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The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patients post operative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer.

The Gish CAPVRF44 Hardshell Venous Reservoirs are sterile, non-pvrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The Gish CAPVRF44 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the ½" venous inlet where it is directed to the bottom of the device and passes through a 160 micron screen filter. Intrathoracic suctioned blood enters the top section of the defoamer/filter cartridge and passes through a defoamer sponge and 20 micron depth filter. The maximum venous flow rate is 8 lpm. The maximum cardiotomy flow rate is 4 lpm.

The provided text describes a 510(k) submission for the Gish CAPVRF44 Hardshell Venous Reservoir with GBS™ Coating. However, it does not contain detailed information about specific acceptance criteria, a comprehensive study proving adherence to those criteria, or the specific elements requested in your prompt (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies).

The document states:

"The Gish CAPVRF44 Hardshell Venous Reservoir with GBS™ Coating has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."

And concludes:

"The conclusion drawn from these tests is that Gish CAPVRF44 Hardshell Venous Reservoir with GBS™ Coating is equivalent in safety and efficacy to its predicate device the Gish CAPVRF45."

This indicates that internal testing was performed against functional requirements and safety standards, and the conclusion was one of substantial equivalence to a predicate device (K964973). This type of submission relies on demonstrating similarity to a previously cleared device, rather than providing independent clinical trial data with detailed performance metrics against predefined acceptance criteria for AI/diagnostic devices as would be expected for your prompt.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, experts, ground truth, or MRMC studies because this information is not present in the provided document. The document pertains to a medical device (a blood reservoir) and its 510(k) clearance process, which typically focuses on bench testing, biocompatibility, and substantial equivalence to a predicate, not AI/ML model validation studies.

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