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

The GE Datex-Ohmeda Aisys CS2 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, Aespire, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals.

The Aisys CS2 supplies set flows of medical gases to the breathing system using electronic gas mixing. Interfaces to control the system include the touch screen, keypad and rotary controller on the main display unit. Selected gas flows are displayed as electronic flow indicators on the system display unit. The Aisys CS2 is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizer cassettes are available to give the user control of the system configuration. The Aisys CS4 systems are also available in pendant models. The system shall support a maximum of two-cylinder supply connections mounted inboard on the machine and supported by cylinder yokes. All models have O2. The Aisys CS2 comes with up to two optional gases (air, N20). Safety features and devices within the Aisys CS2 are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Aisys CS2 system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the CARESCAPE Modules cleared via K123195 (E-sCAiO, EsCAiOV) and K150245 (E-sCAiOVX). The Aisys CS2 is also compatible with legacy M-Gas and E-Gas modules which are in the installed base but are no longer in forward production (M-CAiO and M-CAiOV cleared via K001814, and E-CAiOVX cleared via K051092).

The above modules can be physically integrated into the Anesthesia device, receive electronic power from the said device and communicate measured values to the said device for display on the system display unit.

The anesthetic agent delivery for the Aisys CS2 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 2 is inserted into the active cassette bay. The cassette holds the agent to be delivered - Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys CS2 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 CS2. 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 (VCV) Mode, Pressure Control (PCV) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control Ventilation -Volume Guaranteed (SIMV/PCV-VG) Mode, Synchronized Intermittent Mandatory Ventilation with Pressure Support Ventilation (SIMV/PSV) Mode, Pressure Support with Apnea Backup (PSVPro) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control (SIMV-PC) Mode (Optional), Pressure Control Ventilation- Volume Guaranteed (PCV-VG) mode (Optional), and Continuous Positive Airway Pressure/ Pressure Support Ventilation (CPAP-PSV).

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 CS2. The arm is counter balanced and capable of moving vertically and/or horizontally, and 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 CS2 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 GE Monitors (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 Aisys CS2 frame. An additional option allows the monitor to be linked to the power supply of the Aisys CS2 such that when the Aisys CS2 is turned on, the monitor is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys CS2.

This document is a 510(k) premarket notification for the Aisys CS2 anesthesia system (version 11). It primarily focuses on demonstrating substantial equivalence to a predicate device (Aisys CS2 version 10) through non-clinical testing. Therefore, it does not contain the detailed information about acceptance criteria and a study that proves the device meets those criteria in the way typically found for a diagnostic or AI-driven device.

Based on the provided text, here's a breakdown of what is and is not available:

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

No explicit table of acceptance criteria and reported device performance in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) is provided. This is because the submission is for an anesthesia system, and the "performance" is related to its functional capabilities and compliance with safety standards, rather than a diagnostic accuracy.

The document lists various verification tests and what they verify. For example:

• Privacy and Security: Verifies functionality including an option to disable viewing patient identifiable information.
• Duplicate Interface Detection: Verifies functionality including that the system continues communication with its clients even if a duplicate IP condition is detected.
• Ethernet Interface: Verifies functionality including that the system supports 100Mbps speed and full duplex settings.
• Network Hazard Mitigation: Verifies that the system has no open ports except for specific clients.
• Network Requirements: Verifies that the system supports clock synchronization with a network device.
• Sapphire and HL7: Verifies communication protocols.
• Address Resolution Protocol Requirements: Verifies correct system subnet mask functionality.
• Respiratory Gas Monitors: Verifies all requirements related to Respiratory Gas Monitors, including functionality of the Sample Gas Return option.
• Monitoring Only Mode: Verifies functionality including O2 being administered through the auxiliary O2 port when the mode is enabled.
• System Hazard Mitigations: Verifies functionality including that the system performs as intended during a recovery state.
• Materials Testing: Includes Volatile Organic Compounds, Particulate Matter Testing, Bacterial Filter Efficiency Testing, Viral Filter Efficiency Testing.
• Reprocessing Instructions Validation Testing
• Verification testing for electrical safety and electromagnetic compatibility: Compliance to AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2: 2014, and ISO 80601-2-13: 2011.

For each of these, the implicit "acceptance criterion" is that the system successfully performs or complies with the stated function or standard. The "reported device performance" is the conclusion that these tests were passed and the system is safe and effective.

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

This information is not applicable / not provided for this type of submission. This device is an anesthesia machine, not typically tested with "test sets" of patient data in the same way an AI diagnostic device would be. The testing described is functional and safety verification.

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 applicable / not provided. There is no "ground truth" establishment in the context of diagnostic accuracy for this device. Ground truth is usually relevant for AI/ML models being validated against expert-labeled data.

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

This information is not applicable / not provided. Adjudication methods are used to resolve discrepancies in expert labeling for ground truth, which is not relevant here.

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 applicable / not provided. This is an anesthesia machine, not an AI-assisted diagnostic tool for human "readers" (e.g., radiologists interpreting images). An MRMC study would not be relevant for its evaluation.

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

This information is not applicable / not provided. This is an anesthesia machine. While it contains software, it is not a standalone AI algorithm in the diagnostic sense. It is a system intended for use by trained medical professionals. The software updates mentioned are for standards compliance and usability enhancements, not for independent diagnostic decisions.

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

This information is not applicable / not provided. As explained, there is no "ground truth" akin to diagnostic accuracy for this device. The "ground truth" for its performance is its ability to meet engineering specifications, safety standards, and functional requirements.

8. The sample size for the training set

This information is not applicable / not provided. This device is not an AI/ML model that would have a "training set" of data in the typical sense. The software updates are developed and verified through standard software engineering practices.

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

This information is not applicable / not provided. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

In summary, the provided document is a 510(k) summary for an anesthesia system. The "study" proving it meets acceptance criteria consists of a comprehensive set of non-clinical verification and validation tests covering:

• Software validation (including enhancements like EcoFlow improvements, Monitory Only mode, Network Connectivity, Privacy and Security, etc.)
• Compliance with electrical safety, EMC, and specific medical device standards (e.g., IEC 60601-1, ISO 80601-2-13).
• Materials testing.
• Risk analysis and design reviews.

The acceptance criteria are implicitly that the system functions as intended, meets its specifications, and complies with all relevant safety and performance standards. The "study" is the extensive report of these non-clinical tests, and the conclusion is that the modified device is substantially equivalent to its predicate. Clinical testing was not deemed necessary for the changes introduced in version 11.

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The Carestation 620/650/650c anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

The GE Carestation 620/650/650c anesthesia machines (Carestation 600 series) are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult). The anesthesia systems are suitable for use in a patient environment such as hospitals, surgical centers, or clinics. They represent one of the svstems in a long line of products based on the Datex-Ohmeda Aestiva (K000706). Aespire View (K122445) and Avance CS2 (K131945) Anesthesia Systems. The Carestation 600 series anesthesia systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

The Carestation 600 series anesthesia systems supply set flows of medical gases to the breathing system using needle valve flow controlled gas mixing (O2 with Air, O2 with N2O, or O2 with Air and N2O). Gas flows are adjusted by the user using needle valve control knobs on the main system frame, the flows are displayed on the system display unit as numerical digits and as electronic representations of flow meters. Some models (Carestation 650, 650c) also display the flow digits directly above the flow controls. Carestation 600 series systems are also equipped with an integrated pneumatic flow tube that indicates total mixed gas flow from the 2 or 3 needle valves in the gas mixer (prior to the vaporizer manifold). The Carestation 650/650c systems provide an option for auxiliary mixed Oxygen + Air flow delivery where O2 with Air are blended and delivered to an auxiliary port used to support spontaneously breathing patients using a nasal cannula. An optional auxiliary O2 supply includes a separate O2 flow tube and needle valve flow control that delivers O2 flow to an auxiliary port used to support spontaneously breathing patients using a nasal cannula. The gas flow from the optional auxiliary O2 subsystem does not flow through the total flow tube. An optional auxiliary common gas outlet (ACGO) allows the clinician to direct the fresh gas flow of O2. Air, N2O, or anesthetic agent, through the ACGO port on the front of the system. The ACGO may be used to provide fresh gas to an auxiliary manual breathing circuit.

A large selection of frame options include central brake (Carestation 650) or individual caster brakes (Carestation 620), up to 3 breathing gases, optional storage drawers, and vaporizers are available to give the user control of the system configuration. The Carestation 600 series systems are also available in pendant and wall mount (Carestation 650c) models. All Carestation 600 series models have O2 gas and come with one or two additional gases (Air, N2O, or both). Carestation 600 series systems include two vaporizer positions and are available with up to three back-up gas cylinder connections.

The system uses touchscreen technology, hard keys, and a ComWheel to access system functions, menus, and settings on a 15" color display. The display is mounted on an arm on the left side of the machine. It can be rotated via the arm toward, or away from, the system to adjust the horizontal position. An optional arm is available allowing it to be tilted up or down to adjust the vertical viewing angle, or be moved left or right to adjust the horizontal position of the display. The split screen field can be set to show gas trends, Spirometry loops, airway pressure (Paw) gauge, airway compliance, and optional ecoFLOW information. If none is selected, the waveforms expand to fill the split screen area.

The Carestation 600 series systems accept Tec 6 Plus and Tec 7 vaporizers on a 2position Selectatec vaporizer manifold in the same way the Aestiva, Aespire View and Avance CS2 machines use the Tec 6 Plus or Tec 7 vaporizers. Features and devices within the Carestation 600 series systems are designed to decrease the risk of hypoxic mixtures, multiple anesthetic agent mixtures, complete power failure, or sudden gas supply failures. The Carestation 600 series systems are available with optional integrated respiratory gas monitoring which can be physically integrated into the Carestation 600, receive electronic power from the Carestation 600, and communicate measured values to the Carestation 600 for display on the system display unit. When supplied as an option, integrated respiratory gas monitoring is provided via the GE CARESCAPE series (E-sCAiO and E-sCAiOV) respiratory airway modules (K123195) which is identical to the module used on Avance CS2, or the N-CAiO respiratory airway module which was cleared as part of the GE B40 monitor (K133576).

The Carestation 600 series Anesthesia Ventilator is used in the Carestation 600 series Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. This version of the GE 7900 ventilator (cleared on K023366) is equipped with a built-in monitoring system for inspired oxygen (using an optional O2 cell or optional integrated gas module), patient airway pressure and exhaled volume. Flow sensors in the breathing circuit are used to monitor and control patient ventilation. This allows for the compensation of gas and tubing compression losses, fresh gas contribution, and small gas leakage from the breathing absorber, bellows and pneumatic system connections. User setting and microprocessor calculations control breathing patterns. The user interface keeps ventilation settings in memory. The user may change settings with a simple ventilation parameter setting sequence. A bellows contains breathing gasses to be delivered to the patient and provides a barrier keeping patient gas separate from the ventilatory drive gas. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward from the patent breathing circuit.

This ventilator comes with a standard ventilation mode as well as optional ventilation modes.

Standard ventilation mode:
VCV (Time Cycled, Volume Controlled ventilation)

Optional ventilation modes:
PCV (Time Cycled, Pressure Controlled ventilation) VCV-SIMV (Synchronized Intermittent Mandatory Ventilation Volume Control) PCV-SIMV (Synchronized Intermittent Mandatory Ventilation Pressure Control) PSVPro (Pressure supported ventilation with apnea backup) PCV-VG (Pressure Controlled ventilation - Volume Guaranteed) PCV-VG-SIMV (Synchronized Intermittent Mandatory Ventilation, Pressure Controlled ventilation - Volume Guaranteed) CPAP+PSV (Continuous Positive Airway Pressure/Pressure Support)

The system can include an internal, factory installed, suction regulator and control visible from the front of the machine. It can mount different monitors using an arm or shelf mounts. The mounting is achieved through a combination of GE Healthcare adapters and other third party mounts, including one that allows for the physical integration of the GE Monitor Series B650 (K102239).

The provided text does not contain information about the acceptance criteria and study specifically for an AI/ML powered device. Instead, it describes a medical device, the Carestation 620/650/650c anesthesia system, and its premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device, the Avance CS2, through non-clinical testing.

Therefore, many of the requested details regarding AI/ML device evaluation criteria, such as sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, and training set information, are not available in this document.

However, I can extract the general acceptance criteria for the Carestation 620/650/650c device based on the non-clinical testing performed, which is focused on verifying its safety and functionality and establishing substantial equivalence to a predicate device.

Here's the information that can be extracted or deduced from the provided text:

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

The document broadly states that "Verification and validation testing was performed according to predetermined acceptance criteria." While specific numerical performance metrics are not provided, the types of tests conducted serve as the "acceptance criteria" categories for this device. The reported performance is that the device met these criteria.

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

Not applicable. The testing described is primarily non-clinical verification and validation testing of a hardware/software system, not a study involving a "test set" of patient data for an AI/ML algorithm. No specific sample sizes for these tests are mentioned beyond the implication that sufficient testing was done. The document does not refer to any patient data for testing.

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

Not applicable. This device is not an AI/ML algorithm that requires expert consensus for ground truth. Its functionality is tested against engineering specifications and regulatory standards.

4. Adjudication method for the test set

Not applicable, as there is no "test set" in the context of AI/ML evaluation. Product verification and validation involve testing against predefined specifications and requirements.

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 document describes an anesthesia system, not an AI-assisted diagnostic device. Therefore, no MRMC study or evaluation of human reader improvement with AI is mentioned or relevant.

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

This refers to the performance of the Carestation 620/650/650c as a standalone medical device. The document explicitly states that "Extensive non-clinical testing was performed..." and that "The Carestation 620/650/650c has been thoroughly tested through verification of specifications and validation, including software validation." This means its standalone performance against design specifications was evaluated.

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

The "ground truth" for this device's performance is its compliance with engineering specifications, functional requirements, and relevant voluntary and regulatory standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2). The testing aims to prove that the device operates as designed for its intended use.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI.

The proposed Monitor B40V3 is still a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2.1 (K133576) and now complies with IEC60601-1 3rd edition and RoHS (Restriction of Hazardous Substances) requirements, enabled time synchronization in HL7(Health Level 7) network environment, verified compatibility with CARESCAPE Central Station (K133882) and supported OAC (Optional Activation Codes) tool used in manufacturing and service for product license control. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to interface with following optional extension modules: E-MiniC module (K052582), Airway Gas Option Module (N-CAiO) (K133576), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and Entropy module. Comparing with E-Entropy module version (E-ENTROPY-00) (K061907) supported in predicate device, the proposed Monitor B40V3 supports improved E-Entropy module version (E-ENTROPY-01) (K150298). As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to be compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) with spirometry function disabled. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 still includes features and subsystems that are optional or configurable. The proposed Monitor B40V3 will continue interfacing to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 keeps a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text describes the GE Medical Systems China Co., Ltd. Monitor B40 (K151063), a multi-parameter patient monitor. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in terms of analytical or clinical performance.

Instead, the document focuses on:

• Substantial Equivalence: Demonstrating that the Monitor B40 (V3) is substantially equivalent to its predicate device (Monitor B40V2.1, K133576).
• Design Changes and Rationale: Explaining minor design modifications (e.g., compliance with IEC60601-1 3rd edition, RoHS compliance, time synchronization, compatibility updates, component upgrades due to end-of-life parts) and asserting that these changes do not impact the device's ability to obtain patient measurements or its safety/effectiveness.
• Compliance with Standards: Listing numerous voluntary and international standards the device and its applications comply with (e.g., IEC 60601-1, IEC 62304, ISO 80601-2-56).
• Quality Assurance Measures: Detailing the development process, including risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, safety).

Therefore, many of the requested points cannot be extracted from the provided text. The document explicitly states: "The subject of this premarket submission. The proposed Monitor B40V3 did not require clinical studies to support substantial equivalence." This indicates that detailed performance metrics from a dedicated clinical study for this specific device (B40V3) are not present in this submission.

Here is what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly listed as quantitative performance metrics for a specific function (e.g., arrhythmia detection sensitivity/specificity, NIBP accuracy). Instead, acceptance criteria implicitly refer to compliance with the listed international standards and demonstrating substantial equivalence to the predicate device, implying that its performance is at least as good as the predicate.
• Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided for any of the monitored parameters (ECG, SpO2, NIBP, etc.) for the Monitor B40V3 itself. The document claims "no changes to the parameter measuring principle" and that "all related risks were re-evaluated and found to be unchanged," implying performance is comparable to the predicate device.

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

• Not provided. The document does not describe specific test sets for analytical or clinical performance of the device's monitoring functions. It mentions "Testing on unit level," "Integration testing," "Final acceptance testing," "Performance testing," and "Safety testing" as part of quality assurance, but no details on size, provenance, or type of data are given.

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)

• Not applicable/Not provided. Since no specific clinical or analytical performance study with a 'test set' requiring expert ground truth is described, this information is absent. The submission focuses on technical compliance and substantial equivalence rather than de novo performance validation.

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

• Not applicable/Not provided. As no performance study with a test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not provided. This device is a physiological monitor, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or described.

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

• Not explicitly described as a standalone performance study. The device itself functions in a "standalone" mode as a monitor, and its algorithms (e.g., ECG EKPRO V12, NIBP) operate without human intervention in their core function. However, no specific "standalone study" with performance metrics for these algorithms is described in this document for the B40V3. The document states that the Monitor B40 can be a stand-alone monitor or interfaced to other devices.

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

• Not applicable/Not provided. For a physiological monitor, ground truth would typically be established against highly accurate reference devices or established clinical standards. However, since no specific clinical performance study is detailed, the method for establishing ground truth for performance metrics is not mentioned. Compliance testing for standards (e.g., IEC, ISO) would rely on defined test methodologies and reference values.

8. The sample size for the training set

• Not applicable/Not provided. There is no mention of a "training set" for AI or machine learning algorithms within this submission. The device uses established algorithms for physiological parameter monitoring.

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

• Not applicable/Not provided. As there is no mention of a training set.

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The GE Datex-Ohmeda Aisys 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 Aisys CS2 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, Aespire, Aisys, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals. The Aisys CS2 supplies set flows of medical gases to the breathing system using electronic gas mixing. Interfaces to control the system include the touch screen, keypad and rotary controller on the main display unit. Selected gas flows are 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 vaporizer cassettes are available to give the user control of the system configuration. The Aisys CS systems are also available in pendant models. The system shall support a maximum of two-cylinder supply connections mounted inboard on the machine and supported by cylinder yokes. All models have O2. The Aisys CS 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 CS 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). CARESCAPE Modules are also available for Aisys CS' (EsCAiO, E-sCAiOV cleared via K123195). The above modules can be physically integrated into the Anesthesia device, receive electronic power from the said device and communicate measured values to the said device for display on the system display unit. The anesthetic agent delivery for the Aisys CS2 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, 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) and Continuous Positive Airway Pressure / Pressure Support Ventilation (CPAP/PSV) Mode (Optional). Aisys CS2 also supports optional Pressure Control Ventilation - Volume Guarantee mode with spontaneous breath pressure support (SIMV PCV-VG) 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 CS. 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 CS2 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 GE Monitors (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 Aisys CS frame. An additional option allows the monitor to be linked to the power supply of the Aisys CS2 such that when the Aisys CS2 is turned on, the monitor is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys CS.

The provided text is for a 510(k) Premarket Notification for the GE Datex-Ohmeda Aisys CS2 Anesthesia System. This document describes a new version of an already marketed device and focuses on demonstrating substantial equivalence to the predicate device (GE Datex-Ohmeda Aisys, K110213).

Therefore, the document does not contain the kind of acceptance criteria, study details (like sample sizes, expert qualifications, adjudication methods), or performance metrics associated with a de novo device or a groundbreaking algorithmic performance study. Instead, the focus is on verification and validation of changes relative to a predicate device.

Here's an analysis based on the information available in the provided text, and explicit statements about what is not available due to the nature of this submission:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or numerical performance metrics in the way one would for an AI/algorithm-driven diagnostic device. Instead, the acceptance is based on demonstrating that the updated device continues to meet its specifications and performs as safely and effectively as the predicate device.

The study that "proves" the device meets acceptance criteria is a series of non-clinical tests.

1. Table of acceptance criteria and the reported device performance:

Study Details

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

• Test Set Sample Size: Not applicable/not specified in the context of this 510(k) submission. There isn't a "test set" in the sense of a medical image or patient data set used for algorithmic evaluation. The testing involved various engineering and software validation tests.
• Data Provenance: Not applicable. The testing was non-clinical (e.g., in-house verification and validation).

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

• Number of Experts: Not applicable. Ground truth, in the context of an anesthesia machine, would refer to its functional correctness, safety, and performance according to engineering specifications and regulatory standards, not expert interpretation of medical data.
• Qualifications of Experts: Not applicable. The "ground truth" was established by engineering specifications, regulatory standards, and internal quality assurance processes.

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

• Adjudication Method: Not applicable. This concept is typically relevant for studies involving human interpretation or clinical endpoints, not for the engineering verification and validation of an anesthesia system.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No, an MRMC study was not done. This 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:

• Standalone Performance: Not applicable in the context of an anesthesia system as a "standalone algorithm" performance. The device's performance was evaluated through non-clinical verification and validation testing of its hardware and software functions (e.g., gas mixing, ventilation modes, display accuracy, safety features).

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

• Type of Ground Truth: The ground truth for this device's evaluation was based on engineering specifications, regulatory standards compliance, and internal quality assurance requirements. This includes:
  • Functional requirements (e.g., gas flow rates, ventilation parameters).
  • Safety requirements (e.g., hypoxic mixture prevention, alarm accuracy).
  • Performance requirements (e.g., display accuracy, response times).
  • Compliance with voluntary standards.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device is an anesthesia system developed through traditional engineering and software development processes, not an AI/machine learning model that requires a "training set" of data.

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

• Ground Truth for Training Set: Not applicable. There is no "training set" in the context of this device's development.

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The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE Monitor B450 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation,

· respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), and spirometry)

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE Monitor B450 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

The CARESCAPE Monitor B450 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE Monitor B450 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The CARESCAPE Monitor B450 is not intended for use during MRI.

The CARESCAPE Monitor B450, including both new and existing subsystems interconnected forms a low acuity, portable multi-parameter patient monitoring system. The CARESCAPE Monitor B450 includes the monitor itself with built-in CPU and power unit, the CARESCAPE Software Platform (ESP software version 2 in this submission) and one or two batteries. The CARESCAPE Monitor B450 has a 12 inch touch screen display, mounting for a PSM/PDM hemodynamic module and a frame for one additional parameter measurement module. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader and USB remote control), and additional modules. The CARESCAPE Monitor B450 supports a variety of existing physiological parameter measurement modules and also can connect to OEM medical devices via the existing network infrastructure. The CARESCAPE Monitor B450 interfaces to a variety of other patient monitoring systems via a cabled or wireless network interface. The CARESCAPE Monitor B450 includes features and subsystems that are optional or configurable.

The provided text describes a 510(k) submission for the GE Healthcare CARESCAPE Monitor B450. However, it explicitly states, "The subject of this premarket submission, CARESCAPE Monitor B450 did not require clinical studies to support substantial equivalence."

This means that a study proving the device meets specific acceptance criteria, as typically described for a new or significantly modified device, was not conducted in the context of this 510(k) review. The device's safety and effectiveness were established primarily through non-clinical tests (compliance with standards) and by demonstrating substantial equivalence to a predicate device (CARESCAPE Monitor B650) which used an earlier version of the algorithm (EK-Pro v12 vs. EK-Pro v13).

Therefore, I cannot provide the information requested in points 1-9 as no such study is detailed in the provided document.

Here's a breakdown based on the information provided (or not provided) in the text:

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

• Not provided. No specific acceptance criteria for performance were listed, nor were direct device performance results from a clinical study included. The submission focuses on compliance with general safety and performance standards for medical electrical equipment.

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

• Not applicable. No clinical test set was used or described.

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):

• Not applicable. No clinical test set requiring expert ground truth was described.

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

• Not applicable. No clinical test set requiring adjudication was described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This type of study was not mentioned or performed. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human "readers."

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

• Not applicable in the context of clinical performance evaluation. The document mentions an "improved arrhythmia and ST analysis algorithm called EK-Pro v13," but its performance was not evaluated through a standalone clinical study for this 510(k). Its substantial equivalence was based on its predecessor (EK-Pro v12) in the predicate device and non-clinical testing.

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

• Not applicable. As no clinical study was conducted for this submission, no ground truth was established from clinical data.

8. The sample size for the training set:

• Not provided. No information about a training set for the algorithm was included.

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

• Not provided. As no training set information was included, how ground truth might have been established is also not provided.

Summary based on given document:

The GE Healthcare CARESCAPE Monitor B450's substantial equivalence was established by:

• Demonstrating that its technology (including the new EK-Pro v13 algorithm) is "essentially the same" as the predicate device (CARESCAPE Monitor B650) which used the EK-Pro v12 algorithm.
• Mentioning that the EK-Pro v13 algorithm is "based on the previous algorithm version EK-Pro v12, which has been cleared as part of the predicate device."
• Undergoing comprehensive non-clinical testing for compliance with numerous international safety, performance, and EMC standards (e.g., IEC 60601 series, AAMI EC standards).

The crucial statement is "The subject of this premarket submission, CARESCAPE Monitor B450 did not require clinical studies to support substantial equivalence." This indicates that for this specific 510(k), the FDA did not deem a new clinical performance study necessary to prove the device met acceptance criteria, likely due to its similarity to the already cleared 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 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.

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 (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 Aisys 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 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 (neonatal, pediatric, adult). 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 svstem display unit. The Aisvs 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 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 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 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 Aisvs 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 on to 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 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) and Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV). Ventilator parameters and measurements are displayed on the system display unit.

The provided text describes a premarket notification (510(k)) for the GE Datex-Ohmeda Aisys Anesthesia System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as would be found for a novel device.

The submission states that the modifications made did not require clinical testing, and the functionality was evaluated through nonclinical tests of design verification and validation testing. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria for a new clinical claim is not present in this document.

However, I can extract information about the type of testing performed and the conclusion regarding substantial equivalence.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present:

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

• Not explicitly provided in the document. The document states "The GE Datex-Ohmeda Aisys has been thoroughly tested through verification of specifications and validation, including software validation," but it does not list specific, quantitative acceptance criteria or corresponding reported performance metrics for clinical efficacy or diagnostic accuracy.
• The overall "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to predicate devices. The conclusion states: "The performance data demonstrates the device is substantially equivalent to the predicates."

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

• Not applicable/Not provided. No clinical test set or patient data is mentioned as the basis for the 510(k) in this document. The testing was non-clinical.

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)

• Not applicable/Not provided. No clinical ground truth was established as no clinical testing was performed for this 510(k). Non-clinical testing would involve engineering and quality assurance experts.

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

• Not applicable/Not provided. No clinical test set or adjudication method is mentioned.

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-assisted diagnostic tool. No MRMC study was performed.

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

• Not applicable. This device is an anesthesia system. The software updates relate to user interface, control of gas delivery, and ventilator modes, not standalone algorithmic performance in a diagnostic context. "Standalone" performance testing would be more relevant to the device's functional operation (e.g., accuracy of gas delivery, ventilator parameters) which was covered by non-clinical verification and validation.

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

• Not applicable/Not provided in a clinical sense. For the non-clinical testing, the "ground truth" would be the device's technical specifications and established engineering standards, against which its performance was verified and validated.

8. The sample size for the training set

• Not applicable/Not provided. This document is not describing a machine learning or AI model that requires a training set in the conventional sense. The "software updates" are likely improvements to existing control algorithms and user interface logic.

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

• Not applicable/Not provided. As above, no training set for a machine learning model is mentioned.

Summary of what is present regarding testing:

The document states:

• Reason for 510(k): Updates to the software for the GE Datex-Ohmeda Aisys Anesthesia System, introducing several new features (e.g., pediatric improvements, new ventilation mode CPAP/PSV with backup breaths, lung mechanics procedure options, UI enhancements).
• Basis for Substantial Equivalence: Comparison to legally marketed predicate devices (GE Datex-Ohmeda Aisys (K090233) and GE Datex-Ohmeda Engstrom ventilator (K093886)). No changes to intended use or fundamental scientific technology.
• Testing Performed:
  • Nonclinical Testing: "thoroughly tested through verification of specifications and validation, including software validation."
  • Quality Assurance Measures applied:
    • 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)
  • Clinical Testing: "The modifications made to the GE Datex-Ohmeda Aisys did not require clinical testing. The functionality of the modified software features were completely evaluated by performing nonclinical tests of design verification and validation testing."
• Conclusion: The performance data (nonclinical) demonstrates the device is substantially equivalent to the predicates, with no new questions of safety and effectiveness.

In essence, this 510(k) leverages the predicate devices' established safety and effectiveness, and for the software updates, relies on rigorous non-clinical engineering verification and validation testing rather than new clinical trials or performance studies against specific acceptance criteria for a novel claim.

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