(82 days)
JO CUMPLAY Personal Lubricant is a personal lubricant for penile, anal 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
JO CUMPLAY Personal Lubricant is a non-sterile, water-based personal lubricant for penile, anal 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
Its formulation consists of Water (Aqua), Propylene Glycol, Dimethicone, Dimethiconol, Lauryl Glucoside, Aloe Barbadensis Leaf Powder, Vitamin E Acetate, Hydroxyethylcellulose, PEG-90M, Hydrogenated Polydecene, Acrylic Copolymer, Sodium Acrylates/Beheneth-25 Metharylate Crosspolymer, and Chlorphenesin.
JO CUMPLAY Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in a 4 fl. Oz./120 mL polyethylene terephthalate bottle and capped with matte black Polypropylene (PP) pump closure.
The provided document is a 510(k) Summary for a personal lubricant, not a study involving AI or human readers for comparative effectiveness. Therefore, many of the requested categories related to AI performance, expert ground truth, and MRMC studies are not applicable to this document.
However, I can extract the acceptance criteria and the results of the studies conducted for the device.
Here's the information based on the provided text:
Device: JO CUMPLAY Personal Lubricant
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance/Results |
|---|---|---|
| Appearance | Viscous liquid | Viscous liquid (as per device specifications) |
| Color | White to off-white | White to off-white (as per device specifications) |
| Odor | Odorless | Odorless (as per device specifications) |
| Viscosity (per USP) | 7800 - 8800 cps | (Tested to be within this range, implied by "maintains its specifications") |
| pH (per USP) | 6.8 – 8.0 | (Tested to be within this range, implied by "maintains its specifications") |
| Osmolality (per USP) | 700 – 1000 mOsm/kg | (Tested to be within this range, implied by "maintains its specifications") |
| Total Aerobic Microbial Count (TAMC, per USP ) | ) | ) |
| Staphylococcus aureus: Absent | ||
| Candida albicans: Absent | ||
| Escherichia coli: Absent | ||
| Salmonella/Shigella: Absent | Absent (implied by "maintains its specifications" and "Absence of Pathogenic Organisms: Yes") | |
| Antimicrobial Effectiveness Testing (per USP ) | Bacteria: Meets USP criteria for category 2. No less than 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days | |
| Yeast and Molds: No increase from the initial calculated count at 14 and 28 days | Meets USP criteria (implied by "Antimicrobial Effectiveness Tested: Yes") | |
| Biocompatibility | Acceptable results for Cytotoxicity, Sensitization, Vaginal Irritation, and Acute Systemic Toxicity as per ISO 10993 standards. | Results of testing support the biocompatibility of the device materials. |
| Shelf-Life | Device maintains specifications for the claimed shelf-life. | 2.5 years (results from real-time testing demonstrated maintenance of specifications). |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms. | Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for viscosity, pH, etc.). However, for condom compatibility, the test method is ASTM D7661-10(R) 2017, which would define the sample size.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical performance testing conducted by the manufacturer or a contracted lab. The studies are prospective in the sense that they were conducted specifically for this device submission to demonstrate its performance.
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 is a physical and chemical product, not an AI or diagnostic device that requires expert-established ground truth. The "ground truth" for these tests comes from established international standards (e.g., USP, ISO, ASTM) and analytical methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring human adjudication of results. The tests are based on objective chemical and physical measurements.
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 device is a personal lubricant, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a personal lubricant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical, chemical, and microbiological properties, the "ground truth" is defined by the established specifications and validated test methods from recognized standards (e.g., USP, ISO, ASTM).
- For biocompatibility, the ground truth is determined by the results of standardized biological tests that evaluate the material's interaction with biological systems according to ISO 10993 series.
- For condom compatibility, the ground truth is determined by the results of the specific ASTM standard test method.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI model requiring a training set.
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.