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JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, polyurethane and polyisoprene condoms.

JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are clear, viscous, amber colored, gel type personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Both versions of the subject device have the same formulation, with the exception of the addition of a fragrance to the JO Naturalove Strawberry Fields Flavored Personal Lubricant. These devices are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in 0.1 oz and 0.3 oz polyester-faced laminated pouches.

The provided text describes a 510(k) premarket notification for a medical device, specifically a personal lubricant, and does not contain information about an AI/ML device or its associated studies. Therefore, I cannot provide an answer that includes acceptance criteria for an AI/ML device, sample sizes for test sets, expert qualifications, MRMC studies, or standalone algorithm performance.

The document focuses on demonstrating the substantial equivalence of the "JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant" to a predicate device (JO Gelato Flavored Personal Lubricants) based on physicochemical properties, biocompatibility, shelf-life, and condom compatibility.

Here is an analysis of the available information, structured to address parts of your request where applicable, but noting the absence of AI/ML-specific details:

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

The document provides a "Device Specifications" table, which functions as the acceptance criteria for the physical and chemical properties and microbial counts of the lubricant. The reported performance refers to the device meeting these specifications.

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

The document does not specify the exact sample sizes (e.g., number of batches, units tested) for the performance tests (e.g., viscosity, pH, microbial counts, biocompatibility, shelf-life, condom compatibility). The data provenance (country of origin, retrospective/prospective) is also not mentioned, as these are typically internal laboratory tests conducted by the manufacturer or contracted labs.

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)

This is not applicable to this type of device submission. Ground truth, in the context of an AI/ML device, refers to expertly verified labels or diagnoses. For a personal lubricant, "ground truth" is established by laboratory measurements against defined chemical, physical, and biological standards. There are no "experts" in the sense of clinicians interpreting outputs for ground truth establishment.

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

Not applicable. This device does not involve human interpretation or adjudication of results in the way an AI/ML diagnostic device would.

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 and therefore no MRMC study was conducted.

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)

For the physical and chemical properties, the "ground truth" is derived from established laboratory measurement techniques (e.g., pH meters for pH, viscometers for viscosity, osmometers for osmolality) compared against predetermined standard specifications. For microbial testing, it's based on standard microbiological culture methods. For biocompatibility, it's based on the results of specific in-vitro and in-vivo tests according to ISO 10993 standards. For condom compatibility, it's based on the standard ASTM D7661-10 test method.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

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