(90 days)
Belle Sensilube is intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Belle Sensilube is compatible with natural rubber latex and polyisoprene condoms. Belle Sensilube is not compatible with polyurethane condoms.
Belle Sensilube is a water-based personal lubricant for over-the-counter use. The subject device is a non-sterile liquid preparation containing water, propylene qlycol, hyroxyethylcellulose, polyacrylamide anionic, lactic acid and potassium lactate, and benzoic acid. The subject device will be packaged in a 40 mL high-density polyethylene bottle fitted with a polypropylene cap. The lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
The provided text describes the submission of a 510(k) premarket notification for a personal lubricant named "Belle Sensilube." This document focuses on demonstrating the substantial equivalence of Belle Sensilube to a legally marketed predicate device (KY Banksy Aloe) rather than outlining a study that proves a device meets specific acceptance criteria for a new medical device.
The information you are requesting, such as ground truth establishment for a test set, sample sizes for training/test sets in the context of an AI/ML-driven device, multireader-multicase studies or the effect size of AI assistance on human readers, and the number of experts for ground truth, is not present in this document. This is because Belle Sensilube is a physical product (personal lubricant), not an AI/ML-driven medical device that would require such studies. The regulatory submission process for this type of device primarily involves demonstrating biocompatibility, shelf-life, and compatibility with other medical devices (like condoms) to establish substantial equivalence to an existing product.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them in the context of an AI/ML device, as the provided document pertains to a personal lubricant.
However, I can extract the "acceptance criteria" (specifications) and performance data for Belle Sensilube as a physical product from the document.
Acceptance Criteria and Reported Device Performance for "Belle Sensilube" (as a physical product):
The table below summarizes the specifications (acceptance criteria) for the Belle Sensilube personal lubricant and the implied performance, as the document states the device met these specifications.
| Parameter | Test Method | Specification (Acceptance Criteria) | Reported Device Performance (Implied from the document) |
|---|---|---|---|
| Appearance | Visual | Clear, colorless liquid gel, free from lumps and extraneous matter | Met specification: Clear, colorless liquid gel, free from lumps and extraneous matter. |
| Odor | Olfactory | No objectionable odor | Met specification: No objectionable odor. |
| pH | USP | 3.5 - 4.5 | Met specification: pH was within 3.5 - 4.5. |
| Viscosity | USP | 400 - 1,500 cPs | Met specification: Viscosity was within 400 - 1,500 cPs. |
| Osmolality | USP | 260 - 380 mOsm/kg | Met specification: Osmolality was within 260 - 380 mOsm/kg. |
| Antimicrobial Effectiveness | EP 5.1.3 / USP | Meets USP acceptance criteria for Category 2 products (e.g., bacteria: ≥ 2.0 log reduction at 14 days, no increase from 14-day to 28-day; yeast/molds: no increase from initial calculated count at 14 and 28 days). | Met specification: Demonstrated antimicrobial effectiveness per USP Category 2 criteria. |
| Total Microbial Count | EP 2.6.12 / USP | ||
| Content of benzoic acid | Spectrophotometric | 0.13 - 0.22% w/w | Met specification: Content of benzoic acid was within 0.13 - 0.22% w/w. |
| Biocompatibility | ISO 10993-1, 5, 10, 11, 23 (various parts) | Non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic. | Met specification: Results demonstrate the lubricant is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic. |
| Shelf Life | ASTM F1980-16 (accelerated aging for 9 months at 40°C) | Maintain all Table 1 specifications over a 24-month shelf-life. | Met specification: Device specifications from Table 1 were tested across the device shelf-life and the device met the specifications at all time points, supporting a 24-month shelf-life. |
| Condom Compatibility | ASTM D7661-10 | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms. | Met specification: Belle Sensilube is compatible with natural rubber latex and polyisoprene condoms, and not compatible with polyurethane condoms. |
Since the document is for a personal lubricant, the following requested information is not applicable:
- Sample size used for the test set and the data provenance: Not an AI/ML context. Testing for physical properties does not typically involve "test sets" in the same way.
- Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for a lubricant's physical or chemical properties is established by laboratory measurements against defined standards, not by expert consensus readings of data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-driven device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for a lubricant is based on chemical/physical testing standards (e.g., USP, EP, ASTM standards) and biocompatibility testing.
- 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.
§ 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.