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The SERVO i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants, and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healtheare providers in hospitals or healthcare facilities and for in-hospital transport.

The added indications for use of the NAVA option is when the electrical signal from the diaphragm is intact; NA VA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso-Gastric tube.

The SERVO-i Ventilator is classified as MR Conditional for 1.T. 1.5T and 3T MR scanners. This means that it is safe to use in the MR environment if the MR Environment Declaration for SERVO-i are met.

The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).

The SERVO-s Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants, and adults with respiratory failure or respiratory insufficiency. SERVO-s is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

The SERVO-i Ventilator System (here after called SERVO-i) is intended to provide continuous ventilation for neonate to adult patients in the weight range 0.5-250 kg and with tidal volumes from 2 mL to 4000 mL. SERVO-i consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The ventilator delivers controlled or supported breaths to the patient, with either constant flow or constant pressure, using a set oxygen concentration. SERVO-i will produce visual and audible alarms if vital parameters vary beyond pre-set, or default, limits. The system contains provisions for at least two battery modules to supply the system in the case of mains power failure or during in-hospital transport. The ventilator functionality is controlled by software. The SERVO-i Ventilator System is available in three software versions. Infant. Adult and Universal.

The NAVA (Neurally Adjusted Ventilatory Assist) option is a supported mode for SERVO-i that uses the Edi signal (the electrical activity of the diaphragm) as an addition to the flow/pressure trigger to synchronize the patient efforts with the onset and cycle off. The NAVA option is available in invasive and non-invasive mode.

SERVO-i is MR conditional. The SERVO-i ventilator with MR option have been tested with 1.0, 1.5, 3.0 T scanners without impairing its performance or the image quality of the scanner. Each scanner and its environment form an individual device. The MR Environment Declaration describes how a SERVO-i with MR option can be qualified to be used with an MR scanner forming a safe Medical System. All vital parts of the ventilator have been tested for performance in excessive magnetic fields.

The SERVO-i with Heliox option requires a different mechanical adaptor on the air supply inlet to allow a mixture of Helium and Oxygen to be connected. Furthermore is the software updated to allow safe delivery and monitoring of the Heliox gas mixture.

Accessories for CO2-monitoring, nebulization and flow monitoring at the Y -piece (Y-sensor) are integrated as options in the SERVO-i and the drivers are controlled by the software in the ventilator.

This 510(k) submission for the SERVO-i include changes to receive a new baseline based on compatibility to the third edition standard package of AAMVANSI 60601-1 :2005 and its collateral and particular standards for intensive care ventilators. The submission does also include modifications of the software and hardware to update existing functionalities since the last submission (K073149).

The SERVO-s ventilator system (here after called SERVO-s) is based on the SERVO-i ventilator family platform. SERVO-s ventilation system is a downscaled version based on the SERVO-i ventilator system notified in K041223.

The SERVO-s Ventilator System is intended to provide continuous ventilation for neonate to adult patients in the weight range 2-250 kg and with tidal volumes from 10 mL to 2000 mL. The SERVO-s Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The ventilator delivers controlled or supported breaths to the patient, with either constant flow or constant pressure, using a set oxygen concentration. SERVO-s Ventilator System will produce visual and audible alarms if vital parameters vary beyond preset, or default, limits. The system contains two internal batteries to supply the system with power in the case of mains power failure or during inhospital transport. The ventilator functionality is controlled by software. The SERVO-s Ventilator System is available in two software versions, Infant and Adult.

This 510(k) submission for the SERVO-s include changes to receive a new baseline based on compatibility to the third edition standard package of IEC 60601-1 :2005 and its collateral and particular standards for intensive care ventilators. The submission does also include addition of the Infant option, patient weight range 2-10 kg, with tidal volumes from 10 mL to 350 mL and modifications of the software and hardware to update existing functionalities.

Here's a breakdown of the acceptance criteria and the studies mentioned in the provided 510(k) summary for the GETINGE GROUP SERVO-i and SERVO-s Ventilator Systems, organized according to your requested format.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "studies" described are primarily verification and validation activities rather than formal clinical trials designed to prove efficacy from scratch. The acceptance criteria are largely implied by compliance with standards and successful performance in these verification and validation tests.

Acceptance Criteria and Device Performance

This section synthesizes the implicit acceptance criteria from the various verification and validation activities described and attempts to align them with the reported "performance" based on the conclusions drawn in the document.

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The SERVO-i Ventilator System with Heliox option is intended for treatment and monitoring of patients in the range of neonates, infants, and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities. The SERVO-i Ventilator System with Heliox option is also MR conditional.

The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).

The predicate device SERVO-i Ventilator System is a ventilator, which gives, ventilation (Invasive and Non Invasive) to critical care patients in the weight range 0.5 to 250 Kg's. The modified device adds an option, called "Heliox option", which is a mechanical adaptor along with software for SERVO-i Ventilator System integration.

The provided text is a 510(k) summary for the Maquet SERVO-i Ventilator System with Heliox option. It focuses on demonstrating substantial equivalence to predicate devices and describes the device's intended use and technological characteristics. Crucially, this document does not contain information about acceptance criteria, device performance metrics, or study designs used to prove the device meets specific performance criteria beyond establishing substantial equivalence for regulatory purposes.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details. These types of studies are typically found in more detailed technical documentation or clinical trial reports, which are not part of this 510(k) summary.

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The SERVO-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

The SERVO-i Ventilator with MR environment option is classified as MR Conditional for 1.T. 1.5T and 37 MR scanners. This means that it is safe to use in the MR environment if the conditions in the MR Environment Declaration for SERVO-i are met.

The ventilator is a platform with several selectable ventilation modes, which monitor patients whom need respiratory assistance. The MR environment option makes it possible to qualify the Servo-i ventilator to be used in MR environment

The SERVO-i Ventilator System's acceptance criteria and testing are focused on its "MR environment option" which allows it to be used safely in conjunction with MRI scanners. The provided document is a 510(k) summary, which typically provides an overview of testing rather than a detailed study report.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for magnetic field strength, RF interference limits, or image artifacts) or precise, quantitative reported device performance values. Instead, it describes general claims of compatibility and safety.

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

• Sample Size: The document does not specify a numerical sample size for the devices tested. It refers to "the SERVO-i ventilator with MR option" in general terms.
• Data Provenance: The document implies the testing was conducted by Maquet Critical Care AB, which is a Swedish company. The nature of the testing (e.g., lab testing, in-house verification) suggests it's prospective data generated specifically for this submission. There is no indication of patient data or retrospective studies for this specific MR compatibility claim.

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

The document does not mention the use of experts to establish a "ground truth" in the typical sense for clinical performance. The testing described appears to be engineering and compatibility testing to ensure the device functions correctly in an MR environment and does not interfere with the MRI scanner. Therefore, no information on the number or qualifications of clinical experts for ground truth is provided.

4. Adjudication Method for the Test Set

Not applicable. The testing described is technical verification and validation of MR compatibility, not clinical performance requiring adjudication of patient cases.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on the technical compatibility and safety of the ventilator in an MR environment, not on the comparative clinical effectiveness or improvement of human readers with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The testing performed on the SERVO-i ventilator with the MR option can be considered "standalone" as it evaluates the device's technical performance and its interaction with an MRI system, without direct human-in-the-loop performance being a primary outcome measure for the MR compatibility. The ventilator itself is a standalone medical device.

7. The Type of Ground Truth Used

The ground truth used for this testing is based on:

• Engineering specifications and regulatory standards for MR compatibility: The device must maintain its intended ventilatory function.
• MRI image quality assessment: The device must not cause unacceptable artifacts in the MR images.
• Magnetic field strength measurements: To ensure safety margins.

This is a technical ground truth rather than a clinical ground truth derived from expert consensus or pathology in a diagnostic context.

8. The Sample Size for the Training Set

Not applicable. This submission concerns a physical medical device (ventilator) and its MR compatibility, not an AI/ML algorithm that requires a training set of data.

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

Not applicable, as there is no AI/ML algorithm or training set discussed in the provided document.

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The Servo-i ventilator with NAVA option is intended for treatment and monitoring to improve synchromy between the ventilator and patients. The Servo-i with NAVA option is suitable for patient ranges of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. The added indications for use of the NAVA option is when the brain to the brain to the diaphragm is intact; NAVA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso Gastric tube.

The predicate device Servo-i is a ventilator, which gives, ventilation (Invasive and Non Invasive) to critical care patients in the weight range 0.5 to 250 Kg's The modified device is an option, called NAVA option (Neurally Adjusted Ventilatory Assist) which is a HW module with SW for Servo-i integration, which are added to the predicate device. The Nava option uses an amplifier which in conjunction with a nasogastric feeding tube with microelectrodes detects signals to the diaphragm (Edi). The Edi is used as an additional detector to improve the synchrony between the patient and the ventilator and to give the patient corresponding ventilatory support.

This document is a 510(k) summary for the Maquet Servo-i ventilator with the NAVA (Neurally Adjusted Ventilatory Assist) option. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed acceptance criteria and performance data for a clinical study in the format requested.

The document indicates that "Clinical and non clinical data is submitted to verify that the safe performance is substantial equivalent to the Servo-i ventilator with NAVA option" (Section-Page 13 (55)), but it does not provide the acceptance criteria or results of a specific study to prove the device meets those criteria.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on the limitations:

1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states that clinical and non-clinical data were submitted to verify safe performance and substantial equivalence, but it does not detail specific acceptance criteria or performance metrics and results.

2. Sample size used for the test set and the data provenance:
This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document.

4. Adjudication method for the test set:
This information is not provided in the document.

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 information about an MRMC study or AI assistance is provided. The NAVA option is described as a module to improve synchrony between the patient and the ventilator by detecting signals to the diaphragm (Edi), not an AI-assisted diagnostic or interpretive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The NAVA option is an integral part of a ventilator system, assisting in ventilation. It's not a standalone algorithm in the typical sense of a diagnostic tool that produces an output without human intervention for review. Its function is to modulate the ventilator's output based on physiological signals, which implies continuous operation within the human-in-the-loop context of patient ventilation.

7. The type of ground truth used:
This information is not provided in the document. The general claim is about verifying "safe performance" and "substantial equivalence," but the specific ground truth for any underlying studies is not detailed.

8. The sample size for the training set:
This information is not provided in the document.

9. How the ground truth for the training set was established:
This information is not provided in the document.

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The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of I ne or re Fentually with respiratory failure or respiratory insufficiency. Servo' is a ventilator neonales, thanks and datas will respiratery gain. I o realthcare facilities and for in-hospital transport.

The ventilator is a platform with several selectable ventilation modes which monitor patients whom need respiratory assistance. The Non-Invasive Ventilation Option is a software controlled feature available on the Servo-i ventilator. The microprocessor control of this feature allows a larger range of flow capabilities designed to meet patient needs safely in a non-invasive application.

The provided text does not contain detailed acceptance criteria for a device, nor does it describe a study explicitly proving that the device meets such criteria. The document is primarily a 510(k) summary for a Special 510(k) submission regarding a "NIV option for Servo-i" ventilator and concerns its substantial equivalence to predicate devices.

Therefore, I cannot provide a response filling the requested table and sections as the information is not present in the provided text.

Specifically, the document focuses on:

• Identifying the device and its manufacturer.
• Listing predicate devices.
• Briefly describing the device as a software-controlled feature for the Servo-i ventilator, designed to handle non-invasive ventilation with features like disconnect/leakage detection.
• Stating that the intended uses and indications are largely the same as the unmodified Servo-i, with a minor change in the lower range for infant use with the NIV option.
• The FDA letter confirms the substantial equivalence determination but does not delve into detailed performance acceptance criteria or study results demonstrating compliance with such criteria.

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The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo' is a ventilator system to be used only by health care providers in hospitals or health care facilities and for in-hospital transport.

The ventilator is a ventilator with several selectable modes to individually monitor and treat patients whom needs respiratory assistance. The ventilator is the same as described in the notification K010925 and K022132 (addition of BiVent mode and CO2 module).

The provided text is a 510(k) summary for a Special 510(k) submission for the Servo-i Ventilator System. It focuses on a minor modification to the device, specifically changing the low minute volume alarm for infants. Crucially, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

The 510(k) submission is for a modification to an existing device (Servo-i Ventilator System) and claims substantial equivalence to previously cleared devices (K010925 and K022132 for Servo-i, and K970839 for Servo Ventilator 300 A). The core of this particular submission is that the low minute volume alarm for infants has been changed from 0.10 l/min to 0.06 l/min, to match that of the predicate device, the SV300 ventilator.

Therefore, I cannot provide the requested information from the given text.

This document is a regulatory submission for a minor device change, not a detailed study report on novel device performance or AI/algorithm effectiveness. Such a document would typically not contain the robust clinical study data requested.

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