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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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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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The LIV is an inteqrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults.. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MR1 systems up to 3.0T. Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

The Linde Integrated Valve® ("LIV") is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of userselectable flow settings is available, inclúding low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50 psig oxygen delivery, while an optional bed hanger allows the LV to be readily attached to a bed. The LV is suitable for use in all healthcare settings including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.

The provided document, K101792, describes a premarket notification for the "Linde Integrated Valve - LIV," a portable oxygen delivery system. However, the document does not contain a study that proves the device meets specific acceptance criteria in the manner requested.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Medcyl-E-lite K033897) based on technological characteristics and compliance with a series of recognized international and national standards for medical devices and gas cylinders. This type of submission (510(k)) primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted directly from this document. I will answer based on the information provided, explicitly stating when the requested information is not available.

Description of Acceptance Criteria and Proving Study

The Linde Integrated Valve (LIV) is a portable oxygen delivery system. The acceptance criteria for this device are primarily based on compliance with established safety and performance standards for similar medical devices and gas handling equipment. The "study" that proves the device meets these criteria is a series of non-clinical performance tests confirming adherence to these standards, as detailed in the "Non-Clinical Performance Summary" section of the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for the test set: Not explicitly stated for each individual test or standard listed. The document indicates "safety and performance testing" in general. It is typical for compliance testing to involve a representative sample of devices, but the specific numbers are not provided in this summary.
• Data provenance: Non-clinical (laboratory/engineering) testing and design specifications. The country of origin for the data is not specified, but the standards are international (ISO, EN) and national (DOT, CFR, CE).

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

• Number of experts: Not applicable/not specified. The "ground truth" here is compliance with published, recognized standards and engineering specifications for device performance. These standards are developed by expert committees, but the individual tests themselves typically involve engineering or technical personnel rather than clinical experts establishing a "ground truth" in the diagnostic sense.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not applicable/not specified. Compliance testing generally involves objective measurements against predefined criteria in the standards, rather than expert adjudication of subjective findings.

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

• MRMC study: No. This document describes a medical device (portable oxygen delivery system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant and was not performed.

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

• Standalone performance: Not applicable. This is not an algorithm-based device. Performance testing for this device would assess its mechanical and functional specifications.

7. The type of ground truth used

• Type of ground truth: Predetermined performance parameters and established safety requirements outlined in recognized medical device and gas cylinder standards (e.g., ISO, DOT, EN, CE Mark Directive) and engineering specifications. For MR compatibility, adherence to ASTM standard 2503-05 serves as the ground truth.

8. The sample size for the training set

• Sample size for training set: Not applicable. This device is not an AI/machine learning product requiring a training set.

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

• Ground truth for training set: Not applicable.

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The Helontix Vent is designed to deliver helium/oxygen mixtures to spontaneously breathing patients via a facemask with or without pressure support. The system is designed for facility use and should only be used under the orders of a clinician.

The Helontix Vent delivery system is not intended as a life support device and is not intended for intubated patients.

The Helontix vent is a stand alone assembly to deliver heliox or oxygen. To accomplish this, the Helontix vent consists of a device with a built in battery and a trollev with mounted oxygen and Heliox gas cylinders. When connected to O2 and Heliox (79%He, 21%O2) the Helontix vent delivers a mixture of oxygen and helium in the required fraction to the patient who can breathe over a mask that is connected to the device via a hose system. The Helontix vent interacts with the user via a user interface, i.e. a display, diodes, speaker, several keys and a control wheel. The device informs the user on the screen about set values, monitored values, alarms, ventilation modes and the navigation through the menus while the user can choose the ventilation mode, set values, silence alarms and navigate through menus by using keys and control wheel. The Helontix vent is device designed for Non-invasive Positive Pressure Ventilations (NPPV) for spontaneous breathing patients. The inspiration flow can be either triggered by the patient with a surplus support of pressure (pressure support mode, PSM, 3-30mbar@peak flow 160SLPM) or alternatively a constant flow from 5-60 SLPM without a pressure support (constant flow mode, CFM) can be selected. The breathing circuit, mask and filter used are purchased previously cleared devices.

The provided text describes a 510(k) premarket notification for the Linde Gas Therapeutics Helontix Vent, a device designed to deliver helium/oxygen mixtures to spontaneously breathing patients. The document focuses on establishing substantial equivalence to predicate devices and adherence to regulatory standards, rather than presenting a detailed clinical study with specific acceptance criteria and outcome data in the format requested.

Therefore, the following information can be extracted about the device's validation, but will not fully align with the requested structure of a study proving a device meets acceptance criteria derived from a clinical trial, as that type of study is not described:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the listed voluntary standards and the assertion of "positive results from extensive testing" demonstrating substantial equivalence. The document does not provide a table with specific, measurable performance metrics and corresponding acceptance thresholds for clinical efficacy, nor does it present quantitative results from a specific clinical study for the Helontix Vent. Instead, it refers to regulatory and engineering standards.

2. Sample size used for the test set and the data provenance:
The document does not describe a clinical study or a test set of patient data. The "extensive testing" mentioned refers to engineering and software validation, not a clinical trial with human subjects. Thus, information on sample size and data provenance (country, retrospective/prospective) for a clinical test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set with expert-established ground truth is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication is 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:
Not applicable. The device is a ventilator for heliox delivery, not an AI-powered diagnostic or reader-assistance tool. No MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device for gas delivery, not an algorithm. Performance assessment would involve engineering and physical testing, not algorithm-only performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context refers to compliance with established engineering standards, software requirements, and safety regulations. These are verified through various physical and software tests, rather than human expert consensus on clinical data or pathology.

8. The sample size for the training set:
Not applicable as no machine learning algorithm with a training set is described.

9. How the ground truth for the training set was established:
Not applicable as no machine learning algorithm with a training set is described.

Summary of Study (Based on Provided Text):

The "study" described in the 510(k) summary is primarily a premarket notification to demonstrate substantial equivalence to legally marketed predicate devices and compliance with relevant voluntary standards and regulatory requirements. It is a technical and regulatory validation process, not a clinical study designed to prove device efficacy through patient outcomes or expert reads.

The document states:

• "Positive results from extensive testing demonstrate that the Linde Helontix Vent is substantially equivalent to the predicate devices."
• "EMC, Electrical, Environmental and full performance testing is also provided in support of the submission."
• "The submissions contains full software information regarding the Level of Concern Analysis, Risk Analysis, Software Development, Software Requirements and Design, Verification and Validation testing, and Traceability."

These statements indicate that the device underwent various forms of engineering, software, and performance testing to ensure it met safety requirements and functioned as intended within the parameters of the industry standards listed. The "ground truth" for these tests would be the specifications and requirements defined by those standards and the device's design documentation. No clinical trial with patient-specific outcome data, expert reviews, or AI performance metrics is mentioned or detailed.

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The LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall! be rah Uized or otherwise secured to prevent falling and rolling.

The Linde Integrated Valve™ ("LIV") is a portable oxyqen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of user-selectable flow settings is available, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50psig oxygen delivery, while an optional bed hanger allows the LIV to be readily attached to a bed. The LIV is suitable for use in all healthcare settings, including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.

The Linde Integrated Valve (LIV) is a portable oxygen delivery system. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might for a novel AI/software device.

Here's the breakdown based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the LIV primarily relies on demonstrating substantial equivalence to a predicate device (MEDICYL-E-Lite K033897) rather than setting specific quantitative acceptance criteria for novel performance, as one would for an AI/software device. The "acceptance criteria" here are implicitly met by showing the device's technical characteristics are substantially similar and that it conforms to relevant standards.

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

This is not applicable in the context of this 510(k) summary. This document does not describe a "test set" or data provenance in the way one would for a clinical study comparing AI performance against ground truth. The evaluation is primarily based on engineering design, materials, and compliance with standards, along with a comparison of technological characteristics to a predicate device.

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

Not applicable. This is a medical device (hardware) submission, not an AI/software device submission requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as above.

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. The LIV is a hardware device for oxygen delivery, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for this type of device submission revolves around engineering specifications, material properties, and functionality meeting established standards and being comparable to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. No AI/machine learning training set is involved.

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

Not applicable. No AI/machine learning training set is involved.

In summary:

The provided document is a 510(k) summary for a physical medical device (an oxygen delivery system). It demonstrates the device's safety and effectiveness by establishing substantial equivalence to an already legally marketed predicate device, rather than through a standalone performance study with clinical endpoints or AI-specific validation metrics. The "study" implicitly referenced is the "safety and performance testing and compliance with voluntary standards" conducted by the manufacturer, which is deemed sufficient to demonstrate this equivalence. The "acceptance criteria" are met by matching or exceeding the predicate's characteristics and complying with relevant engineering and safety standards.

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