(178 days)
Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, and tampons and similar type nozzles. It is also compatible with latex condoms.
PharmaPac Lubricating Jelly is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.
The provided text describes a 510(k) submission for a personal lubricant device and does not contain information about acceptance criteria, device performance metrics, or a study that typically involves ground truth, experts, or comparative effectiveness for an AI/ML device. The "Performance Data" section solely refers to stability and microbial studies for the lubricant.
Therefore, most of the requested information cannot be extracted from the given text.
However, I can extract what little "performance data" is mentioned:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Shelf life stability | Confirmed through 24 months |
| Microbial conformance | In accordance with USP standards |
Regarding the other requested information:
- Sample sized used for the test set and the data provenance: Not applicable. The "performance data" concerns product stability and microbial testing, not a test set for an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI/ML device.
- Adjudication method 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. This is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. 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.