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The GE Datex-Ohmeda Aisys 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 Aisys is not suitable for use in a MRI environment.

The GE Datex-Ohmeda Aisys 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 Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals.

The GE Datex-Ohmeda Aisys Carestation 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 indicators on the system display unit. The Aisys 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 Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have O2. The Aisys comes with up to two optional gases (air, N2O). Safety features and devices within the Aisys are designed to decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures. The Aisys 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) and E-Gas Module (E-CAiOVX cleared via K051092) which can be physically intecrated into the Aisys, receive electronic power from the Aisys and communicate measured values to the Aisys for display on the system display unit.

The anesthetic agent delivery for the Aisys is controlled via an anesthesia computer through user input from the central display. The vaporization technology is based upon the electronic vaporizer cleared as part of the Datex-Ohmeda Anesthesia Delivery Unit (ADU) cleared via K973985. An Aladin cassette (also cleared as part of K973895) or Aladin 2 is inserted into the active cassette bay. The cassette holds the agent to be delivered - Halothane, Enflurane, Isoflurane. Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys is designed to allow only one active cassette at a time. Per the user input into the main display, valves within the active cassette bay will open and allow agent to be delivered. The agent is mixed with gas from the FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aisys 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 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) and Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional). Ventilator parameters and measurements are displayed on the system display unit.

The system display unit is mounted to an arm on the top shelf of the Aisys. The arm is counter balanced and capable of moving vertically and/or horizontally, and also tilting the display, enabling the user to position the display to the most advantageous viewing position. The arm length is limited such that the display position is always within the footprint of the Aisys frame. The arm also supports the mounting of additional display units for a variety of patient monitors.

Several frame configurations are available, including one that allows for the physical integration of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Aisys frame. An additional ootion allows the S/5 AM to be linked to the power supply of the Aisys such that when the Aisys 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 Aisys.

The provided text describes the 510(k) premarket notification for the GE Datex-Ohmeda Aisys Anesthesia System. The key information regarding acceptance criteria and study details is presented in the "SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)" and "SUMMARY OF CLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(2)" sections.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GE Datex-Ohmeda Aisys Anesthesia System are compliance with various international and national standards related to medical electrical equipment, anesthesia workstations, and gas cylinders. The reported device performance is that it meets these standards.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of a clinical study with a defined sample size for evaluating performance against an explicit statistical endpoint. Instead, the evaluation focuses on non-clinical testing, including verification of specifications and software validation, and compliance with established international standards.

The term "data provenance" is not applicable in the traditional sense of clinical data here, as the testing described is primarily engineering and regulatory compliance testing rather than clinical study data from patients.

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

This information is not applicable as the evaluation relies on compliance with technical standards and internal verification/validation processes rather than expert-established ground truth from clinical cases. No external "experts" in the context of clinical ground truth determination are mentioned for the non-clinical testing.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a test set requiring adjudication in the context of human expert review. The evaluation is based on meeting technical specifications and standards.

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

An MRMC comparative effectiveness study was not performed, and is not applicable. The device is an anesthesia system, not an AI-assisted diagnostic 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 anesthesia system. While it has embedded software and automated functions, the evaluation is of the complete system's compliance with safety and functional standards, not a standalone algorithm's performance in isolation from the hardware or human operator interaction. The "software validation" performed addresses the functionality of the algorithms within the system.

7. The type of ground truth used

The "ground truth" for this device's evaluation is primarily compliance with established international and national engineering, safety, and performance standards (e.g., EN, IEC, ISO standards) and internal product specifications. For the software, it's defined by the software requirements and design specifications.

8. The sample size for the training set

This information is not applicable. The device is an anesthesia system, and its development and testing do not involve a "training set" in the context of machine learning model development. The software development follows traditional engineering verification and validation processes.

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

This information is not applicable as there is no "training set" in the context of AI/machine learning. The "ground truth" for the device's functionality is established by its design specifications and the requirements of the relevant industry standards.

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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.

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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 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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The GE Datex-Ohmeda Aisys 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 Aisys is not suitable for use in a MRI environment.

The GE Datex-Ohmeda Aisys Carestation 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 indicators on the system display unit. The Aisys 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 Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have O2. The Aisys comes with up to two optional gases (air, N2O). Safety features and devices within the Aisys are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Aisys 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 Aisys, receives electronic power from the Aisys and communicates measured values to the Aisys for display on the system display unit. The anesthetic agent delivery for the Aisys is controlled via an anesthesia computer through user input from the central display. The vaporization technology is based upon the electronic vaporizer cleared as part of the Datex-Ohmeda Anesthesia Delivery Unit (ADU) cleared via K973985. An Aladin cassette (also cleared as part of K973895) or Aladin 2 is inserted into the active cassette bay. The cassette holds the agent to be delivered - Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys is designed to allow only one active cassette at a time. Per the user input into the main display, valves within the active cassette bay will open and allow agent to be delivered. The agent is mixed with gas from the FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient. The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aisys 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) and Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional). Ventilator parameters and measurements are displayed on the system display unit. The system display unit is mounted to an arm on the top shelf of the Aisys. The arm is counter balanced and capable of moving vertically and/or horizontally, and also tilting the display, enabling the user to position the display to the most advantageous viewing position. The arm length is limited such that the display position is always within the footprint of the Aisys frame. The arm also supports the mounting of additional display units for a variety of patient monitors. Several frame configurations are available, including one that allows for the physical integration of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Aisys frame. An additional option allows the S/5 AM to be linked to the power supply of the Aisys such that when the Aisys 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 Aisys.

The provided text is a 510(k) summary for the GE Datex-Ohmeda Aisys Carestation, an anesthesia gas machine. It primarily focuses on demonstrating substantial equivalence to a predicate device and lists voluntary standards the device complies with.

Crucially, this document does not contain explicit acceptance criteria or detailed study results proving the device meets those criteria in the format requested.

Instead, the document states: "The GE Datex-Ohmeda Aisys Carestation has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aisys Carestation to the standards listed above." This indicates that verification and validation testing was performed to ensure compliance with the referenced voluntary standards, but the specifics of that testing (acceptance criteria, reported performance, sample sizes, ground truth, etc.) are not included in this summary.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here's an attempt to answer based on the information available and what can be inferred, with clear indications of what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified in the provided document. Testing would have been conducted on prototypes or production units of the Aisys Carestation, but the number of units or test cases is not detailed.
• Data Provenance: Not applicable in the context of data provenance for AI/ML models. This is a hardware/software medical device. Testing would be performed in a controlled laboratory environment by the manufacturer.

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

• This is not applicable to the type of device and testing described. The "ground truth" for this medical device's performance would be objective measurements against engineering specifications and voluntary standards, not expert consensus on medical images or patient outcomes. Engineering and quality assurance professionals would perform the testing.

4. Adjudication method for the test set

• Not applicable as explained above. Device performance is typically evaluated against pre-defined specifications and regulatory requirements, not through a consensus-based adjudication process.

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/ML diagnostic or assistive device that would involve human "readers" or an MRMC study. The device is an anesthesia gas machine and ventilator.

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

• The device itself is a standalone medical device in its function as an anesthesia gas machine and ventilator. Its performance as an independent system would be evaluated against the technical specifications and standards it claims to meet. There is no "algorithm only" component in the context of AI/ML performance being studied here; rather, it's the integrated system's functionality.

7. The type of ground truth used

• For this type of device, the "ground truth" would be established by:
  • Engineering specifications and design requirements: The device's performance is measured against its intended technical capabilities (e.g., gas flow rates, pressure accuracy, alarm thresholds).
  • Voluntary standards: Compliance is demonstrated against the requirements of standards like UL, EN, IEC, ASTM, and ISO, which often involve specific test methods and performance criteria.
  • Predicate device performance: Substantial equivalence relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model that would use "training data" in the conventional machine learning sense. Its functionality is based on established engineering principles, hardware, and embedded software.

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

• Not applicable, as there is no "training set" in the context of AI/ML data for this device. The design and development of the device would follow medical device design control processes, where requirements are defined and verified.

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The Datex-Ohmeda Entropy Module, E-ENTROPY and accessories are indicated for monitoring the state of the central nervous system (CNS) by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals in the anesthesia environment. The spectral entropies, Response Entropy (RE) and State Entropy (SE), are processed EEG and FEMG variables, and may be used as an aid in monitoring the effects of certain anesthetic agents. The Entropy module is indicated for use by qualified medical personnel only.

The Datex-Ohmeda S/5TM Entropy Module, E-ENTROPY is used for acquiring and processing of raw EEG and FEMG signals. The Entropy algorithm processes the collected signals and yields two Entropy variables - state entropy (SE) and response entropy (RE) - and burst suppression ratio, in addition to one real-time EEG waveform channel. The variables may be used as an aid in monitoring the effects of certain anesthetic agents. Entropy is thus used to assess the adequacy of anesthesia status in relation to other standard physiological signs and monitoring modalities (HR, blood pressure, NMT, MAC etc.). The Datex-Ohmeda Entropy module, E-ENTROPY is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The E-ENTROPY module uses the same Entropy algorithm and accessories as the predicate device, M-ENTROPY (K023459). Entropy monitoring is based on acquisition of raw EEG and FEMG signals and processing them by using the Entropy algorithm - a Datex-Ohmeda application of spectral entropy based on information theory. The E-Entropy Module may be used as an aid in monitoring the effects of certain anesthetic agents. Calculated parameters are: Response Entropy, RE (range 0-100), continuous processed variable for fast detection of activation of facial muscles, i.e. FEMG. State Entropy, SE (range.0-91), continuous processed variable calculated from the EEG. SE is designed to be sensitive to the hypnotic effect of anesthetic drugs in the brain. Burst Suppression Ratio, BSR (range=0-100%), the percentage of epochs in the past 60 seconds in which the EEG signal is considered suppressed. All the calculated parameters can be selected on the display, and trended. The raw EEG signal can be displayed from one of the two monitored channels. The waveform size, color and sweep speed can be adjusted. Alarms for Entropy are taken care of by the host monitor and follow the user interface for alarms in Datex-Ohmeda S/5 patient monitors. There are auditory and visual alarms and user adjustable limits for Entropy variables. The default is OFF, because the device does not provide information to be used for treatment or therapy. The accessories are the same for the E-ENTROPY module and the predicate device, the M-ENTROPY (K023459). The Datex-Ohmeda Entropy sensor is a rectangular shaped, pre-gelled array of three (3) Zipprep® electrodes that is applied to the patient's skin to record electrophysiological (such as EEG) signals. It is a low impedance, single patient use, disposable electrode sensor that is designed for application to the frontal / temporal area. The Datex-Ohmeda Entropy sensor is designed to provide ease of use and electrode placement accuracy. The sensor is used only with M-ENTROPY and E ENTROPY modules. The Datex-Ohmeda Entropy sensor cable connects the Entropy sensor to the ENTROPY module both mechanically and electrically.

The provided PMA (Premarket Approval) document for the Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY and accessories (K050835) is a substantial equivalence claim to a predicate device (Datex-Ohmeda M-ENTROPY Module, K023459). It does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or clinical performance data typically found in a clinical study report.

The document explicitly states that the E-ENTROPY module is a "facelifted version" of the predicate M-ENTROPY module, with the "software and measurement hardware are the same as those of the predicate device (K023459)." Furthermore, it highlights "identical intended use and indications for use," "identical fundamental scientific technology," and the "same entropy calculation algorithm."

Therefore, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device through technological similarity, not on presenting novel performance data against pre-defined acceptance criteria for a new clinical study.

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

This information is not applicable/not available because no specific clinical test set data is presented to prove performance. The submission relies on the established performance of the predicate device.

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

This information is not applicable/not available as no specific clinical test set data or ground truth establishment is described for the E-ENTROPY module.

4. Adjudication Method for the Test Set:

This information is not applicable/not available as no specific clinical test set or adjudication process is described for the E-ENTROPY module.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable/not available. No MRMC study comparing human readers with and without AI assistance is mentioned. The device is for monitoring neurophysiological status, not for interpretation by human readers in a diagnostic setting like medical imaging.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not explicitly detailed as a standalone study for the E-ENTROPY module. The document states that the "software and measurement hardware are the same as those of the predicate device" and that the "same entropy calculation algorithm" is used. It implies that the algorithm's performance was established with the predicate device. The submission describes non-clinical testing focused on safety and electrical compatibility standards (IEC, EN, CSA, UL, AAMI, ISO), and FDA guidance for EEG devices and software.

7. Type of Ground Truth Used:

This information is not applicable/not available as there is no mention of a new study using ground truth for the E-ENTROPY module's performance evaluation. The underlying technology's performance was presumably established with the predicate device.

8. Sample Size for the Training Set:

This information is not applicable/not available. As this is a 510(k) for a device largely identical to its predicate, there is no mention of retraining an AI algorithm or a new training set. The "entropy algorithm" is stated to be the "same."

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

This information is not applicable/not available. Similar to the training set size, this information is not provided as the device is not presented as a newly trained AI model.

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The GE Datex-Ohmeda Anesthesia Delivery Unit 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, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes. The ADU is not suitable for use in a MRI environment.

The GE Datex-Ohmeda ADU supplies set flows of medical gases to the breathing system using mechanical gas mixing. Gas flows are selected by the user using the rotary controller on the frame and then displayed as electronic flow indicators on the system display unit. The ADU is equipped with a traditional flow tube, as well. The ADU is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have 02. The ADU comes with up to two optional gases (air, N2O). Safety features and devices within the ADU are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.

The anesthetic agent delivery for the ADU is controlled via an anesthesia computer through user input from that computer. An Aladin cassette is inserted into the active cassette bay. The cassette holds the agent to be delivered - Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The ADU is designed to allow only one active cassette at a time. Per the user input, valves within the active cassette bay will oney one allow agent to be delivered. The agent is mixed with gas within the FGC unit. After open and the wagent to of gases and agent is delivered to the breathing system and then onto the patient.

The ADU Anesthesia Ventilator is a microprocessor based, electronically controlled, The ADO Ancomesia "Pentilator that provides patient ventilation during surgical procedures. Sensors in the breathing circuit are used to control and monitor patient ventilation. This allows Schools in the oreating of compression losses, fresh gas contribution and small leakage in the for the compensation of our spression. 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 with a sitiple and becare othir pratory Pressure (PEEP) is regulated electronically. Positive ter the paintained in the breathing system so that any leakage that occurs is outward. Pressure is names for the device include Volume Mode, Pressure Control Mode, Pressure Support vith Apnea Backup Mode (Optional) and Synchronized Intermittent Mandatory Ventilation with Aplica Dackap Mode (Optional) and measurements are displayed on the system display unit.

The ADU must be used with additional monitoring that include at least inspired 02, expired volume, expired CO2 and Anesthetic Agent.

An RS-232 serial digital communications port connects to and communicates with external devices such a Datex-Ohmeda S/5 Anesthesia Monitor.

Several frame configurations are available, including one that allows for the physical integration of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). Additional or the Dations allow for the mounting of various patient monitors on the top shelf of the ADU.

This document is a 510(k) summary for the GE Datex-Ohmeda S/5 ADU, an anesthesia delivery unit. It focuses on demonstrating substantial equivalence to previously cleared devices (GE Datex-Ohmeda ADU Carestation and Datex-Ohmeda AS/3 Anesthesia Delivery Unit) rather than detailing specific acceptance criteria and performance studies in the way one might expect for a new AI or diagnostic device.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, adjudication methods, MRMC study, separate AI performance, training set details) are not applicable or not found within this submission document for a medical device of this type.

Here's the information that can be extracted and a clear statement about what is not included in the provided text:

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

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

This information is not provided in the document. This type of submission for an anesthesia machine typically relies on engineering specifications, adherence to standards, and possibly internal testing data, rather than clinical trials with patient-specific test sets in the context of AI or diagnostic algorithms.

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 in the document. Ground truth establishment with experts is generally associated with diagnostic or AI algorithm testing, not with the clearance of an anesthesia delivery unit based on substantial equivalence to existing devices and adherence to performance standards.

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

This information is not provided in the document. As with the previous points, adjudication methods are typically relevant for human interpretation or AI performance assessment, which is not the primary focus of this 510(k) submission.

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 information is not provided in the document. MRMC studies are used for evaluating diagnostic devices and AI systems where human interpretation is part of the workflow. This device is an anesthesia delivery unit, not a diagnostic imaging or AI-assisted interpretation tool.

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

This information is not provided in the document. This device is a complex electromechanical system, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

The concept of "ground truth" in the context of this 510(k) appears to be based on compliance with established safety and performance standards (e.g., UL, EN, ISO, ASTM) and the functional specifications meeting the intended use. This is demonstrated through engineering design, internal testing, and comparison to predicate devices, rather than a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This information is not provided in the document. The device is not learning from a "training set" in the machine learning sense. Its design and functionality are predetermined based on engineering principles and established medical device standards.

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

This information is not provided in the document, as there is no "training set" in the machine learning sense for this device.

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The GE Datex-Ohmeda Aisys Carestation 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 Aisys Carestation is not suitable for use in a MRI environment.

The GE Datex-Ohmeda Aisyis Carestation 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 system comg crecurence gain display unit and then displayed as electronic flow indicators on the system display unit. The Aisys 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 Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have 02. The Aisys comes with up to two optional gases (air, N2O). Safety features and devices within the Aisys are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Aisys 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 Aisys, receives electronic power from the Aisys and communicates measured values to the Aisys for display on the system display unit.

The anesthetic agent delivery for the Aisys is controlled via an anesthesia computer through user I ho unesthetie central display. The vaporization technology is based upon the electronic itiput from the collinar display. The x-Ohmeda Anesthesia Delivery Unit (ADU) cleared via Vaportzer etcared as part of the Bacer as part of K973895) is inserted into the active cassette 15715765. An Indin bassette (as to be delivered - Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys is designed to allow of be ronature. I rigent to a time. Per the user input into the main display, valves within the only one actry cassette bay will opent to be delivered. The agent is mixed with gas from athe FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aisys Anesthesia System. It is a The Dates Onlined 1900 tronically controlled, pneumatically driven ventilator that provides microprocessor based, erections of ocedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the montoning 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 on for concentration "Prakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in merory. 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 feature obeats is ournaler vees. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Mode (Optional) and Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional). Ventilator parameters and measurements are displayed on the system display unit.

The system display unit is mounted to an arm on the top shelf of the Aisys. The arm is counter I he system display and moving vertically and/or horizontally, and also tilting the display, enabling the user to position the display to the most advantageous viewing position. The arm length is limited such that the display position is always within the footprint of the Aisys frame. The arm also supports the mounting of additional display units for a variety of patient monitors.

Several frame configurations are available, including one that allows for the physical integration of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Aisys frame. An additional from the monitor S/5 AM to be linked to the power supply of the Aisys such that when the Aisyis 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 Aisys.

This document pertains to the 510(k) summary for the GE Datex-Ohmeda Aisys Carestation, a type of Anesthesia Gas Machine. As such, it describes a medical device, not an AI/ML-driven solution or a diagnostic tool that would typically undergo the types of studies you've inquired about (e.g., those involving performance metrics like sensitivity/specificity, reader studies, or ground truth establishment by experts).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types. These aspects are specific to the validation of diagnostic or AI-powered devices, which the Aisys Carestation is not.

The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant voluntary standards for medical electrical equipment and anesthesia workstations. The "acceptance criteria" in this context refer to compliance with these standards and established regulatory pathways for anesthesia machines.

Here's what can be inferred from the provided text regarding the closest equivalents to your request:

1. Acceptance Criteria (in the context of a medical device 510(k) application):

   • Substantial Equivalence: The primary acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices.
   • Compliance with Voluntary Standards: The device was designed to comply with applicable portions of specific voluntary standards. This compliance serves as an "acceptance criterion" for safety, performance, and functionality.

2. Study/Evidence that Proves the Device Meets Acceptance Criteria:

   • The document states: "The GE Datex-Ohmeda Aisyis Carestation in accept vehicled through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aisyis Carestation to the standards listed above."
   • While specific study details (like sample sizes or statistical results) are not provided in this 510(k) summary, the "rigorous testing" mentioned typically includes:
     • Bench testing: To verify technical specifications, safety features, and functional performance against engineering requirements and the chosen voluntary standards (e.g., verifying gas flow accuracy, ventilator performance, alarm functionality, electromagnetic compatibility).
     • Software validation: Given the electronic controls and microprocessor-based components, software validation would have been performed.
     • Biocompatibility testing: For patient-contacting materials, though not explicitly mentioned here.
     • Electrical safety testing: To meet standards like UL 2601 and EN/IEC 60601-1.
     • Electromagnetic compatibility (EMC) testing: To meet EN/IEC 60601-1-2.

Summary of available information as per your requested format (with caveats):

• Substantial Equivalence to K040743, K032803, K973985
• UL 2601
• EN 740
• EN/IEC 60601-1
• EN/IEC 60601-1-2
• EN 475
• ASTM F1463-93
• ASTM F1208-94
• ASTM F1101-90
• ISO 5358

Reported Device Performance:
The document states that compliance to these standards was supported by "rigorous testing." No specific performance metrics (e.g., statistical results, accuracy values) are provided in this summary. |
| 2. Sample size and Data Provenance (Test Set) | Not applicable. This is a medical device approval, not a diagnostic algorithm study. Testing involved engineering and regulatory compliance, not typically "test sets" in the AI/ML sense. |
| 3. Number of experts and Qualifications (Ground Truth) | Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on imaging) is not relevant for this device. Safety and performance were assessed against engineering specifications and voluntary standards. |
| 4. Adjudication Method (Test Set) | Not applicable for this type of device and submission. |
| 5. MRMC Comparative Effectiveness Study Effect Size | Not applicable. This is not an AI-assisted diagnostic device. |
| 6. Standalone performance (algorithm only) | Not applicable. This is a physical medical device, not an algorithm. |
| 7. Type of Ground Truth Used | Not applicable in the context of diagnostic/AI ground truth. Device performance verified against technical specifications, engineering requirements, and voluntary standards. |
| 8. Sample Size for Training Set | Not applicable. This is a hardware/software medical device, not an AI/ML model that undergoes "training." |
| 9. How Ground Truth for Training Set was Established | Not applicable. |

The 510(k) summary focuses on demonstrating that the Aisys Carestation is safe and effective for its intended use, based on substantial equivalence to existing devices and compliance with recognized standards, rather than proving diagnostic accuracy via clinical trials or AI performance studies.

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