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The Di-Chem Liquid Sodium Bicarbonate solutions are indicated for use in the treatment of acute and chronic hemodialysis and to be used with an appropriate hemodialysis machine/monitor.

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I apologize, but this document is a 510(k) clearance letter from the FDA for a medical device (Di-Chem Hemo-Lyte Bicarbonate Solution). It primarily focuses on the regulatory aspects of device marketing and substantial equivalence to a predicate device.

The document does not contain information about:

1. Acceptance criteria and reported device performance
2. Sample sizes, data provenance, number of experts, adjudication methods for a test set
3. MRMC comparative effectiveness studies
4. Standalone (algorithm-only) performance studies
5. Type of ground truth used
6. Training set sample size or ground truth establishment for a training set

Therefore, I cannot extract the requested information as it is not present in the provided text. This letter confirms that the device is substantially equivalent to a legally marketed predicate and can be marketed, but it doesn't detail the performance studies and criteria that would be found in a design document, test report, or clinical study summary.

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