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COBE® HARD SHELL VENOUS RESERVOIRS. UNFILTERED AND FILTERED are intended for storage (and filtration, if filtered) of blood during surgical procedures on adults requiring extracorporeal circulation for periods up to six hours.

COBE® VENOUS RESERVOIR BAGS are intended for use as a blood reservoir during extracorporeal blood circulation.

COBE® FLAT SHEET MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours (one model is a variable prime oxygenator intended to be used during cardiac surgical procedures on neonates, infants, pediatrics, and small adults requiring cardiopulmonary bypass).

COBE® HOLLOW FIBER MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas exchange suppport and blood temperature control for periods of up to six hours.

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for various COBE® cardiovascular products, indicating that they have been found substantially equivalent to legally marketed predicate devices.

The document discusses:

• The FDA's review of COBE Cardiovascular, Inc.'s 510(k) notification.
• The determination of substantial equivalence for the listed devices (COBE® Hard Shell Venous Reservoirs, COBE® Venous Reservoir Bags, COBE® Flat Sheet Membrane Oxygenators, COBE® Hollow Fiber Membrane Oxygenators).
• The regulatory classification (Class III).
• General controls provisions and other regulations applicable to the device.
• Instructions for marketing the device and contact information for further regulatory advice.
• The intended indications for use for each device, which describe how the device is meant to be used (e.g., for storage of blood during surgical procedures up to six hours, for extracorporeal gas exchange support and blood temperature control up to six hours).

However, it does not include:

• Specific quantitative acceptance criteria (e.g., performance metrics, thresholds).
• Details of a study proving the device meets acceptance criteria, such as:
  • A table of acceptance criteria vs. reported device performance.
  • Sample sizes or data provenance for a test set.
  • Information on experts or adjudication methods for ground truth.
  • Results of any multi-reader multi-case studies or standalone algorithm performance.
  • Type of ground truth used (e.g., pathology, outcomes data).
  • Training set sample size or ground truth establishment for a training set.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the provided text.

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