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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 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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The INOmax® DSIR Plus 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 ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

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 target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. 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.

The INOmax® DSIR Plus 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 ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax® DSIS 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 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup.

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 DSm® Plus, the only changes to the device includes the labeling for compatibility with respiratory care device.

This document, K200389, is a 510(k) premarket notification for the INOmax DSIR Plus, a nitric oxide administration apparatus. It focuses on demonstrating substantial equivalence to a predicate device (K131686), specifically by adding compatibility with new ventilator and breathing devices.

Based on the provided text, the device performance assessment relies entirely on nonclinical (bench) testing and comparison to a previously cleared predicate device. There is no evidence of clinical studies involving human subjects or AI algorithms in this document. Therefore, many of the requested points regarding AI/MRMC studies, expert ground truth adjudication, and training/test set sample sizes are not applicable to the information presented.

Here's the breakdown of what can be extracted from the document:

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics like "accuracy > X%". Instead, it refers to a "Ventilator/Gas Delivery System Validation Test Protocol" used for the predicate device (K131686) and states that this same protocol, with "insignificant differences," was used for the INOmax DSIR Plus. The general acceptance criterion implied is that the device "performs within published specifications" and that "the hazards were mitigated" based on this protocol.

• Acceptance Criteria (Implied): Performance according to "published specifications" and mitigation of identified hazards, as demonstrated through the "Ventilator/Gas Delivery System Validation Test Protocol."
• Reported Device Performance: "Ultimately, the requirements necessary for the operation of the INOmax DSIR passed." and "This Bench Testing was conducted across all platforms to demonstrate that the INOmax DSIR® Plus performs within published 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 number of patient cases or images. The "test set" in this context refers to the bench testing conducted on the device's compatibility with a list of new ventilator and breathing devices. The document lists 11 specific additional ventilator devices that were tested for compatibility:
  • Covidien PB 980 (K131252)
  • GE Healthcare Carescape R860 (K142679)
  • Fisher & Paykel Healthcare RT330 Breathing Circuit and Optiflow Jr (Class I, 510(k) Exempt under 21 CFR 868.5340)
  • Bunnell Inc Life Pulse 204 (P850064)
  • Drager Perseus A500 (K133886)
  • Fisher & Paykel Healthcare Airvo 2 (K131895)
  • Drager Carina (K072885)
  • Maquet Servo u/n (K151814)
  • Hamilton C3 (K161450)
  • IMT Medical Bellavista (K163127)
  • Maquet Flow-i (K160665)
  • Bio-Med TV-100 (K173973)
  • Phillips V60 (K102985)
• Data Provenance: The data originates from bench testing (laboratory) rather than clinical patient data. Country of origin for the testing is not specified but is presumed to be associated with the manufacturer (Mallinckrodt Manufacturing, LLC, based in Madison, Wisconsin, USA). The testing is prospective in the sense of being conducted specifically for this submission, although it leverages a protocol from a previous clearance.

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. This device is a hardware apparatus for administering nitric oxide, not an AI algorithm requiring expert human interpretation of medical images or data for ground truth. The "ground truth" for the nonclinical testing would be the engineering specifications and expected performance, verified through the validation protocol.

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

Not applicable, as no human expert adjudication of data (like medical images or clinical outcomes) was performed. The "adjudication" of the bench test results would be whether the device passed or failed the predefined engineering/performance criteria in the validation protocol.

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 document explicitly states, "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." This means no human-in-the-loop performance study, MRMC study, or AI assistance was involved.

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

No. This device is a physical medical device, not an AI algorithm.

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

The "ground truth" used for this device's validation was engineering specifications and performance criteria established in the "Ventilator/Gas Delivery System Validation Test Protocol," likely determined by design requirements and regulatory standards for medical devices of this type.

8. The sample size for the training set

Not applicable. There is no AI component or training set mentioned in this submission.

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

Not applicable. There is no AI component or training set mentioned in this submission.

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