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This Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a shaped, teat ended, transparent condom lubricated with a spearmint scented lubricant, and is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492 except where noted.

The provided text is a 510(k) premarket notification for a Durex 'Tingling Pleasure' Male Latex Condom. It is a submission for a medical device that claims substantial equivalence to previously approved devices, rather than a study proving performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, expert ground truth, sample sizes, and comparative effectiveness studies is not applicable to this type of regulatory submission as presented in the provided document.

This submission focuses on demonstrating that the new condom is essentially the same as already legally marketed condoms with minor modifications (primarily the addition of a spearmint scent). The FDA's letter states they have determined the device to be "substantially equivalent" to predicate devices, which means it meets the general controls provisions of the Act.

Here's an attempt to address the request based on the provided text, indicating where information is not applicable:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim for a condom, the acceptance criteria are based on established standards for condoms (ISO 4074:2002 and ASTM D3492) and similarity to predicate devices. The document does not explicitly list numerical acceptance criteria in a table or present new experimental performance data for this specific device beyond its physical description and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The provided document is a 510(k) summary for premarket approval based on substantial equivalence to existing devices. It does not describe a new clinical or laboratory study with a specific test set, sample size, or data provenance in the way a novel device might. The "data" here refers to the comparison of the new device's characteristics to those of its predicates, and its conformance to established standards.

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. Ground truth, in the context of device performance studies, is not a concept directly applied to this 510(k) submission. The "ground truth" for a condom is its ability to prevent pregnancy and STDs, which is well-established for latex condoms. The submission relies on this existing knowledge and the performance of predicate devices.

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

Not applicable. There was no test set requiring expert adjudication for this type of regulatory submission.

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 a study involving human readers or AI assistance. It's a submission for a physical medical device (condom).

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for a condom's effectiveness is established through historical data and extensive use of similar devices for contraception and STD prevention, reflecting long-term outcomes for devices conforming to established standards. This submission leverages that pre-existing understanding rather than generating new outcomes data.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.

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

Not applicable. There is no "training set" or explicit ground truth establishment process described for this regulatory submission.

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