(117 days)
JO H2O Jelly Original 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 H2O Jelly Original Personal Lubricant is a clear/water white, viscous gel-type personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant 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. This product is provided in clear, polyethylene (PE) tubes. These 4 oz. size tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process.
This document is a 510(k) premarket notification for a personal lubricant (JO H2O Jelly Original Personal Lubricant), and as such, it does not contain the kind of detailed study information (like a multi-reader multi-case study, ground truth establishment for a large training set, or specific acceptance criteria for an AI algorithm's performance on a test set) that would be present for an AI/ML medical device.
The "acceptance criteria" discussed in this document refer to the physical and chemical specifications of the lubricant itself, as well as its biocompatibility and condom compatibility, and microbiological quality, not the performance of an AI model. Therefore, I cannot extract the information required by your prompt, such as:
- A table of acceptance criteria and the reported device performance for an AI algorithm.
- Sample size used for the test set and data provenance for AI evaluation.
- Number of experts used to establish ground truth and their qualifications for AI evaluation.
- Adjudication method for AI evaluation.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI evaluation.
- The sample size for the training set for an AI algorithm.
- How the ground truth for the training set was established for an AI algorithm.
Instead, the document details the following regarding the lubricant itself:
1. A table of device specifications (acceptance criteria for the product) and the measured or tested performance:
| Property | Specification | Reported Performance (Implied by "met the device specifications") |
|---|---|---|
| Appearance | Viscous gel | Met specification (implied) |
| Color | Clear, water white | Met specification (implied) |
| Odor | Odorless | Met specification (implied) |
| Viscosity (cps) | 15,500 cps to 35,000 cps | Met specification (implied) |
| pH | 4.00 to 5.00 | Met specification (implied) |
| Specific Gravity | 1.000 to 1.200 | Met specification (implied) |
| Osmolality | 1050 to 1250 mOsm/kg | Met specification (implied) |
| Antimicrobial effectiveness per USP | Meets US acceptance criteria for | |
| Category 2 products | Met USP acceptance criteria (reported explicitly as "Meets US acceptance criteria for Category 2 products") | |
| Total aerobic microbial count (TAMC) per | ||
| USP and | Less than 10 cfu/g | Met specification (reported explicitly as "Less than 10 cfu/g" in line with specification, implying it meets it) |
| Total yeast and mold count (TYMC) per | ||
| USP and | Less than 10 cfu/g | Met specification (reported explicitly as "Less than 10 cfu/g" in line with specification, implying it meets it) |
| Presence of Pathogens per USP | ||
| - Pseudomonas aeruginosa | Absent | Absent (implied by "device met the device specifications") |
| - Staphylococcus aureus | Absent | Absent (implied by "device met the device specifications") |
| - Salmonella/Shigella | Absent | Absent (implied by "device met the device specifications") |
| - Escherichia coli | Absent | Absent (implied by "device met the device specifications") |
| - Candida albicans | Absent | Absent (implied by "device met the device specifications") |
| Biocompatibility | Biocompatible | The results of testing demonstrated that the subject lubricant is biocompatible. |
| Shelf-Life | 2 years at specified properties | Met device specifications at 0, 1, and 2 years during real-time and accelerated aging study. (Reported as "The subject device met the device specifications at all time points.") |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms | Compatible with natural rubber latex and polyisoprene condoms. (Reported as "The results of this test indicated that JO H2O Jelly Original Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms.") |
| Condom Compatibility | Incompatible with polyurethane condoms | Not compatible with polyurethane condoms. (Reported as "This device is not compatible with polyurethane condoms.") |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document does not describe the kind of "test set" or "data provenance" that would apply to an AI/ML device. The testing described is laboratory-based performance testing of the physical product. No geographic data provenance is mentioned. The studies (biocompatibility, shelf-life, condom compatibility) are prospective tests performed on the manufactured product.
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 to this type of device submission. Ground truth is established by standard laboratory testing methods (e.g., USP , ASTM D7661-10) rather than expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable to this type of device submission.
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 physical lubricant, not an AI-based diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this is a physical lubricant, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this product is based on established laboratory standards and test methods for material properties, sterility, biocompatibility, and compatibility with other medical devices (condoms). Examples include:
- USP for antimicrobial effectiveness
- USP and for microbial counts
- USP for pathogen presence
- ISO 10993 series for biocompatibility (e.g., Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity)
- ASTM D7661-10 for condom compatibility
8. The sample size for the training set
- Not applicable; this is a physical lubricant, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable; this is a physical lubricant, not an AI algorithm.
In summary, the provided document describes the safety and effectiveness testing of a personal lubricant, focusing on its physical properties, biocompatibility, and compatibility with condoms, rather than the performance of an AI/ML medical 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.