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The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal diseases).

A condom with a spermicidal lubricant is a sheath which covers the penis with a closely fitted membrane with a lubricant that contains a spermicidal agent, nonoxynol-9.

The provided text is a 510(k) premarket notification for a medical device, specifically Royale® Brand Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical studies in the same way a Premarket Approval (PMA) would. Therefore, the information typically requested in your prompt regarding detailed study designs, expert panels, and specific effect sizes is largely not applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with established voluntary standards and internal testing specifications for condoms. The performance is reported as meeting these specifications.

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

• Sample Size: The document does not specify the exact sample sizes used for the various physical and biocompatibility tests. It only states that "All physical testing, air inflation testing and color fastness testing, including all other in-process, and final release testing, revealed results that conformed to the required specifications."
• Data Provenance: The data provenance is internal to the manufacturer (G. Premjee (USA) Inc.) and is likely from laboratory testing performed on their product. The country of origin for the data is not explicitly stated. The testing would have been retrospective in the sense that it was performed on samples of the manufactured device.

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

• Not Applicable. For this type of device and submission, "ground truth" is not established by expert consensus on clinical findings (e.g., radiology reads). Instead, it's based on objective measurements against established engineering and material standards (ASTM, ISO). The "experts" involved would be the testing engineers and quality control personnel within the manufacturing process who conducted the standardized tests. Their qualifications would typically involve expertise in materials science, quality assurance, and relevant testing methodologies, but specific details are not provided.

4. Adjudication method for the test set

• Not Applicable. Since "ground truth" is not established by human interpretation or clinical outcomes, an adjudication method for conflicting interpretations is not relevant. Pass/fail criteria are defined by the adherence to the numerical or qualitative specifications of the standards (e.g., burst pressure, freedom from holes, biocompatibility assay results).

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 condom, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness analysis is entirely irrelevant.

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

• Not Applicable. As stated above, this is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on objective measurements against established performance standards and specifications (e.g., ASTM-D-3492-96, ISO 4074, biocompatibility guidelines). For example, a condom either passes or fails a water leak test, or its burst volume and pressure meet or do not meet the specified minimums. It also relies on the composition of the device being identical or highly similar to a predicate device for determining substantial equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which is not what this submission is about. The manufacturer produces condoms and tests them against pre-defined standards.

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

• Not applicable. As there is no training set, there is no ground truth for a training set to be established.

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The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal diseases).

A condom is a sheath which completely covers the penis with a closely fitting membrane.

The provided document, a 510(k) summary for the Royale® Brand Latex Condoms, explicitly states that no clinical tests were performed to demonstrate that the device meets acceptance criteria. The submission relies on adherence to voluntary standards and results from physical and in-process testing.

Therefore, many of the requested details, such as sample size for test sets, expert involvement, and ground truth establishment, are not applicable or cannot be extracted from this specific document as they pertain to clinical studies.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. The document explicitly states "Not Applicable" for "Discussion of Clinical Tests Performed." All testing mentioned (physical, air inflation, color fastness, in-process, final release, and shelf-life) appears to be non-clinical, likely performed in a lab setting. The document does not specify sample sizes for these non-clinical tests.

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

• Not Applicable. No clinical studies were performed that would involve experts establishing ground truth for a test set.

4. Adjudication method for the test set:

• Not Applicable. No clinical studies were performed.

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 condom, not an AI-assisted diagnostic tool.

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

• Not Applicable. This device is a condom, not an algorithm.

7. The type of ground truth used:

• Not Applicable for clinical ground truth. For the non-clinical tests, the "ground truth" was adherence to the specifications outlined in the referenced voluntary standards (ASTM, ISO, FDA guidances).

8. The sample size for the training set:

• Not Applicable. No machine learning or AI algorithm was involved.

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

• Not Applicable. No machine learning or AI algorithm was involved.

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