(91 days)
This device is 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 device is compatible with natural rubber latex condoms and not compatible with polyurethane and polyisoprene condoms.
Personal Lubricating Jelly is a water-based personal lubricant containing ingredients that are commonly used in vaginal lubrication devices, including water, glycerin, hydroxyethylcellulose, chlorohexidine glucono delta lactone, methylparaben, and sodium hydroxide. It is provided non-sterile.
The provided document is a 510(k) premarket notification for a medical device (Personal Lubricating Jelly) and is generally not the type of document that would contain detailed information about acceptance criteria and comprehensive study designs as requested in your prompt regarding AI/algorithm performance.
However, I can extract what limited information is available related to performance testing to address some of your points.
Here's an analysis based only on the provided text:
This device is a personal lubricating jelly, not an AI or algorithm-based device, so most of your requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) is not applicable or present in this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, with one specific performance test conducted to support an added claim.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with natural rubber latex condoms as per ASTM D7661-10. | The Personal Lubricating Jelly was tested in accordance with ASTM D7661-10, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The document states that the labeling will be modified to add a statement that the Personal Lubricating Jelly is compatible with natural rubber latex condoms, indicating that the device met the criteria of this standard for compatibility. (Specific numerical results are not provided in this regulatory summary). |
| Equivalence to predicate device for other aspects. | The subject device has the same formulation and specifications as the predicate device (K012203). Both have the same indications for use. This implies that for all other characteristics (e.g., pH, viscosity, osmolality, microbial limits, cytotoxicity, irritation, sensitization), the new device is expected to meet the same performance criteria as the predicate, which would have been established during the predicate's clearance. |
2. Sample size 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 in the document for the condom compatibility testing. The ASTM D7661-10 standard would outline the required sample size, but the summary doesn't include it.
- Data Provenance: Not specified. The study was conducted to support a US FDA submission, but the location of the test facility is not mentioned. It was a prospective test as it was "collected in accordance with ASTM7661-10" to support a new claim.
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 is not an AI/diagnostic device that requires expert ground truth. The condom compatibility test is a laboratory assay.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a laboratory test with objective measurements as defined by the ASTM standard, not a subjective assessment requiring adjudication.
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 a personal lubricant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a personal lubricant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For condom compatibility: The "ground truth" is defined by the objective pass/fail criteria and measurements outlined in the ASTM D7661-10 standard, which evaluates the physical properties and integrity of the condom after lubricant exposure.
- For substantial equivalence (other aspects): The "ground truth" is established by the accepted safety and performance profiles of the legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This device did not involve machine learning or AI, and therefore no training set was used.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.