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Climax Personal Lubricant is a personal lubricant, for penile and/or 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, polyurethane, and polyisoprene condoms.

Climax Personal Lubricant is a non-sterile, water soluble, viscous liquid which is intended to be used as a personal lubricant. The ingredients are Purified Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Diazolidinyl Urea, Methylparaben, Propylparaben. The product specifications include appearance, color, odor, pH, viscosity, specific gravity, osmolality, total aerobic microbial count per USP <61>, total yeast and mold count per USP <61>, absence of pathogenic organisms per USP <62>, and antimicrobial effectiveness per USP <51>. Climax Personal Lubricant is packaged in 5 fl. oz, and 6.5 fl. oz. bottles.

This document describes the premarket notification (510(k)) and summary for a personal lubricant, "Climax Personal Lubricant." It is not for a medical device that uses AI or complex algorithms requiring extensive performance testing with clinical data, ground truth establishment, or multi-reader studies.

Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment cannot be provided from this document as it is not relevant to the type of device (personal lubricant) being discussed.

The document focuses on demonstrating substantial equivalence to a predicate device based on:

• Indications for Use: Same as predicate.
• Technological Characteristics: Largely similar to predicate, with differences not raising new safety/effectiveness questions.
• Performance Testing:
  • Biocompatibility: Tested per ISO 10993 standards (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity).
  • Condom Compatibility: Tested per ASTM D7661-10 with natural rubber latex, polyurethane, and polyisoprene condoms.
  • Shelf Life: Demonstrated maintenance of specifications over proposed shelf life.

The acceptance criteria here are based on meeting these standardized tests rather than clinical performance metrics typical for diagnostic or AI-powered devices. No "ground truth" in the clinical sense (e.g., disease presence/absence determined by pathology) is applicable here.

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The CLIMAX condom is used for contraception and for prophylactic purposes( to help prevent pregnancy and the transmission of sexually transmitted diseases).

CLIMAX Male Natural Rubber Latex Condom

The provided text is related to an FDA 510(k) clearance for "CLIMAX Male Latex Condoms". It does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML medical device.

Therefore, I cannot provide the requested information from the text. The document is a regulatory clearance letter, not a device performance study report.

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