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This product is intended for penile, vaginal and/or anal application 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

KY Grosz Liquid is a is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of Water, PEG-400, Propylene glycol, Xanthan Gum, Carbomer, Benzoic acid, Sodium saccharin, and Sodium hydroxide. KY Grosz Liquid may be packaged in 1.5 fl. oz. (44 mL) or 4.5 fl. oz. (133 mL) bottles composed of high density polyethylene (HDPE), sealed and fitted with a polypropylene (PP) cap. The individual bottles are packaged in an outer cardboard carton. KY Grosz Liquid is a personal lubricant for over-the-counter (OTC) use.

This document describes the premarket notification (510(k)) for the KY Grosz Liquid, a personal lubricant. It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness in comparison to a predicate device, KY Banksy Aloe.

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Information

The document describes several performance tests conducted for the KY Grosz Liquid. However, it does not provide all the granular details requested regarding specific sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, or training set specifics for AI/algorithm-related studies. This is expected as the product is a personal lubricant, not an AI/ML-based medical device.

1. Sample sizes used for the test set and the data provenance:

• Shelf Life: The document states that stability studies were performed, but does not provide the specific sample size of product units tested or the duration of the accelerated aging study. Data provenance is implied to be from the manufacturer's internal testing.
• Biocompatibility Studies (Cytotoxicity, Vaginal Irritation, Sensitization, Acute Systemic Toxicity):
  • Cytotoxicity: Tested on L-929 cells. Sample size of cells or test replicates not specified.
  • Vaginal Irritation: Tested on rabbits. The number of rabbits is not specified.
  • Guinea Pig Maximization Sensitization Test: Tested on guinea pigs. The number of guinea pigs is not specified.
  • Acute Systemic Toxicity: Tested on an unspecified animal model. The number of animals is not specified.
  • Data provenance for biocompatibility studies is implied to be from testing conducted according to ISO standards.
• Condom Compatibility: Tested according to ASTM D7661-10. The number of condoms or test replicates is not specified. Data provenance is implied to be from testing conducted according to ASTM standards.
• Microbial Purity and Preservative Effectiveness: Sample sizes for these microbial tests (cfu/g measurements, log reductions) are not specified. Data provenance is implied to be from testing conducted according to European Pharmacopoeia (EP) standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The tests performed are laboratory-based and do not involve human expert interpretation for "ground truth" in the way an AI/ML diagnostic device would. For example, cytotoxicity is determined by cell viability assays, and irritation by pathological assessment after animal exposure, not by expert consensus on image interpretation.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation or clinical trial endpoints involving human judgment. The tests for a personal lubricant involve standardized laboratory procedures.

4. 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-assisted device.

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

• Not applicable. This is not an AI/algorithm-based device.

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

• The "ground truth" for the various tests corresponds to established scientific and regulatory standards:
  • Physical/Chemical Properties (Appearance, Odor, Viscosity, Osmolality, pH): Measured against defined numerical and descriptive specifications.
  • Microbial Purity & Preservative Effectiveness: Defined by colony-forming units (cfu/g) and log reduction thresholds established in European Pharmacopoeia (EP) standards.
  • Biocompatibility: Determined by standardized biological responses (e.g., cell viability in cytotoxicity, histological assessment in irritation, dermal response in sensitization, animal health in systemic toxicity) according to ISO 10993 series.
  • Condom Compatibility: Assessed using the standardized test method ASTM D7661-10.
  • Shelf Life: Determined by the ability of the device to maintain its physical, chemical, and microbial specifications over time under accelerated aging conditions.

7. The sample size for the training set:

• Not applicable. This is not an AI/ML device; there is no "training set."

8. How the ground truth for the training set was established:

• Not applicable. Since there's no AI/ML component, there's no training set or associated ground truth.

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