(406 days)
Elegance Woman's Lubricant is a non-sterile, oil-based personal lubricant formulated to supplement the body's own natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort.
Elegance Woman's Lubricant is a non-sterile oil-based personal lubricant formulated to supplement the body's own natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort.
Ingredients: Natural oils of plant origin: Glycine Willd (soy), Carthamus tinctorius L.(safflower), and Vitis vinifera (grapeseed).
This document describes the 510(k) submission for "Elegance Woman's Lubricant" and primarily focuses on its substantial equivalence to predicate devices, rather than an AI-driven medical device. Therefore, a significant portion of the requested information, which pertains to AI/ML device testing and performance evaluation, is not applicable or available in the provided text.
Specifically, there is no mention of acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample size for test sets (in the context of AI), data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
The document details the device description, its intended use, a list of predicate devices, and a summary of non-clinical performance for biocompatibility and subject-use reports.
Here's an attempt to extract relevant information and address the prompt, noting the limitations due to the nature of the submitted device:
1. Table of Acceptance Criteria and Reported Device Performance
As "Elegance Woman's Lubricant" is a conventional medical device (personal lubricant) and not an AI/ML diagnostic or prognostic system, the concept of "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or AUC is not applicable. The documentation focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and biocompatibility.
| Criterion Type | Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Highly lubricious, medium-high to high viscosity, liquid, clear, non-irritating, non-sterile. Ingredients Generally Recognized as Safe (GRAS). | Elegance Woman's Lubricant shares these characteristics with predicate devices. Ingredients are natural oils of plant origin: Glycine Willd (soy), Carthamus tinctorius L.(safflower), and Vitis vinifera (grapeseed), all considered GRAS. |
| Biocompatibility / Safety | Non-irritating, non-sensitizing on skin. | "Non-clinical evidence demonstrates biocompatibility and found no skin irritation or sensitivity." The formulation "does not harm vaginal or penile tissue." |
| Effectiveness (Intended Use) | Supplements natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort. | "Subject-use reports demonstrate that Elegance Woman's Lubricant is nonirritating and effective as a personal lubricant." |
| Condom Compatibility | Not explicitly stated as an acceptance criterion for the device itself, but rather a safety warning requirement due to incompatibility. | "This product has not been shown to be compatible with condoms. Labeling will contain a warning to this effect." A warning is present for the "Indications for Use" section: "Do not use this lubricant with condoms. It may weaken the condom's physical properties and make it more likely to break." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Subject-use reports" but does not provide any details on the sample size of these reports, the methodology (e.g., retrospective or prospective), or the country of origin of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided for this type of device. The evaluation of a personal lubricant does not typically involve "experts establishing ground truth" in the way an AI diagnostic tool would be validated. Evaluations are based on biocompatibility testing and user feedback.
4. Adjudication Method for the Test Set
This information is not applicable and not provided.
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
This information is not applicable. The device is a personal lubricant, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a personal lubricant, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For biocompatibility, the "ground truth" would be established through standardized non-clinical laboratory tests demonstrating lack of irritation/sensitization. For effectiveness, the "ground truth" is derived from subjective user reports regarding efficacy in reducing discomfort from vaginal dryness. There is no mention of pathology or objective outcomes data in the provided summary beyond user reports.
8. The Sample Size for the Training Set
This information is not applicable. The device is a personal lubricant; there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
§ 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.