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LUBRIGYN CREAM 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 not compatible with natural rubber latex, polyisoprene and polyurethane condoms.

LUBRIGYN CREAM is a non-sterile, non-oily, water based personal lubricant for the intimate vaginal area. LUBRIGYN CREAM is supplied in a 50 mail airless container and can be used daily to supplement the body's natural lubrication when vaginal dryness causes discomfort. The specifications for the LUBRIGYN CREAM include appearance, color, odor, pH, viscosity, density, emulsion stability, osmolality, total microbial count, total yeast and mold count and absence of pathogen organisms (Escherichia Coli, Pseudomonas Aeruginosa, Staphylococcus Aureus, Enterococcus Species, Candida Albicans).

The provided text describes the 510(k) premarket notification for "LUBRIGYN CREAM" in an airless container. The submission aims to demonstrate substantial equivalence to a predicate device, which is an earlier version of LUBRIGYN CREAM in single-use sachets (K132772).

Here's an analysis based on the request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a typical statistical sense (e.g., minimum sensitivity, specificity) for a diagnostic or AI device. Instead, it focuses on demonstrating equivalence to a predicate device by comparing technological characteristics and conducting stability testing.

2. Sample Size for Test Set and Data Provenance:

The document describes stability testing and comparison of characteristics, not a clinical "test set" in the context of evaluating a diagnostic or AI device.

• Sample Size: Not explicitly stated as a number of subjects or cases. The "sample" for stability testing would refer to units of the LUBRIGYN CREAM product. It mentions "stability tests performed on already expired product," implying multiple units were tested over time.
• Data Provenance: The study is focused on the product itself and its characteristics. The manufacturer is "UNIDERM FARMACEUTICI srl" located in Italy. The testing was conducted internally or by a contracted lab. This is product performance data, not patient-derived data from a specific country.
• Retrospective/Prospective: Stability testing is inherently prospective, as it involves monitoring product characteristics over time.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This is a product performance study, not a study requiring expert clinical review to establish ground truth for a diagnostic or AI device. The "ground truth" here is the established specifications and verified shelf-life of the product.

4. Adjudication Method for Test Set:

Not applicable. There is no "test set" requiring adjudication in the context of diagnostic performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This submission is for a personal lubricant, not a diagnostic or AI device requiring an MRMC study. There's no AI component.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not an algorithm or AI device.

7. Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• Identical Formulation & Manufacturing Process: Verification of consistency with the predicate device.
• Product Release Specifications: Defined by the manufacturer for parameters like pH, viscosity, microbial counts, etc. These are established laboratory standards.
• Stability Test Results: Objective measurements over time showing the product maintains its specifications.

8. Sample Size for Training Set:

Not applicable. There is no "training set" as this is not an AI or machine learning device.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set.

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LUBRIGYN CREAM 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 not compatible with natural rubber latex, polyisoprene and polyurethane condoms.

LUBRIGYN CREAM is a non-sterile, non-oily, water based personal lubricant for the intimate vaginal area. LUBRIGYN CREAM is supplied in single use pouches and can be used daily to supplement the body's natural lubrication when vaginal dryness causes discomfort.

The specifications for the LUBRIGYN CREAM include appearance, color, viscosity, density, emulsion stability, osmolality, total microbial count, total yeast and mold count and absence of pathogen organisms (Escherichia Coli, Pseudomonas Aeruginosa, Staphylococcus Aureus, Enterococcus Species, Candida Albicans).

This document is a 510(k) premarket notification for a medical device called LUBRIGYN CREAM, a personal lubricant. It details the device's indications for use, description, and technological characteristics, and aims to prove substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the "no-clinical performance testing conducted demonstrates that LUBRIGYN CREAM is substantially equivalent to the proposed predicate device." The acceptance criteria for the comparative effectiveness of the device itself are related to demonstrating similarity in performance to a predicate device, as this is a 510(k) submission.

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

The document describes non-clinical performance testing (biocompatibility, stability, microbiological challenge, condom compatibility). It does not mention a clinical "test set" in the context of human subjects or a dataset for an AI algorithm.

• Sample size for non-clinical testing: The specific sample sizes for each of the non-clinical tests (e.g., number of animals for toxicity, number of condoms for compatibility) are not provided in this summary.
• Data provenance: The standard tests cited (ISO 10993 series, USP 51, ASTM D7661-10) are international standards for laboratory testing. The country of origin of the data is not explicitly stated beyond the submitter and consultant being based in Italy. This is prospective data generated specifically for this submission.

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

This information is not applicable. The LUBRIGYN CREAM product is a personal lubricant, and the testing described is non-clinical laboratory testing, not a diagnostic device analyzed by human experts.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no "test set" in the context of human expert review or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a personal lubricant, not a diagnostic device that would typically involve human readers interpreting cases.

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

No, this question is not applicable. The device is a physical product (personal lubricant), not an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" is established by adherence to recognized international and national standards/test methods (ISO, USP, ASTM) that define acceptable performance characteristics for medical devices of this type. For example, for biocompatibility, the ground truth is "non-toxic," "non-sensitizing," etc., as determined by the specific criteria within the ISO standards. For condom compatibility, the ground truth is "compatible" or "not compatible" based on the measurements and criteria outlined in ASTM D7661-10.

8. The Sample Size for the Training Set

This information is not applicable. There is no AI or machine learning component to this device, so there is no "training set."

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

This information is not applicable, as there is no training set.

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