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The Divas Dual Pleasure condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.

This condom is made of a natural rubber latex sheath, which closely fitted membrane. The device is shaped, teat ended, lubricated condom, which is lubricated with a water based warming lubricant. The device is designed to conform to national and international voluntary standards, including ISO 4074 and ASTM D3492, except where noted.

The provided document describes a 510(k) summary for the "Divas Dual Pleasure Male Latex Condom with Warming Lubricant." It details the device's description, intended use, technological characteristics, and its substantial equivalence to predicate devices based on regulatory standards. However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the context of typical medical device performance studies (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device).

Instead, this submission is for a condom, and its acceptance is based on conformance to established voluntary standards for condoms and lubricants.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to legally marketed predicate devices, rather than a clinical performance study with defined acceptance criteria for metrics like accuracy, sensitivity, or specificity.

To address the specific points you requested, based on the absence of such information in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The device's performance is gauged by its adherence to existing voluntary standards (ISO 4074 and ASTM D3492 for condoms, and conformity with predicate lubricant characteristics).
2. Sample size used for the test set and the data provenance: Not applicable/Not provided for a performance study. The document refers to manufacturing according to standards, implying testing of product batches in accordance with those standards, rather than a "test set" for a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth is not established by experts in this context; rather, it's defined by established engineering and material standards for condoms and lubricants.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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 not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device (condom), the "ground truth" would be the engineering specifications and performance requirements outlined in the voluntary standards (ISO 4074 and ASTM D3492) that the product is designed to meet (e.g., burst pressure, freedom from holes, dimensions, lubricant properties).
8. The sample size for the training set: Not applicable. This is not an AI/diagnostic device.
9. How the ground truth for the training set was established: Not applicable.

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