(191 days)
K-Y® Brand YOURS+MINE™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.
The devices are personal lubricants compatible with latex condom.
The provided text describes a 510(k) premarket notification for a personal lubricant, K-Y® Brand YOURS+MINE™. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for a typical AI/ML medical device.
Based on the provided information, here's a breakdown of the requested elements:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly uses the "substantial equivalence" framework, meaning the device's performance should be comparable to a legally marketed predicate device. The acceptance criteria are therefore tied to demonstrating this equivalence through various tests.
| Acceptance Criteria Category | Actual Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Condom Compatibility | Demonstrates 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." |
| Lubricity | Lubricity is comparable to the predicate device. | "Lubricity of the proposed device is comparable to the lubricity of predicate device." |
| Safety (Pre-clinical/Human Use) | Shows the device is safe for use as a personal lubricant. | "The pre-clinical evaluation and testing and human use data show that the proposed device is safe for use as a personal lubricant." |
| Technological Characteristics Equivalence | Same technological characteristics as currently marketed condom compatible personal lubricants. | "The proposed device has the same technological characteristics as currently marketed condom compatible personal lubricants." |
| Indications for Use Equivalence | Similar indications for use as the predicate device. | "The proposed device and predicate device have similar indications..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "laboratory testing, pre-clinical evaluations and testing, and human use," but does not specify the sample sizes for these tests.
The data provenance is also not specified, such as country of origin or whether it was retrospective or prospective. It infers prospective testing for "pre-clinical evaluations and testing, and human use."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. For a personal lubricant, "ground truth" would generally refer to established scientific standards for chemical and physical properties, and safety evaluations. The document does not detail who performed these evaluations or their qualifications beyond stating it was "laboratory testing" and "pre-clinical evaluations."
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of personal lubricant testing, formal adjudication methods (like 2+1 reader consensus) are typically not applicable. The evaluations likely relied on established laboratory protocols and safety assessment methodologies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted as this device is a personal lubricant, not an AI/ML diagnostic tool that would involve human readers interpreting cases.
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 algorithm or AI/ML product. Therefore, standalone performance of an algorithm is not relevant.
7. The Type of Ground Truth Used:
The ground truth for this device appears to be based on:
- Established scientific and engineering principles for condom compatibility (e.g., integrity, burst pressure).
- Biophysical measurements for lubricity.
- Safety assessments based on pre-clinical evaluations (e.g., toxicology, irritation studies) and human use data (e.g., adverse event reporting, user acceptability).
- Comparison to a legally marketed predicate device and its established performance and safety profiles.
8. The Sample Size for the Training Set:
Not applicable. This device is a personal lubricant and does not involve AI/ML that requires a training set. The term "training set" is not relevant to this submission.
9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reasons as above.
§ 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.