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Grosz Warming Liquid 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, polyisoprene and polyurethane condoms.

Grosz Play Tingling 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.

Grosz KY Yours & Mine is intended for penile, vaginal and/or anal application to mosturize 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.

Grosz Warming Liquid is a non-sterile, silicone-based personal lubricant compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of Dimethicone and Sensate. Grosz Warming Liquid is packaged in a 30 mL high density polyethylene bottle (HDPE) mono layer and topped with a polypropylene cap. The bottle is then packaged in a carton. Grosz Warming Liquid is a personal lubricant for over-the-counter (OTC) use.

Grosz Play Tingling is a non-sterile, water-based personal lubricant compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene Glycol, Carbomer, Xanthan Gum, Sensate, Benzoic Acid, Sodium Saccharin, and Sodium Hydroxide. Grosz Play Tingling is packaged in a 50 mL HDPE bottle and topped with a polypropylene cap. The bottle is then packaged in a carton. Grosz Play Tingling is a personal lubricant for OTC use.

Grosz KY Yours & Mine are two personal lubricants with the same formulations and specifications as Grosz Warming Liquid and Grosz Play Tingling, respectively, packaged together and compatible with natural rubber latex and polyisoprene condoms. Grosz KY Yours & Mine is not compatible with polyurethane condoms when used as intended. Grosz KY Yours and Grosz KY Mine are individual lubricants separately packaged in a 44 mL polyethylene terephthalate bottles and topped with a polypropylene cap and packaged together in a carton. Grosz KY Yours & Mine are for OTC use.

The provided text describes information for a 510(k) submission for personal lubricants (Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine). It details the product specifications, comparison to a predicate device, and performance data to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text presents two tables (Table 1 for Grosz Warming Liquid and Grosz KY Yours, Table 2 for Grosz Play Tingling and Grosz KY Mine) listing properties and their corresponding specifications, which serve as acceptance criteria. The performance is reported as meeting these specifications throughout the shelf-life duration.

Table 1: Grosz Warming Liquid and Grosz KY Yours

Table 2: Grosz Play Tingling and Grosz KY Mine

Study to Prove Device Meets Acceptance Criteria

The document refers to various performance tests conducted to demonstrate that the devices meet the acceptance criteria and are substantially equivalent to the predicate devices. These include:

• Biocompatibility Studies: Cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing were performed in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1.
• Shelf-Life Testing: Accelerated aging and real-time testing were conducted for Grosz Warming Liquid and Grosz KY Yours, and accelerated aging testing for Grosz Play Tingling and Grosz KY Mine. All specified properties (from Tables 1 and 2) were met throughout their respective shelf-life durations (15 months for Grosz Warming Liquid, 2 years for the others).
• Condom Compatibility Testing: Evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Specific compatibility results are provided for each product.
• Microbial Testing: Total aerobic microbial count (TAMC), total yeast and mold count (TYMC), and absence of specific pathogens were tested according to methods equivalent to USP <61> and EP 8.0 Section: 2.6.13 or USP <62>.
• Physical/Chemical Properties: Viscosity (per USP <912>), pH (per USP <791>), and Osmolality (per USP <785>) were tested where applicable, with results meeting the specified ranges.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test sets in the performance studies (e.g., number of batches, number of samples per test). It mentions that "the results of this testing demonstrated that the subject lubricants are biocompatible" and "all specifications... were met throughout the shelf-life duration," implying that sufficient samples were tested to support these conclusions.

The provenance (country of origin, retrospective/prospective) of the data is not mentioned. These types of studies for personal lubricants are typically laboratory-based tests on manufactured products, rather than clinical studies involving human subjects for the primary performance criteria listed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for the performance criteria of these personal lubricants is established by adherence to recognized national and international standards and pharmacopeial monographs (e.g., USP, ISO, ASTM, EP). These tests have objective endpoints (e.g., cfu/g, cPs, pH values, log reduction) that do not typically require expert human interpretation in the same way an imaging or diagnostic device might.

4. Adjudication Method for the Test Set

Not applicable, as expert consensus or adjudication is not typically used for these types of objective laboratory performance tests.

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 device is a personal lubricant, not an AI-assisted diagnostic or imaging device for which MRMC studies would be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a personal lubricant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance criteria is based on established scientific standards, pharmacopeial monographs, and consensus standards (e.g., USP <912> Viscosity, USP <51> Antimicrobial Effectiveness, ASTM D7661-10 for Condom Compatibility, ISO 10993 for Biocompatibility, EP for Pathogens). These standards define the acceptable ranges or outcomes for each property.

8. The Sample Size for the Training Set

Not applicable. This device is a personal lubricant, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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