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Intended use

This device is intended for use in anesthetizing adults, pediatric patients, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is equipped with the following basic functions:

• Ventilation monitoring
• Inspiratory 02 measurement
• Device monitoring
• Anesthetic gas receiving system

The following options are additionally available:

• Patient-gas measurement module for 02, CO2, N2O, and anesthetic gases
• 02 insufflation

Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents.

Ventilation is accomplished on the patient through a laryngeal mask, a breathing mask, or an endotracheal tube.

The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow).

Indications

The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.

The Atlan anesthesia workstation was developed and is manufactured by Dräger in Lübeck, Germany. The anesthesia workstation is specified for inhalational anesthesia using volatile anesthetic agents and/or patient ventilation, including the delivery of oxygen and the monitoring of device functions as well as the patient's and/or anesthetic parameters. Atlan is available in different device variants and can be upgraded by software and hardware options as well as attachable accessories.

The Atlan anesthesia workstation consists of four major subsystems, each of which operates on its own specific principle while interacting with the other subsystems to achieve the intended use. These major subsystems include:

• Gas reception and delivery, i.e., gas mixer o
• o Anesthetic breathing system
• o Anesthetic ventilator
• o Anesthetic gas scavenger

The Atlan anesthesia workstation receives medical gases from a cylinder or central gas supply, creates a gas mixture, or composition, and delivers this mixture at a determined flow rate to the anesthetic breathing system.

Atlan's anesthetic breathing system is the interface between the anesthesia workstation and the patient. Its purpose is to deliver the gas composition to the patient. While doing so, the anesthetic breathing system converts the continuous gas flow to the patient's intermittent respiratory flow, supports controlled or assisted ventilation, and allows for gas sampling and pressure measurements. Furthermore, the anesthetic breathing system conditions the inspiratory gas by means of a heater and removes carbon dioxides from the patient's expired qas.

The anesthetic ventilator drives fresh gas from the anesthetic breathing system to the patient and expired gas to the anesthetic gas scavenger.

Atlan's integrated anesthetic gas scavenger collects all waste anesthetic gases received from the breathing circuit and passes it on to a hospital disposal system.

The anesthesia workstation is also comprised of several minor subsystems whose interactions with the main subsystems help to address considerations of patient safety and system integrity. The minor subsystems include:

• o Gas monitoring
• o Ventilation and airway monitoring
• Device monitoring, including system self test o
• Embedded control display o
• RFID capabilities o

The provided text is a 510(k) Premarket Notification Summary for the "Atlan" anesthesia workstation. It describes the device, its intended use, and compares it to a predicate device (Perseus A500, K133886) and several reference devices.

However, the document does not contain specific acceptance criteria tables, reported device performance metrics, sample sizes for test sets, data provenance, information about expert ground truth establishment, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance data, or details about training set ground truth establishment.

Instead, it states that "The Atlan anesthesia workstation is a new device and has undergone extensive testing to qualify it with e.g., national and international consensus standards, technical system requirements and other requirements." It then lists the types of verification and validation activities performed, such as:

• Sterilization
• Biocompatibility
• Software, including cybersecurity
• Electrical safety
• Electromagnetic compatibility (EMC)
• Compliance with various IEC and ISO standards (e.g., IEC 60601-1-8 for alarm systems, ISO 80601-2-13 for anesthetic workstations, ISO 80601-2-55 for respiratory gas monitors)
• Waveforms, including comparisons to the predicate device and performance as per ASTM-F1101
• Technical System Requirements (risk control measures, technical data, essential safety and performance)
• Accessories compatibility
• Human factors engineering (IEC 60601-1-6 for Usability, IEC 62366-1 for the application of usability engineering to medical devices)

The document concludes that "The conclusions drawn from non-clinical tests and the comparison of intended use and technological characteristics with its predicate demonstrate that the new product Atlan is as safe, as effective and performs as well as or better than the legally marketed device Perseus K133886 as identified in this section of the submission."

Therefore, I cannot provide the requested table and detailed study information because it is not present in the provided text. The document summarizes the types of testing performed and the conclusion of those tests but does not offer the specific data points requested in your prompt.

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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 indication for Flow-c/Flow-e Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

The indication for the Flow-i/Flow-c/Flow-e Anesthesia system is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family 4.7 are high-performance Anesthesia systems designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult.

Flow Anesthesia family is a software-controlled semi-closed system for inhalation Anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).

The Flow-i/-c/-e 4.7 consists of a core, where gases are mixed and administered, and a User Interface where the settings are made and ventilation and anesthesia are monitored.

The Flow-i/-c/-e 4.7 is based on the cleared predicate device FLOW-i 4.2 (K160665) with some improvements.

The provided text is a 510(k) Summary for an anesthesia system. It outlines the device description, indications for use, comparison to a predicate device, and non-clinical testing. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets those criteria for an AI/algorithm-based device.

This document describes a medical device (anesthesia system) which is hardware and software controlled, but there is no mention of an AI/algorithm that performs diagnostic or prognostic functions, or that assists human readers in an interpretive task. The "MAC Brain" mentioned is a display indicator based on a calculated MAC value, not an AI model requiring a separate validation study with human experts, MRMC studies, or specific performance metrics like sensitivity/specificity against ground truth.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance for an AI/algorithm.
2. Sample size used for the test set and data provenance for an AI/algorithm.
3. Number of experts and their qualifications for establishing ground truth for an AI/algorithm.
4. Adjudication method for an AI/algorithm's test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for an AI/algorithm.
8. Training set sample size for an AI algorithm.
9. How ground truth for the training set was established for an AI algorithm.

The document focuses on demonstrating substantial equivalence of an anesthesia machine to a predicate device, based on changes that "do not affect the overall performance or technology of the device" or "raise different questions about safety and effectiveness." The testing mentioned (Software: Code review, Static code analysis, System testing; Performance: System testing, Regression, Free User testing, Waveform testing, Comparative testing for MAC Brain, Comparative testing for Recruitment Maneuver) is typical for hardware and software validation of a medical device, not specifically for an AI/ML algorithm requiring clinical performance studies against human experts or a gold standard.

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The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (information systems) it is connected to.

The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. patient monitors.

The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.

This document primarily describes a 510(k) premarket notification for the GE Healthcare Unity Network ID, focusing on its substantial equivalence to a predicate device, Unity Network ID V8 (K170199). It does not contain information about acceptance criteria for device performance with specific metrics or detailed study results where a device's performance is measured against those criteria.

The information provided describes the device's function (data collection and clinical information management), its intended use, and the changes made from the predicate device (primarily software updates to support new third-party devices).

However, it explicitly states:
"The Unity Network ID V9 was tested to assure that the device meets its design specifications. Testing included all new or modified features."
and
"The subject of this premarket submission, Unity Network ID V9, did not require clinical studies to support substantial equivalence."

Therefore, based on the provided text, I cannot describe the acceptance criteria and study as requested, because specific performance acceptance criteria and a study demonstrating the device meets those criteria are not detailed.

The document only states that non-clinical tests were performed to ensure compliance with voluntary standards and design specifications. It lists general quality assurance measures applied during development and testing but does not provide specific performance metrics, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical performance study for AI/machine learning devices.

Here's a breakdown of the specific points you requested, noting what is and isn't available in the provided text:

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

   • Not Available: The document does not provide a table of acceptance criteria nor reported device performance metrics against such criteria. It states the device "meets its design specifications" and "comply with, applicable voluntary standards," but no specifics are given.

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

   • Not Available: No test set sample sizes or data provenance are mentioned as no clinical studies were performed. The testing described is non-clinical verification and validation of design specifications.

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

   • Not Applicable/Not Available: Since no clinical studies were required and no test sets with ground truth are described, there is no information about experts establishing ground truth.

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

   • Not Applicable/Not Available: No clinical test set or adjudication method is described.

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

   • Not Applicable/Not Available: This device is a data collection and management system, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.

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

   • Not Applicable/Not Available: This device is not an algorithm for diagnostic or prognostic purposes, but rather an interface for data transmission. Standalone performance in the context of an algorithm is not relevant here.

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

   • Not Applicable/Not Available: No ground truth in the context of a clinical performance study is mentioned.

8. The sample size for the training set

   • Not Applicable/Not Available: This device is not an AI/machine learning model that requires a training set in the conventional sense. Its "training" would involve configuring it to correctly interpret and transmit data from specific third-party devices, which is part of its design and verification process, not a machine learning training process.

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

   • Not Applicable/Not Available: See point 8.

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