(160 days)
K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to lubricate and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.
K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, is a nonsterile, anhydrous, fragranced, glycol-in-silicone emulsion that provides a warming sensation upon contact with ambient moisture on the skin. It is composed of a combination of lubricants and emollients, an antioxidant, a gelling agent, a thickener, a film former, a stabilizer, a surfactant, and a fragrance. The emulsion is off-white to beige in color with a slight hint of vanilla and/or floral scent. It has a viscosity, specific gravity, and lubricity typical for emulsions of this type.
The product will be filled in printed black 3.0 ounce high density polyethylene (HDPE) heart shaped bottles, sealed with black pump closures, and packaged in printed cartons.
This document is a 510(k) Premarket Notification from the FDA regarding the K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant. It's a regulatory approval, not a scientific study describing algorithm performance. Therefore, most of the requested information about acceptance criteria, study design, and ground truth for an AI/device performance study is not applicable.
However, I can extract information regarding the device's performance in the context of its regulatory approval.
Overview of the Device and its Changes:
The device, K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant, is a personal lubricant. It is a slightly modified version of a previously cleared device (K-Y® Brand Intrigue™ 2-in-1 Massage Creme™). The primary difference is the addition of a fragrance.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria with numerical targets. Instead, it describes compliance with established standards and satisfactory results from specific tests to demonstrate safety and effectiveness in the context of substantial equivalence to a predicate device.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Pass ISO 10993-5:2009 for Cytotoxicity | Results demonstrate that the device is biocompatible. |
| Pass ISO 10993-10:2010 for Guinea Pig Maximization Sensitization | Results demonstrate that the device is biocompatible. | |
| Pass ISO 10993-10:2010 for Vaginal Irritation | Results demonstrate that the device is biocompatible. | |
| Pass ISO 10993-11:2006 for Acute Systemic Toxicity | Results demonstrate that the device is biocompatible. | |
| Condom Compatibility | Meet ASTM D7661-10 integrity for condoms | Not compatible with natural rubber latex, polyisoprene, or polyurethane condoms (mechanical and/or physical integrity affected). |
| Stability/Shelf-life | Support a two-year shelf-life | Satisfactory results to support a 2-year expiration date. |
| Substantial Equivalence | No new types of questions of safety or effectiveness compared to predicate; no change in intended use or fundamental scientific technology. | Concluded to be substantially equivalent to the predicate device. |
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 provide details on sample sizes for the biocompatibility, condom compatibility, or stability tests. These tests are typically conducted in a laboratory setting (prospective testing) but the document does not specify the country of origin for 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)
This information is not applicable. The evaluations (biocompatibility, condom compatibility, stability) are technical laboratory tests, not expert-driven assessments of a "ground truth" as might be found in diagnostic AI studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used for expert consensus in diagnostic studies, not for laboratory performance tests of a physical product.
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
No such study was conducted. This is a physical product (personal lubricant), not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical product (personal lubricant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on established scientific and regulatory standards for safety and performance:
- Biocompatibility: Adherence to ISO 10993 series standards.
- Condom Compatibility: Adherence to ASTM D7661-10.
- Stability: Laboratory testing to demonstrate shelf-life.
8. The sample size for the training set
This information is not applicable. This is a physical product, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is a physical product, not an AI model that requires a training set and ground truth establishment for it.
§ 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.