboratory testing described.

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

• No. This is not an AI/diagnostic device that would require an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a personal lubricant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the "acceptance criteria" presented (device specifications) is derived from:

• Analytical Chemistry and Physical Property Measurements: e.g., pH meters, viscometers, osmolality measurements.
• Microbiological Testing: e.g., plate counts for microbial limits, specific assays for pathogen absence and antimicrobial effectiveness.
• Biocompatibility Testing Standards: Following ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity).
• Condom Compatibility Standards: Following ASTM D7661-10.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that uses a "training set."

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

• Not applicable.

In summary: The provided document is a 510(k) premarket notification for a medical device (a personal lubricant). Its purpose is to demonstrate substantial equivalence to a predicate device, primarily through non-clinical performance data (product specifications, biocompatibility, shelf-life, condom compatibility). It does not involve a clinical study with human subjects, diagnostic performance metrics, or AI algorithms, which are often associated with the detailed "acceptance criteria" and "study" descriptions requested in the prompt.

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