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510(k) Data Aggregation
(296 days)
Gynomunal 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 with polyisoprene condoms, but not with polyurethane condoms.
Gynomunal is a non-sterile, water-based, ivory to slightly yellow personal lubricant with a shelflife of 36 months. Gynomunal device specifications include color, odor, pH, viscosity, osmolality, antimicrobial effectiveness (Compliance with USP <51>), and microbiological quality (Compliance with USP <61>, <62>, and <1111>).
The provided document is a 510(k) summary for the Gynomunal Vaginal Gel, a personal lubricant. It details the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document lists several device specifications and performance criteria that Gynomunal must meet.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical-Chemical Characteristics | |
| Color | Homogeneous, Translucent Gel (Ivory, to slight yellow) |
| Odor | Characteristic |
| pH | 5.5-6.5 |
| Viscosity | 45,000-65,000 mPa*s |
| Osmolality | 2,000 -3,000 mOsmol/Kg |
| Antimicrobial Effectiveness | |
| Antimicrobial Effectiveness | Complies to USP <51> |
| Microbiological Quality | |
| Total Aerobic Microbial Counts | <100 cfu/g |
| Total Yeast and Mold counts | <10 cfu/g |
| Microbial Absence | P. aeruginosa, S. aureus, C. albicans |
| Biocompatibility | |
| Cytotoxicity (ISO 10993-5:2009) | Demonstrated to be biocompatible |
| Vaginal Irritation (ISO 10993-10:2010) | Demonstrated to be biocompatible |
| Guinea Pig Maximization Sensitization (ISO 10993-10:2010) | Demonstrated to be biocompatible |
| Acute Systemic Toxicity (ISO 10993-11:2006) | Demonstrated to be biocompatible |
| Shelf-life | |
| Maintain specifications for 36 months | Demonstrated to maintain specifications throughout its 36-month shelf-life |
| Condom Compatibility | |
| Compatible with natural rubber latex condoms | Compatible (per ASTM D7661-10 and ISO 4074) |
| Compatible with polyisoprene condoms | Compatible (per ASTM D7661-10 and ISO 4074) |
| Compatible with polyurethane condoms | Not compatible (stated directly in "Indications for Use") |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each test. For the condom compatibility study, it mentions that an "independent laboratory" was commissioned but does not provide details on the number of condoms or lubricant samples tested. The data provenance is implied to be from an independent laboratory, but the country of origin is not specified. The tests appear to be prospective laboratory studies conducted by the manufacturer or commissioned by them.
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 does not mention the use of "experts" to establish ground truth in the context of human interpretation, as this is a personal lubricant and not an image-based diagnostic device. The ground truth for its performance is established through standardized laboratory tests (e.g., ISO, USP, ASTM standards) and objective measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As described above, the acceptance criteria are based on objective, standardized laboratory measurements and not on human adjudication of subjective data.
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. Gynomunal is a personal lubricant, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or assessment of AI assistance for human readers is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. Gynomunal is a physical product, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant. The device's performance is inherently "standalone" in that it performs its intended function independently of human interpretation of its output (beyond the user's experience).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for Gynomunal's performance is based on objective, standardized laboratory measurements and scientific standards. This includes:
- Physical-chemical assays: pH, viscosity, osmolality measurements.
- Microbiological testing: Total aerobic microbial counts, yeast and mold counts, and specific pathogen absence, adhering to USP standards.
- Biocompatibility testing: Following ISO 10993 standards for cytotoxicity, irritation, sensitization, and systemic toxicity.
- Stability/Shelf-life testing: Real-time and accelerated testing to ensure specifications are maintained over time.
- Condom compatibility testing: Adherence to ASTM D7661-10 and ISO 4074 standards for material integrity.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no "training set" in that context. The development and formulation of the product would have involved various R&D experiments and testing, but these are not referred to as "training sets."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device. The ground truth for product development and validation relies on established scientific principles, analytical chemistry, microbiology, and biocompatibility testing standards.
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