Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device