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The GE Datex-Ohmeda S/5 ADU 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, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes. The ADU is not suitable for use in a MRI environment.

The S/5 ADU (Anesthesia Delivery Unit) Carestation is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. It is to be used only by trained and qualified medical professionals.

The S/5 ADU Carestation (shortened as 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 O2. 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 open and allow agent to be delivered. The agent is mixed with gas within the FGC unit. After mixing, the combination 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, pneumatically driven ventilator that provides patient ventilation during surgical procedures. Sensors in the breathing circuit are used to control and monitor patient ventilation. 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 reaulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. 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. Ventilator parameters 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 S/5 Anesthesia Monitor (most recently cleared via K051400). Several frame configurations are available, including one that allows for the physical integration of the S/5 Anesthesia Monitor. Additional configurations allow for the mounting of various patient monitors on the top shelf of the ADU.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Datex-Ohmeda S/5 ADU Carestation:

Summary of Acceptance Criteria and Device Performance for K090892: GE Datex-Ohmeda S/5 ADU Carestation

It's important to note that this 510(k) submission is for a modification to a previously cleared device, not a completely new device entering the market. Therefore, the focus is on demonstrating that the changes do not introduce new questions of safety or effectiveness and that the modified device maintains performance equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines an indirect set of "acceptance criteria" through compliance with recognized standards and a comparison to predicate devices, rather than specific performance metrics directly tied to a new clinical study. The device's performance is accepted if it meets these standards and is substantially equivalent.

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

The document explicitly states: "The modifications to the ADU did not require clinical testing."
Therefore, there is no specific test set or clinical data of human subjects mentioned in this submission. The evaluation relies on non-clinical testing and comparison to predicate devices.

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

Not applicable, as no clinical test set requiring expert-established ground truth was conducted.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was conducted.

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

No MRMC study was performed or mentioned, as no clinical testing was required for this 510(k). The evaluation revolves around engineering verification and validation.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study, in the traditional sense of an algorithm, was not performed, nor is it applicable to this device. This is a medical device (anesthesia machine) with hardware and software, not an AI/algorithm-only product. The non-clinical testing, including software validation, serves as the "standalone" evaluation of the device's functional and safety performance.

7. Type of Ground Truth Used (for any testing):

For the non-clinical testing mentioned, the "ground truth" would be established by:

• Engineering specifications and design requirements.
• The requirements and performance benchmarks set by the listed national and international standards (e.g., UL, EN, IEC, ASTM, ISO).
• The established performance characteristics of the predicate devices.

8. Sample Size for the Training Set:

Not applicable. This device is an anesthesia machine, not an AI model that requires a training set in the machine learning sense. The "training" for such a device effectively comes from its design, development, and adherence to established engineering principles and standards.

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

Not applicable. There is no training set in the context of machine learning for this device. The "ground truth" for its development is based on medical device design principles, safety standards, and functional requirements for anesthesia delivery and ventilation.

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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 Masimo Compatible Saturation Module, E-MASIMO, and accessories are indicated for monitoring arterial oxygen saturation and pulse rate of hospitalized patients. The device is indicated for use by qualified medical personnel only.

The Masimo Compatible Saturation Module, E-MASIMO, is a single-width plug-in parameter module for a S/5 Modular Monitoring system. The Masimo Compatible Saturation Module, E-MASIMO is used for measuring noninvasive arterial oxygen saturation (SpO2) and pulse rate of hospitalized patients. The SpO2 measurement is based on light transillumination and is made optically with an infrared light and a red light sources and a photosensitive detector. The SpO2 value and pulse rate are calculated based on the signals, which are measured with the photosensitive detector in the SpO2 sensor.

The Masimo Compatible Saturation Module, E-MASIMO consists of an electronic measurement board based on MasimoSET® technology (OEM from Masimo Inc.), an interface board and connector flex board designed by GE Healthcare Finland Oy (former Datex-Ohmeda Div) for connecting the Masimo measurement board to a Datex-Ohmeda S/5 modular monitor.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device for a Masimo Compatible Saturation Module (E-MASIMO), rather than presenting a study to prove the device meets specific performance acceptance criteria through clinical trials or extensive validation. The submission primarily relies on a comparative approach, asserting that the new device is as safe and effective as its predicate. Therefore, much of the requested information regarding acceptance criteria, study sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based diagnostic devices, is not explicitly available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria and a detailed table of device performance against these criteria are not provided in this 510(k) summary. The submission states that the device "complies with the voluntary standards as detailed in Section 4.2 Specific Standards and Guidance of this submission," but these standards and their specific requirements are not included in the provided text.

The conclusion states: "The results of these tests and analysis demonstrated that the Masimo Compatible Saturation Module, E-MASIMO is as safe, as effective, and performs as well as the predicate device." This is a general statement of equivalence, not a report of specific performance metrics against pre-defined acceptance criteria.

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

The document does not specify any sample size for a test set or data provenance (e.g., country of origin, retrospective or prospective) for performance evaluation. The "Test Summary" lists various quality assurance measures (risk analysis, requirements reviews, design reviews, subsystem verification, integration testing, final acceptance testing, performance testing, safety testing, environmental testing), but these appear to be related to engineering and manufacturing quality rather than specific clinical performance validation studies with defined test sets.

Given the nature of the device (a saturation module based on existing MasimoSET® technology integrated into GE Healthcare monitors), the performance is likely assumed to be inherited from the proven MasimoSET® technology and the predicate device, with the primary focus of this submission being the integration and compatibility.

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

Not applicable and not mentioned. This type of information is typically required for diagnostic devices where human expert interpretation is the gold standard. For a pulse oximeter module, the "ground truth" for SpO2 measurements would typically be derived from co-oximetry, not expert visual assessment. However, no such detailed clinical study is described here.

4. Adjudication Method for the Test Set

Not applicable and not mentioned. As there's no described test set requiring human interpretation, no adjudication method would be in place.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done or described. This type of study is relevant for imaging or diagnostic tools where human readers interpret results, sometimes with AI assistance. The E-MASIMO is a measurement device (pulse oximeter module), not an interpretative diagnostic system.

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

The device itself is a standalone module designed to run an algorithm (MasimoSET® technology) for SpO2 and pulse rate measurement. Therefore, its performance is inherently a "standalone" or "algorithm only" performance within the context of hardware integration. However, the document does not present a specific standalone performance study in terms of accuracy metrics against reference standards. It relies on the equivalence to the predicate device and the underlying MasimoSET® technology.

7. The Type of Ground Truth Used

Not explicitly stated for any formal clinical validation study. For pulse oximetry, the gold standard (ground truth) for oxygen saturation is typically arterial blood gas analysis with co-oximetry. However, this 510(k) summary is not detailing a de novo clinical validation study against such a ground truth. It assumes the underlying MasimoSET® technology has already established its accuracy, and the focus is on the integration and compatibility.

8. The Sample Size for the Training Set

Not applicable and not mentioned. This device is not an AI/ML system that requires a "training set" in the conventional sense of machine learning algorithms. It is a hardware module incorporating a pre-existing signal processing technology (MasimoSET®).

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

Not applicable and not mentioned for the same reasons as above.

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