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Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).

The Skyn Original Polyisoprene Lubricated Male Condom – Flavored is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with flavor oil provides a pleasant aroma/flavor for the end user. 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 190±10mm, 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 3 year shelf-life.

The provided text describes a 510(k) premarket notification for a medical device, specifically a flavored male condom. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets acceptance criteria in the typical sense of diagnostic or AI-driven medical devices. Therefore, much of the requested information regarding AI-specific studies (e.g., test sets, ground truth, expert adjudication, MRMC studies) is not applicable or cannot be extracted from this document.

However, I can provide the acceptance criteria and a summary of the performance data as presented for this specific device based on the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for the mechanical property, biocompatibility, or shelf-life tests. It mentions that performance testing was conducted according to ISO 23409:2011 and FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)." The provenance of the data is that these were tests conducted by the manufacturer, Ansell Healthcare Products LLC, for their K171172 submission. The tests were likely prospective in nature, specifically designed to support this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The "ground truth" for condom performance is established through standardized physical, chemical, and biological testing as per international standards (ISO) and FDA guidance, not through expert consensus or interpretation of medical images/diagnoses.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation or uncertain clinical outcomes. Condom performance tests rely on objective measurements and pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical medical device (condom), not an AI-driven diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as there is no algorithm involved.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective measurements against established engineering and biological standards (ISO 23409:2011) and regulatory guidance documents from the FDA for condom testing. This includes:

• Physical properties (e.g., dimensions, strength, integrity) confirmed through laboratory testing.
• Chemical properties (e.g., lubricant composition, flavor oil compatibility).
• Biocompatibility assessments based on recognized biological evaluation standards.
• Shelf-life stability data.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for an AI algorithm.

Ask a specific question about this device

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

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.

Ask a specific question about this device