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The NOxBOXi Nitric Oxide Delivery System is intended for use by healthcare professionals for the delivery and monitoring of a constant (user set) concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in the inspiratory ventilator lines of a patient undergoing nitric oxide therapy (iNO).

The NOxBOXi Nitric Oxide Delivery System Includes:

• · The NOxBOXi head unit, which delivers NO gas while in the intelligent delivery mode.
• · Continuous monitoring and alarms for NO, O2, and NO2.
• The integrated NOxMixer, which provides a backup NO delivery capability that is intended to deliver a continuous flow of NO, mixed with O2, for iNO therapy and provides a continuous treatment option during transit and transfer conditions within hospitals.

The NOxBOXi Nitric Oxide Delivery System must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging (currently neonates). Refer to this material prior to use.

The NOxBOXi Nitric Oxide Delivery System (NOxBOXi) simultaneously delivers Nitric Oxide (NO) medical gas, while monitoring Nitric Oxide, Nitrogen Dioxide and Oxygen levels in the inspiratory limb of a ventilator for patients undergoing inhaled Nitric Oxide Therapy.

The system is designed for use by healthcare professionals to administer treatment to patients undergoing inhaled Nitric Oxide (iNO) therapy. The NOxBOXi will deliver nitric oxide in a synchronous manner to a single patient.

An integrated component to the NOxBOXi, the NOxMixer is intended to deliver a continuous flow of Nitric Oxide from the NOxBOXi, mixed in line with Oxygen (O₂) for use in iNO therapy. The NOxMixer will be used in conjunction with manually bagging a patient.

The NOxBOXi includes the NOxBOXi Head Unit, a NOxFLOW sample line, two NO feed hoses, two regulators (connector type dependent on the gas supplier), a test circuit, NO, O₂ & NO2 monitors, power supply, drainage syringe, Operating Manual & Technical Guide.

Optional accessories include 4 separate NOxKITs (22mm, 12 mm, & 10mm), one way valve for HFOV (High Frequency Oscillatory Ventilation), bagging kits (hyperinflation & selfinflating) and circuit reducers (22f – 15m).

Here's an analysis of the acceptance criteria and study information for the NOxBOXi Nitric Oxide Delivery System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission relies on demonstrating "substantial equivalence" to a predicate device, rather than proving efficacy and safety through extensive clinical trials as seen with PMAs. Therefore, most of the studies mentioned are non-clinical (bench testing, software validation, usability testing), and a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm-only performance is not applicable in this context. The acceptance criteria are largely based on engineering and safety standards rather than clinical performance metrics like sensitivity and specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary for a device delivering and monitoring a gas, the "acceptance criteria" and "device performance" are primarily related to the accuracy of gas delivery, monitoring, and safety standards.

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

• Test Set Sample Size: Not explicitly stated in terms of patient numbers or specific data points. The testing described focuses on device performance, electrical safety, EMC, software validation, biocompatibility, and usability, which are typically performed on the device itself and its components, or with simulated data/environments.
• Data Provenance: The studies are primarily non-clinical bench testing and simulations. No patient data (retrospective or prospective) is mentioned as being used for the substantial equivalence determination for the device's technical performance.

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

• Number of Experts: Not applicable. The "ground truth" for non-clinical performance and safety tests is established by published engineering standards (e.g., ISO, IEC), regulatory guidelines, and internal specifications, rather than expert interpretation of clinical data.
• Qualifications of Experts: N/A for establishing ground truth in this context. Test engineers and qualified personnel would have performed and validated the tests according to established protocols.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are typically used in clinical studies where multiple human readers interpret medical images or data and their interpretations need to be reconciled to form a robust "ground truth." For non-clinical device testing, results are usually compared directly against pre-defined performance specifications from recognized standards or internal design requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images, and the goal is to assess how a new technology (e.g., AI) impacts their diagnostic performance. The NOxBOXi is a gas delivery and monitoring system, not an imaging diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance Study: Yes, in essence, the "non-clinical performance data" and "software verification and validation" sections describe standalone testing of the device's functional integrity. The device's ability to precisely deliver and monitor gases according to its specifications, and the functionality of its software, were tested independently of human intervention during the gas delivery process after initial user setup. However, it's important to differentiate this from "standalone AI performance" often discussed for diagnostic AI, as this device primarily involves control systems and sensor-based monitoring rather than complex AI interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The ground truth for the non-clinical tests involved:
  • Engineering Standards and Specifications: For electrical safety (ISO 60601-1), EMC (ISO 60601-1-2), respiratory gas monitors (ISO 80601-2-55), biocompatibility (ISO 10993-1), and software (FDA Guidance, ISO 62304).
  • Reference Measurements/Calibrated Equipment: For accuracy of NO delivery, NO/NO2 analyzer accuracy, purity of gas, and NO2 production.
  • Usability Feedback: For usability testing (ISO 62366, FDA guidance), user feedback identifies issues and informs design improvements, rather than establishing a "truth" about a medical condition.
  • Predicate Device Performance: Used as a benchmark for comparison to demonstrate substantial equivalence, rather than strict "ground truth."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a hardware system with embedded software, not a machine learning or AI model that requires a "training set" in the conventional sense of data-driven learning. Its operating parameters are based on physical laws, engineering principles, and pre-programmed algorithms, not learned from a dataset.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI model. The "ground truth" for the device's design and operational parameters is established through scientific principles, engineering design, and adherence to relevant national and international standards for medical gas delivery and monitoring systems.

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The Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.

The Medipure Oxygen-LC System is an integrated medical gas delivery system. The Medipure Oxygen-LC System is comprised of the Cavagna MVA2 series oxygen Valve Integrated Pressure Regulator (VIPR) permanently mounted to a large steel cylinder, either K or T size, and protected by a plastic guard. The Medipure Oxygen-LC System is a result of a design modification to the previously cleared Praxair Grab 'n Go Plus System (K132778).

This document describes the Medipure Oxygen-LC System, an integrated medical gas delivery system, and its substantial equivalence to a predicate device (Grab 'n Go Plus System, K132778). The modification involves using a high-strength Cr Mo steel cylinder (K or T size) instead of an aluminum one, and a new plastic shroud.

The information provided focuses on demonstrating substantial equivalence rather than a detailed clinical effectiveness study with acceptance criteria and performance statistics of a novel medical device. The data presented is primarily non-clinical performance data to verify that the design changes do not negatively impact safety and effectiveness compared to the predicate.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific numerical targets and matching device performance statistics in the way a clinical study evaluating a novel diagnostic or therapeutic device would. Instead, it refers to compliance with established standards and specifications for medical gas delivery systems.

• 49 CFR §173.301(h)(3) DOT: "Cylinder valve protection" (Ensuring compliance with Department of Transportation regulations for cylinder valve protection). | The device "passed all testing" and is compliant with ISO 11117-2008 and DOT Title 49 CFR Part 173.301(h)(3). |
  | Functional/Gas Delivery | - ISO 10524-3: "Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves" (Ensuring proper function, pressure regulation, and safety of the integrated valve pressure regulator).
• Product specifications of the Medipure Oxygen-LC System (equivalent to the predicate device). | The device "passed all testing". Internal verification and validation testing confirms that product specifications are met and are equivalent to the predicate device. |
  | Purity/Safety | - Total Suspended Particulate, Odor and Oxygen Analysis: (Ensuring the delivered oxygen is free from contaminants and meets purity standards). | The device "passed all testing". |

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

• Sample Size for Test Set: The document does not specify the number of units or cylinders tested. It refers to "verification testing of the Medipure Oxygen-LC System," implying a device-level testing approach rather than a population-based study.
• Data Provenance: The testing was "Internal verification and validation testing," which indicates it was conducted by the manufacturer (Praxair Distribution, Incorporated).
• Retrospective or Prospective: The testing described is prospective as it was conducted on the newly designed Medipure Oxygen-LC System.
• Country of Origin of the Data: Not explicitly stated, but given the manufacturer's location (Tonawanda, New York, U.S.A.) and the US regulatory context (FDA submission), it's highly likely the testing was conducted in the US or by facilities compliant with US standards.

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

This type of information is not applicable to the non-clinical performance and engineering validation tests described. Ground truth for these tests is established by objective measurements against engineering specifications and regulatory standards, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This is not applicable for the engineering and functional tests performed. Adjudication methods are typically used in clinical trials or studies where there are subjective interpretations of data (e.g., medical image reading).

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

No, an MRMC comparative effectiveness study was not done. The device is a medical gas delivery system, not an AI-powered diagnostic or assistive tool for human readers.

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

Not Applicable. The device is a physical integrated delivery system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests was:

• Compliance with International Standards: ISO 11117:2008, ISO 10524-3.
• Compliance with Federal Regulations: 49 CFR §173.301(h)(3) DOT.
• Internal Product Specifications: The device's design specifications, which are stated to be equivalent to the previously cleared predicate device.
• Objective Measurements: Such as pressure regulation, particulate analysis, odor analysis, and oxygen analysis.

8. The Sample Size for the Training Set

Not Applicable. This is not a machine learning or AI device that requires a training set.

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

Not Applicable. As above, no training set was used.

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