(78 days)
JO Gelato Flavored Personal Lubricants are water-based personal lubricants for penile and/or vaginal application, intended to lubricate and moisturize, 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, polyurethane and polyisoprene condoms.
JO Gelato Flavored Personal Lubricants are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. The device is a non-sterile lubricant for penile and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in Polyethylene Terephthalate (PET) bottles fitted with Polypropylene caps or foil sachets. The individual bottles are sealed using an induction seal constructed of aluminized mylar.
The provided document describes the safety and effectiveness testing for "JO Gelato Flavored Personal Lubricants." However, this document is a 510(k) summary for a medical device (personal lubricant), not an AI/ML powered device. As such, the specific criteria requested for AI/ML devices (such as effect size of AI assistance, number of experts, adjudication methods, ground truth types for training) are not applicable to the information provided.
I can provide the acceptance criteria and the study descriptions for the device itself as presented in the document.
Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria | Reported Device Performance and Study |
|---|---|---|
| Physical/Chemical Specifications | ||
| Appearance | Clear, semi-viscous liquid | Met during shelf-life testing at 0, 1, and 2 years. |
| Color | Clear | Met during shelf-life testing at 0, 1, and 2 years. |
| Odor | Sweet/Characteristic | Met during shelf-life testing at 0, 1, and 2 years. |
| Viscosity (cps) | 2000 cps to 3700 cps | Met during shelf-life testing at 0, 1, and 2 years. |
| Specific Gravity | 0.900 to 1.050 | Met during shelf-life testing at 0, 1, and 2 years. |
| pH | 5.0 to 6.0 | Met during shelf-life testing at 0, 1, and 2 years. |
| Osmolality | 1350 to 1550 mOsm/kg | Met during shelf-life testing at 0, 1, and 2 years. |
| Antimicrobial Effectiveness | Meets USP acceptance criteria for Category 2 products | Met. Tested per USP . |
| Microbial Counts | ||
| Total aerobic microbial count (TAMC) per USP and | Less than 10 cfu/g | Met. Tested per USP and . |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | Met. Tested per USP and . |
| **Presence of Pathogens per USP ** | Absent (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella, Escherichia coli, Candida albicans) | Met. Tested per USP . |
| Biocompatibility | Lubricant is biocompatible | Demonstrated through independent third-party laboratory studies including: Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity, and Sensitization testing. Performed in accordance with 2016 FDA guidance document Use of International Standard ISO 10993-1 and ISO 10993-1:2009 for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), Penile Irritation (ISO 10993-10:2010), and Acute Systemic Toxicity (ISO 10993-11:2006). |
| Shelf-Life | Two-year shelf-life with specifications maintained | Demonstrated through a real-time and accelerated aging study. All device specifications (listed in Table 1) were tested at 0, 1, and 2 years for both PET bottles and foil sachets packaging. The device met specifications at all time points. |
| Condom Compatibility | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms | Demonstrated through testing in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results indicated compatibility with all three types of condoms. |
Due to the nature of this submission being for a personal lubricant and not an AI/ML medical device, the following specific questions are either not applicable or cannot be answered from the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a non-AI/ML device. Biocompatibility tests use animal models (e.g., rabbits, guinea pigs). Shelf-life and condom compatibility tests use samples of the product. Specific sample sizes are not explicitly mentioned but are inherent to the cited ASTM and ISO standards.
- 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. "Ground truth" in the context of AI/ML is not relevant here. The evaluation is based on scientific standards and laboratory testing by independent third-party laboratories.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Evaluation is based on meeting pre-defined scientific and regulatory specifications.
- 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 not an AI-powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. "Ground truth" for this device comes from established scientific and regulatory standards (e.g., USP monographs, ISO standards, ASTM standards) and direct measurement of physical, chemical, and biological properties.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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.