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The CODAN Spike is designed to be used to transfer medication from a vial to a syringe and from syringe to an IV set.

The Codan Spike is a sterile, nonpyrogenic, multiple dose vial adapter for the preparation and withdrawal of medications and cytotoxic solutions. The Codan Spike contains a 0.20 pm pressure resistant hydrophobic filter that is pressure stable and hydrophobic.

It appears the provided document describes a 510(k) premarket notification for a medical device called the "CODAN Spike Vial Adapter." This is a regulatory submission for a device, not a study evaluating an AI algorithm or diagnostic tool.

Therefore, the information requested in your prompt (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, etc.) is not applicable to this document. The document describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence for regulatory approval, not to present performance data from a clinical or diagnostic study in the way you've outlined.

The document discusses:

• Device Name: CODAN Spike Vial Adapter
• Predicate Devices: Acacia Transfer Pins and Micron Filter (K901063), B. Braun Mini-Spike® Dispensing Pin™ (K925401)
• Device Description: A sterile, nonpyrogenic, multiple dose vial adapter with a 0.20 pm pressure resistant hydrophobic filter.
• Intended Use: To transfer medication from a vial to a syringe and from a syringe to an IV set.
• Comparison to Predicate Devices: Stated that the CODAN Spike is substantially equivalent to the predicate devices in materials, design, and intended uses.

There is no mention of acceptance criteria for a diagnostic performance study, results from such a study, sample sizes, ground truth, or expert involvement as would be relevant for an AI or diagnostic device evaluation.

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