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The Remed Preventor Strawberry Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.

The Remed Preventor Strawberry Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry flavor and no color additives.

While this document describes a 510(k) clearance for a natural rubber latex condom, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.

The document is a clearance letter from the FDA for a medical device (condom). It states the device is substantially equivalent to legally marketed predicate devices for contraception and prevention of sexually transmitted diseases. It references general controls and regulations but does not include specific performance studies or acceptance criteria for that type of device, which typically involve different testing methodologies than those for AI algorithms.

Therefore, I cannot provide the requested table or information regarding:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide specific quantitative acceptance criteria or detailed performance results in the way an AI study would (e.g., sensitivity, specificity thresholds).
2. Sample size used for the test set and the data provenance: Not applicable to this type of device clearance document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic device.
6. Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable in the context of an AI algorithm.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

To answer your request, I would need a document detailing the clinical validation or performance study of an AI/algorithm-based medical device, not a 510(k) clearance letter for a non-AI physical medical device.

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