(103 days)
JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are personal lubricants 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. These products are compatible with natural rubber latex, polyurethane and polyisoprene condoms.
JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are clear, viscous, amber colored, gel type personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. These devices are non-sterile personal lubricants for penile, anal 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. Both versions of the subject device have the same formulation, with the exception of the addition of a fragrance to the JO Naturalove Strawberry Fields Flavored Personal Lubricant. These devices are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in 0.1 oz and 0.3 oz polyester-faced laminated pouches.
The provided text describes a 510(k) premarket notification for a medical device, specifically a personal lubricant, and does not contain information about an AI/ML device or its associated studies. Therefore, I cannot provide an answer that includes acceptance criteria for an AI/ML device, sample sizes for test sets, expert qualifications, MRMC studies, or standalone algorithm performance.
The document focuses on demonstrating the substantial equivalence of the "JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant" to a predicate device (JO Gelato Flavored Personal Lubricants) based on physicochemical properties, biocompatibility, shelf-life, and condom compatibility.
Here is an analysis of the available information, structured to address parts of your request where applicable, but noting the absence of AI/ML-specific details:
1. A table of acceptance criteria and the reported device performance
The document provides a "Device Specifications" table, which functions as the acceptance criteria for the physical and chemical properties and microbial counts of the lubricant. The reported performance refers to the device meeting these specifications.
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Clear, viscous gel | Met specification (implied by "The subject devices met the device specifications at all time points.") |
| Color | Amber | Met specification |
| Odor | Characteristic | Met specification |
| Viscosity (cps) | 10,500 cps to 21,000 cps | Met specification |
| pH | 5.0 to 6.3 | Met specification |
| Specific Gravity | 0.975 to 1.20 | Met specification |
| Osmolality | 650 to 800 mOsm/kg | Met specification |
| Antimicrobial effectiveness per USP | Meets US acceptance criteria for Category 2 products | Met acceptance criteria |
| Total aerobic microbial count (TAMC) per USP and | Less than 10 cfu/g | Met specification |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | Met specification |
| Presence of Pathogens per USP (Pseudomonas aeruginosa) | Absent | Absent |
| Presence of Pathogens per USP (Staphylococcus aureus) | Absent | Absent |
| Presence of Pathogens per USP (Salmonella/Shigella) | Absent | Absent |
| Presence of Pathogens per USP (Escherichia coli) | Absent | Absent |
| Presence of Pathogens per USP (Candida albicans) | Absent | Absent |
| Biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Penile Irritation, Acute Systemic Toxicity) | Biocompatible per ISO 10993 standards | Demonstrated biocompatible |
| Shelf-Life | 2 years (maintaining all device specifications) | 2 years (met specifications at 0, 1, and 2 years) |
| Condom Compatibility (Natural rubber latex, polyisoprene, polyurethane) | Compatible per ASTM D7661-10 | Compatible |
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 specify the exact sample sizes (e.g., number of batches, units tested) for the performance tests (e.g., viscosity, pH, microbial counts, biocompatibility, shelf-life, condom compatibility). The data provenance (country of origin, retrospective/prospective) is also not mentioned, as these are typically internal laboratory tests conducted by the manufacturer or contracted labs.
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 is not applicable to this type of device submission. Ground truth, in the context of an AI/ML device, refers to expertly verified labels or diagnoses. For a personal lubricant, "ground truth" is established by laboratory measurements against defined chemical, physical, and biological standards. There are no "experts" in the sense of clinicians interpreting outputs for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This device does not involve human interpretation or adjudication of results in the way an AI/ML diagnostic device would.
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 not an AI/ML device and therefore no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and chemical properties, the "ground truth" is derived from established laboratory measurement techniques (e.g., pH meters for pH, viscometers for viscosity, osmometers for osmolality) compared against predetermined standard specifications. For microbial testing, it's based on standard microbiological culture methods. For biocompatibility, it's based on the results of specific in-vitro and in-vivo tests according to ISO 10993 standards. For condom compatibility, it's based on the standard ASTM D7661-10 test method.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.
§ 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.