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Servo-air Lite Ventilator System is an assist ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring.

Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above.

Servo-air Lite Ventilator System is to be used only by healthcare professionals.

Servo-air Lite Ventilator System is to be used only in professional health care facilities and for transport within these facilities. It is not intended for transport between health care facilities.

The Servo-air Lite 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 Servo-air Lite Ventilator System is based on the cleared reference device Servo-air Ventilator System (K192604), with additions based on reference device Servo-u Ventilator System (K201874).

The ventilator delivers controlled or supported breaths to the patient, with constant pressure, using a set oxygen concentration. The ventilator can also deliver High Flow therapy with a constant flow.

Servo-air Lite contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard).

Accessories for CO2 monitoring are available as options.

The Servo-air Lite Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings.

The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.

The provided text describes a 510(k) submission for the Servo-air Lite Ventilator System, which is a medical device and not an AI/ML-based device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable in the context of an AI/ML device.

The document discusses non-clinical testing and performance for the ventilator system, focusing on:

• Software: Code review, static code analysis, unit tests, and integration tests.
• Performance: System testing, regression testing, free user testing, and waveform testing.
• Biocompatibility: Volatile Organic Compounds, Particulate Testing, Leachable testing.
• Human Factors Validation Testing.
• Compliance with various product standards (e.g., ANSI/AAMI ES 60601-1, IEC 60601-1-2) and biocompatibility standards (AAMI/ANSI/ISO 10993-1).

The conclusion states that the device is substantially equivalent to the predicate device (Respironics V60 K102985) based on equivalent indications for use and that no new questions of safety and effectiveness are raised. They have conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output meets the design input requirements and appropriate product standards.

However, the document does not provide specific acceptance criteria in a table or detailed results of these tests that would typically be presented for an AI/ML device's performance metrics like sensitivity, specificity, or AUC.

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The Servo-u Ventilator System is:

• intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

The Servo-n Ventilator System is:

• intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

The Servo-u MR Ventilator System is:

• intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities
• to be used in MR environment according to specified conditions
• with 1.5 T or 3 T MR scanners
• outside magnetic fields >20 mT/200 Gauss

The Servo-u/n/u MR Ventilator Systems 4.1 consist of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.

The Servo-u/n/u MR Ventilator Systems 4.1 are based on the cleared predicate device Servo-u/n Ventilator Systems 2.1 (K180098) with some improvements. The ventilation modes in the Servo-u/n/u MR 4.1 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the devices, i.e. Servo-u/n/u MR 4.1.

The ventilators deliver controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration. The ventilators can also deliver High Flow therapy with a constant flow.

The Electrical activity of the diaphragm (Edi) is a measurement of the patients own breathing efforts. The Edi functionality makes it possible to monitor Edi activity in all ventilation modes, High Flow therapy as well as in Standby.

NAVA stands for Neurally Adjusted Ventilatory Assist and is a supported mode of ventilation based on the Edi, delivering assist in proportion to and synchronized with the patient's respiratory drive. NAVA is available as an invasive and a non-invasive mode. The included parts related to this mode, such as Edi module and Edi catheters are identical to the cleared predicate devices Servo-u/n 2.1 (K180098).

Servo-u/n contain a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard). It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098). Not available on Servo-u MR.

Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098).

The Servo-u/n/u MR Ventilator Systems will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings. The alarm handling is similar to the one used in the cleared predicate devices Servo-u/n 2.1 (K180098).

The Servo-u/n/u MR Ventilator Systems contain provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport. The batteries are identical to the one used for the cleared predicate devices Servo-u/n 2.1 (K180098).

Based on the provided text, the device in question is the "Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1". This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

*Crucially, this document does not contain any information regarding clinical studies, acceptance criteria, or performance data in the context of an AI/human reader study. It focuses on the technical modifications, safety, and regulatory compliance of a medical device (ventilator systems) to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information for the following reasons:

• No AI component or human reader study: The document describes hardware and software updates to ventilator systems. There is no mention of an Artificial Intelligence (AI) component or any study involving human readers or expert consensus on clinical images/data.
• Focus on Substantial Equivalence: The primary goal of this 510(k) submission is to demonstrate that the updated ventilator systems are "substantially equivalent" to previously cleared predicate devices, primarily through engineering testing, software verification, and adherence to performance standards, not through clinical comparative effectiveness trials in the way an AI diagnostic tool would be evaluated.
• Type of Testing: The non-clinical testing listed (code review, static code analysis, unit tests, integration tests, specification and system-level verification testing, waveform testing, biocompatibility, human factors validation testing) are typical for medical device development to ensure functionality and safety, not AI model performance.

In summary, the provided text does not contain the information necessary to answer your request about acceptance criteria and a study proving an AI device meets those criteria. The document pertains to the clearance of ventilator systems, not an AI diagnostic or assistive device.

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The indication for Flow-c/Flow-e Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

The indication for the Flow-i/Flow-c/Flow-e Anesthesia system is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family 4.7 are high-performance Anesthesia systems designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult.

Flow Anesthesia family is a software-controlled semi-closed system for inhalation Anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).

The Flow-i/-c/-e 4.7 consists of a core, where gases are mixed and administered, and a User Interface where the settings are made and ventilation and anesthesia are monitored.

The Flow-i/-c/-e 4.7 is based on the cleared predicate device FLOW-i 4.2 (K160665) with some improvements.

The provided text is a 510(k) Summary for an anesthesia system. It outlines the device description, indications for use, comparison to a predicate device, and non-clinical testing. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets those criteria for an AI/algorithm-based device.

This document describes a medical device (anesthesia system) which is hardware and software controlled, but there is no mention of an AI/algorithm that performs diagnostic or prognostic functions, or that assists human readers in an interpretive task. The "MAC Brain" mentioned is a display indicator based on a calculated MAC value, not an AI model requiring a separate validation study with human experts, MRMC studies, or specific performance metrics like sensitivity/specificity against ground truth.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance for an AI/algorithm.
2. Sample size used for the test set and data provenance for an AI/algorithm.
3. Number of experts and their qualifications for establishing ground truth for an AI/algorithm.
4. Adjudication method for an AI/algorithm's test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for an AI/algorithm.
8. Training set sample size for an AI algorithm.
9. How ground truth for the training set was established for an AI algorithm.

The document focuses on demonstrating substantial equivalence of an anesthesia machine to a predicate device, based on changes that "do not affect the overall performance or technology of the device" or "raise different questions about safety and effectiveness." The testing mentioned (Software: Code review, Static code analysis, System testing; Performance: System testing, Regression, Free User testing, Waveform testing, Comparative testing for MAC Brain, Comparative testing for Recruitment Maneuver) is typical for hardware and software validation of a medical device, not specifically for an AI/ML algorithm requiring clinical performance studies against human experts or a gold standard.

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The Servo Guard is a bacterial/viral filter for applications in respiratory care.The filter is intended to be used in patient circuits to reduce the spread of viruses and bacteria from patient/persomel and to protect the patient circuits and ventilators from contamination. The filter shall only be used with the ventilators Servo-i and Servo-s.

A Breathing Circuit Bacteria Filter is intended to protect from contamination as well as to reduce particles such as dust and microbiological matters from gases used in the patient circuit of a respiratory device. The bacterial/viral filter is a disposable accessory normally used on the expiratory limb of the ventilator breathing system to reduce possible cross contamination between patient and equipment and between patient. It can also be used on the inspiratory pipe, in order to reduce dust particles to the patient.

This document is a 510(k) summary for the Servo Guard bacterial/viral filter. It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's the information requested based on the provided text, focusing on the study that proves the device meets the acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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The SERVO-U ventilator system is:

• intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

• to provide monitoring of the patient's breathing drive
• to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
• for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-n ventilator system is:

• intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

• to provide monitoring of the patient's breathing drive
• to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
• for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-U/n 2.1 is available in two models, SERVO-U and SERVO-n. The SERVO-U/n 2.1 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 SERVO-U/n 2.1 is based on the cleared predicate device SERVO-U/n 1.1 (K151814), with some improvements. The ventilation modes in the SERVO-U/n 2.1 are similar as in the predicate device, even though the standard configurations of available modes and optional modes differ between the devices, i.e. SERVO-U, SERVO-n and the cleared predicate device SERVO-U/n 1.1. The ventilator delivers controlled or supported breaths to the patient, with constant flow, constant pressure or pressure proportional to the Edi signal (the electrical activity of the diaphragm) of the patient, using a set oxygen concentration. SERVO-U/n contains a dedicated controller circuit for the Aerogen Pro and Solo nebulizers (included as standard). Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. The SERVO-U/n Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and produce alarm recordings. The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.

The provided text is a 510(k) summary for the SERVO-U/n Ventilator System 2.1. It details the device's intended use and compares it to a predicate device, CERVO-U/n 1.1. However, it does not describe an AI/algorithm-driven device performance study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

Instead, the document states: "No clinical investigation has been performed since it has been concluded based on literature data, state of the art knowledge and applicable product standards that SERVO-U/n 2.1 has no new clinical aspects or risks which are not already discussed and evaluated in the 510(k) submission for the cleared predicate device SERVO-U/n 1.1 (K151814)."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/algorithm-driven device, as no such study is presented or referenced in the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of Intended Use: States it's identical.
• Comparison of Technology Characteristics: Details improvements and changes from the predicate without introducing AI components.
• Non-clinical Testing and Performance: Lists design verification activities (code review, unit tests, system tests, regression testing, etc.), compliance with product standards (e.g., ANSI/AAMI, IEC, ISO), and biocompatibility evaluation.

The key takeaway is that the clearance for the SERVO-U/n Ventilator System 2.1 is based on its substantial equivalence to a previous version and adherence to recognized standards, not on an AI performance study.

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The indication for FLOW-i Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

FLOW-i Anesthesia System is a Anesthesia system designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult.

FLOW-i Anesthesia System is a software-controlled semi-closed system for inhalation Anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).

The most important performance features of the FLOW-i Anesthesia System are:

• a ventilator whose functionality is based on ICU-ventilator technology, o
• the volume reflector technology. O
• the electronically controlled injector vaporizers and o
• the ergonomic design. O

This 510(k) submission for the FLOW-i Anesthesia System is based on the following modifications:

• Updates of the product for compliance with 3td edition of the 60601 standard package .
  • IEC 60601-1:2005 O
  • ISO 80601-2-13:2011 o
  • ISO 80601-2-55:2011 O
• Implementation of a new function that provides recommended ventilation values (PBW)
• Possibility to set a lower alarm limit for the Airway pressure alarm: High
• Display of Airway resistance measurement following an Inspiratory and/or Expiratory Hold

This document describes the marketing application for changes to the Maquet FLOW-i Anesthesia System, specifically versions C20, C30, and C40. The primary purpose of the document is to demonstrate "substantial equivalence" to a previously cleared predicate device (FLOW-i Anesthesia System version 3.0, K133958), allowing the manufacturer to market the updated device without a new premarket approval application (PMA).

Based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way a clinical AI/ML device would be evaluated for accuracy or performance on a test set of data.

This document is a 510(k) summary, which focuses on device modifications and demonstration of substantial equivalence through non-clinical testing and comparison to a predicate device, rather than a clinical performance study with predefined acceptance criteria for diagnostic/therapeutic efficacy.

Therefore, it is not possible to fill out the requested table and details regarding acceptance criteria, test set sample size, expert ground truth establishment, MRMC studies, or standalone performance, as these concepts are not applicable to the information provided in this 510(k) submission.

The acceptance criteria here pertain to meeting regulatory standards, ensuring safety, and demonstrating that the modifications do not introduce new questions of safety and effectiveness, meaning its performance is equivalent to the predicate device.

However, I can extract the following relevant information regarding the changes and how the manufacturer demonstrated the device's continued performance and safety:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present acceptance criteria as quantitative performance metrics for a diagnostic or therapeutic function. Instead, it details that the modifications introduce new functionalities and updates for regulatory compliance, and that the device "performs within its specifications and within the limits of the applied performance standards."

The "acceptance criteria" can be inferred as successful completion of the listed non-clinical tests and demonstration that the modified device remains substantially equivalent to the predicate. The "performance" is the successful outcome of these tests and the comparison to the predicate.

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

• Sample Size: Not applicable in the context of a "test set" for a diagnostic/therapeutic AI/ML algorithm. This submission focuses on engineering validation and verification.
• Data Provenance: Not applicable. The tests performed are laboratory/bench testing and engineering evaluations against design requirements and safety standards. There is no patient data involved in the "test set."

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

• Not applicable. Ground truth in this context refers to engineering specifications and regulatory compliance, not expert clinical labels on patient data. Performance was verified against technical specifications and standard requirements.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set:

• Not applicable. This is not a clinical study involving human readers or interpretation of results that require 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:

• No MRMC comparative effectiveness study was done. This 510(k) is for modifications to a medical device (anesthesia system), not a diagnostic AI/ML algorithm that assists human readers.

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

• Not applicable. The device is a physical anesthesia system with integrated software, not a standalone algorithm. Its "performance" is its ability to deliver and monitor anesthesia according to specifications and safety standards.

7. The Type of Ground Truth Used:

• Ground Truth Type: Engineering specifications, industry standards (e.g., IEC 60601, ISO 80601), and the performance characteristics of the predicate device.
• Examples: Accuracy range for gas concentrations (e.g., Sevoflurane conc: Accuracy: ±0.15 vol% @ (0-1%)), pressure ranges, alarm thresholds, volume measurement accuracy.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML algorithm trained on a dataset. The software changes are programming implementations, not machine learning model training.

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

• Not applicable. There is no concept of a "training set" in the context of this device's modifications. The software and hardware changes are based on design requirements, safety standards, and user needs, which were then verified and validated through non-clinical testing.

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The Edi catheter ENFit is intended for:

• . Administrating nutrition, fluids and medications via the naso-gastro-enteric route
• . Aspiration via the naso-gastroenteric route
• . Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available

The Edi Catheter ENFit is a sterile, single use nasogastric feeding tube that carries electrode rings that record diaphragm electrical activity (Edi signal). The Edi Catheter ENFit is an accessory to be used with patients in the range of neonates, infants, and adults together with the SERVO ventilator system. The Edi signal is used as an additional detector to improve the synchrony between the patient and the ventilator and to give the patient corresponding ventilatory support in the ventilation modes NAVA and NIV NAVA.
As a nasogastric feeding tube, the Edi Catheter ENFit is used for administration of nutrition, fluids and medications, as well as and aspiration via the naso-gastroenteric route. For the 12 Fr and 16 Fr catheters, a sump lumen is available for air venting the feeding tube to the atmosphere.
The new ENFit connector which is compliant with ISO 80369-3 is introduced in order to avoid misconnections with small-bore connectors used for other healthcare applications than enteral feeding.

This document is a 510(k) Summary for a medical device called the "Edi Catheter ENFit." It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study demonstrating the device meets those criteria in the context of diagnostic performance or clinical effectiveness with human readers or AI.

The document focuses on engineering and material changes from a predicate device, primarily the adoption of a new ENFit connector, and verifies that these changes do not compromise the device's basic function or safety.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of evaluation (e.g., diagnostic accuracy, reader study) than what is presented here.

Here's what can be answered based on the provided text, and where gaps exist:

1. Table of acceptance criteria and the reported device performance

   • Acceptance Criteria (as related to the changes in the device): The document outlines several non-clinical tests performed to ensure the new ENFit connector and other minor design changes meet safety and performance standards. These are implicit acceptance criteria related to engineering and material properties, not diagnostic performance.
     • Fluid Leakage
     • Stress Cracking
     • Resistance to separation from axial load
     • Resistance to separation from unscrewing
     • Resistance to overriding
     • Disconnection by unscrewing
     • Biocompatibility (conformance to ISO 10993-1:2009)
     • Stability after accelerated aging
     • Usability validation for the ENFit connector
   • Reported Device Performance: The document states, "The testing demonstrates that the proposed device conform to all requirements of the Edi Catheter ENFit." It also notes that biocompatibility testing "demonstrated the biological safety of all parts of the proposed feeding tubes that have contact with the patient." Specific quantitative performance values for each of the listed tests are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable for this type of submission. The testing described is primarily non-clinical engineering and material testing, not a clinical study involving a 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

   • Not applicable. There is no "ground truth" establishment by medical experts described for this type of engineering and safety testing.

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

   • Not applicable. No clinical test set or adjudication process 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

   • No. This device is a nasogastric feeding tube with electrodes to transfer electrical activity of the diaphragm (Edi signals). It is not an imaging device or an AI-powered diagnostic tool, and no MRMC study or AI-related improvement is mentioned.

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

   • No. This device is not an algorithm.

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

   • Not applicable. The "ground truth" for the non-clinical testing would be the engineering specifications and ISO standards themselves. Biological safety relies on conformance to ISO 10993-1.

8. The sample size for the training set

   • Not applicable. No training set is mentioned as this device is not an AI/ML algorithm.

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

   • Not applicable. No training set is mentioned.

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The SERVO-U ventilator system is:

• intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

• to provide monitoring of the patient's breathing drive
• to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
• for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-n ventilator system is:

• intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

• to provide monitoring of the patient's breathing drive
• to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
• for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-U/n Ventilator System is available in two models, SERVO-U and SERVOn. The SERVO-U/n 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 SERVO-U/n Ventilator System is built on the same architecture as the cleared predicate device SERVO-i Ventilator System (K123149). The ventilation modes in the SERVO-U/n Ventilator System are identical to the ventilation modes in the cleared predicate device, even though the standard configurations of available modes and optional modes differ between the devices i.e. SERVO-U, SERVO-n and the cleared predicate device SERVO-i Ventilator System (K123149).

The ventilator delivers controlled or supported breaths to the patient, with constant flow. constant pressure or pressure proportional to the Edi signal (the electrical activity of the diaphragm) of the patient, using a set oxygen concentration.

NAVA (Neurally Adiusted Ventilatory Assist) is a supported mode for SERVO-U/n that uses the Edi signal as an addition to the flow/pressure trigger to synchronize the patient efforts with the onset and cycle off of supported breaths. NAVA is available in invasive and non-invasive modes. These ventilation modes are identical in the SERVO-U/n Ventilation system and the cleared predicate device SERVO-i Ventilator System (K123149). Furthermore, the included hardware parts Edi module and Edi catheters are also identical to the ones used for the cleared predicate device SERVO-i Ventilator System (K123149).

SERVO-U/n contains a dedicated controller circuit for the Aerogen Pro and Solo nebulizers (included as standard). In the cleared predicate device SERVO-i Ventilator System (K123149) the corresponding nebulizer function is available as an optional module.

Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. The CO2 monitoring option is updated with Capnostat 5 and the Y sensor is based on a new technology and measuring function compared to the corresponding options for the cleared predicate device SERVO-i Ventilator System (K123149).

The SERVO-U/n Ventilator System will produce visual and audible alarms if any parameter varies beyond preset or default limits and produce alarm recordings. The alarm handling is very similar to the one used in the cleared predicate device SERVO-i Ventilator System (K123149), except the possibility to set alarm off for leakage related alarms in Neonatal Patient category when leakage compensation is activated. Additionally, an Inspiratory tidal volume (VT) too high alarm has been added in the neonatal patient category and three alarms have been removed in the Non-invasive modes.

The system contains provisions for battery modules to supply the system in the case of mains power failure or during in-hospital transport. The batteries are identical to the one used for the cleared predicate device SERVO-i Ventilator System (K123149).

System parts:
The SERVO-U/n Ventilator System consists of the following parts:

• User interface, where all user interactions are performed.
• Patient unit with all connections to the patient, to power and gases.
• Mobile cart, on wheels, for using the ventilator on either the left or the right side of the patient.

This document describes the premarket notification (510(k)) for the SERVO-U and SERVO-n Ventilator System. It largely focuses on demonstrating substantial equivalence to a predicate device (SERVO-i Ventilator System, K123149) rather than presenting a study to prove acceptance criteria for novel device performance. Therefore, the information typically requested regarding acceptance criteria and a proving study for a new AI/ML device is not fully available in this document.

However, based on the provided text, here's what can be extracted and inferred:

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

The document doesn't present a formal table of acceptance criteria with reported performance in the way one might expect for a new device claiming specific performance metrics. Instead, "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device and compliance with relevant standards. The "reported device performance" is mainly a statement that the device performs "within its specifications and within the limits of the applied product performance standards."

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

• Sample size for test set: Not explicitly stated as a single "test set" in the context of typical AI/ML evaluation. The design verification and validation activities involved various types of testing (code review, unit tests, integration tests, system tests, Free User Testing, regression testing, biocompatibility testing, usability testing, and an animal study). The number of test cases or "samples" for each of these activities is not quantified.
• Data provenance: Not directly applicable in the sense of a clinical dataset. The testing conducted was primarily non-clinical (engineering verification, lab testing, animal study).
  • Animal study: Done to evaluate the performance of the Y sensor algorithm at different degrees of humidity and leakage and its effect on tidal volume measurements. Provenance (e.g., country) is not specified.

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 ground truth for the verification and validation activities would largely be established by engineering specifications, regulatory standards, and expert review within the company. For "Free User Testing" and "usability validation," the "experts" would be representative users (healthcare providers), but their number and specific qualifications are not detailed.

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

Not applicable in the context of this 510(k) submission. Adjudication methods are typically relevant for human review of clinical data, especially in studies involving subjective assessments of images or patient outcomes. The testing described here is primarily technical and performance-based.

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 MRMC comparative effectiveness study was done. This device is a ventilator, 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:

The device itself is a standalone medical device (a ventilator). The "performance" described is of the device's various functions and components, rather than the performance of an isolated algorithm. The document emphasizes the integration of hardware and software.

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

The "ground truth" for the various verification and validation activities would primarily consist of:

• Engineering specifications and design input requirements: For system tests, unit tests, integration tests, and code reviews.
• Applicable product standards: For compliance testing.
• Predefined performance ranges and accuracy limits: For sensor evaluations (e.g., Y sensor in animal study, CO2 analyzer).
• Simulated physiological conditions: Used in lab testing.
• User expectations and safety requirements: For usability and risk analysis.

8. The sample size for the training set:

Not applicable. This document describes a medical device (ventilator), not an AI/ML system that undergoes "training" in the conventional sense.

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

Not applicable, as no training set for an AI/ML algorithm is described.

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The guide wire is intended to be used as a stylet into the MAQUET Edi Catheter to stiffen it in order to simplify its placement in the intended patient population comprising adult, pediatric, infant and neonatal patients.

The function of the Guide wire for Edi Catheters is to provide the necessary stiffness to facilitate the clinicians in the placement of the Maquet Critical Care AB nasogastric feeding tube called Edi Catheter. The guide wire is inserted as a stylet into the feeding lumen of the Edi catheter prior to insertion of the Edi catheter in the patient and is removed right after the placement of the Edi catheter is completed.

The Guide wire for Edi Catheter consists of symmetrical stainless steel wire surrounded by a spiral stainless steel wire which is PTFE (polytetrafluoro-ethylene) coated. It also has soft and rounded ends. A safety ribbon runs thru the length of the Guide wire and is welded at each end to contain the coil of the spring. The Guide wire for Edi Catheter is provided in a non-sterile package and is for single use only. The individually packed Guide wires are delivered to the customer in an outer plastic bag containing five (5) Guide wires.

The provided text describes a 510(k) premarket notification for a medical device: "Guide wire for Edi Catheter" (K153461). The review emphasizes the device's substantial equivalence to a legally marketed predicate device (K101199).

However, the document does not contain the kind of detailed information about acceptance criteria and studies that would be typical for complex diagnostic or AI-powered devices. The device in question, a guide wire, is a relatively simple mechanical accessory. Therefore, the "study" referenced in the prompt (and expected for AI/diagnostic devices) is not present here. Instead, the "proof" of meeting acceptance criteria comes from demonstrating material and functional equivalence, as well as biocompatibility.

Here's an analysis based on the provided text, heavily constrained by the fact that it's a submission for a guide wire, not a high-tech diagnostic:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" and "device performance" in the sense of accuracy, sensitivity, or specificity (as would be seen for diagnostic tools) are not present for this guide wire. Instead, the acceptance criteria are implicitly met by demonstrating:

• Cytotoxicity
• Sensitization
• Intracutaneous reactivity
  (Implicitly, these tests were passed, demonstrating the device is biocompatible.) |
  | Material Integrity | The guide wire maintains its structural integrity and design characteristics during intended use. | Functional Verification Activities Performed:
• Fracture and Flex testing
• Corrosion resistance
• Particulate matter
  (Implicitly, these tests were passed, ensuring the guide wire remains intact and functional.) |
  | Functional Equivalence | The device performs its intended function (stiffening the Edi Catheter for placement) equivalently to the predicate device. | "The Guide wire for Edi Catheter has the same technical specifications and performance as the cleared Guide wire for Edi Catheters, K101199. The only difference is the updated coating process."
  "The intended use for the subject device is identical with the intended use of the predicate device."
  (Demonstrated through technical comparison and the lack of negative findings in other tests.) |
  | Manufacturing Process | The change in manufacturing (PFOA removal) does not adversely affect safety or performance while adhering to regulatory requirements. | PFOA removed from manufacturing process due to EPA mandate. The manufacturer asserts that the "processing aid should not be present in the finished coating of the predicate device since the PFOA is completely dissipated at the point the coating is cured." The non-clinical testing (biocompatibility and functional) implicitly confirms no adverse impact from this change. |

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

This information is not provided in the document. For a guide wire, "test set" would typically refer to the number of units tested for biocompatibility and functional properties. These are not clinical studies with patient data.

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

This concept is not applicable to this device and the type of evaluation described. "Ground truth" established by experts is relevant for diagnostic or AI-driven devices where clinical interpretation is involved. For a guide wire, ground truth is based on objective physical and chemical testing (e.g., material composition, strength, corrosion resistance) and regulatory standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of clinical data, which is not part of this submission for a guide wire.

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 is not applicable. The device is a guide wire, a mechanical accessory, not an AI-powered diagnostic tool. No human reader or AI assistance is involved in its direct function.

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

This is not applicable. The device is a guide wire, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Established Biocompatibility Standards: (ISO 10993-1, ODE General Program Memorandum #G95-1)
• Engineering and Material Science Principles: For fracture, flex, corrosion resistance, and particulate matter testing.
• Comparison to Predicate Device Specifications: Demonstrating equivalence in technical specifications and performance to a previously cleared device.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no "training set."

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of non-clinical, laboratory-based tests and a technical comparison to a predicate device. This "study" consists of:

• Biocompatibility Testing: Cytotoxicity, Sensitization, Intracutaneous reactivity (following ISO 10993-1 and G95-1 guidelines). These tests confirm the materials are safe for patient contact.
• Functional Verification Activities: Fracture and Flex testing, Corrosion resistance, and Particulate matter testing. These tests ensure the guide wire performs its mechanical function reliably and does not degrade or shed dangerous particles.
• Technical Specification Comparison: The manufacturer asserts that the new device has "the same technical specifications and performance" as the cleared predicate device (K101199), with the only change being the PFOA-free coating process, which is considered an improvement due to regulatory mandates, and is implicitly covered by the re-performed biocompatibility and functional tests.

The conclusion is that the new guide wire is "substantially equivalent" to the predicate device because the manufacturing change (removal of PFOA) does not impact the intended use, indications for use, or fundamental technology, as supported by the non-clinical testing.

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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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