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HyaloGYN® is a personal lubricant for 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 polyisoprene condoms.

HyaloGYN is a line extension to add a formulation of HyaloGYN not made with parabens. It is a nonsterile, colorless, odorless, transparent, aqueous, hydrating gel that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid), propylene glycol, a carbomer, preservatives and sodium hydroxide (to balance the pH). The hyaluronic acid is manufactured using a bacterial fermentation process.

HyaloGYN is a non-hormonal vaginal moisturizer intended to hydrate the vaginal epithelium because of the strong hydrating properties of its hyaluronic acid derivative component. The carbomer and propylene glycol combine with the hyaluronic acid derivative to enable HyaloGYN to achieve its thick, viscous gel form, and the mucoadhesive properties to allow it to adhere to the vaginal mucosa, enhancing the residence time, thus hydrating this tissue. It is provided in an aluminum tube and packaged together with single-use applicators in a cardboard box. HyaloGYN has a shelf life of 3 years.

This document is a 510(k) summary for the HyaloGYN Vaginal Hydrating Gel, demonstrating its substantial equivalence to previously cleared devices. It describes the device, its intended use, and provides a summary of performance data including biocompatibility, bench testing, and a clinical study.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the device's main function (vaginal moisturizing and lubrication) in the typical sense of numerical thresholds for sensitivity, specificity, or similar metrics for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the successful completion of various tests and the positive outcomes of the clinical study, demonstrating safety and effectiveness for its intended use.

However, where an explicit criterion is mentioned (condom compatibility), it is included. For other assessments, the "acceptance criteria" are interpreted as successful completion of the test/study without adverse findings, and "reported device performance" summarizes the key findings.

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

• Sample size for the test set:
  • Clinical Study: 80 women were enrolled.
  • Biocompatibility and Bench Testing: Sample sizes are not explicitly stated for these tests, but they were conducted on the device material itself.
• Data provenance:
  • Clinical Study: Conducted in Italy, and was a prospective, open, uncontrolled pilot clinical study.
  • Other tests (Biocompatibility, Bench, Stability): The specific origin of data for these tests is not explicitly stated beyond being conducted by Fidia.

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)

• The document refers to "investigator's overall assessment of tolerability score (98.7%)" in the clinical study. It does not specify the number of investigators/experts or their specific qualifications (e.g., years of experience, specialty beyond being the study investigator) who established ground truth for the clinical performance points like tolerability and moisturizing effects.
• For biocompatibility and bench testing, "experts" involved are implied to be personnel conducting the tests according to ISO/ASTM standards, but their specific number and qualifications are not detailed.

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

• The document does not describe an explicit adjudication method (like 2+1 or 3+1) for the clinical study's outcomes. It was an "open, uncontrolled clinical study" where a single investigator's assessment contributed to the "tolerability score."

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
• This device is a vaginal hydrating gel, not an AI or diagnostic imaging device. Therefore, a study assessing human reader improvement with AI assistance is not applicable.

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

• No, this is not an algorithm or AI device. Therefore, "standalone" algorithm performance is not applicable. The device itself (the gel) is the "standalone" product being tested.

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

• Clinical Study: The ground truth for effectiveness (moisturizing effects) and safety (tolerability, absence of adverse events, no alterations of vaginal ecosystem) was established through clinical observation and assessment by the study investigator based on pre-defined clinical endpoints and patient feedback.
• Biocompatibility Testing: Ground truth established by adherence to and results of standardized ISO test methods.
• Bench Testing: Ground truth established by adherence to product specifications at release (e.g., pH, viscosity, microbial counts) and standardized ASTM test methods (condom compatibility).

8. The sample size for the training set

• This device is a medical product (gel), not an AI algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable. Its formulation and design would be based on scientific principles and previous research/development, not algorithmic training data.

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

• As stated above, this is not an AI algorithm, so there is no "training set" in the context of machine learning. The "ground truth" for the device's formulation and design would be based on chemical, biological, and pharmaceutical principles, historical data from similar products, and laboratory studies of its components.

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HYALO GYN 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 condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin.

HYALO GYN is a colorless, odorless, transparent, aqueous, hydrating gel that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid), propylene glycol, a carbomer, preservatives (methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate), and sodium hydroxide (to balance the pH). The hyaluronic acid is manufactured using a bacterial fermentation process. HYALO GYN is intended for use as a personal lubricant. HYALO GYN is compatible with latex condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin. HYALO GYN has a pH of 5.5-6.5 and a shelf life of 3 years.

HYALO GYN acts as a moisturizer and lubricant because of the strong hydrating properties of its hyaluronic acid derivative component. The carbomer and propylene glycol, combined with the hyaluronic acid derivative, enable HYALO GYN to achieve its thick, viscous gel form, and the mucoadhesive properties of the product allow it to adhere to the vaginal mucosa, enhancing the residence time, thus hydrating and protecting this tissue.

The provided document is a 510(k) summary for the device HYALO GYN®, a vaginal lubricant. It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness for substantial equivalence to a predicate device.

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

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for all performance aspects. Instead, it describes studies and their outcomes to support safety and effectiveness. Based on the information provided, the following table summarizes the performance data and the implied criteria met:

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

• Clinical Study:
  • Sample Size: 80 women.
  • Data Provenance: Conducted in Italy; "pilot, open, uncontrolled clinical study" which typically implies prospective data collection for the duration of the study.
• Biocompatibility Studies: Specific sample sizes are not provided for the individual in vitro and animal studies (cytotoxicity, acute intraperitoneal toxicity, skin sensitization, vaginal tolerance).
• Non-Clinical Performance (Condom Compatibility, Stability): Specific sample sizes are not provided for the individual tests.

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)

• For the clinical study, the document mentions "the investigator's overall assessment of tolerability score (98.7%)". The number and qualifications of the investigators (experts) are not specified.
• For other performance assessments (biocompatibility, condom compatibility, stability), the "ground truth" or evaluators are implied by the nature of the tests (e.g., laboratory personnel for cytotoxicity, tensile strength measurements). Specific details on the number or qualifications of experts involved in establishing ground truth for these non-clinical tests are not provided.

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

• For the clinical study, the document states it was an "open, uncontrolled clinical study." There is no mention of an adjudication method for the clinical outcomes or adverse events. The tolerability assessment was by "the investigator."
• For non-clinical tests, adjudication methods are generally not applicable in the same way as for clinical studies involving subjective assessments.

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

• No, an MRMC comparative effectiveness study was not done. This study is for a medical device that is a personal lubricant, not an AI-assisted diagnostic or imaging device, so such a study design is not applicable.

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

• No, a standalone (algorithm only) performance study was not done. This device is a physical product (a lubricant), not an algorithm or AI.

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

• Clinical Study: The effectiveness (moisturizing effects, tolerability, absence of adverse events, no alterations of vaginal ecosystem) was assessed based on clinical observation and patient outcomes data, likely clinician assessment and patient-reported symptoms, though specific details of the assessment tools are not provided. The tolerability score was based on "the investigator's overall assessment."
• Biocompatibility Studies: Ground truth was established through laboratory testing standards and measurements (e.g., cell viability for cytotoxicity, animal responses for toxicity and irritation).
• Non-Clinical Performance (Condom Compatibility, Stability): Ground truth was established through standardized physical and chemical laboratory tests (e.g., tensile strength testing, stability protocols).

8. The sample size for the training set

• For a device like HYALO GYN® (a lubricant), the concept of a "training set" as understood in machine learning or AI is not applicable. The device's performance is not based on a trained algorithm. Its formulation is developed through pharmaceutical research and manufacturing processes, and then tested for safety and efficacy.

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

• As noted above, a "training set" is not applicable for this type of medical device. The "ground truth" for its development would involve established scientific principles, pharmaceutical formulation expertise, and pre-clinical testing to ensure its properties met the intended design specifications, but not in the context of an algorithm's training data.

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