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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 Giraffe Incubator Carestation is an Infant 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 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 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.

This document is a 510(k) premarket notification for the "Giraffe Incubator Carestation CS1" (K213553). The submission seeks to demonstrate substantial equivalence to a legally marketed predicate device, the "Giraffe Omnibed Carestation CS1" (K152814), specifically concerning modifications to porthole and wall latches.

Device Description:
The device, Giraffe OmniBed Carestation CS1, is a combination of an infant incubator and an infant radiant warmer. It provides a temperature-controlled environment for neonates. The modified device primarily features changes to the porthole latch design (from "press to open" to "turn to open") and the wall latches (addition of a secondary "catch" mechanism on the north side). The overall dimensions have also slightly increased in width from 66 cm to 68 cm.

Acceptance Criteria and Reported Device Performance:

The provided document defines acceptance criteria through compliance with voluntary standards and system performance metrics, and the reported device performance is that it meets these criteria.

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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 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 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.

The provided document describes the Giraffe Incubator Carestation CS1, a medical device. The submission focuses on modifications to the porthole and wall latches of an existing predicate device (K152809). The document does not describe the device's main performance in terms of medical outcomes but rather the safety and functionality of the latch modifications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria for the overall medical device performance (e.g., temperature control accuracy, humidity control). Instead, it focuses on demonstrating that the modified latch mechanisms continue to meet existing safety and performance standards, and that their functionality is equivalent or improved compared to the predicate without introducing new risks.

However, the document lists system performance specifications that are identical to the predicate device, implying these are the baseline acceptance criteria for the overall incubator function. For the latch modifications, the acceptance criteria are demonstrated through successful completion of various tests.

Acceptance Criteria (Implied from "Identical" or "Meets all performance and standards requirements") and Reported Performance for the General Device:

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

The document describes non-clinical testing which includes various functional and reliability bench tests for the modified latches, as well as summative usability testing.

• Test Set Sample Size: The document does not specify a numerical sample size for the bench tests (e.g., number of latches tested, number of cycles for reliability). It lists the types of tests performed. For the "Summative Usability Testing," the sample size of participants is not provided.
• Data Provenance: The testing appears to be prospective and conducted by GE Healthcare (the submitter) in their own labs, as part of their quality system. The country of origin of the data is not explicitly stated but can be inferred to be internally generated by the manufacturer.

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

• Number of Experts: Not specified for the bench tests. For the "Summative Usability Testing," the number of participants is not provided, and whether these participants are considered "experts" (e.g., clinicians) or typical end-users is not detailed.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions (e.g., for image interpretation). The testing involves physical and functional evaluation against established standards and internal quality criteria. For usability, the findings are reported, implying evaluation against predefined usability metrics and safety outcomes.

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 submission is for an infant incubator with modified latches, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not applicable. This device does not have an "algorithm only" component that would require standalone performance evaluation typical of AI/ML software.

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

For the latch modifications, the "ground truth" is defined by:

• Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-19.
• Engineering Specifications: Internal design requirements for load, torque, cycles, and physical dimensions that ensure safety and functionality.
• Risk Analysis: Identification and mitigation of potential risks associated with the changes.
• Usability Objectives: Ensuring the modified latches do not introduce new use errors or significantly alter the user experience negatively.

8. The sample size for the training set

• Not applicable. This device submission does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As there is no training set mentioned or relevant for this device, there is no ground truth established for one.

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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 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 OmniBed Carestation is an updated version of the cleared predicate Giraffe OmniBed. The Giraffe OmniBed Carestation is a combination device that can function as an incubator (with the canopy closed) or as an infant radiant warmer (with the canopy open) 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. With the canopy closed, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed 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 operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors.

With the canopy opened, 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, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The proposed modification of the Giraffe OmniBed is referred to as the Giraffe OmniBed Carestation.

The Giraffe OmniBed Carestation updates the graphical monochrome display user interface (UI) on the predicate to a digital touchscreen UI, with the required software changes to support the new format and layout. The main system control software was not changed; however the software for the UI was updated because of the UI format change. The modified Giraffe OmniBed Carestation maintains the predicate Giraffe OmniBed functionality, performance, and clinical workflows. The changes also include a modified device visual indicator light and the capability for Hands Free Alarm Silencing (HFAS).

Other modifications being made for the Giraffe OmniBed Carestation include upgrading the power supply from 75W to 120W to support the increased power requirements of the touchscreen and associated electronics.

There is no change in the indications for use or intended use of the system. There are no changes to the patient contacting materials of the device, and they remain identical to the predicate. The changes made do not affect the function, performance, safety, or clinical use of the device.

This document is a marketing submission (510(k) summary) for a medical device, specifically a neonatal incubator/warmer, and not a study proving a device meets acceptance criteria. Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document, as it does not contain the specifics of a performance study with defined acceptance criteria and results.

The document states: "The subject of this premarket submission, Giraffe OmniBed Carestation, did not require clinical studies to support substantial equivalence." This means that the manufacturer is claiming substantial equivalence based on non-clinical tests (such as electrical safety, performance verification against standards, software testing) and the device's technological similarity to previously cleared predicate devices, rather than through a comparative clinical study.

Here's what can be inferred and what cannot, based on the provided text:

What Can Be Inferred/Extracted (to some extent):

• Device Name: Giraffe OmniBed Carestation CS1 (K152814)
• Device Type: Combination infant incubator and infant warmer.
• Indication for Use: To provide heat in a controlled manner to neonates unable to thermoregulate. Can operate as an incubator (closed canopy) or radiant warmer (open canopy). May incorporate a Servo Controlled Oxygen Delivery System for stable oxygen concentration (21-65%).
• Predicate Device(s): Giraffe OmniBed (K101788, K071175, K020543, K993407)
• Key Modification: Updates the graphical monochrome display user interface (UI) to a digital touchscreen UI, with associated software changes. Also, an upgraded power supply (75W to 120W) and updated visual indicator light and Hands Free Alarm Silencing (HFAS) capability.
• Determination of Substantial Equivalence: Based on non-clinical tests and technological similarity to predicates.
• Non-Clinical Tests Mentioned (examples of types of tests, not specific results or acceptance criteria):
  • Risk Analysis
  • Design Reviews
  • Unit level testing (Module verification)
  • Integration testing (System verification)
  • Software testing (Verification and Validation, IEC 62304:2006)
  • Performance testing (Verification of performance specifications, including IEC 60601-2-21:2009 for warmers, IEC 60601-2-19:2009 for incubators)
  • Safety and EMC testing (Verification ES 60601-1:2005+A1 2012, IEC60601-1-2:2007)
  • Usability testing (Validation IEC 62366: 2014)

What Cannot Be Extracted (because the document is not a study report):

1. A table of acceptance criteria and the reported device performance: This document lists types of tests performed (e.g., performance testing against standards), but it does not provide the specific numerical acceptance criteria (e.g., "temperature stability must be within +/- 0.5°C") nor the measured device performance against those criteria.
2. Sample sizes used for the test set and the data provenance: Not applicable as it's not a clinical study. The non-clinical tests would have involved specific test units, but the "sample size" of patients/data as in a clinical study is not relevant here.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable as no clinical ground truth was established for "testing" in the sense of patient data. Usability testing might involve experts, but details are not provided.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: No, the document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." An MRMC study would be a clinical study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is electro-mechanical, not AI-driven in the sense of an algorithm interpreting data to generate a finding.
7. The type of ground truth used: Not applicable. Ground truth for clinical studies would be, for example, pathology results for a lesion, or confirmed diagnosis; here, "ground truth" would be the engineering specifications and performance standards.
8. The sample size for the training set: Not applicable. This device is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence of a medical device based on non-clinical testing and comparison to predicate devices, not a report of a study designed to prove the device meets specific clinical acceptance criteria.

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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 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 Incubator Carestation is an updated version of the cleared predicate Giraffe Incubator. 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 incorporates an optional weighing scale, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The provided text describes a 510(k) premarket notification for the "Giraffe Incubator Carestation CS1", which is an updated version of a predicate device, the "Giraffe Incubator". The focus of the modifications is primarily on updating the user interface from a graphical monochrome display to a digital touchscreen.

Based on the provided document, the device in question does not involve AI or machine learning algorithms, and therefore, the acceptance criteria and study information related to those aspects are not applicable. The device is a neonatal incubator, and the modifications are related to its hardware and user interface.

Consequently, many of the requested points regarding AI/ML device performance and studies cannot be answered from this document.

Here's what can be extracted:

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

The document does not provide a specific table of acceptance criteria with detailed performance metrics in the way one would for an AI/ML diagnostic device with quantifiable sensitivity, specificity, etc. Instead, it refers to compliance with voluntary standards and quality assurance measures for the modified device to demonstrate substantial equivalence to the predicate device.

The "reported device performance" is essentially the device's adherence to these standards and the successful verification and validation activities.

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

This information is not provided in the document as it is not an AI/ML study. The testing described is verification and validation of hardware and software components, not a clinical trial on a 'test set' of patient data in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable for a device that is not an AI/ML diagnostic tool. Validation activities would involve engineers and testers.

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

This information is not provided and is not applicable.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is an incubator, not a standalone algorithm.

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

For the hardware and software modifications, the "ground truth" would be engineering specifications, established medical device safety and performance standards (like IEC 60601-2-19), and the functional requirements derived from the predicate device. These are verified through various testing methodologies described (module verification, system verification, etc.). It's not a clinical 'ground truth' in the diagnostic sense.

8. The sample size for the training set

This information is not applicable as there is no mention of a training set, the device is not an AI/ML product.

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

This information is not applicable as there is no mention of a training set, the device is not an AI/ML product.

In summary, the provided document describes a 510(k) submission for an updated medical device (a neonatal incubator) with hardware and user interface modifications, not an AI/ML-driven device. Therefore, most of the detailed questions related to AI/ML study design and performance metrics found in your request are not addressed by this document. The safety and effectiveness are established through compliance with existing standards and verification/validation testing against the predicate device.

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