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The COBE C Hemodialysis Delivery System is indicated for patients in acute or chronic renal failure and when the physician prescribes hemodialysis or ultrafiltration. The COBE® Cx System may be used with both high permeability and low permeability (conventional) dialyzers. The COBE® Cartridge Set is intended for use with the COBE Centrysystem 3 Hemodialysis Delivery System, or the COBE C* Hemodialysis Delivery System only.

COBE® Model Cx™ Hemodialysis Delivery System and COBE® Cartridge Blood Tubing Set

The provided document is a 510(k) clearance letter from the FDA for the COBE® Cx™ Hemodialysis Delivery System and COBE Cartridge® Blood Tubing Set. This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document lacks all of the following information:

1. A table of acceptance criteria and the reported device performance: This letter only states that the device is "substantially equivalent" to a predicate device. It does not provide any specific performance metrics or acceptance criteria that were met by the device itself.
2. Sample size used for the test set and the data provenance: No information about a test set, its size, or its origin is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or ground truth establishment.
4. Adjudication method for the test set: Not applicable as no test set details are provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: This type of study is not mentioned in the clearance letter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a hemodialysis delivery system and blood tubing set, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. The type of ground truth used: Not applicable as ground truth is not mentioned.
8. The sample size for the training set: There is no mention of a training set.
9. How the ground truth for the training set was established: Not applicable as no training set details are provided.

In summary, this document is a regulatory clearance letter, not a study report. To find the requested information, one would typically need to refer to the 510(k) submission itself (K982760), which would contain the technical data and studies demonstrating substantial equivalence to the predicate device.

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