(147 days)
Interections of 2-in-1 Massage Crème™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's in ural. lubrication. This product is compatible with latex condoms.
This device is developed for non-therapeutic body massage and personal lubricant compatible with latex condom that imparts a warming sensation upon the skin.
The provided document is a 510(k) premarket notification for a medical device: K-Y® Brand IntrigueTM 2-in-1 Massage CrèmeTM. This is a personal lubricant, and the submission primarily focuses on demonstrating its substantial equivalence to a predicate device, K-Y® Brand Touch MassageTM 2-in-1 Warming® body massage + Personal lubricant.
The information provided does not describe a study involving an AI or algorithm-driven device. Instead, it outlines the regulatory submission for a physical personal lubricant. Therefore, I cannot provide details on acceptance criteria and a study that proves an AI device meets these criteria based on the input text.
However, I can extract information related to the performance data presented for this physical device, which addresses some aspects of your request, even though it's not for an AI.
Here's the relevant information based on the provided text, structured to align with your request where applicable, but noting its non-relevance for AI:
1. A table of acceptance criteria and the reported device performance
Since this is not an AI device, there are no specific quantitative acceptance criteria like sensitivity, specificity, or AUC that would typically be reported for an AI. Instead, the "acceptance criteria" are implied by the safety and performance standards for personal lubricants, particularly condom compatibility and lubricity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with leading commercial brands of latex condoms | "Laboratory test results demonstrated that the proposed device is compatible with the leading commercial brands of latex condoms." |
| Provides lubricity for use as a personal lubricant | "Laboratory test results demonstrated that the proposed device...provides lubricity for use as a personal lubricant." |
| Safety for use as a personal lubricant | "The pre-clinical evaluation and testing as well as human use data show that the proposed device is safe for use as a personal lubricant." |
| Equivalence in performance to predicate devices | "The results from laboratory testing, pre-clinical evaluations and testing, and human use show that the proposed device performs equivalently to the predicate devices." (Predicate: K-Y® Brand Touch MassageTM 2-in-1 Warming® body massage + Personal lubricant) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "laboratory testing, pre-clinical evaluations and testing, and human use data." However, it does not provide specific sample sizes for these tests. The provenance (e.g., country of origin, retrospective/prospective) is also not detailed in the provided text.
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)
This is not applicable to this type of device submission. Ground truth, in the context of AI, usually refers to labeled data for diagnostic purposes. For a personal lubricant, "ground truth" would be established through physical and chemical testing, and human sensory evaluation, not through expert consensus in the diagnostic sense. The document does not specify the number or qualifications of individuals conducting "pre-clinical evaluation" or participating in "human use data collection."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a diagnostic AI device requiring adjudication of interpretations.
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 is not an AI device, and no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for its performance characteristics would be based on:
- Laboratory test results: For condom compatibility and lubricity (e.g., measuring force, friction, integrity).
- Pre-clinical evaluation and testing: Likely involving various biological and chemical assays to assess safety.
- Human use data: Direct experience and feedback from individuals using the product to confirm safety and performance (e.g., absence of irritation, desired lubricity).
8. The sample size for the training set
Not applicable, as there is no training set for an AI algorithm here.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI algorithm here.
In summary, the provided document is a regulatory submission for a physical medical device (personal lubricant) and does not concern an AI or algorithm-driven device. Therefore, most of the questions regarding AI-specific criteria are not applicable. The information describes standard laboratory, pre-clinical, and human use testing to demonstrate the safety and performance of a physical product.
§ 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.