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The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment.

This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe Incubator Carestation is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature-controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe OmniBed Carestation is a device that can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode) based on the user's selection. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

In the closed bed mode of operation, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed bed compartment. Warm air is circulated through the closed patient compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors.

In the open bed mode, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient.

The Giraffe OmniBed Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The Giraffe Incubator Carestation is an enclosed infant bed, which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the closed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The Giraffe Incubator Carestation has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort.

The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

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The Carestation750/750c anesthesia systems are intended to provide monitored anesthesia care, general inhalation anesthesia and/ or ventilatory support to a wide range of patients (neonatal, 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 750/750c anesthesia machines (Carestation 750 series) are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonate, 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 systems in a long line of products based on the Datex-Ohmeda Aestiva (K000706), Aespire View (K122445), Aisys CS2 (K170872), Avance CS2 (K131945), Carestation 620/650/650c (Carestation 600 series) (K151570) Anesthesia Systems. The Carestation 750 series anesthesia systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

The Carestation™ 750/750c anesthesia systems combine advanced anesthesia delivery, patient monitoring. and care information management. The contemporary, compact design allows for easy mobility and addresses many ergonomic considerations including an effective cable management solution, aesthetic covers, and an expandable work surface area. Optional integrated features include auxiliary common gas outlet, auxiliary 02 outlet, auxiliary 02+Air outlet, suction control, and respiratory gas monitoring. The system provides integration of ventilation and gas delivery on a 15-inch color graphical touchscreen interface. This system also features electronic gas mixing of oxygen and a balance gas of either N2O or Air. The Carestation 750 series represents one of the systems in a long line of products based on the Datex-Ohmeda Aestiva (K000706), AespireView (K122445), Aisys CS2 (K170872), Avance CS2 (K131945), and Carestation 600 Series (K151570) Anesthesia Systems.

This anesthesia system is designed for mixing and delivering inhalation anesthetics (Isoflurane, Sevoflurane, or Desflurane), Air, O2, and N2O. This anesthesia system has Recruitment maneuvers, a feature to perform automated lung recruitment maneuver in a single step or in multi steps.

This anesthesia system uses electronic flow valve ventilation technology offering Volume Control Ventilation with tidal volume compensation and electronic PEEP. This technology also features Pressure Control Ventilation, optional Pressure Support Ventilation with an Apnea Backup (PSVPro™) that is used for spontaneously breathing patients, Synchronized Intermittent Mandatory Ventilation (SIMV) modes, Pressure Control Ventilation-Volume Guarantee (PCVG), Continuous Positive Airway Pressure + Pressure Support Ventilation (CPAP + PSV), and VCV Cardiac Bypass. In Volume Control Ventilation, a patient can be ventilated using a minimal tidal volume of 20 ml. In Pressure Control Ventilation, volumes as low as 5 ml can be measured. These advanced features allow for the ventilation of a broad patient range. The device includes the following basic components:

The Carestation 750 series anesthesia systems supply set flows of medical gases to the breathing system using an electronic gas mixer (O2 with Air or O2 with N2O). Gas flows are adjusted by the user on the touchscreen, the flows are displayed on the system graphical user interface assembly as numerical digits and as electronic representations of flow meters. The system provides an option for auxiliary mixed Oxygen + Air flow delivery where 02 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 electronic gas mixer.

The Carestation 750 series models include up to 3 breathing gases with O2 and Air as standard, and N20 as an optional breathing gas. The systems include two vaporizer positions compatible with, Isoflurane, Sevotlurane, and Desflurane vaporizers. The Carestation 750 is available with up to three back-up gas cylinder connections. The Carestation 750 series systems are also available in pendant (Carestation 750c) models.

The system uses touchscreen technology, hard keys, and a Comwheel to access system functions, menus, and settings on a 15'' color graphical user interface assembly (aka display). The graphical user interface assembly 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. The arm is available allowing the display to be tilted up or down to adjust the vertical viewing angle or be tilted left or right to adjust the horizontal position of the display. An optional arm can be raised/lowered and rotated 360 degrees. A split screen field can be set to show gas trends, Spirometry loops, a Paw gauge, airway compliance, and optional ecoFlow information. If none is selected, the waveforms expand to fill the split screen area.

The Carestation 750 series systems accept Tec 7, and Tec 820/850 series vaporizers on a 2position Selectatec manifold. Safety features and devices within the systems are designed to decrease the risk of hypoxic mixtures, multiple anesthetic agent mixtures, complete power failure, or sudden gas supply The Carestation 750 series systems are available with optional integrated respiratory gas failures. monitoring which can be physically integrated into the system, receive electronic power from the Carestation 750/750c, and communicate measured values to the Carestation 750/750c for display on the system graphical user interface assembly. When supplied as an option, integrated respiratory gas monitoring is provided via the GE CARESCAPE series (EsCAiO or E-sCAiOV) respiratory airway modules (GE Healthcare Finland Oy, CE 0537) which is identical to the module used on Avance CS2.

The Anesthesia Ventilator used in the Carestation 750 series is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. This version of the GE 7900 ventilator is equipped with a built-in system for monitoring inspired oxygen (using an optional 02 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 settings 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 occurs is outward from the patent breathing circuit.

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

Standard ventilation modes:

• VCV (Time Cycled, Volume Controlled Ventilation) .
• . PCV (Time Cycled, Pressure Control Ventilation)

Optional ventilation modes:

• 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 Carestation 750 system also includes an optional cable management solution, which can help user to manage the various cables attached to the system.

The provided document is a 510(k) Premarket Notification for the Carestation 750/750c anesthesia system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Carestation 620/650/650c) through technological characteristic comparison and bench testing against recognized standards.

Therefore, the document does not contain the kind of detailed information typically found in a study proving a device meets acceptance criteria related to a specific performance metric or clinical outcome, especially for AI or algorithmic performance. There is no information about:

• Specific acceptance criteria for device performance in terms of diagnostic accuracy or clinical effectiveness. The acceptance criteria mentioned are related to compliance with quality assurance measures and recognized safety standards.
• A study that proves the device meets acceptance criteria in a clinical setting with patient data, experts, or specific performance metrics like sensitivity, specificity, or effect sizes.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
• Ground truth types or sample sizes for training sets in the context of AI/algorithms.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance, albeit in a different context than what might be expected for an AI-driven device:

1. Table of Acceptance Criteria and Reported Device Performance (based on compliance criteria):

The study that proves the device meets the acceptance criteria is described as:

• Bench testing: "Bench testing was performed to establish substantial equivalence of the Carestation 750/750c."
• Verification and validation testing: "Verification and validation testing was performed according to predetermined acceptance criteria, which concluded that the Carestation 750/750c is substantially equivalent to the predicate Carestation 620/650/650c."
• Non-clinical design verification and validation tests: "The Carestation 750/750c anesthesia machines incorporate modifications to the predicate Carestation 620/650/650c. These modifications did not require clinical testing. The changes made were completely evaluated by non-clinical design verification and validation tests to verify and validate the safety and functionality of the anesthesia machines."

Regarding the specific questions about AI/algorithmic studies, the document provides no relevant information:

2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The testing focused on engineering validation and adherence to standards, not on a clinical test set with patient data for algorithmic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth in the context of clinical expert review is not mentioned.
4. Adjudication method: Not applicable/Not provided.
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 machine, 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: Not applicable. The device itself is an anesthesia machine, not a standalone algorithm.
7. The type of ground truth used: For the engineering and standards compliance, the "ground truth" would be the specifications and requirements of the standards themselves, as well as validated engineering measurements against design specifications.
8. The sample size for the training set: Not applicable/Not provided. This is not an AI/ML submission that would typically involve training sets of data for model development.
9. How the ground truth for the training set was established: Not applicable/Not provided.

In summary, this document is a regulatory submission for an anesthesia machine, which relies on demonstrating equivalence to an existing device through rigorous engineering testing and compliance with established medical device standards. It does not describe an AI or algorithm evaluation study.

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The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.

The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules.

Not all features are available for all patient types or product configurations.

O2 Therapy is intended to be used for all adult patients and pediatric patients greater than 10 kg in weight.

The CARESCAPE R860 ventilator is not a pulmonary function calculation device.

The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

The CARESCAPE R860 is a flexible, adaptable, intuitive critical care ventilator offering invasive and non-invasive ventilation support. Touchscreen capability allows the user to quickly and easily access patient information and procedures. A wide selection of performance options gives the user full control of the system configuration. Icons represent configurable views of past (historical trends), present (patient status), and future patient needs (clinical decision support). The CARESCAPE R860 features patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.

The CARESCAPE R860 ventilator is intended for healthcare facility use, including withinfacility transport.

The ventilator offers multiple ventilation modes:

• A/C VC (Assist Control Volume Control)
• A/C PC (Assist Control Pressure Control)
• A/C PRVC (Assist Control Pressure Regulated Volume Control)
• SIMV VC (Synchronized Intermittent Mandatory Ventilation Volume Control)
• SIMV PC (Synchronized Intermittent Mandatory Ventilation Pressure Control)
• CPAP/PS (Continuous Positive Airway Pressure/Pressure Support)
• SBT (Spontaneous Breathing Trial)
• nCPAP (nasal Continuous Positive Airway Pressure)
• SIMV PRVC (Synchronized Intermittent Mandatory Ventilation Pressure . Regulated Volume Control)
• BiLevel
• BiLevel VG (BiLevel airway pressure ventilation Volume Guaranteed)
• VS (Volume Support)
• NIV (Non-Invasive Ventilation)
• APRV (Airway Pressure Release Ventilation)

In addition, a breathing support mode, O2 Therapy, is being added as a new feature in this 510(k). The O2 Therapy mode is available for adult and pediatric patients weighing greater than 10kg.

Optional functionality includes integrated respiratory gas monitoring, capabilities to measure SpiroDynamics, and calculation of functional residual capacity of mechanically ventilated patients. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, which are physically integrated into the CARESCAPE R860, can receive electronic power from the CARESCAPE R860 and communicate measured values to the CARESCAPE R860 for display on the system display unit.

This document is a 510(k) Pre-market Notification for a medical device (CARESCAPE R860 ventilator). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that a new AI/ML-based device meets specific performance criteria through a traditional clinical study with ground truth.

Therefore, many of the requested elements (e.g., acceptance criteria for AI performance, sample size for test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets) are not applicable in this context.

The document describes engineering verification and validation testing and compliance with recognized consensus standards to demonstrate that the modified device remains safe and effective and is substantially equivalent to its predicate.

Here's the information that is applicable and can be extracted from the provided text, along with explanations of why other points are not relevant:

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

The document doesn't present specific acceptance criteria in the format of a clinical performance study with AI metrics (like sensitivity, specificity, or AUC). Instead, it discusses the device's functional performance specifications and how they align with the predicate device and relevant standards. The "performance" is demonstrated through verification and validation that the modified device continues to meet its functional specifications and standards.

The closest to "acceptance criteria" are the specifications listed in the "Substantial Equivalence to the predicate CARESCAPE R860" and "Substantial Equivalence to the reference device, Hamilton G5" tables. The "reported device performance" is implied by the statement that the device meets these specifications and has undergone "Verification and validation was performed to demonstrate that the changes to the software continue to comply with applicable standards and guidances, and the product continues to meet the performance specifications."

Here's a partial summary derived from the tables:

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

This information is not applicable as this is not a study involving a clinical test set from patient data for AI model evaluation. The "test set" here refers to engineering and software verification and validation activities. The document states:

• "Non-clinical testing was performed to establish substantial equivalence of the CARESCAPE R860."
• "Verification and validation testing has been performed according to predetermined acceptance criteria..."
• "Testing included: Software verification and validation, Waveform comparison analysis, System verification, Accuracy testing, Stress testing."
• "Where the changes to the ventilator affected compliance with applicable consensus standards, testing was performed to confirm continued compliance, or to demonstrate compliance with the recognized version of the standard."

The document does not detail specific sample sizes for these engineering tests (e.g., number of test cycles, duration of stress tests, number of waveforms analyzed). Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of non-clinical testing.

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. This submission focuses on hardware and software changes to a ventilator, not on a diagnostic AI device requiring expert-labeled ground truth from patient data. The "ground truth" for this device's performance is typically defined by engineering specifications, relevant industry standards, and established methods for measuring ventilator performance using test lungs and specialized equipment.

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

Not applicable. Adjudication methods are relevant for clinical studies where human experts disagree on interpretations of medical data used as ground truth for an AI assessment. This is an engineering verification and validation submission for a physical device.

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

Not applicable. This is not an AI-assisted diagnostic or clinical decision support device that would involve human readers.

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

Not applicable. This device (a ventilator) is not a standalone algorithm in the sense of AI/ML. Its performance is inherent in its electromechanical and software operation, which is verified against engineering specifications, not evaluated as an "algorithm only" with data processing outputs.

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

The "ground truth" in this context is based on engineering specifications, established physical principles, and recognized consensus standards for medical device performance. For example, accuracy testing involves comparing device measurements (e.g., FiO2, flow, volume) against known, precise inputs from calibrated equipment. Waveform comparison analysis involves comparing generated waveforms against theoretical or expected waveforms.

8. The sample size for the training set

Not applicable. This device introduction does not describe the development or training of an AI/ML model from a "training set" of data. The software development follows traditional engineering processes, not AI model training.

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

Not applicable. Per point 8, there is no AI/ML training set as described in the context of diagnostic or prognostic AI.

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The Tec 820 and Tec 850 vaporizers are designed for use in continuous flow techniques of inhalation anesthesia. They are available in isoflurane and sevoflurane. Each vaporizer is agent specific and is clearly labeled with the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed for use only with General Electric's Selectatec Series Manifolds.

The Datex-Ohmeda Tec™ 820 and Tec 850 vaporizers are designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. The vaporizers are available in Sevoflurane and Isoflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.
The output concentration of the Tec 820/850 vaporizer is regulated by the "variable flow-split" method, where a total flow of fresh gas from upstream enters the vaporizer where it is split into two streams. One stream flows into the fresh gas bypass circuit and the other stream flows through the vaporizing chamber where it is saturated with the vapor of the liquid anesthetic agent.
Both gas paths have methods to regulate the flow to achieve desired total output agent concentration. Before exiting the vaporizer through the gas outlet, the split gas streams are joined. The combined total flow then flows out from the vaporizer via the Selectatec circuitry to the anesthesia gas delivery system.

The provided text describes the 510(k) premarket notification for the Tec 820 and Tec 850 anesthetic vaporizers, demonstrating their substantial equivalence to a predicate device (Tec 7). This submission is for medical hardware, not a software-based AI/ML device. Therefore, the questions related to AI/ML device performance (like MRMC studies, standalone AI performance, number of experts, and training/test set details) are not applicable to this document.

However, I can extract the information relevant to the device's acceptance criteria and the non-clinical study that proves it meets those criteria.

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

The document refers to "Design Inputs" as the acceptance criteria and "Result" as the reported device performance.

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

The document describes "non-clinical tests" and "functional testing" to verify and validate the performance of the vaporizer. It does not specify a "sample size for the test set" in terms of number of devices tested, but rather indicates that "The Tec 820 and Tec 850 have been fully verified and validated". There's no mention of country of origin for data as this relates to manufactured product testing, not patient data. The testing is retrospective in the sense that it's performed on manufactured devices after design, to prove the design meets specifications.

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

Not applicable. This is not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" here is the design specifications and functional requirements of the vaporizer, established through engineering design and regulatory standards.

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

Not applicable. This is not an AI/ML device requiring human adjudication of performance outcomes. The outcomes are objective measurements against engineering specifications ("PASS" or "FAIL").

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

Not applicable. This is a hardware device (anesthetic vaporizer), not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. This is a hardware device. Its performance is inherent to the device itself.

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

The "ground truth" for this device's performance validation is its design inputs and specifications, as established by the manufacturer, and meeting relevant recognized standards for medical devices of this type. The objective tests performed (e.g., concentration accuracy, flow range, temperature compensation) measured the actual device performance against these pre-defined engineering targets.

8. The sample size for the training set:

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

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

Not applicable. There is no training set for a hardware device.

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The GE Healthcare anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The GE Healthcare anesthesia machines are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

The GE Healthcare anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The GE Healthcare anesthesia machines are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

The GE Healthcare anesthesia systems supply set flows of medical gases to the breathing system. Gas flows are selected by the user and displayed on the display unit or through pneumatic flow meters. A large selection of options may be available to configure the system, including frames, brake style, gases, and anesthetic agents.

The GE anesthesia machines include a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure, and inhaled and exhaled volume. Flow, gas, and pressure 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. 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).

This is a 510(k) premarket notification for a medical device family (GE Healthcare anesthesia machines) and not a study describing a new algorithm or AI. Therefore, much of the requested information regarding AI-specific acceptance criteria and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or available in this document.

However, based on the provided text, I can infer the acceptance criteria for substantial equivalence and summarize the study that proves the device meets those criteria.

The primary purpose of this 510(k) submission is to demonstrate that the modified GE Healthcare anesthesia machines, incorporating two alternate flow sensors, are substantially equivalent to their previously cleared predicate devices. The "study" here refers to the non-clinical testing performed to establish this substantial equivalence.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly tied to the performance requirements of the predicate devices. The goal is to show that the modified devices perform equivalently and raise no new questions of safety or effectiveness.

Study Details (Non-AI Specific)

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

   • The document describes a series of non-clinical tests (component-level and system-level testing, biocompatibility testing, reprocessing validation). It does not specify a "test set" in the context of patient data or algorithm performance. Instead, it refers to tests on the device's components and the complete system.
   • Data provenance: Not explicitly stated as country of origin, but the submission is from GE Healthcare, Datex-Ohmeda, Inc., located in Madison, Wisconsin, USA. The testing is described as occurring prior to the submission date (September 2017). This is a retrospective analysis of engineering, functional, and safety tests performed on the device.

2. 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. This submission does not involve clinical data that would require expert ground truth labeling in the context of an AI/algorithm study. The "ground truth" for these tests are engineering specifications, validated test methods, and compliance with industry standards.

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

   • Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image review), not for objective engineering tests on a physical device.

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:

   • Not applicable. This is not an AI/software device that assists human readers. It is a modification to an anesthesia gas machine.

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

   • Not applicable. This is not an AI/algorithm. Performance tests were conducted on the modified physical device.

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

   • The ground truth for these tests are established engineering specifications, validated test methods, and compliance with relevant voluntary industry standards (e.g., ISO 10993 for biocompatibility) that define the expected performance and safety characteristics of an anesthesia gas machine.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning model that undergoes training with a dataset.

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

   • Not applicable. See #7.

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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 CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.
Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules.
Not all features are available for all patient types or product configurations.
The CARESCAPE R860 ventilator is not a pulmonary function calculation device.
The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

The CARESCAPE R860 is a flexible, adaptable, intuitive critical care ventilator. Touchscreen capability allows the user to quickly and easily access patient information and procedures. A wide selection of performance options gives the user full control of the system configuration. The CARESCAPE R860 features patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.
The CARESCAPE R860 is designed to provide mechanical ventilation for adult, pediatric and neonatal patient types weighing 0.25 kg and above, and having degrees of pulmonary impairment varying from minor to severe.
The CARESCAPE R860 introduces a new user interface with touch screen capabilities. Icons represent configurable views of past (historical trends), present (patient status), and possible future patient needs through clinical decision support, including Spontaneous Breathing Trial to evaluate a patient's ability to breath spontaneously for a limited, specified duration of time.
This ventilator comes with standard ventilation modes as well as purchasable ventilation modes and clinical decision support features.
Standard ventilation modes:

• A/C VC (Assist Control Volume Control) .
• A/C PC (Assist Control Pressure Control) .
• A/C PRVC (Assist Control Pressure Regulated Volume Control)
• SIMV VC (Synchronized Intermittent Mandatory Ventilation Volume Control) ●
• SIMV PC (Synchronized Intermittent Mandatory Ventilation Pressure Control)
• CPAP/PS (Continuous Positive Airway Pressure/Pressure Support)
• SBT (Spontaneous Breathing Trial) .
  Purchasable ventilation modes:
• . nCPAP (nasal Continuous Positive Airway Pressure)
• . SIMV PRVC (Synchronized Intermittent Mandatory Ventilation Pressure Regulated Volume Control)
• . BiLevel
• . BiLevel VG (BiLevel airway pressure ventilation Volume Guaranteed)
• VS (Volume Support) ●
• NIV (Non-Invasive Ventilation) .
• . APRV (Airway Pressure Release Ventilation)
  Additional features:
• . FRC (Functional Residual Capacity)
• . SpiroDynamics
  The CARESCAPE R860 is based on the Engström Carestation feature set and contains similar performance characteristics to the Engström family of ventilators.
  The CARESCAPE R860 is a microprocessor-based, pneumatically controlled, data driven ventilator which includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb nebulizer control board. The ventilator consists of two main components: the display and the ventilator unit. The display allows the user to interface with the system through a resistive touch screen and Trim Knob with keys. The CARESCAPE R860 also includes an optional module bay which allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.
  The user interface for control of nebulization is provided via the ventilator display unit. The standard nebulizer board is provided with the CARESCAPE R860. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.
  Optional accessories common to the CARESCAPE R860 and the predicate Engström family of ventilators include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets. Additional optional accessories include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, adjustable mounting rail, nebulizer and components, and module bay.
  The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air supply. The compressor is installed in the base of the ventilator cart. The compressor is powered from AC mains only. A source of compressed oxygen is required to be connected to ventilator equipped with the optional compressor. The use of an integrated air compressor was first cleared on the predicate Engström Carestation and Engström Pro in K050597.
  Optional functionality includes integrated respiratory gas monitoring, capabilities to measure SpiroDynamics via a GE supplied intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/Wash Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), E-MiniC module (K052582), or E-sCO, E-sCOV, E-sCAiO, E-sCAiOV (K123195) which are physically integrated into the CARESCAPE R860, receive electronic power from the CARESCAPE R860 and communicate measured values to the CARESCAPE R860 for display on the system display unit.

This document, a 510(k) Pre-market Notification, describes the CARESCAPE R860 ventilator and asserts its substantial equivalence to a predicate device, the Engström Carestation.

Based on the provided text, the CARESCAPE R860 device is a ventilator, not an AI/ML powered device designed to meet specific performance criteria based on an AI model's output. Therefore, many of the requested criteria regarding AI model evaluation (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or type of ground truth) are not applicable (N/A) in this context.

The document primarily focuses on demonstrating the device's adherence to regulatory standards and its functional equivalence to a previously cleared device through non-clinical testing.

Here's the information extracted and filled out based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a ventilator and not an AI/ML diagnostic or predictive device, the "acceptance criteria" are related to compliance with medical device standards and functional equivalence to a predicate, rather than specific performance metrics like sensitivity or specificity for an AI model.

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

• Sample Size for Test Set: N/A (No specific "test set" in the context of AI/ML evaluation is mentioned. The testing involved functional verification and validation of a medical device against engineering specifications and regulatory standards.)
• Data Provenance: N/A (The testing performed is non-clinical, involving the device itself rather than patient data.)

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)

• Number of Experts: N/A
• Qualifications of Experts: N/A
  • Explanation: Ground truth in this context refers to the correct functioning of the ventilator according to engineering specifications and regulatory standards. This is typically established through engineering and quality assurance processes, not by expert medical review of output data.

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

• Adjudication Method: N/A

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 Done: No.
• Effect Size: N/A
  • Explanation: This is not an AI-assisted diagnostic device, so MRMC studies are not relevant.

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

• Standalone Performance: N/A
  • Explanation: This device is a ventilator, performing mechanical functions. While it has software, it's not an AI algorithm in the sense of making diagnostic or treatment recommendations that would have a standalone performance evaluated against a ground truth. Its "performance" is its ability to deliver ventilation parameters accurately and safely.

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

• Type of Ground Truth: Engineering specifications, regulatory standards (e.g., ISO 80601-2-12 for medical ventilators), and performance characteristics of the predicate device (Engström Carestation). The "ground truth" is the established correct mechanical and software operation within specified tolerances.

8. The sample size for the training set

• Sample Size for Training Set: N/A (No AI model training involved.)

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

• How Ground Truth Established: N/A (No AI model training involved.)

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The Aespire View 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 Aespire View (version 7) anesthesia system with 7900 ventilator is intended to provide general inhalation anesthesia and ventilator support to a wide range of patients. The system is to be used only by trained and qualified medical professionals.

The Aespire View (version 7) supplies set flows of medical gases to the breathing system (predicate device cleared via 510k submissions K092864 and K122445). A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. It is available in trollev and pendant models, with two or three gases, two vaporizer positions and up to three cylinder connections. All models connect to oxygen and can additionally connect with up to two optional gases (air and N2O). The Aespire View system accepts Tec 6+ and Tec 7 vaporizers on a Selectatec manifold. Safety features are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Aespire View provides optional electronic Total Fresh Gas Flow (TFS) monitoring. The Aespire View also features a color display.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aespire View anesthesia machine. 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, bellow 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 using the ComWheel. 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 Support Ventilation (SIMV/PSV) Mode, Pressure Support with Apnea Backup (PSVPro) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control (SIMV-PC) Mode (Optional), and Pressure Control Ventilation- Volume Guaranteed (PCV-VG) mode (Optional).

The provided text describes a 510(k) premarket notification for the "Aespire View" anesthesia system. This device is an updated version of a previously cleared predicate device. The document explicitly states that clinical testing was NOT required for this submission. Therefore, the information requested regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning performance metrics usually derived from clinical studies (like accuracy, sensitivity, specificity, or reader improvement with AI), is not available in this document.

The submission focuses on non-clinical testing to demonstrate substantial equivalence to the predicate device, primarily due to software and hardware modifications and updated standards compliance.

Here's an analysis based on the provided text, focusing on the absence of clinical performance data:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in the context of clinical performance for this submission. The "acceptance criteria" discussed are related to compliance with standards (e.g., IEC 60601-1) and verification/validation activities for software and hardware changes. No specific clinical performance metrics (e.g., accuracy, sensitivity) with corresponding acceptance thresholds are mentioned because clinical testing was not deemed necessary.

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

Not applicable for a clinical test set. The document refers to "testing on unit level," "integration testing," and "performance testing" but does not specify sample sizes in terms of patient data as there was no clinical study.

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

Not applicable as no clinical ground truth was established for a clinical test set.

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

Not applicable as no clinical test set requiring adjudication 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:

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 not an algorithm for diagnostic interpretation in a standalone capacity.

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

Not applicable for clinical ground truth. The "ground truth" in this context would be defined by engineering specifications and standards against which the device's functional performance was verified.

8. The sample size for the training set:

Not applicable as no machine learning model was developed or trained for this submission in a way that would involve a "training set" of clinical data.

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

Not applicable for the same reasons as above.

Summary of Non-Clinical Testing and "Acceptance Criteria" for this submission:

The document outlines a series of non-clinical tests and standards compliance achieved by the Aespire View (version 7). These form the basis for its "acceptance" and determination of substantial equivalence.

In conclusion, this FDA 510(k) submission for the Aespire View anesthesia system did not involve a clinical study or generate clinical performance data against acceptance criteria, as the modifications were deemed to not require clinical testing to establish substantial equivalence. The "study" that proves the device meets (non-clinical) acceptance criteria involved extensive engineering verification and validation, along with adherence to recognized international standards.

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The GE Datex-Ohmeda Engström Carestation and Engström Pro are designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. Optional Neonatal capabilities on Engström Carestation and Engström Pro expand the patient range to 0.25 kg.

The GE Datex-Ohmeda Engström Carestation and Engström Pro are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry, and volume monitoring. Options include an Aerogen Aeroneb nebulizer, data capture accessory, and an integrated air compressor. Options available on Engström Carestation only include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, capabilities to measure SpiroDynamics via an intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/Wash Out method.

Not all features are available with all patient populations.

The Engström Carestation is not a pulmonary function calculation device.

The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

The GE Datex-Ohmeda Engström Carestation and Engström Pro are flexible, and intuitive, critical care ventilators. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation and Engström Pro feature patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.

Both the GE Datex-Ohmeda Engström Carestation and Engström Pro are designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. Optional Neonatal capabilities allow the Engström Carestation and Engström Pro to be used with patients weighing 0.25 kg and above.

The modes of ventilation currently available include:

1. Volume Controlled (VCV)
2. Pressure Controlled (PCV)
3. Pressure Controlled, Volume Guaranteed (PCV-VG)
4. Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC)
5. Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC)
6. Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG)
7. Bi-level Airway Pressure Ventilation
8. Constant Positive Airway Pressure Support Ventilation (CPAP/PSV)
9. Apnea backup (available in SIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel, CPAP/PSV, and VG-PS)
10. Non-invasive ventilation (NIV), not available in neonatal mode
11. Infant Nasal CPAP (nCPAP), only available in neonatal mode
12. Volume Guarantee. Pressure Support (VG-PS), only available in neonatal mode

The GE Datex-Ohmeda Engström Carestation and Engström Pro are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulizer control board.

The ventilator consists of two main components: a display and a ventilator unit. The display allows the user to interface with the system and control settings through use of soft keys on the display, a com wheel, and a resistive touch screen. The Engström Carestation also includes a module bay that allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

The user interface for control of nebulization is provided via the ventilator display unit. The standard nebulizer board is provided with both the Engström Carestation and Engström Pro variants. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.

The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air supply. The compressor is installed in the base of the ventilator cart. The compressor is powered from AC mains only. A source of compressed oxygen is required to be connected to Engström Carestation/Engström Pro equipped with the optional compressor. The use of an integrated air compressor was first cleared in K050597.

Optional accessories common to both Engström Carestation and Engström Pro include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets, and a data capture accessory. Additional optional accessories specific to the Engström Carestation include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, and module bay. Optional functionality specific to the Engström Carestation includes integrated respiratory gas monitoring, capabilities to measure SpiroDynamics via a GE supplied intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/Wash Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, M-C. M-COV. M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher (K001814), E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), or M-Mini-CO2 Module (K023454) or E-MiniC module (K052582) which are physically integrated into the Engström Carestation, receive electronic power from the Engström Carestation and communicate measured values to the Engström Carestation for display on the system display unit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Datex-Ohmeda Engström Carestation and Engström Pro ventilators.

This 510(k) submission (K140575) is primarily for the addition of an alternate integrated air compressor (EVair) to the existing GE Datex-Ohmeda Engström Carestation and Engström Pro ventilators, which were previously cleared under K111116. The submission states "There have been no changes to the intended use or fundamental scientific technology." and "The addition of the alternate compressor, EVair, does not affect the safe or effective use of the ventilator as the compressor interfaces with the ventilator in the same manner, and performs in an equivalent manner. There is no change to the Engstrom performance as a result of this change." Consequently, the acceptance criteria and studies focus specifically on the new compressor and its functional equivalence, rather than a broad re-evaluation of the entire ventilator system.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) (adding an alternate component), the acceptance criteria are framed around functional equivalence and safety of the new EVair compressor compared to the predicate EVair03.

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

The provided document describes nonclinical testing only.

• Sample Size: The document does not specify a quantitative "sample size" in terms of units tested for the compressor, nor does it refer to patient data. Testing appears to be on developmental units of the EVair compressor integrated with the Engström ventilators.
• Data Provenance: The testing was "nonclinical," meaning it did not involve human patients. It was conducted by the manufacturer, Datex-Ohmeda, Inc. (GE Healthcare). There is no mention of country of origin for specific test data, but the company is based in Madison, WI, USA. The testing is prospective in the sense that it evaluates a newly designed component (EVair compressor) before its market release.

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

• The concept of "ground truth established by experts" is not directly applicable here as this is a nonclinical engineering and functional equivalence study for a medical device component.
• The ground truth for this type of evaluation is typically defined by engineering specifications, regulatory standards (e.g., ISO, IEC for medical electrical equipment), and the performance characteristics of the legally marketed predicate device.
• The "experts" involved would be the manufacturer's engineers, quality assurance personnel, and regulatory specialists who designed, tested, and evaluated the device against these objective criteria. Their qualifications would stem from their professional expertise in medical device development, testing, and regulatory requirements.

4. Adjudication Method for the Test Set

• Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers (e.g., radiologists interpreting images) where consensus or a tie-breaking mechanism is needed to establish a "true" label.
• This submission describes nonclinical engineering testing. Therefore, such adjudication methods are not applicable. The results of the tests (e.g., pressure measurements, acoustic levels, vibration, thermal performance, software function) are objective, quantitative data compared against predefined specifications and predicate performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done.
• MRMC studies are clinical studies designed to evaluate the diagnostic performance of human readers, often comparing performance with and without an AI-assisted device.
• This 510(k) submission is for an alternate component (air compressor) of a ventilator, not a diagnostic AI device. The submission explicitly states: "The modifications made to the Engström ventilator did not require clinical testing."

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

• This question is framed for AI/algorithm-based devices. The Engström Carestation and Engström Pro are physical medical devices (ventilators) with microprocessor control, not standalone AI algorithms.
• The "standalone performance" of the EVair compressor itself was evaluated during its design and verification to meet engineering specifications (acoustics, vibration, thermal dissipation) and then its integrated performance with the ventilator system was verified. This can be considered the equivalent of a "standalone" functional test for the component.

7. The Type of Ground Truth Used

• For this nonclinical submission, the ground truth is based on:
  • Engineering Specifications: Detailed technical requirements for component performance (e.g., pressure ranges, flow rates, alarm thresholds, acoustic limits, vibration levels, thermal profiles).
  • Regulatory Standards: Compliance with relevant national and international standards for medical devices, particularly continuous ventilators (e.g., 21 CFR 868.5895, ISO, IEC standards).
  • Predicate Device Performance: The demonstrated safe and effective performance of the previously cleared predicate device (Engstrom Ventilator K111116 and its EVair03 compressor). The new EVair compressor was evaluated against the functional performance of the EVair03.

8. The Sample Size for the Training Set

• This question is relevant for machine learning or AI models.
• Not applicable. This submission is for a physical medical device and its component, not an AI model requiring a training set.

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

• Not applicable, as there is no training set for an AI model in this submission.

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