(88 days)
JO Agapé Original Personal Lubricant is a 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 product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
MUSE Essence Water-Based Lubricant is a 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 product is compatible with natural rubber lates and polyisoprene condoms. This product is not compatible with polyurethane condoms.
#LubeLife Water-Based Lubricant is a 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 product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
#LubeLife Water-Based Anal Lubricant is a 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 product is compatible with natural rubber lates and polyisoprene condoms. This product is not compatible with polyurethane condoms.
JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are clear/water white, viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile 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. All of these devices contain the same formulation.
The provided document is a 510(k) premarket notification for personal lubricants. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study data for a novel device or AI/ML-driven medical device. Therefore, much of the requested information (like AI assistance effect size, expert qualifications, sample size for training sets, etc.) is not applicable or available in this context.
However, I can extract information related to the device specifications and the performance studies conducted to show that the device meets certain standards.
Here's the available information relevant to acceptance criteria and performance, as best as can be inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document provides "Device Specifications" which act as acceptance criteria for the physical and chemical properties, and microbial limits of the lubricants. It also states the results of performance tests.
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Clear, viscous liquid | Clear, viscous liquid (stated in Device Description) |
| Color | Clear, water white | Clear, water white (stated in Device Description) |
| Odor | Odorless | Odorless (reported in Table 1) |
| Viscosity (cps) | 2400 cps to 3100 cps | Within 2400 cps to 3100 cps (reported in Table 1) |
| pH | 3.6 to 4.5 | Within 3.6 to 4.5 (reported in Table 1) |
| Specific Gravity | 1.020 to 1.026 | Within 1.020 to 1.026 (reported in Table 1) |
| Osmolality | 600 to 700 mOsm/kg | Within 600 to 700 mOsm/kg (reported in Table 1) |
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products. | Meets USP acceptance criteria. (reported in Table 1) |
| Total aerobic microbial count (TAMC) per USP and | Less than 10 cfu/g | Less than 10 cfu/g (reported in Table 1) |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | Less than 10 cfu/g (reported in Table 1) |
| Presence of Pathogens per USP | Absent for listed pathogens | Absent for Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli, Candida albicans (reported in Table 1) |
| Biocompatibility | Passing reactivity score (cytotoxicity, irritation), Non-sensitizing, Non-systemically toxic | Slightly cytotoxic (passing), Mildly irritating (passing), non-sensitizing, non-systemically toxic (Summary of Performance Data) |
| Condom Compatibility | Compatible with Natural Rubber Latex and Polyisoprene condoms | Compatible with Natural Rubber Latex and Polyisoprene condoms; Not compatible with Polyurethane condoms (Summary of Performance Data) |
| Shelf life | 2 years (after accelerated aging studies) | 2 years (Summary of Performance Data) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test conducted (e.g., number of lubricant samples for chemical/microbial tests, number of animals for biocompatibility, or number of condoms for compatibility).
- Provenance: The tests were performed in accordance with recognized standards (USP, ISO, ASTM). The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, but given they are performance tests for regulatory submission, they would generally be prospective studies conducted in a controlled laboratory environment.
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 device is a personal lubricant, not an interpretive medical device like an AI/ML diagnostic. The "ground truth" here refers to objective physical, chemical, and biological properties measured via standardized lab tests, not expert consensus on interpretations.
4. Adjudication method for the test set
Not applicable for this type of device and testing. Test results are typically objective measurements against a defined specification.
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-driven device or an interpretive device requiring human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical product (lubricant), not an algorithm.
7. The type of ground truth used
The "ground truth" for the acceptance criteria and performance evaluations are based on:
- Standardized Test Methods: USP (United States Pharmacopeia), ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials) standards for chemical composition, physical properties, microbiological contamination, biocompatibility, and condom compatibility.
- Objective Measurements: Laboratory measurements against predefined numerical or qualitative specifications.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of medical device as it is not an AI/ML system.
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.