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SASMAR® CLASSIC 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, polyisoprene, and polyurethane condoms.

SASMAR® ORIGINAL 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, polyisoprene, and polyurethane condoms.

SASMAR® VANILLA 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, polyisoprene, and polyurethane condoms.

SASMAR® WARMING 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, polyisoprene, and polyurethane condoms.

SASMAR® CHERRY 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, polyisoprene, and polyurethane condoms.

SASMAR® MELON 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, polylsoprene, and polyurethane condoms.

SASMAR® PINA COLADA 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, polyisoprene, and polyurethane condoms.

SASMAR® STRAWBERRY 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, polyisoprene, and polyurethane condoms.

Device Description

SASMAR® ORIGINAL is a non-sterile silicone based personal lubricant for penile and/or vaginal application intended to facilitate condom use, provide additional moisture to relieve vaginal dryness and enhance pleasure during sexual intimacy. The device may be used as a massage lotion and is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. This product is provided in a plastic pump dispenser or a foil laminate sachet and is available over-the-counter.

SASMAR® CLASSIC is a non-sterile water-based personal lubricant for penile and/or vaginal application intended to facilitate condom use, provide additional moisture to relieve vaginal dryness and enhance pleasure during sexual intimacy. The formula is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device is available in the following variant personal lubricant formulas: SASMAR® Warming, SASMAR® Vanilla, SASMAR® Melon, SASMAR® Cherry, SASMAR® Strawberry or SASMAR® Pina Colada. This product is provided in a plastic pump dispenser, a plastic tube with flip-top closure or a foil laminate sachet and is available over-the-counter.

AI/ML Overview

The provided text describes a 510(k) submission for personal lubricants (SASMAR® ORIGINAL and SASMAR® CLASSIC, and their flavored variants). This type of submission is for medical devices, but the acceptance criteria and study detailed are not related to AI/ML device performance for diagnostic or prognostic purposes, but rather to the physical and chemical properties and biocompatibility of the lubricants. Therefore, many of the requested categories in the prompt are not applicable.

Here's an analysis based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Condom Compatibility	Testing per ASTM D7661 indicates that the lubricant formulations are compatible with condoms (natural rubber latex, polyisoprene, and polyurethane condoms).
Biocompatibility	Testing for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity in accordance with ISO 10993 indicated device biocompatibility.
Physical and Chemical Properties	Bench testing indicated that the lubricant has an appropriate viscosity, pH, osmolarity, specific gravity, appearance, color, and odor for substantial equivalence to the predicates.
Microbial Quality	USP testing for Total Aerobic Microbial Count, Total Yeast and Mold Count, absence of microbial pathogens, and antimicrobial effectiveness indicated microbial quality.
Shelf-Life	Long term, accelerated, and real-time aging tests for physical parameters and microbial characteristics indicate a 30-month shelf-life for the lubricants.

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

The text does not specify sample sizes for any of the tests conducted (e.g., how many condoms were tested for compatibility, how many samples for biocompatibility, etc.). The provenance of the data is also not specified beyond the fact that testing was performed according to international standards (ASTM D7661, ISO 10993, USP).

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

Not applicable. The "ground truth" here relates to objective physical, chemical, and biological properties, not interpretations by human experts from medical images or clinical data. The tests performed are standardized laboratory tests.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from expert opinions, typically in diagnostic or prognostic studies where there might be disagreement in interpretations. For the physical and chemical tests described, the results are quantitative or qualitative assessments based on predefined measurement methods.

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 prognostic tool. Therefore, MRMC studies and assessment of AI assistance for human readers are irrelevant.

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

Not applicable. This device is not an algorithm or AI system. Its performance is assessed directly through laboratory testing of its physical, chemical, and biological properties.

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

The "ground truth" for the device's performance is established through standardized laboratory testing and adherence to specific industry standards (ASTM D7661 for condom compatibility, ISO 10993 for biocompatibility, USP for microbial quality) and internal bench testing for physical characteristics. These methods provide objective, measurable outcomes.

8. The sample size for the training set

Not applicable. The document describes the testing and properties of a physical product (personal lubricant), not the development or training of an AI/ML model. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an AI/ML model.

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