(58 days)
Astroglide® O Oil Personal Lubricant & Massage Oil 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 not compatible with condoms.
Astroglide® O Oil Personal Lubricant & Massage Oil is non-sterile, light yellow, lightly coconut and ylang-ylang scented, and oil-based lubricant. All oils used in the subject formulation are certified organic, and the subject lubricant is a USDA certified organic final product. This product is not a spermicide or contraceptive. It is NOT compatible with natural rubber latex, polyurethane, or polyisoprene condoms.
This product primary packaging is a PETE amber bottle with a screw on polypropylene flip-top cap. The bottle and cap constitute the device are labeled front and back and then packaged in a cardboard carton which constitutes the final packaging.
The provided text is a 510(k) summary for the Astroglide® O Oil Personal Lubricant & Massage Oil. It details the device, its intended use, and its comparison to a predicate device. However, it does not describe a study involving an AI-powered device or software. Therefore, I cannot extract the information requested about acceptance criteria, study details, ground truth, or MRMC studies for an AI device from this document.
The document focuses on non-clinical performance testing for a personal lubricant to demonstrate its safety and effectiveness, which is a different type of evaluation than what would be conducted for an AI/ML medical device.
If the request was intended to ask about the non-clinical performance testing detailed in the document, here is a summary of that information:
1. A table of acceptance criteria and the reported device performance for Astroglide® O Oil Personal Lubricant & Massage Oil (non-AI device):
| Parameter | Specification (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Color | Light yellow | Light yellow (as described) |
| Clarity | Clear | Clear (as described) |
| Odor | Coconut and ylang-ylang | Coconut and ylang-ylang (as described) |
| Absence of particulate matter | Absent | Absent (as described) |
| Viscosity | 60-120 cP | Within the specified range of 60-120 cP |
| Total yeast/mold count | ) | ) |
| Biocompatibility - Cytotoxicity | Non-cytotoxic (ISO 10993-5: 2009/(R)2014) | Found to be non-cytotoxic |
| Biocompatibility - Sensitization | Non-sensitizing (ISO 10993-10: 2010/(R)2014) | Found to be non-sensitizing |
| Biocompatibility - Vaginal Irritation | Non-irritating (ISO 10993-10: 2010/(R)2014) | Found to be non-irritating |
| Biocompatibility - Systemic Toxicity | Non-systematically toxic (ISO 10993-11: 2006/(R)2010) | Found to be non-systematically toxic |
| Condom Compatibility (Natural rubber latex, polyisoprene, polyurethane) | Compatible (ASTM D7661-10 - implied predicate compatibility) | NOT Compatible (This is a key difference and limitation) |
| Shelf Life | Maintained specifications over 18-month shelf-life (ASTM F1980-07) | Maintained specifications over the duration of its shelf life |
Regarding the other points (#2-9), this information is not applicable to an AI device and is not contained in the document for this non-AI product.
- Sample size for test set and data provenance: N/A for an AI device. For the lubricant, samples were tested per the specified ASTM and USP methods.
- Number of experts and qualifications: N/A for an AI device. Testing was conducted according to standardized laboratory methods.
- Adjudication method: N/A for an AI device.
- MRMC comparative effectiveness study: N/A as this is not an AI device.
- Standalone performance: N/A as this is not an AI device. Its performance is evaluated through material and biological testing.
- Type of ground truth used: N/A for an AI device. The ground truth for this product is based on established scientific standards and analytical test results for chemical and biological properties.
- Sample size for training set: N/A as this is not an AI device.
- How ground truth for training set was established: N/A as this is not an AI device.
§ 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.