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The Ulspira TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO, NO2 and O2 concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy.

The Ulspira TS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Refer to this material prior to use.

The Ulspira TS primary NO therapy system delivers NO gas in the 0-80 ppm range while in the Constant Rate or flow sensing modes. This includes:

· Continuous integrated monitoring for inspired NO, NO2 and a comprehensive alarm system.

· A touch-screen user interface with a waveform display of the ventilation device flow as measured in the inspiratory limb.

• Cylinder handling facilitated by manual or an automatic cylinder switch which is reactive to the detected gas supply state of NO cylinders, and a low O2 pressure alarm when using an oxygen cylinder.

· An automated emergency dosing algorithm activated by certain high-risk alarms, which impact patient dosing, to avoid sudden cessation of therapy.

· Compatibility with a wide inspiratory flow rate range of 0.25-120 //min, utilizing an automatically detected low or high flow sensor.

· An internal battery which provides at least two hours of uninterrupted therapy and a 12V DC inlet for additional external battery access.

The integrated Ulspira TS pneumatic backup NO therapy system provides backup NO delivery capability that is intended to deliver a continuous flow of NO mixed with O2, for iNO therapy which allows continuous treatment during transit within hospitals.

Ulspira TS Nitric Oxide Therapy System delivers physician-prescribed NO therapy gas and monitors inspired Nitric Oxide, Nitrogen Dioxide, and Oxygen gas in combination with a respiratory device.

The main device functionalities of the Ulspira TS Nitric Oxide Therapy System include:

• A primary delivery system to administer NO gas into a respiratory device circuit.

• Monitoring of NO, NO2, and O2 gas concentrations close to the patient interface.

• System includes a user interface that contains all controls used to set the NO delivery and monitoring parameters. All set parameters as well as other information are shown on the user interface screen.

• The system will produce visual and audible alarms if vital parameters vary beyond preset or default limits.

• The system includes an integrated pneumatic back-up system for manual hand bagging in order to deliver NO therapy in the event of a failure of the primary delivery system and during manual ventilation.

The Ulspira TS system consists of the base unit, the mobile cart and bedside rail holder, and various components and accessories, including the gas regulators and patient kits for use with validated respiratory devices.

The provided text is a 510(k) summary for the ULSPIRA TS™ Nitric Oxide Therapy System, focusing on its substantial equivalence to a predicate device after minor modifications (primarily expanded compatibility with additional respiratory devices and a minor software update). As such, it does not contain the detailed, explicit criteria and study results typically found in an AI/ML medical device submission that would precisely fit all aspects of your requested output.

The document describes a non-clinical test summary, which is designed to show the device functions as intended when connected to other equipment, rather than a clinical study evaluating diagnostic or therapeutic efficacy with human subjects.

Therefore, I will extract and infer the closest applicable information from the provided text, while also explicitly stating what information is not available based on the nature of this 510(k) submission.

Here's an attempt to answer your request based on the provided document:

Acceptance Criteria and Device Performance for ULSPIRA TS™ Nitric Oxide Therapy System

The ULSPIRA TS™ Nitric Oxide Therapy System is a Class II device (21 CFR 868.5165) intended for the delivery and monitoring of inhaled nitric oxide (iNO). This submission (K242374) is for modifications to an existing cleared device (K212409), primarily focused on expanding compatibility with additional respiratory devices and a minor software update (Version 1.6 from 1.5).

The performance evaluation in this 510(k) is a non-clinical test summary designed to demonstrate that the modified device functions within specifications when used with the newly included ventilators. This is a technical performance assessment, not a clinical study involving diagnostic accuracy, human reader performance, or patient outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this specific 510(k) are implicitly tied to the device performing "within specifications" when connected to new ventilators and maintaining the same performance characteristics as the predicate device. The document explicitly lists performance specifications for the nitric oxide delivery and gas analysis components, which were maintained.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The test set included seven additional ventilators. The "data" are technical measurements (e.g., NO/NO2/O2 concentration, flow rates) the device exhibited when connected to these ventilators under various conditions (e.g., multiple levels of NO delivery: 0, 1, 5, 20, 40, and 80 ppm). This is a technical validation, not observational patient data.
• Data Provenance: This was a non-clinical, laboratory-based engineering test conducted to assess device compatibility and performance with specific ventilator models. The location of the testing is not specified, but it would typically be conducted by the manufacturer or a certified testing laboratory. It is retrospective in the sense that it evaluates the function of a developed device against set technical specifications, not a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This submission details engineering and functional performance testing of a medical device, not the evaluation of an AI algorithm based on human expert annotations or diagnoses. Therefore, there was no "ground truth" derived from expert consensus on medical images or patient outcomes. The "ground truth" for this testing was the known input parameters (e.g., target NO concentration, ventilator settings) and the expected physical and chemical measurements (e.g., measured NO/NO2/O2 levels).

4. Adjudication Method for the Test Set

• Not Applicable. As there was no human expert review or labeling involved, there was no adjudication method like 2+1 or 3+1. The performance was measured against the device's technical specifications and engineering design requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks (e.g., radiologists reading images with and without AI assistance). This device is a nitric oxide delivery and monitoring system, and the study focused on its technical performance and compatibility with other medical equipment, not on influencing human diagnostic accuracy.

6. Standalone (Algorithm Only) Performance

• Partially Applicable / Inferred. The core of the submission effectively is a standalone performance evaluation of the device as a system. The testing evaluated the device's ability to deliver and monitor gases within its specified accuracy, independently confirmed for each of the new ventilators. While an "algorithm" is mentioned (e.g., automated emergency dosing algorithm), the performance reported is of the integrated system (hardware + software). The "algorithm only" concept usually applies more directly to AI/ML algorithms performing diagnostic tasks on data, rather than control systems for drug delivery.

7. Type of Ground Truth Used

• The "ground truth" for this non-clinical testing was based on known engineering specifications and measurable physical/chemical parameters. For example, if the device was set to deliver 20 ppm of NO, the "ground truth" for accuracy assessment would be the actual concentration measured by a highly accurate reference instrument. It was not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

• Not Applicable/Not Provided. This document describes the premarket notification for a device change, primarily concerning hardware compatibility and a minor software update. It is not a submission for an AI/ML model where a "training set" of data would be used to develop a learned algorithm. The software changes are described as "Improvements in onscreen appearance" and "correct minor items noted during software testing," indicating traditional software development, verification, and validation, not machine learning model training.

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

• Not Applicable. As there was no "training set" for an AI/ML algorithm in the context of this 510(k) submission, there was no establishment of ground truth for such a set.

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The Evolve DS (delivery system) delivers INOMAX® (nitric oxide 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, to the patient throughout the inspired breath. It uses a specially designed Injector Module, which enables tracking of the gas delivery system waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with ventilators and respiratory care devices for which the Evolve DS has been validated. The Evolve DS provides continuous integrated monitoring of inspired NO2 and NO with a comprehensive alarm system. The Evolve DS also provides monitoring and alarms for the drug delivery system.

The Evolve DS incorporates a battery that provides up to 4 hours of uninterrupted NO delivery in the absence of external power. The Evolve DS also incorporates an integrated electronic blender that functions as a backup delivery device to provide an adjustable INOmax dose with user supplied oxygen to a manual resuscitator or gas delivery system. The electronic blender incorporates a separate control and delivery pathway that serves as a redundant mechanism for nitric oxide delivery in the event of a main system fault.

The Evolve DS must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The Evolve DS is indicated for a maximum of 14 days use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU), and secondary targeted clinical setting is the transport of neonates.

The EVOLVE Nitric Oxide (NO) Delivery System (DS) is used for administration and monitoring of INOMAX (nitric oxide for inhalation). It is comprised of a main delivery device (EVOLVE), an electronic blender (eINOblender) for backup use, and a Cart which holds the EVOLVE as well as INOMAX drug cylinders, an oxygen cylinder and miscellaneous parts.

The EVOLVE Nitric Oxide Delivery System utilizes Technology component technology to deliver Nitric Oxide gas to the patient. The components consist of a main delivery device (EVOLVE), an electronic blender (eINOblender) for backup use, and a Cart which holds the EVOLVE as well as INOMAX drug cylinders, an oxygen cylinder and miscellaneous parts. In this revision of the EVOLVE Nitric Oxide Delivery System, the changes to the device includes the labeling for compatibility with respiratory care devices.

The provided FDA document describes a 510(k) premarket notification for the EVOLVE Nitric Oxide Delivery System. This submission is for an updated version of a previously cleared device (K240410 and K222930), primarily focusing on expanded labeling for compatibility with additional ventilator and breathing devices.

Therefore, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of device performance, as it pertains to a labeling update for compatibility. Clinical studies were explicitly stated as "not applicable to this submission."

Here's a breakdown of what can be extracted based on your request, and what cannot:

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

This information is not provided in the document. The filing is for a change in labeling for compatibility with more ventilator devices, not for demonstrating new performance criteria for the core device. It implicitly relies on the original clearance for the device's performance specifications.

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

• Sample size for test set: Not explicitly stated as a numerical value for patients or cases. The "test set" in this context refers to the additional ventilator and breathing devices with which compatibility was tested.
• Data Provenance: The testing was "conducted across all platforms to demonstrate that the EVOLVE Nitric Oxide Delivery System performs within published specifications." This suggests laboratory or bench testing rather than clinical data from a specific geographic region or a prospective/retrospective study on human subjects.

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 information is not provided. The testing described is focused on the device's functional performance and compatibility with other medical equipment, not on clinical interpretations that would require expert consensus for ground truth.

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

This information is not provided, as the nature of the "test set" does not involve clinical judgment 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:

This information is not applicable/provided. The device described is a nitric oxide delivery system, not an AI-assisted diagnostic or therapeutic device that would involve human readers or image interpretation.

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

This information is not applicable/provided for the same reasons as above. The device doesn't involve an algorithm in the sense of AI for diagnostic or interpretive tasks.

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

The "ground truth" for the compatibility testing appears to be the published specifications of the EVOLVE Nitric Oxide Delivery System and the functional operation of the connected ventilator devices. The testing aimed to demonstrate that the EVOLVE system "performs within published specifications" when used with the additional ventilators.

8. The sample size for the training set:

This is not applicable/provided. The submission is not for a machine learning or AI-based device that would typically have a training set.

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

This is not applicable/provided.

Summary of what is available from the document:

• Device Name: EVOLVE Nitric Oxide Delivery System
• Purpose of Submission: Updated labeling for compatibility with additional ventilator and breathing devices.
• Testing Conducted: "Ventilator / Gas Delivery System Validation Test Protocol" was used to validate hazard mitigation and demonstrate performance within published specifications across various ventilator platforms. This was the same protocol used in previous clearances (K222930 and K240410).
• Clinical Studies: Explicitly stated as "not applicable to this submission."
• Predicate Device: EVOLVE Nitric Oxide Delivery System (K240410). The current device is considered substantially equivalent.

In conclusion, the supplied document does not describe the types of performance studies (e.g., diagnostic accuracy, clinical effectiveness) and associated acceptance criteria that would typically involve many of the points in your request. Instead, it focuses on technical compatibility validation for a medical device.

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The Evolve DS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The Evolve DS is indicated for a maximum of 14 days use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU), and secondary targeted clinical setting is the transport of neonates.

The EVOLVE Nitric Oxide (NO) Delivery System (DS) is used for administration and monitoring of INOMAX (nitric oxide for inhalation). It is comprised of a main delivery device (EVOLVE), an electronic blender (eINOblender) for backup use, and a Cart which holds the EVOLVE as well as INOMAX drug cylinders, an oxygen cylinder and miscellaneous parts.

This submission is for an updated labeling for compatibility with additional ventilator and breathing devices for the EVOLVE Nitric Oxide Delivery System, not a new device or a software-driven diagnostic. Therefore, the detailed information about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment typically required for AI/ML device studies is not available in this document.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K222930) by evaluating the impact of new ventilator compatibility labeling.

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

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

The document does not provide a specific table of acceptance criteria and reported device performance in the context of an algorithmic diagnostic. Instead, it refers to the performance of the overall EVOLVE Nitric Oxide Delivery System, which is a hardware-based medical device.

The "Summary of Non-Clinical Tests" section mentions:
"The Mallinckrodt Ventilator / Gas Delivery System Validation Test Protocol was used to validate the hazards identified from risk input were mitigated. Testing was conducted across all platforms to demonstrate that the EVOLVE DS performs within published specifications. Ultimately, the requirements necessary for the operation of the EVOLVE Nitric Oxide Delivery System passed."

This indicates that the acceptance criteria were likely related to the device working within its published specifications when interfaced with the new ventilators, and the reported device performance was that it "passed" these requirements. However, specific quantitative metrics are not provided.

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

This information is not applicable and therefore not provided in the document. The study was a non-clinical validation test of device compatibility, not a clinical study on patient data.

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 information is not applicable. The "ground truth" here would be the functional performance of the device and its compatibility with ventilators, established through engineering and technical validation rather than expert clinical consensus on diagnostic outcomes.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human readers to resolve discrepancies in diagnoses or interpretations. This was a non-clinical validation.

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 submission is not for an AI device or a diagnostic requiring human reader interpretation.

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

No, a standalone algorithm performance study was not done. This device is a hardware delivery system, not an algorithm.

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

The "ground truth" used for this non-clinical validation was the functional performance of the device and its compatibility with the listed ventilators according to its published specifications and safety requirements. This would be established through engineering tests and measurements, rather than clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable. There is no training set as it's not an AI/ML device.

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

This information is not applicable, as there is no training set.

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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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Ask a specific question about this device

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 inspirator 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.

This submission is for the addition of compatibility claims for specific ventilators and for the ventilators previously cleared for pediation. It is not related to product changes. 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 document is a 510(k) summary for the NOxBOXi Nitric Oxide Delivery System, seeking clearance for additional ventilator compatibility. It is important to note that this document does not contain the detailed methodology and results of a clinical study or a multi-reader multi-case (MRMC) comparative effectiveness study. Instead, it focuses on non-clinical performance data and adherence to various standards and guidance documents to demonstrate substantial equivalence to a previously cleared device.

Therefore, many of the requested items (e.g., ground truth establishment, expert qualifications, adjudication methods, MRMC study effect sizes, standalone performance, training set details) are not explicitly present in this type of regulatory submission, as they would typically be part of a full clinical trial report or a more comprehensive performance study dossier.

However, I can extract and infer information about the acceptance criteria and the type of study conducted to prove the device meets these criteria based on the provided text, particularly from section "9. Non-Clinical and Usability Performance Data" and the comparison table in section "8. Substantial Equivalence Discussion".

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are implicitly defined by the technical specifications of the predicate device (K220898) and the accuracy requirements outlined in relevant FDA guidance documents. The "study" in this context is primarily non-clinical testing to ensure the device maintains its performance and safety profile, especially with the added ventilator compatibilities.

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

• Sample Size for Test Set: The document indicates that testing was "limited to the aspects that could be affected by including compatibility with additional ventilators and ventilator categories." This implies bench testing and performance verification on the device itself and its interaction with a sample of the listed ventilators. The specific number of ventilators tested or the number of test cycles is not provided in this summary.
• Data Provenance: The data provenance is from non-clinical (bench) testing performed by the manufacturer, Linde Gas & Equipment Inc. and NOxBOX Ltd. The country of origin of the data is not specified, but the submission is to the U.S. FDA. The testing conducted for this submission (ventilator compatibility) was of a prospective nature (i.e., new tests performed for this specific submission).

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

This type of information (experts, qualifications) is not applicable or not provided in this 510(k) summary because the study proving the device meets criteria is based on:

• Comparison to an existing predicate device's established performance.
• Direct technical measurements and verification testing (bench testing) against defined engineering specifications and regulatory standards.
• The criteria are objective performance metrics (e.g., accuracy of gas delivery, flow rates, alarm functionality, electrical safety), not subjective interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for studies involving subjective human interpretation (e.g., image reading by radiologists). This submission relies on objective engineering and performance testing.

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

No. A MRMC comparative effectiveness study was not done. This type of study is used to evaluate how human readers' performance with a medical device (e.g., AI assistance) compares to their performance without it. The NOxBOXi is a medical device for gas delivery and monitoring, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The submission 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

Not applicable for this device type. The NOxBOXi is a physical gas delivery and monitoring system, not an algorithm. Its "performance" is its ability to accurately deliver and monitor gases, which is assessed through bench testing, not algorithmic standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims are:

• For the technical specifications, it is the design specifications and measured performance against those specifications as verified in non-clinical testing.
• For regulatory compliance, it is the requirements of various international standards (e.g., ISO, IEC) and FDA guidance documents.
• For substantial equivalence, it is the previously cleared predicate device's established performance and safety profile.

8. The Sample Size for the Training Set

Not applicable. This submission describes a physical medical device and its non-clinical performance verification, not a machine learning model that would require a training set.

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

Not applicable. As stated above, this is not an AI/ML device that uses training data.

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The Ulspira TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO, NO2 and O2 concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy.

The Ulspira TS must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Refer to this material prior to use.

The Ulspira TS primary NO therapy system delivers NO gas in the 0-80 ppm range while in the Constant Rate or flow sensing modes. This includes:

• Continuous integrated monitoring for inspired NO, NO2 and a comprehensive alarm system.

· A touch-screen user interface with a waveform display of the ventilation device flow as measured in the inspiratory limb.

· Cylinder handling facilitated by manual or an automatic cylinder switch which is reactive to the detected gas supply state of NO cylinders, and a low O2 pressure alarm when using an oxygen cylinder.

• An automated emergency dosing activated by certain high-risk alarms, which impact patient dosing, to avoid sudden cessation of therapy.

· Compatibility with a wide inspiratory flow rate range of 0.25-120 1/min, utilizing an automatically detected low or high flow sensor.

• An internal battery which provides at least two hours of uninterrupted therapy and a 12V DC inlet for additional external battery access.

The integrated Ulspira TS pneumatic backup NO therapy system provides backup NO delivery capability that is intended to deliver a continuous flow of NO mixed with O2, for iNO therapy which allows continuous treatment during transit within hospitals.

Ulspira TS Nitric Oxide Therapy System delivers physician-prescribed NO therapy gas and monitors inspired Nitric Oxide, Nitrogen Dioxide, and Oxygen gas in combination with a respiratory device.

The main device functionalities of the Ulspira TS Nitric Oxide Therapy System include:

• A primary delivery system to administer NO gas into a respiratory device circuit.
• Monitoring of NO, NO2, and O2 gas concentrations close to the patient interface. ।
• System includes a user interface that contains all controls used to set the NO delivery and monitoring parameters. All set i parameters as well as other information are shown on the user interface screen.
• -The system will produce visual and audible alarms if vital parameters vary beyond preset or default limits.
• -The system includes an integrated pneumatic back-up system for manual hand bagging in order to the rapy in the event of a failure of the primary delivery system and during manual ventilation.

The Ulspira TS system consists of the base unit, the mobile cart and bedside rail holder, and various components and accessories, including the gas regulators and patient kits for use with validated respiratory devices.

Although the provided text describes the ULSPIRA TS Nitric Oxide Therapy System's indications for use, its technical characteristics compared to a predicate device, and the non-clinical performance data (verification and validation activities and applied standards), it does not contain explicit acceptance criteria or a study design and results that directly "prove the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC.

The document focuses on demonstrating substantial equivalence to a predicate device (INOmax DSIR Plus) based on technical comparisons and non-clinical testing. This type of submission (510(k)) generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, often without requiring extensive new clinical efficacy studies if technological differences are minor and can be addressed through non-clinical means.

Therefore, many of the requested details about clinical studies, expert consensus, and effects on human readers are not available in the provided text.

Here's a breakdown of what can be extracted and what is not present:

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

The document presents a comparison to a predicate device, showing "Comparison" remarks that indicate substantial equivalence or identify differences that are still considered acceptable (e.g., meeting regulatory guidance). It does not explicitly list "acceptance criteria" as pass/fail thresholds for clinical metrics but rather as similar technical specifications or compliance with standards.

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 describes non-clinical performance data (verification and validation activities) rather than clinical study data. It mentions "performance testing (verification including primary & backup NO delivery, gas monitoring, & compatibility with ventilators identified in labeling)" but does not specify a sample size for a test set in cases or patients, nor does it indicate data provenance (country, retrospective/prospective). This suggests the testing was bench/lab-based rather than a clinical trial with patient data.

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)

Not applicable/Not provided. The testing described is primarily engineering/performance verification against specifications and standards, not clinical ground truth established by experts.

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

Not applicable/Not provided. This refers to a clinical study method, which is not detailed in the provided non-clinical data.

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/Not provided. This device is a nitric oxide therapy system, not an AI-assisted diagnostic or treatment planning tool that would typically involve "human readers" or AI assistance in that context.

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

Not applicable/Not provided in this context. The device itself performs delivery and monitoring; there isn't an "algorithm only" performance that would be separate from the integrated system's function. The performance testing is for the whole system.

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

The "ground truth" for the non-clinical performance data would be the established engineering specifications, regulatory standards, and physical measurements (e.g., gas concentrations measured by reference instruments, flow rates, alarm thresholds, battery duration). There is no mention of clinical ground truth from expert consensus, pathology, or outcomes data, as this was not a clinical efficacy study.

8. The sample size for the training set

Not applicable/Not provided. This implies a machine learning or AI context, which is not described for this device's submission.

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

Not applicable/Not provided. As above, this is relevant for AI/ML models, not for the technical equivalence and performance verification described for this nitric oxide therapy system.

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The INOmax® DSIR Plus delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant on of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with ventilators and respiratory care devices that the INOmax DSIR Plus has been validated with.

The INOmax® DSIR Plus provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax® DSIR Plus incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax® DSIR Plus includes a backup NO delivery capability that provides a fixed flow of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breath. It may also use the INOblender® for backup.

The INOmax® DSIR Plus must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging inserts and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. INOmax DSIR Plus is indicated for a maximum of 14 days of use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSR® Plus uses a "dual-channel" design to ensure the safe delivery of INOMAX®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX® delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.

All revisions of INOmax DSm® Plus utilize component technology to deliver Nitric Oxide gas to the patient. The components consist of the Delivery System unit, the blender, a stand/cart and the NO gas tanks. In this revision of the INOmax DSIR® Plus, the significant changes to the device include the labeling and main circuit board.

The provided text describes a 510(k) premarket notification for the INOmax DSIR® Plus device, which is a nitric oxide administration apparatus. It focuses on demonstrating substantial equivalence to a predicate device (K200389) rather than an AI/ML-based device requiring a study to prove meeting acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML device evaluations) are not applicable to this submission.

The document explicitly states: "The subject of this premarket submission, INOmax DSm® Plus, did not require clinical studies to support substantial equivalence." This reinforces that the evaluation was based on non-clinical tests demonstrating design changes and continued safety/performance relative to the predicate, not on a clinical performance study with human subjects or AI-based diagnostic/prognostic output.

The "acceptance criteria" for this device, as implied by the submission, are largely related to engineering, safety, and performance as compared to the predicate device, and these were met through non-clinical testing.

Here's a breakdown of the relevant information provided, mapping it to your request where applicable, and noting where information is not present due to the nature of the submission:

Acceptance Criteria and Device Performance (Not Applicable in the AI/ML sense):

Detailed Breakdown per your request:

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

   • As shown in the table above, the "acceptance criteria" are implied by the non-clinical tests performed (e.g., meeting IEC standards, successful risk analysis, verification of functionality). The "reported performance" is that these tests were passed, supporting substantial equivalence. There are no quantitative performance metrics like sensitivity/specificity for a diagnostic AI.

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

   • Not applicable. This was not a data-driven performance study in the context of AI/ML. "Testing" refers to hardware, software, and system verification/validation against engineering specifications and recognized standards, not a clinical test set of patient data.

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):

   • Not applicable. There was no "ground truth" to establish in the context of an AI/ML diagnostic or prognostic system. The device's function is gas delivery and monitoring, not diagnosis.

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

   • Not applicable. No expert review or adjudication process was described or required for this type of device 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. This device is not an AI-assisted diagnostic tool.

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

   • Not applicable. The device itself is a medical apparatus, not an algorithm, and its performance is assessed via engineering and system validation, not standalone algorithmic evaluations.

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

   • Not applicable. No "ground truth" in the AI/ML sense was used. Device functionality and safety were verified against engineering specifications, simulated physiological conditions (e.g., gas flow and concentration measurements), and recognized standards.

8. The sample size for the training set:

   • Not applicable. There was no AI/ML training set.

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

   • Not applicable. There was no AI/ML training set.

In summary, the provided document is a 510(k) summary for a medical device that delivers and monitors nitric oxide. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (e.g., electrical safety, performance testing, software verification, biocompatibility), rather than clinical performance studies involving a test set with established ground truth, which would be typical for AI/ML-based diagnostic or prognostic devices.

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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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