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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 , total yeast and mold count per USP , absence of pathogenic organisms per USP , and antimicrobial effectiveness per USP . 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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Walgreen's Personal Lubricating Jelly 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. It can ease insertion of rectal thermometers, enemas and tampons. This product is compatible with latex condoms.

Walgreen's Personal Lubricating Jelly is a non-sterile, aqueous based personal lubricant designed to supplement the body's own natural lubrication fluids. It is specifically formulated to be a clear, nonirritating, non-greasy, gel-like liquid and is compatible for use with or without a condom during intimate sexual activity as evidenced by condom compatibility test results. Walgreen's Personal Lubricating Jelly is a water-based personal lubricant containing chlorhexidine digluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water. This product is designed in LDPE tube w/ plastic flip-top cap.

The Walgreen's Personal Lubricating Jelly is a personal lubricant. The provided information does not describe an AI/ML device, therefore, the requested information on studies, test sets, ground truth, and training sets is not applicable.

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The submission is for a medical device (personal lubricant) and not an AI/ML device that would typically involve test sets or data provenance in this context. The product was tested by independent laboratories, but specific sample sizes and data provenance for these tests are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The submission is for a medical device (personal lubricant) and not an AI/ML device. Ground truth as typically understood for AI/ML validation is not relevant here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The assessment relied on laboratory testing for condom compatibility, biocompatibility, and preservative effectiveness, and comparison of chemical ingredients and intended use to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

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