(189 days)
LifeStyles® Luxe™ Premium 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, polyurethane, and polyisoprene condoms.
LifeStyles® Luxe™ Premium Personal Lubricant is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a biocompatible gel-like liquid that lasts longer than hydrous lubricants, without drying out or becoming sticky, and is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.
The provided text describes a 510(k) submission for a personal lubricant, not an AI-powered medical device or diagnostic tool. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and sample sizes for training/test sets are not applicable to this document.
However, I can extract the acceptance criteria and the "device performance" as reported for this personal lubricant, even though they are for a different type of product than typically discussed in AI contexts.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Description of Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Compatibility with Condoms: Compatibility with natural rubber latex, polyurethane, and polyisoprene condoms. | Testing per ASTM D7661 indicated that the lubricant formulation is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. |
| Biocompatibility: Absence of cytotoxicity, vaginal irritation, sensitization, and systemic toxicity. | Testing in accordance with ISO 10993 indicated device biocompatibility for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity. |
| Lubrication Duration: Lasts longer than hydrous lubricants without drying out or becoming sticky. | Bench testing indicated that the lubricant lasts longer than hydrous lubricants, without drying out or becoming sticky. |
| Physical Properties: Appropriate viscosity, specific gravity, appearance, color, and odor for substantial equivalence to the predicate. | Bench testing indicated that it has an appropriate viscosity, specific gravity, appearance, color and odor for substantial equivalence to the predicate. |
| Microbial Quality: Meets microbial limits. | Microbial limits testing was conducted per USP and USP indicated microbial quality. |
| Shelf-Life: Minimum shelf-life of 3 years. | Realtime and accelerated aging tests indicate a 3 year shelf-life for the lubricant. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a distinct "sample size" in the context of a test set for an AI model. The testing described (ASTM D7661, ISO 10993, USP /, bench testing, aging tests) would have involved specific sample sizes of the lubricant and test materials (e.g., condom samples, biological samples for biocompatibility), but these quantities are not detailed in this summary.
- Data Provenance: Not applicable in the AI sense. The testing was conducted for regulatory purposes to demonstrate safety and effectiveness for a medical device (personal lubricant) in the USA (submission by Ansell Healthcare Products, LLC in Dothan, AL).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical and chemical product, not one requiring expert human interpretation for "ground truth" as in medical imaging or diagnostics. The "ground truth" here is derived from standardized laboratory tests and measurements.
4. Adjudication method
Not applicable. There was no need for adjudication as the "ground truth" was established through objective tests, not human interpretation.
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-powered device or a diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a personal lubricant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance was established through:
- Standardized laboratory testing: ASTM D7661 for condom compatibility, ISO 10993 for biocompatibility, USP and USP for microbial quality.
- Bench testing: For aspects like lubrication duration, viscosity, specific gravity, appearance, color, and odor.
- Realtime and accelerated aging tests: For shelf-life.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this product as it is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.