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The Galactography kit is designed to perform safe and effective, contrast media enhanced radiography of the mammary ducts.

The Galactography kit is designed to perform safe and effective, contrast media enhanced radiography of the mammary ducts.

The provided document is a 510(k) summary for the "Manan™ Galactography Kit," a manual surgical instrument. It primarily outlines the administrative details of the submission and states that the device is substantially equivalent to a previously marketed device.

Based on the content, the document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

Here's what can and cannot be answered from the provided text:

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

   • Not available. The document does not specify any performance acceptance criteria or report performance metrics from a study.

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

   • Not available. There is no mention of a test set, sample size, or data provenance.

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 available. There is no mention of ground truth establishment or experts.

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

   • Not available. No adjudication method is described.

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 device is a manual surgical instrument, not an AI or imaging interpretation device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.

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

   • Not applicable. This is a manual surgical instrument, not an algorithm.

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

   • Not available. No ground truth is described.

8. The sample size for the training set:

   • Not applicable. This is a manual surgical instrument, not a learning algorithm.

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

   • Not applicable. This is a manual surgical instrument, not a learning algorithm.

Conclusion:

The provided 510(k) summary is a regulatory document indicating the "Manan™ Galactography Kit" is substantially equivalent to a predicate device (Manan Medical Products Galactography Kit, K881671). It does not contain the details of performance studies, acceptance criteria, sample sizes, expert ground truth establishment, or any information related to AI or algorithm performance that your questions seek. Such information is typically found in detailed technical reports or clinical study summaries, which are not part of this 510(k) summary.

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