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pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal application . intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, synthetic polyisoprene, and polyurethane condoms.

The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is a non-sterile, silicone-based personal lubricant. This over-the-counter product is formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® Backdoor Anal Glide or pjur® Analyse Me! Device is a silicone based lubricant contains neither a contraceptive nor a spermicide. The product contains Cyclopentasiloxane, Dimethicone, Dimethiconol, and jojoba.

This document is a 510(k) Pre-market Notification for a medical device, specifically personal lubricants. It does not contain information about an AI/ML powered medical device study with acceptance criteria. Instead, it details the substantial equivalence of the "pjur® Backdoor Anal Glide or pjur® Analyse Me!" personal lubricants to a predicate device, "Wet Platinum Premium Lubricant® (K130012)".

The "acceptance criteria" discussed are related to the performance of the lubricant itself and its compatibility with condoms, rather than the performance of an AI algorithm.

Here's a breakdown of the requested information based on the provided document, noting where the information is not applicable to AI/ML studies:

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

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