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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, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling (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 (NO2), and Oxygen (O2) 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 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, and NO2 monitors, power supply, drainage syringe, Operating Manual & Technical Guide.

This submission is for the introduction of new compatible ventilators including the addition of pediatric categories for existing ventilators, an additional optional software mode which disables the "Vent Flow Idle" alarm to reduce this alarm which may not be necessary and is considered a "nuisance" alarm in certain situations. Alarm initiations are still recorded in the log file. Additionally, language choices other than English have been disabled for this mode. There are no changes to the indications for use of the product, patient population of neonates, and there are no significant design changes.

The provided text is a 510(k) summary for the NOxBOXi Nitric Oxide Delivery System, focusing on changes to compatible ventilators and an optional software mode. It does not present a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-enabled devices, which often involve performance metrics like sensitivity, specificity, or AUC against a defined ground truth.

Instead, this document describes a modification to an already cleared medical device (NOxBOXi Nitric Oxide Delivery System). The "study" here refers to non-clinical performance testing to demonstrate that these changes do not alter the substantial equivalence of the modified device to its predicate. The acceptance criteria are therefore related to the safety and performance parameters of the delivery system itself, rather than diagnostic or analytical accuracy of an AI model.

Therefore, many of the requested points related to AI/ML study design (like sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance for an algorithm) are not applicable to this document's content.

However, I can extract information related to the device's technical specifications and the testing performed for this submission.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the existing performance characteristics of the predicate device (K231823) and regulatory standards. The reported "performance" for this submission is that the device, with the new ventilator compatibility and software mode, continues to meet these original performance specifications and does not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance:

• Test Set Description: The "test set" here refers to the specific modifications being evaluated: the compatibility with additional ventilators and an optional software mode.
• Sample Size: Not quantified in terms of a "sample size" of patients or images, as this is a hardware/software modification submission. The testing involves specific ventilator models and configurations, and the software mode itself.
• Data Provenance: Not applicable in the context of clinical data or patient-derived data for an AI/ML model. The testing is non-clinical, likely bench testing, and usability testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of this 510(k) summary. Ground truth as typically understood for AI/ML diagnostic devices (e.g., expert radiological reads) is not established here. The "truth" is based on the engineering specifications and performance of the device under various conditions and its compliance with regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This relates to clinical endpoint adjudication, which is not described.

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. This is not an AI-enabled diagnostic device.

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

• No. This is a medical device for gas delivery and monitoring, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's performance, as demonstrated in this submission, is based on:
  • Engineering specifications and design requirements.
  • Validated test methods conforming to international standards (e.g., ISO, IEC).
  • Compliance with FDA guidance documents related to nitric oxide delivery apparatus and software.
  • Bench testing results for parameters like accuracy, flow rates, alarm functionality, and gas purity.

8. The sample size for the training set:

• Not applicable. This document does not describe an AI/ML model with a training set.

9. How the ground truth for the training set was established:

• Not applicable. This document does not describe an AI/ML model with a training set.

Summary of the study conducted:

The "study" or testing performed for this 510(k) submission was non-clinical performance testing and usability testing. The purpose was to demonstrate that adding compatibility with new ventilators (including pediatric categories for existing ones) and an optional software mode does not adversely impact the safety or effectiveness of the NOxBOXi Nitric Oxide Delivery System, and that it remains substantially equivalent to its predicate device (K231823). The testing focused on validating that the changes did not introduce new safety concerns or alter the specified performance characteristics of the device. This involved testing against international standards and FDA guidance relevant to medical devices, particularly those for nitric oxide delivery systems. No clinical testing was required for this specific submission given the nature of the changes.

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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, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling (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, O3 & 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).

This submission is for the addition of compatibility claims for specific ventilators and is not related to product changes. It also introduces a new accessory, a modified sample line. There are no changes to the indications for use of the product and there are no significant design changes.

This document is a 510(k) premarket notification for the NOxBOXi Nitric Oxide Delivery System, specifically for adding compatibility claims for additional ventilators and introducing a new accessory. The submission states that there are no changes to the product itself, its indications for use, or its general design. Therefore, the device specifications and acceptance criteria are those of the previously cleared predicate device, K201339.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this submission is for adding compatibility claims and an accessory without product changes, the acceptance criteria and reported device performance are identical to the predicate device (K201339) and relate to its general operational specifications. The document compares the subject device (K220898) with the predicate (K201339) and explicitly states "No Change" for all performance parameters. Therefore, the acceptance criteria and performance are as listed below:

The study that proves the device meets these acceptance criteria is referenced as a series of non-clinical performance data and compliance to international standards and FDA guidance documents. The submission states, "Testing for this submission was limited to the aspects that could be affected by including compatibility with additional ventilators and introduction of a new accessory. No additional usability testing was conducted for this submission. No clinical testing was required to support substantial equivalency of this medical device." The previous clearances (K171696 and K201339) would have established the initial performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily refers to "non-clinical performance data" and testing for compatibility with additional ventilators and a new accessory. It does not specify a "test set" in the context of clinical trials or expert review of cases. The testing conducted appears to be engineering and validation testing rather than human subject testing.

• Sample size for compatibility testing: Not explicitly stated as a number of specific ventilators, but a list of manufacturers is provided (e.g., Bio-Med Devices, Bunnel, Carefusion, Drägerwerk, Hamilton Medical, Philips Respironics, etc.). It implies that various models from these manufacturers were tested for compatibility.
• Data provenance: Not explicitly stated. The manufacturer is "NOxBOX Ltd.", suggesting the testing could have occurred in the UK or other locations where the manufacturer operates. The submission correspondent is in Austin, Texas, USA. Given the context of FDA submission, the data would need to be acceptable to the US regulatory body, but the origin itself isn't specified.
• Retrospective or prospective: Not applicable for this type of non-clinical engineering and validation testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the submission describes non-clinical engineering and validation testing, not a study involving expert review of cases for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the submission describes non-clinical engineering and validation testing, not a study involving expert review of cases for ground truth establishment.

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

This section is not applicable. The NOxBOXi Nitric Oxide Delivery System is a medical device for delivering and monitoring nitric oxide, not an AI-assisted diagnostic tool involving human readers.

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

This section is not applicable in the context of an "algorithm only" performance. The device is hardware with integrated software for delivery and monitoring, not an AI algorithm performing a standalone task. Its performance is inherent to its design and validated through engineering tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance evaluation, the "ground truth" would be established by:

• Reference standards/equipment: Calibration gases, calibrated flow meters, pressure sensors, and gas analyzers that provide highly accurate measurements of NO, NO2, and O2 concentrations, flow rates, and pressures.
• Engineering specifications: The device's design specifications for accuracy, delivery ranges, and alarm thresholds serve as the targets for "ground truth".
• Standardized test methods: Compliance with international standards (e.g., ISO 80601-2-55 for respiratory gas monitors) and FDA guidance documents implies validated test methodologies where the "true" values are known or traceable to national/international standards.

8. The sample size for the training set

This section is not applicable. The document does not describe a machine learning algorithm that requires a "training set" of data. The device's functionality is based on established engineering principles and calibrated sensors/actuators.

9. How the ground truth for the training set was established

This section is not applicable for the reasons stated in point 8.

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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 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).

This submission is for the addition of compatibility claims for specific ventilators and is not related to product changes. There are no changes to the indications for use of the product and there are no significant design changes.

This document describes a Special 510(k) submission (K201339) for the NOxBOXi Nitric Oxide Delivery System. This submission is specifically for adding compatibility claims for additional ventilators and does not involve product changes or changes to the indications for use. Therefore, the validation and acceptance criteria primarily refer to the original K171696 clearance.

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values in the typical format of a clinical study or performance verification. Instead, it refers to broad categories of performance and compliance with standards. The "Comparison of Characteristics With Changes From Device Cleared in K171696" table shows that no changes were made to the core technical parameters of the device concerning its primary functions (NO administration, monitoring accuracy, battery backup, etc.). The acceptance criterion for this specific submission (K201339) is that the device, with the added ventilator compatibility, continues to meet safety and effectiveness standards, as demonstrated by non-clinical testing.

The acceptance criteria for the original device (K171696) can be inferred from the tests performed:

2. Sample size used for the test set and the data provenance

For the K201339 submission, the testing was limited to non-clinical bench testing to verify compatibility with additional ventilators. There is no mention of a human patient test set or sample size in this document for this specific submission. The provenance is internal testing performed by the manufacturer or their agents. The nature of this submission is purely technical validation without clinical data.

For the original K171696, while biological and performance standards were met, specific "sample sizes" for patient data are not detailed, as these are typically bench and engineering tests rather than clinical trials with patient cohorts.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Given that the testing for this submission was non-clinical (ventilator compatibility), the "ground truth" would have been established through engineering and performance specifications, likely by the manufacturer's R&D and quality assurance teams, rather than medical experts for clinical ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is generally not applicable to the type of non-clinical, bench testing described for this device. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical reading studies, which were not performed for this submission.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a nitric oxide delivery system, not an AI-assisted diagnostic or therapeutic tool for which such studies would be relevant. The document explicitly states: "No clinical testing was required to support substantial equivalency of this medical device."

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

This question is not applicable as the NOxBOXi system is a medical device for delivering and monitoring nitric oxide, not an algorithm or AI system. It operates with a "human-in-the-loop" as healthcare professionals operate and monitor the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the specific K201339 submission, the "ground truth" for ventilator compatibility was established through engineering specifications and verification testing to ensure that the device's interaction with the additional ventilators did not compromise their functionality or the safety and effectiveness of the NOxBOXi system. This is based on objective measurements and compliance with applicable standards, not clinical ground truth like pathology or outcomes data.

For the core device (K171696), the ground truth for its performance characteristics (e.g., accuracy of gas delivery and monitoring) would have been established against calibrated reference standards and established measurement methodologies during verification and validation testing.

8. The sample size for the training set

This information is not applicable as the device is not described as an AI/machine learning system that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is not described as an AI/machine learning system that requires a training set and associated ground truth.

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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 GeNOsyl™ MV-1000 delivers nitric oxide (NO) for inhalation therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user. It is indicated to be used with the Bio-Med Devices CV-2+ ventilator. It provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. It incorporates a battery that provides up to 1 hour of uninterrupted NO delivery in the absence of an external power source. It includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patient's breathing circuit.

GeNOsyl MV-1000 Delivery System includes four components: 1. Nitric oxide administration apparatus, primary delivery system 2. Nitric oxide gas analyzer 3. Nitrogen dioxide gas analyzer 4. Nitric oxide administration apparatus, backup delivery system. The nitric oxide administration apparatus adds nitric oxide to gases that are to be inhaled by the patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system. The concentration of nitric oxide is maintained approximately constant during the inspiratory flow regardless of the variation in flow rate within the inspiratory portion of the respiratory cycle. The concentration of inspired nitric oxide will or must be set by the user, typically in the range of 0 to 80 parts per million (ppm). The administration apparatus includes a pressure regulator and connectors with fittings which are specific for nitric oxide gas cylinders, containing 800 ppm nitric oxide in nitrogen. The nitric oxide delivery apparatus shall minimize the time that nitric oxide is mixed with oxygen and thus minimize the concentration of nitrogen dioxide in the gas inhaled by the patient. In the presence of O2, some conversion of nitric oxide to nitrogen dioxide will occur. The GeNOsyI™ administration apparatus includes a cartridge which will serve a dual purpose: a mixing chamber and to convert any transient nitrogen dioxide to nitric oxide prior to inhalation by the patient. The administration device includes two nitric oxide gas concentration analyzers, a nitrogen dioxide gas analyzer, and an oxygen analyzer with a programmable alarm system. Gas analyzers shall be identified in the labeling for the nitric oxide gas administration device. The administration device also includes an instantaneous backup circuit that delivers a fixed flow of NO and can be activated by the user in case of device failure. Nitric oxide and nitrogen dioxide gas analyzers are devices intended to measure the concentration of nitric oxide and nitrogen dioxide in respiratory gas mixtures during administration of nitric oxide. The gas should be sampled from the inspiratory limb of the patient circuit. The nitric oxide gas analyzer includes provisions for setting upper and lower measured nitric oxide concentrations at which an alarm will be activated. The nitrogen dioxide gas analyzer includes provisions for setting upper measured nitrogen dioxide concentrations at which an alarm will be activated and a shutdown condition will stop the NO injection. The delivery system shall include a nitric oxide administration apparatus for use as a "backup" system for administration of nitric oxide when the main administration apparatus cannot be used.

The provided text describes the GeNOsyl™ MV-1000 Nitric Oxide Delivery System, but it is a 510(k) summary for regulatory clearance and does not contain a dedicated study section with detailed acceptance criteria and reported device performance in the way a clinical study report would.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Ikaria INOmax DS - K061901) by comparing features and performance specifications. The "Performance Specifications" within the comparison table implicitly serve as acceptance criteria, and the statement "The proposed device's performance and specifications are equivalent to the predicate" implies that these criteria were met through various performance tests.

Here's an attempt to extract the requested information based on the available text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Since a direct "acceptance criteria" table is not provided, I will construct one based on the performance specifications listed for the GeNOsyl™ MV-1000, assuming these values represent the targets the device aimed to achieve and, by achieving substantial equivalence, implicitly met. The document states "The proposed device's performance and specifications are equivalent to the predicate," which is the reported device performance.

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