(90 days)
Just like Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural latex, polyisoprene, and polyurethane condoms.
The Just Like Me Personal Lubricant is a non-sterile, water based, over-the- counter personal lubricant formulated to be a clear, non-irritating, non-greasy, odorless liquid.
The proposed device contains a blend of ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without natural rubber latex, polyisoprene, and polyurethane condoms during intimate sexual activity as evidenced by condom compatibility testing.
The provided document is a 510(k) summary for a personal lubricant, "Just Like Me Personal Lubricant." It details the device's characteristics and performance testing to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on your request:
1. A table of acceptance criteria and the reported device performance
The document provides the results of various performance tests, with a focus on safety and compatibility. The "acceptance criteria" are implied by the "Results" column, indicating that the product passed or met specific safety standards.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity (Direct Contact) | Product should be non-toxic | Product is Non-toxic |
| ISO GUINEA PIG MAXIMIZATION SENSITIZATION TEST | Product should not elicit a sensitization response | Product does not elicit a sensitization response |
| Vaginal Mucosa Irritation with Histopathology | Product should be considered a non-irritant to vaginal tissue | Product is considered a non-irritant to vaginal tissue |
| Acute Systemic Toxicity | No evidence of systemic toxicity | There is no evidence of system toxicity |
| Condom Compatibility (ASTM D7661-10 with Natural Rubber Latex, Polyisoprene, and Polyurethane condoms) | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms |
| Shelf Life Testing (Accelerated aging study) | Met specifications for viscosity, specific gravity, appearance, color, odor, Preservative Effectiveness, Antimicrobial Effectiveness, TAMC, TYMC, Absence of Pathogenic organism for 2 years | Achieved a 2-year shelf life, meeting all specified parameters after aging |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not explicitly state the sample sizes for the individual biocompatibility tests or the condom compatibility testing (e.g., number of animals for in-vivo tests, number of condoms tested). It mentions testing "three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms," but not the number of individual condoms per brand.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is implied that the testing was performed to support a US FDA submission, but the location of the labs is not given.
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 information is not applicable to this document. The studies described are laboratory-based performance tests (biocompatibility, shelf life, condom compatibility), not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is established by objective measurements and standardized protocols, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically relevant for clinical studies where multiple experts evaluate ambiguous cases. For the laboratory tests detailed, the results are determined by analytical methods and direct measurement, not by interpretive adjudication.
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
This information is not applicable. This document describes performance testing for a personal lubricant, not an AI-powered diagnostic device or a device involving human readers. Therefore, an MRMC study and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. As previously stated, this document does not concern an AI algorithm or software. It pertains to a physical medical device (personal lubricant) where performance is measured through laboratory testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed is based on:
- Standardized Laboratory Assays: For biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity), the ground truth is established by the specific endpoints and criteria defined in ISO 10993 standards. These involve biological responses measured in cells or animals.
- Physical Property Measurements: For condom compatibility, the ground truth is determined by meeting the criteria outlined in ASTM D7661-10, which assesses physical integrity after lubricant exposure.
- Chemical and Microbiological Specifications: For shelf-life testing, the ground truth is the product's ability to maintain its specified viscosity, specific gravity, appearance, color, odor, preservative effectiveness, antimicrobial effectiveness, and freedom from pathogens (TAMC, TYMC, Absence of Pathogenic organism) over time.
These are all objective, measurable parameters defined by recognized standards and specifications, rather than expert interpretation of complex clinical data.
8. The sample size for the training set
This information is not applicable. This submission is for a physical medical device (a lubricant) and not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for an AI/ML algorithm, the method for establishing its ground truth is irrelevant to this document.
§ 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.