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The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary NO delivery system for long-term use.

The INOblender is a Nitric Oxide Administration Apparatus - Back-up System. It provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient.

The provided text describes the INOblender device and its substantial equivalence to a predicate device but does not contain information about specific acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or the details of a study verifying these metrics.

Instead, the document focuses on:

• Device Identification: Proprietary Name, Common Name, Classification, Panel.
• Predicate Devices: Fadasis Medical FM-1 NO Blender (K003665 and K011874).
• Indications for Use: As a back-up or for short-term attended use when a primary nitric oxide delivery system is impractical, including within medical facilities and during transport. It explicitly states it's not for long-term primary use.
• Compliance with Standards: CGA 626, IEC 60601-1, and FDA Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus.
• General Testing Performed: "All testing indicated the INOblender met its design input specifications, design output specifications, hazard analysis and risk control requirements." Specific test reports mentioned are:
  • INOblender Test Plan
  • INOblender Integrity Test Report
  • INOblender Reliability Testing
  • INOblender Verification Test Report
  • INOblender Testing Against Predicate Test Plan

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, device performance, sample sizes, ground truth, or expert involvement. The document only confirms that general testing was done and the device "met its design input specifications" and was found substantially equivalent to a predicate.

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