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Medline Natural Lubricating Liquid 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.

The Medline Natural Lubricating Liquid is a non-sterile aqueous personal lubricant. Medline Natural Liquid is clear, odorless and colorless. The ingredients are similar to other personal lubricants currently on the market.

The Medline Natural Lubricating Liquid is compatible with natural rubber latex, polyisoprene and polyurethane condoms. The product will be offered in two sizes, a 2.5 fluid ounce and a 5 fluid ounce. The primary packaging consists of a polyethylene terephthalate (PETG) bottle with a screw down, flip top polypropylene closure. Each bottle of product will be packaged into a cardboard carton, which constitutes the product's outer packaging.

The provided text describes the regulatory submission for the "Medline Natural Lubricating Liquid" and its comparison to a predicate device. This is a medical device submission, and the "studies" mentioned relate to non-clinical and a small clinical study for safety, not typically AI-driven comparative effectiveness studies or standalone algorithm performance. Therefore, many of the requested categories regarding AI-specific studies (MRMC, standalone algorithm, training set details) are not applicable to this document.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Device Name: Medline Natural Lubricating Liquid

Study Details

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

   • Biocompatibility: Not specified in the document, but typically involves in vitro and in vivo animal models as per ISO 10993. Data provenance is not specified but would be from laboratory testing.
   • Condom Compatibility: Not specified for the number of condoms tested. Data provenance from laboratory testing.
   • Shelf Life: Not specified for the number of units tested. Data provenance from laboratory testing.
   • Clinical Safety (In-use): 27 subjects participated in a 10-day study. Data provenance is from this prospective clinical study. Country of origin not specified.

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

   • Not applicable in the context of the provided document. The "ground truth" for these types of device tests is established through standardized laboratory methods (e.g., ISO, ASTM standards) and direct observation of safety in a small clinical trial, rather than expert consensus on interpretive tasks.

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

   • Not applicable. The tests performed are objective laboratory and safety studies, not interpretive tasks requiring adjudication between human readers.

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:

   • No, not applicable. This document describes a medical device (personal lubricant) and its regulatory submission, not an AI-powered diagnostic or interpretive tool.

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

   • No, not applicable. This document describes a medical device (personal lubricant), not an algorithm.

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

   • Biocompatibility: Established by adherence to ISO 10993 standards and laboratory results (e.g., cell viability, irritation scores, systemic toxicity markers).
   • Condom Compatibility: Established by adherence to ASTM D7661-10 through objective measurements of condom integrity and performance after lubricant exposure.
   • Shelf Life: Established by objective chemical/physical property testing and microbiological testing over time, in accordance with ASTM F1980-07:2011.
   • Clinical Safety (In-use): Established based on reported adverse events and observations of safety in the 10-day clinical study, likely through participant feedback questionnaires or medical assessments.

7. The sample size for the training set:

   • Not applicable. This document is not about an AI algorithm that requires a training set.

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

   • Not applicable. This document is not about an AI algorithm that requires a training set.

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