(164 days)
The Skyn Original Polyisoprene Lubricated Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
The Skyn Original Polyisoprene Lubricated Male Condom is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with fragrance oil. Fragrance oil acts as a masking agent to minimize odor originated from condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length >180mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-year shelf-life.
This document describes the premarket notification for a medical device, specifically, the Skyn Original Polyisoprene Lubricated Male Condom. It focuses on demonstrating substantial equivalence to a predicate device, not on AI/ML device performance. Therefore, many of the requested categories related to AI/ML device performance are not applicable to this submission.
Here's an analysis based on the provided text, flagging where information is not relevant to an AI/ML context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ISO 23409:2011 and FDA Guidance) | Reported Device Performance |
|---|---|
| Mechanical properties (e.g., burst pressure, elongation) | Equivalent to predicate device (K070800 Lifestyles Lubricated Polyisoprene Latex Male Condom) |
| 5-year shelf-life | Met its 5-year shelf-life specification |
| Biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity) with fragrance oil | Passing results |
| Not explicitly stated what "passing results" entails beyond "equivalent to" for mechanical properties and "met" for shelf-life. Specific numerical values for the performance criteria are not provided in this summary. |
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: Not explicitly stated for each specific test (mechanical properties, shelf-life, biocompatibility). The text mentions "Performance testing conducted..." and "biocompatibility tests conducted," implying a test set was used, but the size is not quantified.
- Data Provenance: Not specified. It's likely internal testing conducted by Ansell Healthcare Products, LLC given the nature of a 510(k) submission. Retrospective/Prospective is not relevant in this context; it's product testing.
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/ML device involving human interpretation. The "ground truth" here is established by standardized testing methods outlined in ISO 23409:2011 and FDA guidance, typically executed by laboratory technicians and engineers, not "experts" in the AI/ML sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in AI/ML studies. For a physical device, performance is measured against established standards.
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 a physical medical device (condom), not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on pre-defined specifications and standardized test methods outlined in ISO 23409:2011 ("Male Condoms – Requirements and test methods for condoms made from synthetic materials") and FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)." These standards dictate how mechanical properties, shelf-life, and biocompatibility are measured and what constitutes acceptable performance.
8. The sample size for the training set
- Not Applicable. This is a physical medical device. There is no "training set" in the AI/ML sense. The device is manufactured and then tested according to established standards.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this device.
§ 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.