Search Results

The device 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.

Vaginal Moisturizing Gel is identical to the predicate device except that it is presented in 8 pre-filled applicators for easy use.

Vaginal Moisturizing Gel is intended for use as a personal lubricant. This product is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. The following parameters are included as part of the product specification:
• Appearance
• Color
• Odor
• pH
• Viscosity
• Osmolality
• Antimicrobial effectiveness
• Total Aerobic Microbial Count (TAMC)
• Total Yeast and Mold Count (TYMC)
• Absence of Pathogenic Organisms (at minimum Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans)

Vaginal Moisturizing Gel has a pH of 4.5-5.0 and a shelf life of 18

This document describes the FDA's decision to clear the "Vaginal Moisturizing Gel" for marketing and provides a summary of the device's characteristics and supporting data. However, it does not include detailed acceptance criteria or a study proving the device meets them in the format requested. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria.

Therefore, I cannot populate the table and answer the questions directly as the information is not present within the provided text.

Based on the document, I can extract the following relevant information regarding the device:

• Device Name: Vaginal Moisturizing Gel
• Intended Use: 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. Compatible with natural rubber latex and polyisoprene condoms.
• Predicate Device: Internal Hydrating Gel (K141718)
• Key claim for substantial equivalence: Identical to the predicate device except for packaging (8 pre-filled applicators) and has identical technological characteristics.

Here's an analysis of what is provided and why it doesn't fit the request:

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

• Not Available: The document lists "product specifications" (Appearance, Color, Odor, pH, Viscosity, Osmolality, Antimicrobial effectiveness, TAMC, TYMC, Absence of Pathogenic Organisms) for the device and states it has a pH of 4.5-5.0. However, it does not provide any specific acceptance criteria (e.g., minimum/maximum values, thresholds, statistical targets) for these parameters, nor does it report the actual performance values obtained from testing against these criteria.

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

• Not Available: The document mentions "non-clinical testing" for condom compatibility and biocompatibility studies. However, it does not provide any sample sizes for these tests or the provenance of the data.

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)

• Not Applicable/Not Available: This type of information (expert consensus, ground truth establishment) is typically relevant for diagnostic devices or AI-driven systems where human interpretation is involved. For a personal lubricant, ground truth generally refers to objective physical, chemical, and biological properties, often established through standardized laboratory methods rather than expert consensus on interpretation. The document does not mention any experts involved in establishing ground truth for the performance tests.

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

• Not Applicable/Not Available: Adjudication methods are typically used in clinical trials or studies where multiple readers/evaluators assess data and disagreements need to be resolved. This is not reported for the non-clinical tests summarized.

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 device is a personal lubricant, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study or AI-related performance metrics are irrelevant.

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

• Not Applicable: As stated above, this is not an AI-driven device.

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

• Objective Laboratory Measurements: The "ground truth" for this device would be established through objective laboratory measurements for parameters like pH, viscosity, osmolality, microbial counts, and chemical analysis of extractables/leachables, as well as standardized physical testing for condom compatibility (ASTM D7661-10). These are not explicitly categorized as "ground truth" in the document but represent the objective standards against which the device was tested.

8. The sample size for the training set

• Not Applicable: This device is not an AI/ML device that requires a training set.

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

• Not Applicable: As above, no training set is involved.

Summary of available information related to performance/testing:

The document states:

• Biocompatibility Data: A study of extractable and leachable materials from the new applicator was conducted according to USP . Extracts were analyzed using infrared analysis, GC-MS, and ICP-MS. Risk analysis showed that ethanol extractable materials were in amounts much lower than the tolerable intake of any component.
• Performance Testing - Non-Clinical: The device was tested for condom compatibility according to ASTM D7661-10 and found to be compatible with natural rubber latex and polyisoprene condoms.
• Product Specifications: pH of 4.5-5.0 and a shelf life of 18 months.

In conclusion, while the document confirms certain tests were performed and their outcomes (e.g., compatible with condoms, extractables below tolerable limits), it does not provide the detailed "acceptance criteria" and "reported device performance" in a quantitative table format that your request envisions, nor does it contain the specific sample sizes, expert involvement, or AI-related study details. The FDA's clearance is based on the device being "substantially equivalent" to an existing predicate rather than meeting a set of novel, explicitly defined performance acceptance criteria in this document.

Ask a specific question about this device