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

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 describes a 510(k) premarket notification for Latex Condoms - Spermicidal Lubricant - Natural and assorted colors (Royale brand or private label). This document focuses on demonstrating substantial equivalence to predicate devices based on adherence to voluntary standards and physical testing, rather than a clinical study involving human participants or AI algorithms.

Therefore, many of the requested categories related to clinical study design, AI performance, expert ground truth, and reader studies are not applicable to this submission.

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:

• Sample Size: Not explicitly stated for each test. The document refers to "all physical testing" and "all other in-process, and final release testing," implying a comprehensive testing regimen rather than a specific test set sample size.
• Data Provenance: Not explicitly stated. The testing was conducted by Suretex Prophylactics (India) Limited, so the data would originate from their facilities. The document states "real-time testing data to support such claim" for shelf life, indicating prospective data collection for that specific criterion.

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

• Not Applicable. This submission is based on adherence to engineering standards and physical/material testing, not on clinical interpretation or expert ground truth for diagnostic accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. No expert adjudication was relevant for the type of testing performed. Results were compared against established engineering and material specifications.

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 submission is for a medical device (condoms) and does not involve AI or human readers for interpretation.

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

• Not Applicable. This submission is for a physical medical device and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Engineering and Material Specifications: The "ground truth" for the acceptance criteria was defined by internationally recognized standards (ASTM D3492-96, ISO 4074 parts 1 & 6) and FDA guidance (biocompatibility). For shelf life, it was "real-time testing data."

8. The sample size for the training set:

• Not Applicable. This submission does not involve a training set as it pertains to physical device testing, not machine learning or AI.

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

• Not Applicable. This submission does not involve a training set.

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