(88 days)
Silicone Personal Lubricant is a silicone-based personal lubricant for 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.
ALL-IN-ONE is a silicone-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 product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
Silicone Personal Lubricant and ALL-IN-ONE are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. The 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.
These products are provided in Polyethylene Terephthalate (PET) bottles capped with natural polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. There is also 16 fl. oz./480 mL bottle with a different configuration for the Silicone Personal Lubricant. This consists of a clear Polyethylene Terephthalate (PET) bottle with a polypropylene lotion pump instead of the disc top dispenser used in all other sizes. This bottle is configured with a shrink wrap seal. These products are also available in polyester-faced laminated pouches.
The provided document is a 510(k) premarket notification for a medical device: "Silicone Personal Lubricant, ALL-IN-ONE." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
The document does not describe an AI/ML-driven medical device, nor does it detail a study involving human readers, ground truth establishment by experts, or MRMC comparative effectiveness. The "acceptance criteria" discussed are for the physical and chemical properties of a personal lubricant, and the "study" involves laboratory testing to confirm these properties and biocompatibility.
Therefore, I cannot extract the information required to answer your questions regarding a device that uses AI/ML, human readers, or expert-established ground truth. The document describes a traditional medical device (a lubricant) and its physical, chemical, and biological testing for substantial equivalence.
Here's an analysis based on the document related to the lubricant's acceptance criteria and performance, as much as possible given the focus of the original request on AI/ML devices:
1. A table of acceptance criteria and the reported device performance:
The document describes the device specifications as performance criteria.
| Property | Specification | Reported Device Performance (Implied from "met the device specifications") |
|---|---|---|
| Appearance | Clear, semi-viscous liquid | Clear, semi-viscous liquid |
| Color | Clear | Clear |
| Odor | Odorless | Odorless |
| Viscosity (cps) | 800 cps to 1075 cps | Within 800 cps to 1075 cps range |
| Specific Gravity | 0.850 to 1.020 | Within 0.850 to 1.020 range |
| Antimicrobial effectiveness per USP | Meets US acceptance criteria for Category 2 products | Met USP criteria |
| Total aerobic microbial count (TAMC) per USP and | Less than 10 cfu/g | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | Less than 10 cfu/g |
| Presence of Pathogens per USP : | ||
| - Pseudomonas aeruginosa | Absent | Absent |
| - Staphylococcus aureus | Absent | Absent |
| - Salmonella | Absent | Absent |
| - Escherichia coli | Absent | Absent |
| - Candida albicans | Absent | Absent |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing | Demonstrated as non-cytotoxic, non-irritating, non-sensitizing |
| Shelf-Life | 2 years (with specifications met at 0, 1, 2 years) | Met specifications at 0, 1, and 2 years |
| Condom Compatibility | Compatible with natural rubber latex, polyurethane and polyisoprene condoms | Demonstrated compatibility with these condom types |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated in terms of number of units or batches, but testing was performed according to Pharmacopeial standards (USP) and ISO standards. These standards typically specify the number of samples to be tested.
- Data Provenance: Not specified in terms of country of origin. The studies appear to be laboratory-based (e.g., in vitro, animal irritation studies as per ISO 10993). The document states "real time and accelerated aging study" for shelf-life, which implies prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the studies are for a physical/chemical product, not an AI/ML device requiring human expert annotation or ground truth based on medical imaging or diagnostic outcomes. Testing was performed according to established international standards (ISO, ASTM, USP).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The "tests" are laboratory-based, objective measurements and biological assessments against predefined criteria. There is no human subjective assessment or adjudication process described as would be for an AI/ML system.
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/ML diagnostic tool. No human reader 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 algorithm. The "standalone performance" refers to the lubricant's intrinsic properties as measured in a lab.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is based on:
- Established physical/chemical specifications (e.g., viscosity, specific gravity, appearance, odor).
- Microbiological absence/presence thresholds per USP ,,.
- Biocompatibility criteria defined by ISO 10993 standards (e.g., lack of cytotoxicity, irritation, sensitization).
- Condom compatibility per ASTM D7661-10.
These are objective, quantitative or qualitative laboratory results against predefined standards, not expert consensus on medical images or diagnostic outcomes.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML model.
§ 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.