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The GE Datex-Ohmeda Avance CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

The GE Datex-Ohmeda Avance CS2 anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). They represent one of the systems in a long line of products based on the Datex-Ohmeda Excel. Aestiva, and Aespire Anesthesia Systems. Avance systems are to be used only by trained and qualified medical professionals trained in the administration of general anesthesia.

The Avance and Avance CS2 anesthesia systems supply set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the electronic controls on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance systems are equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames options including central brake or individual caster brakes, gases, and vaporizers are available to give the user control of the system configuration. The Avance systems are also available in pendant models. Avance systems are available with two or three gases, up to three vaporizer positions and up to three cvlinder connections. All models have O2. The Avance systems come with up to two optional gases (air, N2O).

The Avance systems accept Tec 6 Plus and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance systems are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance systems are available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the GE Compact Gas Airway Modules Series: M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above cleared via K001814) and E-Gas Compact Gas Airway Module (E-CAiOVX software revision 3.2 and above cleared via K051092) which can be physically integrated into the Avance, receive electronic power from the Avance and communicate measured values to the Avance for display on the system display unit. In addition to M-Gas and E-gas modules, the Avance CS- can utilize the GE CARESCAPE Respiratory Module (E-sCAiO, E-sCAiOV cleared via K123195).

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber. bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Control Ventilation (VCV), Pressure Control Ventilation (PCV) (optional), Synchronized Intermittent Mandatory Ventilation/Pressure Support (SIMV/PSV) (optional), Pressure Support Ventilation (PSVPro) (optional), Synchronized Intermittent Mandatory Ventilation-Pressure Control (SIMV-PC) (optional), Pressure Control Ventilation-Volume Guaranteed (PCV-VG) (optional), Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV), Pressure Control Ventilation-Volume Guaranteed with Pressure Support Ventilation (SIMV PCV-VG) (optional), and Volume Control Ventilation Mode for Cardiac Bypass Mode (optional). Ventilator parameters and measurements are displayed on the system display unit.

Several frame configurations are available, including one that allows for the physical integration of the GE Monitor Series (cleared Carescape B850 via K092027 and B650 cleared on K102239). These configurations also provide cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Avance frame. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Avance.

The provided text is a 510(k) summary for the GE Datex-Ohmeda Avance CS2 Anesthesia System. It details the device's description, intended use, and a comparison to a predicate device. However, it explicitly states that no clinical testing was required or conducted for the modifications made to this version of the device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them, as these are typically derived from clinical or comprehensive performance studies which were not performed in this case.

Specifically, the document states:

• "The modifications made to the GE Datex-Ohmeda Avance CS2 did not require clinical testing. The functionality of the modified features was completely evaluated by performing nonclinical tests of design verification and validation testing."

Without a clinical study or a study specifically designed to establish performance against acceptance criteria, I cannot fill out the requested table or provide details on sample sizes, expert involvement, ground truth establishment, or comparative effectiveness.

The only "testing" mentioned is nonclinical verification and validation testing, which includes:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation)

This nonclinical testing served to confirm that the changes made (primarily updated labeling to include the use of an optional CARESCAPE respiratory module) did not alter the fundamental scientific technology or indications for use, and that the device remained substantially equivalent to its predicate.

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The GE Datex-Ohmeda Avance CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

The GE Datex-Ohmeda Avance and Avance CS anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). They represent one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, and Aespire Anesthesia Systems. Avance systems are to be used only by trained and qualified medical professionals trained in the administration of general anesthesia.

The Avance and Avance CS2 anesthesia systems supply set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the electronic controls on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance systems are equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames options including central brake or individual caster brakes, gases, and vaporizers are available to give the user control of the system configuration. The Avance systems are also available in pendant models. Avance systems are available with two or three gases, up to three vaporizer positions and up to three cylinder connections. All models have O2. The Avance systems come with up to two optional gases (air, N2O).

The Avance systems accept Tec 6 Plus and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance systems are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance systems are available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the GE Compact Gas Airway Modules Series: M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above cleared via K001814) and E-Gas Compact Gas Airway Module (E-CAiOVX software revision 3.2 and above cleared via K051092) which can be physically integrated into the Avance, receive electronic power from the Avance and communicate measured values to the Avance for display on the system display unit.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Control Ventilation (VCV), Pressure Control Ventilation (PCV) (optional), Synchronized Intermittent Mandatory Ventilation/Pressure Support (SIMV/PSV) (optional), Pressure Support Ventilation (PSVPro) (optional), Synchronized Intermittent Mandatory Ventilation-Pressure Control (SIMV-PC) (optional), Pressure Control Ventilation-Volume Guaranteed (PCV-VG) (optional), Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV), Pressure Control Ventilation-Volume Guaranteed with Pressure Support Ventilation (SIMV PCV-VG) (optional), and Volume Control Ventilation Mode for Cardiac Bypass Mode (optional). Ventilator parameters and measurements are displayed on the system display unit.

Several frame configurations are available, including one that allows for the physical integration of the GE Monitor Series(most recently cleared Carescape B850 via K092027 and B650 cleared on K102239). These configurations also provide cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Avance frame. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Avance.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the GE Datex-Ohmeda Avance CS2 Anesthesia System:

Based on the provided document, the application is for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than undergoing new clinical trials for efficacy. Therefore, much of the information typically requested for acceptance criteria and a deep dive into study design for novel devices is not present or not applicable in this context.

The document explicitly states: "The modifications made to the GE Datex-Ohmeda Avance to create the GE Datex-Ohmeda Avance CS2 did not require clinical testing. The functionality of the modified features was completely evaluated by performing nonclinical tests of design verification and validation testing."

This immediately tells us that there was no standalone clinical study with human patients to prove device performance against specific acceptance criteria in the way one might expect for a new, high-risk device.

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

1. Table of Acceptance Criteria and the Reported Device Performance

Given the nature of a 510(k) for an updated device, the "acceptance criteria" are primarily related to meeting specifications, voluntary standards, and demonstrating that the new features do not negatively impact safety and effectiveness compared to the predicate device. There isn't a table of specific clinical performance metrics (e.g., accuracy of a diagnostic feature, rates of successful treatment) with corresponding target values and achieved results reported in this summary.

Acceptance Criteria (Implied from 510(k) process and text):

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

• Test Set Sample Size: Not applicable in the context of human clinical data for this specific device. The testing involved "nonclinical tests of design verification and validation testing," including unit-level testing, integration testing, performance testing, safety testing, and simulated use testing. These are not typically quantified with "sample sizes" in the same way as human subject studies; rather, they involve testing various components, configurations, and scenarios.
• Data Provenance: Not applicable as no clinical data from patients was used. The data provenance would be from internal engineering and quality testing (e.g., lab test data, simulated environment data).

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

• Not applicable. Since no clinical testing was performed and no ground truth was established from patient data, there's no mention of experts establishing a ground truth for a test set in a diagnostic or outcome-based scenario. The "ground truth" for nonclinical testing would be engineering specifications and functional requirements.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication in the context of human data. Adjudication methods (like 2+1, 3+1) are typically used for resolving disagreements among human readers/experts in interpreting clinical data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an anesthesia system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant and was not performed.

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

• Not applicable. This is an anesthesia machine, not an algorithm-only device. Its performance is inherent in its hardware, software, and integrated components, designed to operate with a medical professional as the "human in the loop" administering anesthesia.

7. The Type of Ground Truth Used

• For Nonclinical Testing: The ground truth would be based on engineering specifications, design requirements, and established performance benchmarks derived from the predicate device and relevant industry standards.
• For Substantial Equivalence: The ultimate "ground truth" for the 510(k) process is the safety and effectiveness profile of the predicate device (GE Datex-Ohmeda Avance, K112722). The new device must demonstrate it meets this same standard.

8. The Sample Size for the Training Set

• Not applicable. Given the device type and the absence of clinical studies, there is no mention of a "training set" in the context of machine learning. The testing performed (verification and validation) is based on engineering principles and quality assurance, not statistical training sets.

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

• Not applicable, as there was no machine learning training set mentioned.

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The GE Datex-Ohmeda Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

The GE Datex-Ohmeda Avance is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, and Aespire Anesthesia Systems. It is to be used only by trained and qualified medical professionals in the administration of general anesthesia. The Datex-Ohmeda Avance Anesthesia System supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames options, gases, and vaporizers are available to give the user control of the system configuration. The Avance is also available in wall-mount and pendant models. It is available with two or three gases, up to two vaporizer positions and up to three cylinder connections. All models have O2. The Avance comes with up to two optional gases (air, N2O). The Avance systems accept Tec 4, Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above cleared via K001814) and E-Gas Module (E-CAiOVX software revision 4.5 and above cleared via K051092) which can be physically integrated into the Avance, receive electronic power from the Avance and communicate measured values to the Avance for display on the system display unit. The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance Anesthesia System. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Control Ventilation (VCV), Pressure Control Ventilation (PCV) (optional), Synchronized Intermittent Mandatory Ventilation/Pressure, Support (SIMV/PSV) (optional), Pressure Support Ventilation (PSVPro) (optional), Synchronized Intermittent Mandatory Ventilation-Pressure Control (SIMV-PC) (optional), Pressure Control Ventilation-Volume Guaranteed (PCV-VG) (optional), Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV), and Volume Control Ventilation Mode for Cardiac Bypass Mode. Ventilator parameters and measurements are displayed on the system display unit. Several frame configurations are available, including one that allows for the physical integration of the GE Monitors (most recently cleared Carescape B850 via K092027 and B650 cleared on K102239). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Avance frame. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Avance.

The provided text is a 510(k) Premarket Notification summary for the GE Datex-Ohmeda Avance Anesthesia System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria and performing a study to prove they are met.

Therefore, the requested information categories concerning acceptance criteria and study design are not directly applicable or present in this type of regulatory submission. The document explicitly states: "The modifications made to the GE Datex-Ohmeda Avance did not require clinical testing."

However, I can extract information related to the non-clinical testing that was performed to support the substantial equivalence claim, which serves as a form of acceptance in the context of a 510(k) submission.

Here's a breakdown of the available information, addressing as many of your points as possible:

Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for an updated device, the "acceptance criteria" are implicitly tied to demonstrating that the updated device performs equivalently or better than the predicate devices and meets its own verified specifications. The document does not provide a table for specific performance metrics and their acceptance ranges. Instead, it describes a robust non-clinical testing approach.

Study Details (Non-Clinical)

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

   • Test Set Sample Size: Not specified as a number of "samples" in the clinical sense. The testing involved various modules, integrated systems, and simulated use of the device.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the testing was conducted internally by the manufacturer (Datex-Ohmeda Inc.) as part of their development process. It is by nature "prospective" in the sense that the tests were designed and executed to evaluate the new device's modifications.

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

   • Number of Experts: Not specified. This type of non-clinical engineering validation typically involves internal engineers, quality assurance personnel, and potentially subject matter experts who understand anesthesia systems.
   • Qualifications of Experts: Not specified, but implied to be qualified technical and engineering personnel involved in the device's design, development, and testing at Datex-Ohmeda.

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

   • Adjudication Method: Not applicable. This concept pertains to clinical studies where independent reviewers agree on ground truth. In non-clinical engineering testing, "adjudication" is managed through formal test protocols, defect tracking, and review processes by the development and quality teams.

4. 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 is not an AI-assisted diagnostic device, but an anesthesia system. Therefore, MRMC studies are not relevant. This document explicitly states: "The modifications made to the GE Datex-Ohmeda Avance did not require clinical testing."

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

   • Standalone Performance: The non-clinical testing evaluates the device's inherent performance characteristics, including its software logic and hardware functionality, in a standalone manner (i.e., its ability to perform its functions as designed without direct human intervention in the moment of testing, though human users operate the system during its intended use). The testing verifies that the "algorithm only" (software) performs as specified.

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

   • Ground Truth: For non-clinical engineering validation, the "ground truth" is defined by the device's design specifications, industry standards, and regulatory requirements. The device is tested against these predefined criteria to ensure it performs as intended and safely.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model.

In summary: The GE Datex-Ohmeda Avance Anesthesia System underwent a non-clinical verification and validation process. The "acceptance criteria" were met through demonstrating compliance with design specifications, software validation, risk analysis, and adherence to voluntary standards. No clinical studies were deemed necessary due to the nature of the modifications and the substantial equivalence claim.

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The GE Datex-Ohmeda Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Avance is not suitable for use in a MRI environment.

The GE Datex-Ohmeda Avance is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, Aespire, and Aisys Anesthesia Systems. It is to be used only by trained and qualified medical professionals.

The Datex-Ohmeda Avance Anesthesia System supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The Avance is also available in wall-mount and pendant models. It is available with two or three gases, up to two vaporizer positions and up to three cylinder connections. All models have O2. The Avance comes with up to two optional qases (air, N2O).

The Avance systems accept Tec 4. Tec 5. Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiQV software revision 3.2 and above K# 001814) which is physically integrated into the Avance, receives electronic power from the Avance and communicates measured values to the Avance for display on the system display unit.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance Anesthesia System. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh qas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is requlated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Mode (Optional), Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional), Pressure Controlled Ventilation with Volume Guarantee (PCV-VG), and Volume Control Ventilation Mode for Cardiac Bypass Mode. Ventilator parameters and measurements are displayed on the system display unit.

Several options enable the mounting of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K051400). An additional option allows the S/5 AM to be linked to the power supply of the Avance such that when the Avance is turned on, the S/5 AM is also turned on, Additional configurations allow for the mounting of various patient monitors on the top shelf of the Avance.

The provided document is a 510(k) Premarket Notification for the GE Datex-Ohmeda Avance Anesthesia System. This submission focuses on software updates to an existing, legally marketed device (K071142) and claims substantial equivalence to its predicate device and another similar device (GE Datex-Ohmeda Aisys K073707).

The document explicitly states: "The modifications made to the GE Datex-Ohmeda Avance did not require clinical testing."

Therefore, the sections of your request pertaining to clinical studies and performance metrics against acceptance criteria cannot be fulfilled, as no such study was conducted or reported in this 510(k) submission. This K081844 submission is primarily about non-clinical verification of changes through engineering and software validation, and compliance with recognized standards.

Here's a breakdown of the information that can be extracted or inferred from the provided text, primarily regarding non-clinical testing and the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed, there are no reported device performance metrics from a clinical setting to compare against acceptance criteria. The document focuses on compliance with recognized standards and non-clinical verification.

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

• None. No clinical test set or data provenance is mentioned as no clinical testing was performed for this 510(k) submission.

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)

• None. Not applicable as no clinical test set was used.

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

• None. Not applicable as no clinical test set was used.

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-assisted diagnostic device, and no MRMC study was performed. The device is an anesthesia system undergoing software updates.

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

• Not applicable in the context of diagnostic algorithms. This device is an anesthesia system with integrated software, not a standalone diagnostic algorithm. The software validation would have assessed its performance in an integrated system, but not in a "standalone" sense as understood for diagnostic AI.

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

• For non-clinical testing: The "ground truth" was established by the specifications for the device, the requirements of the listed international standards (e.g., EN, IEC, ISO), and the intended functionality of the software updates. Verification and validation activities confirmed that the device operated according to these established engineering and regulatory requirements.

8. The sample size for the training set

• Not applicable. This submission describes software updates to an existing anesthesia system, not a machine learning or AI model trained on a specific dataset.

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

• Not applicable. No training set for an AI model was used in this submission.

Ask a specific question about this device

The GE Datex-Ohmeda Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Avance is not suitable for use in a MRI environment.

The Datex-Ohmeda Avance Anesthesia System supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The Avance is also available in wall-mount and pendant models. It is available with two or three gases, up to two vaporizer positions and up to three cylinder connections. All models have 02. The Avance comes with up to two optional gases (air, N2O). The Avance systems accept Tec 4, Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above K# 001814) which is physically integrated into the Avance, receives electronic power from the Avance and communicates measured values to the Avance for display on the system display unit. The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance Anesthesia System. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Mode (Optional), Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional), Pressure Controlled Ventilation with Volume Guarantee (PCV-VG), and Volume Control Ventilation Mode for Cardiac Bypass Mode, Ventilator parameters and measurements are displayed on the system display unit. Several options enable the mounting of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). An additional option allows the S/5 AM to be linked to the power supply of the Avance such that when the Avance is turned on, the S/5 AM is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Avance.

The provided document, K071142, is a 510(k) summary for the GE Datex-Ohmeda Avance Anesthesia System. This document describes the device, its intended use, and its substantial equivalence to predicate devices, along with compliance to voluntary standards. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way typically expected for an AI/ML medical device (e.g., sensitivity, specificity, or F1 score with associated confidence intervals).

The document is a submission for an anesthesia system, a traditional medical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the concepts of "test set," "ground truth," "experts for ground truth," "adjudication method," "MRMC study," "standalone performance," and "training set" as they relate to AI/ML device performance evaluation are not applicable or present in this 510(k) summary.

Instead, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a device like the GE Datex-Ohmeda Avance Anesthesia System are typically related to:

• Compliance with recognized voluntary standards: This is explicitly stated in the document.
• Performance specifications: Such as accuracy of gas delivery, ventilator performance (e.g., tidal volume, respiratory rate accuracy), pressure and oxygen monitoring accuracy, and safety features. These are usually evaluated through engineering tests, bench testing, and potentially animal or human factors studies, but the specifics are generally not detailed in a 510(k) summary document itself.
• Substantial equivalence: Demonstrating that the new device performs as safely and effectively as a legally marketed predicate device.

Given the information available in K071142, I can only extract details related to the voluntary standards compliance, which serves as a form of acceptance criteria for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance:

The statement "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above" serves as the proof that the device meets these acceptance criteria. The specific details of this "rigorous testing" (e.g., test protocols, results, sample sizes for engineering tests) are not provided in this 510(k) summary, as they are typically part of a more extensive submission file.

For the remaining AI/ML specific questions (2-9), the relevant information is NOT present in this 510(k) document because it pertains to a traditional medical device (anesthesia system), not an AI/ML algorithm.

Summary for AI/ML Specific Questions (N/A for this device):

2. Sample size used for the test set and the data provenance: Not applicable. (No AI/ML test set.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (No AI/ML ground truth.)
4. Adjudication method: Not applicable. (No AI/ML 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: Not applicable. (This is not an AI-assisted diagnostic or prognostic device.)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. (This is not an AI/ML algorithm.)
7. The type of ground truth used: Not applicable. (No AI/ML ground truth.)
8. The sample size for the training set: Not applicable. (No AI/ML training set.)
9. How the ground truth for the training set was established: Not applicable. (No AI/ML training set.)

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