(49 days)
LUBi Water Based 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 rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
LUBi Water Based Personal Lubricant is a clear, colorless, moderate sweet perfume and viscous 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, 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 sold as an over-the-counter (OTC) product in an 8.54 fl. oz. / 250 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. The device is composed of water (aqua), glycerin, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, disodium ethylenediaminetetraacetic acid (EDTA).
The provided document is a 510(k) Pre-market Notification for a medical device (LUBi Water Based Personal Lubricant). It does not contain information typically found in a study proving a device meets acceptance criteria for an AI/ML-driven device.
Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, training set information, etc.) are not applicable to the content provided, as this is a submission for a personal lubricant, not an AI/ML diagnostic or therapeutic device.
However, I can extract the acceptance criteria and reported device performance from the document where available for the physical and chemical properties of the lubricant, and also comment on the type of studies performed for a medical device like this.
Acceptance Criteria and Device Performance (for a Personal Lubricant)
The document primarily focuses on the physical, chemical, and biological compatibility aspects of the LUBi Water Based Personal Lubricant.
1. Table of Acceptance Criteria and Reported Device Performance:
| Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Highly viscous liquid | Highly viscous liquid |
| Color | Clear | Clear |
| Odor | Moderate sweet perfume | Moderate sweet perfume |
| Viscosity (per USP) | 28,500-30,000 mPa.s | Met specification (implied, as all specifications were met across shelf life) |
| pH (per USP ) | 7.5-8.0 | Met specification (implied, as all specifications were met across shelf life) |
| Osmolality (per USP) | 1,000-1,100 mOsm/kg | Met specification (implied, as all specifications were met across shelf life) |
| Antimicrobial Effectiveness (per USP) | - No less than a 2.0 log reduction from initial count at 14 days and no increase from 14-day count at 28 days for E. coli, P. aeruginosa, S. aureus |
- No increase from initial calculated count at 14 and 28 days for C. albicans, A. niger | Met specification (implied, as all specifications were met across shelf life) |
| Total Aerobic Microbial Count (TAMC) (per USP and ) | and )** | )** | Absent for S. aureus, Salmonella spp., E. coli, P. aeruginosa, Clostridia, C. albicans | All absent (Met specification, implied as all specifications were met across shelf life) |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic | Demonstrated to be non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic |
| Shelf-Life | 3 years (device specifications met throughout) | 3 years (all device specifications listed in Table 1 were tested and met across the shelf life duration) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms (as per ASTM D7661-10) |
Regarding an AI/ML-driven device study (which this is not):
As the given input describes a personal lubricant and not an AI/ML-driven device, the following points are largely not applicable to this specific submission. However, if this were an AI/ML device, this is how I would address the questions based on best practices:
2. Sample size used for the test set and the data provenance: Not applicable. For an AI/ML device, this would detail the number of cases (e.g., images, patient records) used for final model evaluation, and whether they were collected prospectively or retrospectively and their geographical origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For an AI/ML device, this would specify the number and specialty of clinicians (e.g., radiologists, pathologists) who provided labels for the test data, along with their experience levels.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. For an AI/ML device, this would describe the process of resolving disagreements among experts when establishing ground truth (e.g., two experts agree, or a third expert adjudicates disagreement).
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 type of study evaluates how an AI system impacts human reader performance, which isn't relevant for a personal lubricant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This evaluates the AI algorithm's performance in isolation, which isn't relevant for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): "Ground truth" for this device comes from laboratory testing against established physical, chemical, and biological standards (e.g., USP monographs, ASTM standards, ISO 10993).
8. The sample size for the training set: Not applicable. This device is not an AI/ML system, so there's no "training set."
9. How the ground truth for the training set was established: Not applicable. As there's no training set in the AI/ML sense, this question does not apply. The "ground truth" for the lubricant's properties is established by recognized scientific and regulatory standards.
§ 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.