(205 days)
[Continuous Silkiness - Warm & Tingling][Continuous Silkiness] is a personal lubricant, for penile 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. Not compatible with polyurethane or other condoms.
The device will be available in two forms - as the TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant and as the TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant - each an aqueous, non-sterile, clear personal lubricant compatible with natural rubber latex and polyisoprene condoms. TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant consists of low levels of sensory ingredients.
TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant is composed of propylene glycol, water, dimethicone, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, and propy|paraben, TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant is composed of propylene glycol, water, dimethicone, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, menthol, propylparaben, and vanillyl butyl ether. Each product is not a spermicide or a contraceptive and is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, flip top polypropylene (PP) closure constituting the device's primary packaging. One bottle is packaged into a cardboard carton, which constitutes the device outer packaging.
The provided text is a 510(k) Premarket Notification for a personal lubricant, not a device that uses AI or requires the extensive study types mentioned in your request (MRMC, standalone algorithm, ground truth establishment for training/test sets with experts).
Therefore, I cannot fulfill your request as it pertains to a medical device that would involve the requested AI-specific acceptance criteria and study details. The document describes biocompatibility testing, condom compatibility testing, and shelf-life studies for a personal lubricant.
Here's an attempt to extract relevant information from the provided text, reinterpreting your request to fit the context of a personal lubricant:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Similar cytotoxicity profile to currently marketed lubricants | Cytotoxicity profile similar to currently marketed personal lubricants |
| Rabbit Vaginal Irritation | Non-irritating | Non-irritating |
| Rabbit Penile Irritation | Non-irritating | Non-irritating |
| Acute Systemic Toxicity | Non-systemically toxic | Non-systemically toxic |
| Guinea Pig Maximization | Non-sensitizing | Non-sensitizing |
| Primary Rabbit Skin Irritation | Non-irritating | Non-irritating |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms | Compatible with commercially available natural rubber latex condoms and polyisoprene condoms |
| Shelf-life | Two-year shelf-life (based on accelerated aging) | Two-year shelf-life based on the results of an accelerated aging study |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of rabbits, number of guinea pigs) are not specified in the provided document. The data provenance is not explicitly stated but would typically be from laboratory studies.
- Condom Compatibility: The document states "Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested." This indicates a sample size of at least 4 types of condoms (3 natural rubber latex + 1 polyisoprene). The data provenance is laboratory testing using ASTM D7761-10.
- Shelf-life: Not specified, but likely refers to samples of the lubricant product itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the type of device and testing described. Biocompatibility and condom compatibility tests rely on standardized protocols and objective measurements, not expert human interpretation in the way an AI diagnostic tool would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. The tests are laboratory-based with objective endpoints measured according to established standards.
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 is not applicable as the device is a personal lubricant, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a personal lubricant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the tests described:
- Biocompatibility: Ground truth is established by the observed biological responses in accordance with ISO 10993 standards and comparison to known safe materials/responses.
- Condom Compatibility: Ground truth is based on the physical integrity and burst properties of condoms after exposure to the lubricant, as measured by ASTM D7761-10.
- Shelf-life: Ground truth is based on chemical and physical stability measurements over time.
8. The sample size for the training set
This is not applicable as there is no "training set" for a personal lubricant in the context of AI development.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" for a personal lubricant in the context of AI development.
§ 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.