(188 days)
Trophikos Vaginal Moisturizer is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
Trophikos Vaginal Moisturizer is a water-based, non-sterile personal lubricant, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, glycerin, Simmondsia Chinensis (Jojoba) seed oil, cetyl alcohol, dimethicone, tetrahexyldecyl ascorbate, Leuconostoc/radish root ferment filtrate, sodium hyaluronate, palmitoyl tripeptide-5, acetyl tetrapeptide-2, hydrogenated lecithin, ubiquinone, tocopheryl acetate, caprylyl glycol, tocopherol, citric acid, potassium sorbate, squalane, glyceryl stearate, polyacrylate crosspolymer-6, and tbutyl alcohol. Trophikos Vaginal Moisturizer is packaged in 30 mL airless bottles made of styrene-acrylonitrile, with a piston made of polyethylene, and an aluminum base. Trophikos Vaginal Moisturizer is a personal lubricant with over-the-counter (OTC) use.
The provided text describes the Trophikos Vaginal Moisturizer, which is a personal lubricant. The information focuses on its performance testing and how it demonstrates substantial equivalence to a predicate device, rather than a study proving it meets acceptance criteria for an AI/ML powered medical device. Therefore, much of the requested information regarding AI/ML studies is not applicable.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are referred to as "Specifications" in the document (Table 1). The reported device performance is that these specifications were "met" across the shelf life duration.
| Parameter | Specifications (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Appearance | Gel Cream | Met (implied, as all parameters met specifications) |
| Odor | Characteristic | Met (implied, as all parameters met specifications) |
| Color | Off-White | Met (implied, as all parameters met specifications) |
| pH per USP | 3.8 – 4.6 | Met (implied, as all parameters met specifications) |
| Viscosity per USP | 25,000 - 75,000 cP | Met (implied, as all parameters met specifications) |
| Osmolality per USP | 750 – 840 mOsm/kg | Met (implied, as all parameters met specifications) |
| Total Yeast and Mold Count (TYMC) per USP and | ≤ 10 cfu/g | Met (implied, as all parameters met specifications) |
| Total Aerobic Microbial Count (TAMC) per USP and | ≤ 100 cfu/g | Met (implied, as all parameters met specifications) |
| Absence of Pathogenic Organism per USP | E. coli, Salmonella, C.albicans, S. aureus, P. aeruginosa (all Absent) | Met (implied, as all parameters met specifications) |
| Antimicrobial Effectiveness per USP (Bacteria) | No less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count | Met (implied, as all parameters met specifications) |
| Antimicrobial Effectiveness per USP (Yeast/Mold) | No increase from the initial calculated count at 14 and 28 days | Met (implied, as all parameters met specifications) |
Additionally, specific performance tests were conducted:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Evaluation in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, including specific tests for Cytotoxicity (ISO 10993-5), Guinea Pig Maximization Sensitization (ISO 10993-10), Vaginal Irritation (ISO 10993-10), and Acute Systemic Toxicity (ISO 10993-11). The results must be adequate to support the conclusion that the device is biocompatible. | Performed, and "the results provided are adequate to support the conclusion that the subject device is biocompatible." |
| Condom Compatibility | Evaluation in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms". Determine compatibility with natural rubber latex, polyisoprene, and polyurethane condoms. | "The results of the testing indicate that the subject device is compatible with natural rubber latex and polyisoprene condoms. The subject device is not compatible with polyurethane condoms." |
| Shelf Life | All device parameters listed in Table 1 (Appearance, Odor, Color, pH, Viscosity, Osmolality, Microbial Counts, Antimicrobial Effectiveness) must meet their respective specifications across the shelf life duration. | "All device parameters listed in Table 1 were tested and met the specifications across the shelf life duration." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document pertains to a medical device (vaginal moisturizer), not an AI/ML software. Therefore, the concept of a "test set" for an algorithm is not applicable. The performance testing involves laboratory tests on the product itself (e.g., chemical properties, microbial counts, biocompatibility with tissue models/animals, and compatibility with condoms). The document does not specify the sample sizes for these tests or the data provenance in terms of country of origin, nor is it relevant given the nature of the device.
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, as this is not an AI/ML device relying on expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device requiring adjudication of results from a test set.
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. The device is a physical product (vaginal moisturizer), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and chemical properties and microbial tests, the "ground truth" is defined by established laboratory testing standards (e.g., USP, ASTM) and the specified ranges or thresholds. For biocompatibility, the ground truth is determined by the results of the ISO 10993 series tests. For condom compatibility, the ground truth is determined by the results of the ASTM D7661-10 test. There isn't an "expert consensus" or "pathology" type of ground truth in the context of this product's evaluation.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
In summary, the provided document is a 510(k) clearance letter for a physical medical device (vaginal moisturizer) and details its physical, chemical, and biological performance characteristics against established standards, rather than the performance of an AI/ML algorithm.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.