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The Medcomp Ash Split-Cath™ Double Lumen Catheter is designed for chronic hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the jugular vein. Although this catheter may be inserted into the subclavian vein, the internal jugular is the preferred site.

Medcomp Ash Split-Cath 28cm & 32cm Double Lumen Catheter

The provided text describes a 510(k) premarket notification for the Medcomp Ash Split-Cath 28cm & 32cm, a double lumen catheter designed for chronic hemodialysis and apheresis. This document is a letter from the FDA to Medcomp, indicating that the device has been deemed "substantially equivalent" to devices marketed prior to May 28, 1976.

This document is a regulatory letter approving a medical device based on substantial equivalence, not a study describing acceptance criteria and device performance data.

Therefore, I cannot extract the requested information as the document does not contain:

1. A table of acceptance criteria and reported device performance: This document is an approval letter, not a performance report.
2. Sample size used for the test set and data provenance: No study data is provided.
3. Number of experts and their qualifications for ground truth: No study data is provided.
4. Adjudication method for the test set: No study data is provided.
5. MRMC comparative effectiveness study details or effect size: No study data is provided, and this type of study is typically for AI/software, not a physical medical device like a catheter.
6. Standalone (algorithm only) performance: Not applicable to a physical medical device.
7. Type of ground truth used: No study data is provided.
8. Sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm.
9. How ground truth for the training set was established: Not applicable.

The letter explicitly states that the device is "substantially equivalent" to predicate devices, meaning its safety and effectiveness are considered comparable to devices already on the market, rather than being evaluated through a new clinical performance study with specific acceptance criteria detailed in this document. Any performance details would have been submitted as part of the 510(k) application, but are not included in this FDA response letter.

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