(274 days)
Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal lubricant 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, but is not compatible with polyurethane condoms.
Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubrican are non-sterile, translucent, non-greasy, aqueous thick liquid intended for use as a personal lubricant. Luvena Enhanced Moisturizer and Luvena Enhanced Persona Lubricant are packed in a plastic bottle. These devices are neither contraceptives nor spermicidals, nor do they contain any such component. They are compatible with latex and polyisoprene condoms and not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to the standards defined by ASTM D7661.
The provided document is a 510(k) premarket notification summary for
"Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant." It is a regulatory approval document and not a scientific study report on device performance with specific acceptance criteria that are typically described for AI/ML devices or diagnostic tools.
Therefore, the requested information elements related to AI/ML device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training sets, are not applicable to this document. This document pertains to the regulatory submission for a personal lubricant and moisturizer.
However, I can extract the relevant "acceptance criteria" and "reported device performance" type information from the document as they relate to the product's physical and biological properties.
Here's a summary of the acceptance criteria (as product specifications and testing standards) and reported performance as described in the document, which allowed the device to demonstrate substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Test | Acceptance Criteria (Standard/Specification) | Reported Device Performance |
|---|---|---|
| Product Specifications (for final formulation) | Color/Appearance, Odor, pH, Viscosity, Osmolality, Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC), Absence of pathogenic organisms, Antimicrobial Effectiveness. | Specifications met (details of specific values not provided, but implicitly passed to support submission). |
| Biocompatibility | Generally following ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity). | The results demonstrate that the subject lubricants are biocompatible. |
| Antimicrobial Preservative Effectiveness | USP | Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant passed the Antimicrobial Effectiveness test. |
| Lubricant-Condom Compatibility | ASTM D7661 | Found to be compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms. |
| Shelf Life | Not explicitly stated (implied to ensure stability over time). | The results of real time testing support the proposed shelf life for the subject lubricants. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes physical, chemical, and biological testing of a product based on established standards, not a clinical trial or algorithm performance study with a "test set" of patient 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. This document describes laboratory testing against established physical and biological standards, not the establishment of ground truth for a diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 is a product demonstrating substantial equivalence to a predicate device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" (or basis for evaluation) for the device's properties was based on established regulatory standards and testing methodologies such as ISO 10993-1 for biocompatibility, USP for antimicrobial effectiveness, and ASTM D7661 for condom compatibility. Product specifications (pH, viscosity, etc.) also serve as internal ground truths for manufacturing control.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- 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.