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The twoplus Applicator is indicated for over-the-counter home use by individuals who choose not to conceive through intercourse. The twoplus Applicator kit allows for semen collection and the vaginal canal. The twoplus Applicator should be used during the ovulatory phase of the menstrual cycle.

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I am sorry, but the provided text does not contain information about the acceptance criteria or any study details that prove the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "twoplus™ Applicator". It primarily discusses regulatory compliance and general information regarding the device's classification and marketing.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether standalone performance was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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