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The BMC Catheter Connector Cable is intended to be used to Connect the BMC RF Perforation Generator to Baylis Medical perforation catheters.

BMC Catheter Connector Cable, Model RFP-101

This document is a 510(k) premarket notification decision letter from the FDA to Baylis Medical Company, Inc. regarding their BMC Catheter Connector Cable, Model RFP-101.

This type of document (a 510(k) clearance letter) generally does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and study design.

The 510(k) process primarily evaluates substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. While a manufacturer provides evidence to support this, the FDA's clearance letter itself doesn't typically publish the specific acceptance criteria, study methodologies, or detailed performance results in the way you've requested. Those details would be in the company's 510(k) submission, which is a much more extensive document.

Therefore, for this specific document, I cannot provide the requested information.

To be clear, here's why the questions cannot be answered from the provided text:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The letter simply states the device is "substantially equivalent."
• 2. Sample sized used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method for the test set: Not mentioned.
• 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 mentioned. This device is a cable, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. Again, this is a cable, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.
• 8. The sample size for the training set: Not mentioned.
• 9. How the ground truth for the training set was established: Not mentioned.

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