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To be used during hysterosonography, hysterosalpingogram, salpingoplasties, and hydrotubation.

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The provided text is an FDA 510(k) clearance letter for a device named "Uterine Injector." It announces that the device has been found substantially equivalent to a legally marketed predicate device.

However, this document does not contain any information regarding acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert qualifications.

The letter is primarily focused on regulatory clearance and does not include the technical details of the device's validation or clinical performance studies. Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. 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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To be used during hysterosalpingograms, salpingoplasties, and hydrotubation.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a Uterine Injector device. It confirms substantial equivalence but does not contain any information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text. The document is solely an FDA clearance letter acknowledging the device's substantial equivalence to a predicate device for its stated intended uses.

Ask a specific question about this device