(192 days)
INTIMOL™ Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a latex condom.
INTIMOL™ is a non-sterile, aqueous-based personal lubricant designed to supplement the body's own natural lubrication fluids. It is specifically formulated to be a clear, non-irritating, non-greasy, non-staining, gel-like liquid and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility test results. This device is not a contraceptive or spermicide, nor does it contain any such component. The product is packaged in a plastic bottle with a flip-top cap.
The provided text describes the 510(k) summary for INTIMOL™ Liquid Personal Lubricant, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a novel device.
Therefore, much of the requested information about device performance, ground truth, and specific study designs (like MRMC or standalone performance) is not available in this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The product was tested by independent laboratories for condom compatibility, biocompatibility and preservative effectiveness. Final results from these tests demonstrate that the device meets established acceptance criteria in accordance with the identified industry standards." However, the specific quantitative acceptance criteria and the numerical reported device performance are not provided in this summary.
The "Summary of Technological Characteristics" table compares features of INTIMOL™ to predicate devices, but these are characteristics, not performance metrics subject to acceptance criteria in the same way, for example, a diagnostic's sensitivity and specificity would be.
| Feature | Intimol™ Personal Lubricant (Reported Performance - Implied) | Acceptance Criteria (Implied - "meets established acceptance criteria") |
|---|---|---|
| Condom compatibility | Meets established acceptance criteria | Established industry standards relevant to condom compatibility |
| Biocompatibility | Meets established acceptance criteria | Established industry standards relevant to biocompatibility |
| Preservative effectiveness | Meets established acceptance criteria | Established industry standards relevant to preservative effectiveness |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "tests" were conducted but provides no details on the number of samples used for condom compatibility, biocompatibility, or preservative effectiveness testing.
- Data Provenance: Not specified. It states "tested by independent laboratories," but no information on the country of origin of the data or whether the studies were retrospective or prospective is given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a personal lubricant, not a diagnostic, image analysis, or clinical decision support device that would typically involve expert ground truth establishment for a test set in the way a medical imaging AI would. The "ground truth" for this device relates to laboratory testing against defined standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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 device is not an AI-assisted diagnostic or image analysis tool, therefore an MRMC comparative effectiveness study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of this device is based on established industry standards for condom compatibility, biocompatibility, and preservative effectiveness. These are likely quantitative laboratory tests with predefined pass/fail criteria.
8. The sample size for the training set
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.