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Überlube 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Überlube is a clear, colorless, semi-viscous silicone-based personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. The device is not compatible for use with polyurethane condoms. The device is a non-sterile lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is normally packaged in glass bottles with pump tops or in foil samples. It may also be packaged in stoppered glass vials or plastic bottles. The specifications for Überlube include appearance, odor, viscosity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.

This document is a 510(k) summary for Überlube, a personal lubricant. It describes the device, its intended use, and provides evidence of its safety and effectiveness. However, it does not describe a study in the context of an AI/medical device (e.g., using imaging data, or clinical outcomes data etc.). Instead, the performance data provided is related to material compatibility and biocompatibility tests for a lubricant product.

Therefore, many of the requested fields related to AI/medical device studies (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, etc.) are not applicable to this submission.

Here is the information that can be extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Cytotoxicity
• Vaginal irritation
• Sensitization
• Systemic toxicity |
  | Microbial Limits (per USP and USP ) | Indicated microbial quality. (Specific microbial counts or thresholds are not provided in this summary, only that "microbial quality" was indicated.) |
  | Shelf-Life (Real-time aging tests) | 3-year shelf life. |
  | Specifications (Appearance, Odor, Viscosity) | Not explicitly stated as acceptance criteria, but listed as product specifications:
• Appearance: Clear, colorless, semi-viscous
• Odor: Not specified, but implied to be acceptable
• Viscosity: Semi-viscous (specific range not provided)
• Total aerobic microbial count: Included in microbial limits testing
• Total yeast and mold count: Included in microbial limits testing
• Absence of pathogenic organisms: Included in microbial limits testing |

2. Sample size used for the test set and the data provenance

• Not Applicable in the context of an AI/medical device study with patient data.
• For the material compatibility (ASTM D7661-10), biocompatibility (ISO 10993-1), microbial limits (USP and USP ), and shelf-life testing, specific sample sizes for each test are not provided in this summary. The data provenance is laboratory testing conducted by Überlube LLC or their contractors, not clinical data from specific countries.

3. 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 an AI/medical device study with expert ground truth.
• The "ground truth" for these tests would be the established scientific standards and methods of the respective normative documents (e.g., ASTM D7661-10, ISO 10993-1). The experts involved would be the laboratory technicians and scientists performing and interpreting these standardized tests, whose qualifications are inherent to their roles in accredited testing facilities.

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

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data. The tests performed are standardized laboratory assays.

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 a product demonstrating material properties and biological safety, not an AI or imaging device involving human readers.

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

• Not Applicable. This product does not involve an algorithm.

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

• The "ground truth" for these studies is the outcome of standardized laboratory tests and established scientific methods, as defined by international standards (e.g., ASTM, ISO, USP). For example, a condom either passes or fails the ASTM D7661-10 test for compatibility based on specific metrics defined in that standard.

8. The sample size for the training set

• Not Applicable. This product does not use a training set as it is not an AI/machine learning device.

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

• Not Applicable. This product does not use a training set.

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