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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 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 INOblender is designed to take constant oxygen (02) gas flow (5 to 14 L/min) from the integrated O2 flowmeter and blend in NO at the setting on the NO blender's concentration control dial (5 to 80 ppm). The NO blender is calibrated for cylinder concentrations of 800 ppm NO in a balance of nitrogen (N2).

The provided document does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML diagnostic devices. This document is a 510(k) summary for a medical device called INOblender®, which is a Nitric Oxide administration apparatus.

Here's why the requested information cannot be fully provided from this document:

• Device Type: The INOblender® is a physical medical device (blender for gas delivery), not an AI/ML diagnostic software or algorithm. Therefore, the concepts of "algorithm only performance," "human readers improve with AI," "ground truth establishment" of a "test set" and "training set" in the context of diagnostic accuracy are not applicable.
• Study Type: The submission is primarily focused on demonstrating substantial equivalence to a predicate device, not on proving diagnostic accuracy or effectiveness through clinical trials in the sense of AI/ML performance.

However, I can extract information related to the device's non-clinical testing which serves as the "study" demonstrating its capabilities.

Here's a breakdown of the available information based on your request, adapted to the context of this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative table with specific targets and achieved results. Instead, it lists four requirements that were tested for compatibility with a new respiratory care device. The "reported device performance" is the conclusion that these requirements were met.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of diagnostic data. The "test set" here refers to the device itself and its interaction with a specific new respiratory care device. The testing was conducted by setting up the INOblender® and the new respiratory care device. The number of such setups or repetitions is not specified, but it's not data in the sense of patient cases.
• Data Provenance: Not applicable in the context of diagnostic data. The "testing" refers to equipment performance validation, likely conducted in a laboratory setting by the manufacturer. Details like country of origin for such engineering tests are not provided and typically not relevant for this type of submission. The tests were "non-clinical."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant for this type of device. The "ground truth" for these tests would be the known operational parameters and specifications of the devices themselves and the physical/chemical measurements taken during the compatibility and performance tests.
• Qualifications of Experts: Not applicable. The "experts" involved would be engineers and technicians performing the physical and chemical tests, adhering to established protocols. Their specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of diagnostic data. For physical device performance testing, the results are typically objectively measured and compared against predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the purpose of the INOblender®.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The INOblender® is a physical device that functions to deliver gas, not an algorithm. Its "standalone" performance would relate to its ability to accurately blend and deliver gases according to its specifications. The document states "INOblender® NO dose delivery accuracy" was tested, which can be considered a standalone performance aspect for the device's primary function.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the non-clinical tests was established by known engineering specifications, physical/chemical measurement standards, and the manufacturer's recommendations for calibration and operation. For example, "NO dose delivery accuracy" would be compared against a known, precise NO concentration generated by the device itself or measured by a calibrated external sensor.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no AI/ML algorithm involved, so there is no "training set" in the context of machine learning. The device is hardware-based, relying on established physical and chemical principles.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable for the reasons mentioned above.

Summary of Device-Specific Information:

• Device Name: INOblender®
• Intended Use: To provide user-set concentrations of inhaled Nitric Oxide (NO) mixed into a constant flow of oxygen gas. Intended as a backup to a primary NO delivery system or for short-term attended use when a primary device is impractical.
• Technology: Component technology (blender, regulator, NO gas tank).
• Predicate Device: K052663 (another INOblender® with slightly different labeling for compatibility with resuscitators).
• Non-Clinical Tests:
  • O2 dilution
  • Effect on respiratory care device (compatibility with Fisher & Paykel NeoPuff)
  • INOblender® NO dose delivery accuracy
  • NO2 generation
• Clinical Tests: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." (Meaning, no clinical tests were performed for this specific submission, as it relied on non-clinical data and substantial equivalence to a predicate).

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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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The FM-1 NO Blender 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 FM-1 NO Blender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot be used. In this capacity, it can be used with a self-inflating manual resuscitator bag. This intended use includes applications within a medical facility. The FM-1 NO blender is not intended for use as a primary NO delivery system for long term use. (Note: These indications for use are unchanged form K003665.

The Fadasis Medical FM-1 NO Blender is substantially equivalent to the Fadasis FM-1 NO Blender, The 1 addis Incontaint I 1 1 rith 510(k) premarket notification number K003665. The purpose of this Which was clouded by I DA whan 2000 (EEK, rather than stainless steel, in the capillary tubes.
The new FM-1 NO blender is identical to the predicate FM-1 NO blender with the exception of the capillary tube material, which has been changed to PEEK from stainless steel.

The provided document describes a Special 510(k) submission for the Fadasis Medical FM-1 NO Blender, where the only change from the previously cleared device (K003665) is the material used for capillary tubes (from stainless steel to PEEK). Therefore, the study presented focuses on validating this material change.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance results for the FM-1 NO Blender. Instead, it states that "All testing indicated the FM-1 NO Blender met its design input specifications, design output specifications, hazard analysis and risk control requirements."

However, the validation and verification activities listed in text within the section titled "The Fadasis Medical FM-1 NO Blender was designed to comply with the limited applicable portions of the following:" implicitly define the performance areas checked.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for the individual tests (e.g., how many units were drop-tested, how many resuscitator bag validation cycles were performed). It refers to "All testing."
• Data Provenance: Not explicitly stated, but given it's an FDA submission, the tests were presumably performed at the manufacturer's facility in Middleton, WI, USA. The data would be prospective for the specific tests performed for this submission, validating the PEEK material. For the original K003665, the data would have been prospective for that submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the context of this device. The testing is for engineering performance, material compatibility, and functional validation of a medical device, not for interpretation of medical images or diagnoses. Ground truth is established by engineering specifications and objective measurements.

4. Adjudication Method for the Test Set

Not applicable. The testing involves engineering measurements and functional assessments rather than subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a nitric oxide blender, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a hardware medical device; it's not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's performance validation is based on:

• Engineering Design Specifications: The device's intended operational parameters, flow rates, concentration ranges, safety limits, etc.
• Regulatory Standards: Compliance with CGA 626, IEC 601-1, and FDA Guidance Documents.
• Material Science Principles: For the FTIR testing of PEEK, the ground truth would be the known chemical and physical properties of PEEK for medical applications and its compatibility with the intended gases.
• Functional Requirements: The ability to perform its intended use (blending NO, oxygen, and nitrogen; operating with resuscitator bags; regulator function).

8. The Sample Size for the Training Set

Not applicable. This is a hardware device validation, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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