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

The Farma-Derma Repagyn Vaginal Suppositories are a non-sterile hyaluronic acid and glycerides based semi-solid preparation presented in the form of vaginal suppositories of 2 g in weight individually packed in a polyvinyl chloride (PVC)/polyethylene (PE) blister. The device is available for sale in a pack containing 10 vaginal suppositories (two blisters of 5 vaginal suppositories each) while the sample pack contains 3 vaginal suppositories (one blister).

Due to its specific shape the device can be introduced into the vaginal cavity using a finger.

Repagyn Vaginal Suppositories are a Hyaluronic acid (HA) based product; the HA is mixed in with semi-synthetic glycerides that represent the major quantity of material used in the formulation.

When the vaginal suppository is in contact with the vaginal mucosa it melts due to body temperature and becomes a viscous mass which remains in contact with the vaginal mucosa.

It acts similarly to other vaginal creams or gels for topical application with Hyaluronic acid based formulations.

This document is a 510(k) premarket notification for a medical device called "Repagyn Vaginal Suppositories." It is a submission to the FDA (Food and Drug Administration) for clearance to market the device.

The document does not contain information related to software or AI-based medical devices. It describes a physical medical device (vaginal suppositories) and its performance data, which focuses on biocompatibility, shelf life, and condom compatibility.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details for AI/software performance, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance. The questions in your prompt are geared towards evaluating AI/software performance, which is not applicable to the content of this document.

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