(97 days)
The Sensuva Personal Lubricants are personal lubricants, for penile, anal 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. These products are compatible with natural latex, polyisoprene, and polyurethane condoms.
The Sensuva Personal Lubricants are water-based, non-sterile personal lubricants for over-the-counter use, formulated to be slightly cloudy and odorless. The device is designed to supplement the body's own natural lubrication and is compatible for use with natural rubber latex, polyurethane, and polyisoprene condoms during intimate sexual activity. Sensuva Personal Lubricants are neither a contraceptive nor a spermicide.
The provided document is a 510(k) summary for a medical device (Sensuva Personal Lubricants). It outlines the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than detailing an AI/ML device study.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies related to an AI/ML device cannot be extracted from this document, as it does not pertain to such a device.
However, I can extract the acceptance criteria and performance related to the physical and chemical properties of the Sensuva Personal Lubricants, as described in the "Summary of Non-Clinical Performance Testing" section, and how they meet established standards.
Acceptance Criteria for Sensuva Personal Lubricants (Non-AI/ML Device):
| Acceptance Criteria (Property) | Reported Device Performance |
|---|---|
| Appearance | Slight hazy, viscous liquid |
| Color | Particle-Free / slightly cloudy color |
| Odor for original flavor | Odorless |
| Viscosity (cps) | 4,000 cps - 6,800 cps |
| pH | 4-5 |
| Osmolality | 380-550 mOsm/kg |
| Specific Gravity | 0.95 - 1.05 |
| Antimicrobial effectiveness per USP | Meets US acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP and | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g |
| Presence of Pathogens per USP : | |
| - Pseudomonas aeruginosa | Absent |
| - Staphylococcus aureus | Absent |
| - Salmonella/Shigella | Absent |
| - Escherichia coli | Absent |
| - Candida albicans | Absent |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (per ISO 10993-5:2009) |
| Biocompatibility (Sensitization) | Non-sensitizing (per ISO 10993-10:2010), non-irritating (per ISO 10993-10:2010) |
| Biocompatibility (Vaginal Irritation) | Non-irritating (per ISO 10993-10:2010) |
| Biocompatibility (Acute Systemic Toxicity) | Non-systemically toxic (per ISO 10993-11:2006) |
| Shelf-life | 19 months (per ASTM F1980-16, with all device specifications maintained) |
| Condom Compatibility (Natural rubber latex, polyisoprene, polyurethane condoms) | Compatible (per ASTM D7661-10) |
Study Information (Non-AI/ML Device):
- Sample size used for the test set and the data provenance: Not explicitly detailed for each test beyond "the Sensuva Personal Lubricants." The data provenance is internal testing performed for FDA 510(k) submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these physical and chemical tests is established by adherence to recognized international and U.S. standards (e.g., ISO, USP, ASTM) and observed laboratory results, not expert consensus in the human interpretation sense.
- Adjudication method for the test set: Not applicable. Results are based on direct measurement and observation against established scientific and regulatory standards.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML device that requires human-reader interaction studies.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI/ML device.
- The type of ground truth used:
- Biocompatibility: Established by adherence to ISO 10993 standards (10993-5:2009, 10993-10:2010, 10993-11:2006).
- Shelf-Life: Established by accelerated aging studies per ASTM F1980-16.
- Condom Compatibility: Established by ASTM D7661-10.
- Physical/Chemical Properties & Microbial Counts: Established by USP standards (, , , ) and internal specifications.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML 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.