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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 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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