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The monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport.

The monitor B125/B105 is intended for use under the direct supervision of a licensed health care practitioner.

The monitor B125/B105 is not intended for use during MRI.

The monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network.

The monitor B125/B105 monitors and displays: ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/ Bladder/Axillary/Skin/Airway/Room/Myocardial/ Core/Surface temperature, impedance respiration rate, airway Gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac output (C.O.) and Entropy.

The monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

The proposed Monitor B125/B105 is a multi-parameter patient monitor that was developed based on predicate Monitor B125/B105 (K171580) to provide additional monitored parameters: Airway gases, Entropy and Cardiac output, by supporting additional optional modules previously cleared by FDA: CARESCAPE Respiratory module (K171028), Airway Ga Option N-CAiO(K151063), E-Entropy Module (K150298) (E-ENTROPY-01) and E-COP module (K052976) with extension interface rack and/or second frame(B1X5-F2).

In addition to the added parameters, the proposed Monitor B125/B105 offers several enhanced software features:

• Enabled the Impedance Respiration measurement for Neonates (in addition to Ped/Adult);
• Option called "Full Disclosure" to allow the display of parameter waveforms for up to 36 hours;
• National Early Warning Score (NEWS) calculation provided ;
• Additional printing capabilities to a remote recorder/Laser printer connected to a central station;
• Adoption of EK-Pro V14 ECG algorithm (previously cleared K191323) to support enhanced arrhythmia detection performance;
• Added Irregular, SV Tachy and Supra Ventricular Contraction (SVC), three more arrhythmia alarms;
• Enhanced parameter alarm priority adjustment/ configuration options,
• Cybersecurity enhancements.

The proposed monitor B125 and B105 is based on the previous design, and therefore shares a common software and hardware platform with its primary predicate, the Monitor B125/B105 (K171580). The primary function and operation of the monitors remain unchanged from the predicate. The difference between the two models (B125 and B105) is the LCD screen size. B125 has a 12-inch display; B105 has a 10-inch display. There is no change from the predicate in the display size.

As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 is a multi-parameter patient monitor, utilizing an LCD display with an integrated keypad and an identical pre-configuration patient parameter measurement module (Hemo module) which provides basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2. The proposed Monitor B125/B105 uses the identical E-MiniC module (K052582) and equivalent optional thermal recorder module as the predicate B125/B105 (K171580).

As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 interfaces to a variety of existing central station systems via a cabled or wireless network interface. The wireless interface is implemented with the identical integrated WIFI module (WLAN module type: B1x5-01. FCC ID: OU5B1X501) as used in the predicate Monitor B125/B105 (K171580).

As with the predicate Monitor B125/B105 (K171580), proposed Monitor B105/B125 includes features and subsystems that are optional or configurable. It can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided document is a 510(k) Premarket Notification for the GE Medical Systems Information Technologies, Inc. Monitor B125/B105. It details the device's indications for use, its equivalence to predicate devices, and the non-clinical tests performed to support its substantial equivalence.

However, the document explicitly states in Section "14. Clinical (807.92(b)(2)): Summary of Clinical Tests:" that "the proposed Monitor B125/B105 did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide information regarding acceptance criteria and a study that proves the device meets them because:

• No clinical study was conducted. The submission relies on substantial equivalence to existing predicate devices and non-clinical testing.
• Acceptance criteria related to performance metrics for clinical outcomes (e.g., sensitivity, specificity for arrhythmia detection in a clinical trial setting with human readers) are not present in this document as no such clinical study was performed. The acceptance criteria for the device's performance would be related to its ability to accurately measure and display physiological parameters, which was assessed through non-clinical bench testing and comparison to predicate devices, not through a clinical trial with a test set of patient data and expert ground truth.

Because no clinical study was performed as part of this 510(k) submission, the requested information elements (1-9) which pertain to a clinical study evaluating device performance, cannot be extracted from this document. The document focuses on demonstrating substantial equivalence based on technological characteristics and non-clinical performance, rather than providing results from a new clinical efficacy or effectiveness study.

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

The GE Datex-Ohmeda Aisys CS2 is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, Aespire, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals.

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

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

The anesthetic agent delivery for the Aisys CS2 is controlled via an anesthesia computer through user input from the central display. The vaporization technology is based upon the electronic vaporizer cleared as part of the Datex-Ohmeda Anesthesia Delivery Unit (ADU) cleared via K973985. An Aladin 2 is inserted into the active cassette bay. The cassette holds the agent to be delivered - Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys CS2 is designed to allow only one active cassette at a time. Per the user input into the main display, valves within the active cassette bay will open and allow agent to be delivered. The agent is mixed with gas from the FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aisys CS2. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices.

Ventilator modes for the device include Volume Control (VCV) Mode, Pressure Control (PCV) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control Ventilation -Volume Guaranteed (SIMV/PCV-VG) Mode, Synchronized Intermittent Mandatory Ventilation with Pressure Support Ventilation (SIMV/PSV) Mode, Pressure Support with Apnea Backup (PSVPro) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control (SIMV-PC) Mode (Optional), Pressure Control Ventilation- Volume Guaranteed (PCV-VG) mode (Optional), and Continuous Positive Airway Pressure/ Pressure Support Ventilation (CPAP-PSV).

Ventilator parameters and measurements are displayed on the system display unit.

The system display unit is mounted to an arm on the top shelf of the Aisys CS2. The arm is counter balanced and capable of moving vertically and/or horizontally, and tilting the display, enabling the user to position the display to the most advantageous viewing position. The arm length is limited such that the display position is always within the footprint of the Aisys CS2 frame. The arm also supports the mounting of additional display units for a variety of patient monitors.

Several frame configurations are available, including one that allows for the physical integration of the GE Monitors (cleared Carescape B850 via K092027 and B650 cleared on K102239). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Aisys CS2 frame. An additional option allows the monitor to be linked to the power supply of the Aisys CS2 such that when the Aisys CS2 is turned on, the monitor is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys CS2.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

4. Adjudication method for the test set

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

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

Instead, the document focuses on:

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40i is intended for use under the direct supervision of a licensed health care practitioner. The B40i is not intended for use during MRI. The B40i can be a stand-alone monitor or interfaced to other devices via a network. The B40i monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

The proposed monitor B40i is a multi-parameter patient monitor that is developed based on the predicate Monitor B40 (K133576) platform. The proposed monitor B40i provides support for optional modules (E-Entropy module (K061907) and CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195). The proposed monitor B40i is also compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) but with disabled spirometry function. The proposed monitor B40i supports Airway Gas Option (N-CAiO). The proposed monitor B40i expands the impedance respiration parameter feature to cover the neonatal patient population compared to the predicate Monitor B40 (K133576). This parameter feature patient population extension to cover neonatal patient population uses Patient Data Module as predicate (K071073), which impedance respiration implementation especially concerning the algorithm used is based on the predicate Aware Transport (K042642). The proposed monitor B40i utilizes 12 inch LCD display panel and LED backlight with an integrated keypad and a pre-configuration patient parameter measurement module. The proposed monitor B40i interfaces with the optional E-MiniC (K052582) and Thermal Recorder with an extension rack. As with the predicate Monitor B40, the proposed monitor B40i includes features and subsystems that are optional or configurable. The proposed monitor B40i interfaces to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40, the proposed monitor B40i has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text is a 510(k) Summary for the GE Healthcare B40i Patient Monitor. This document describes the device and its claimed substantial equivalence to predicate devices, but it does not contain a study demonstrating that the B40i device meets specific acceptance criteria based on performance data.

The document primarily focuses on:

• Device Description and Intended Use: Outlining what the B40i monitors (ECG, SpO2, NIBP, temperature, airway gases, Entropy) and for which patient populations (adult, pediatric, neonatal) and environments (hospital, intra-hospital transport).
• Comparison to Predicate Devices: A detailed table comparing the B40i to similar legally marketed devices (Monitor B40 and Patient Data Module), highlighting that most features/functions are identical or enhanced (e.g., neonatal impedance respiration expanded).
• Summary of Non-Clinical Tests: Listing the quality assurance measures and voluntary standards (IEC, AAMI, ISO) with which the device complies. This indicates that safety and performance were tested according to recognized standards.
• Statement on Clinical Tests: Explicitly stating that "No additional clinical tests were performed for proposed monitor B40i."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from this document. The document relies on comparison to predicate devices and compliance with standards to establish substantial equivalence, rather than presenting a novel performance study with specific acceptance criteria.

However, I can extract the acceptance criteria implied by the comparison to predicate devices and the listed standards, and present the device's reported performance as stated for the predicate devices, since the submission claims substantial equivalence and often refers to the same performance specifications.

Based on the provided K143676 510(k) Summary, here's what can be inferred and extracted, recognizing that this document does not present a new performance study with specific acceptance criteria for the B40i itself, but rather establishes equivalence to predicate devices which presumably met these criteria:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The device claims to be substantially equivalent to its predicates, which means its performance should meet or exceed the performance of the predicate if they are identical. The acceptance criteria are typically defined by recognized international standards (e.g., AAMI, IEC, ISO) and the specifications of the predicate devices. The reported device performance for the B40i is stated as identical to the predicate device's performance for most parameters.

Regarding the study that proves the device meets the acceptance criteria:

The document explicitly states: "No additional clinical tests were performed for proposed monitor B40i."
Instead of a new performance study for the B40i, the submission relies on bench testing against voluntary standards and comparison to legally marketed predicate devices (K133576 Monitor B40 and K071073 Patient Data Module) to demonstrate substantial equivalence. The argument is that the B40i's fundamental technology, performance specifications, and intended use are sufficiently similar to (or improved upon but within the same performance envelope as) the predicate devices, which were previously cleared by the FDA.

Therefore, for questions 2-9 requiring details about a study, the direct answer based on this document is that no new clinical performance study with specific acceptance criteria for the B40i was conducted or presented. The device's performance is asserted through comparison and compliance with standards.

Here's an attempt to answer the remaining points based on the understanding that no new performance study specific to the B40i is detailed here:

2. Sample size used for the test set and the data provenance: Not applicable, as no new clinical or performance test set for the B40i is described in this document. Performance claims are based on substantial equivalence to predicate devices and compliance testing to standards, but details of those predicate studies' sample sizes or data provenance are not provided here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance testing would typically be established during the development and clearance of the predicate devices or through standard reference methods. This document does not detail such for the B40i.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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: Not applicable. This is a patient monitor, not an AI-powered diagnostic imaging device involving human reader interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device as a "multi-parameter patient monitor" which inherently has a standalone monitoring function. Performance measurements like SpO2 accuracy, NIBP accuracy, ECG arrhythmia detection (algorithms like EKPRO V12 and SuperStat DINAMAP) are implicitly standalone algorithm performances tested against specified accuracy ranges as part of standard compliance. However, details of such tests (e.g., specific test protocols, datasets) for the B40i are not provided beyond the statement of compliance to standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For parameters like SpO2 and NIBP, ground truth would typically be established using invasive reference methods (e.g., co-oximetry, arterial line) for physiological signals. For ECG/arrhythmia, it would involve expert review of annotated ECG waveforms, often from standard databases. The B40i relies on algorithms (EKPRO V12, SuperStat) that were validated against such ground truths during their initial development and predicate device clearances.
8. The sample size for the training set: Not applicable to this FDA submission for the B40i. Training sets relate to algorithm development. The document refers to existing algorithms (e.g., EKPRO V12 for ECG, SuperStat DINAMAP for NIBP, Nellcor/Masimo for SpO2) from predicate devices or modules. Details of their training sets are not included here.
9. How the ground truth for the training set was established: Not applicable, for the reasons mentioned in point 8.

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

• Adjudication Method: N/A

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner.

The Monitor B40 is not intended for use during MRI.

The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network.

The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring.

Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

The proposed Monitor B40V2.1 still is a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2 (K130584) and now includes supporting for an additional optional extension module Airway Gas Option (N-CAiO), and few software improvements by adding alarm breakthrough, extending the upper limit of ECG PVC (Premature Ventricular Contraction) alarm and providing four waveform scale options for Masimo SpO2 and Nellcor SpO2. Same as the predicate Monitor B40V2 (K130584), the proposed Monitor B40V2.1 continues interfacing with following optional extension modules: E-MiniC module (K052582), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and E-Entropy module (K061907). The compatibility with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) is also provided but with spirometry function disabled.

The proposed Monitor B40V2.1 still has a 12.1 inch LCD display but is from different LCD manufacturer and LCD backlight is changed from CCFL to LED due to RoHS compliance.

As with the predicate Patient Monitor B40V2 (K130584), the proposed Patient Monitor B40V2.1 still includes features and subsystems that are optional or configurable. The proposed Patient Monitor B40V2.1 will continue interfacing to a variety of existing central station systems via a cabled network interface.

As with the predicate Patient Monitor B40V2 (K130584), the proposed Patient Monitor B40V2.1 keeps a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text describes a 510(k) premarket notification for a multi-parameter patient monitor (Monitor B40V2.1) and its substantial equivalence to a predicate device, the Monitor B40V2 (K130584).

Here's an analysis of the requested information:

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

The document does not explicitly present a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics for an AI/algorithm. Instead, the "acceptance criteria" are implied by the determination of "substantial equivalence" to a predicate device. The performance is assessed based on whether the changes made to the device have a significant impact on its ability to obtain patient measurements.

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

The document explicitly states: "The proposed Monitor B40V2.1 did not require clinical studies to support substantial equivalence." Therefore, there is no test set sample size and no data provenance mentioned for a clinical study related to this specific device (B40V2.1). The evaluation was based on non-clinical tests and a comparison to the predicate device.

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

Since no clinical studies were performed for the B40V2.1, there were no experts used to establish ground truth for a test set. The evaluation relies on the established safety and efficacy of the predicate device and the non-clinical assessment of the changes.

4. Adjudication method for the test set:

As no clinical test set was used, there was no adjudication method employed.

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 MRMC comparative effectiveness study was done as this device is a multi-parameter patient monitor, not an AI or imaging diagnostic tool that would typically involve human "readers" in the context of AI assistance. The focus is on the device's ability to continuously monitor physiological parameters.

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

The device is a standalone multi-parameter patient monitor, meaning it operates to collect and display physiological data. However, the evaluation described is not a "standalone algorithm performance" study in the typical sense of AI, but rather a demonstration of the device's inherent functionality as a medical instrument. No specific algorithm-only performance study details are provided beyond the statement that "there are no changes to the parameter measuring hardware."

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

For the specific device (Monitor B40V2.1), no explicit ground truth based on expert consensus, pathology, or outcomes data was used because clinical studies were not required. The "ground truth" for demonstrating substantial equivalence was effectively the established performance and safety of the predicate device (Monitor B40V2) and the assessment that the changes introduced did not alter these fundamental aspects. The non-clinical tests (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing) are intended to ensure the device performs as intended and meets relevant standards.

8. The sample size for the training set:

Not applicable. This document describes a traditional medical device (patient monitor) and its modifications, not an AI/machine learning algorithm requiring a "training set."

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

Not applicable for the same reason as above.

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

The GE Datex-Ohmeda Aisys CS2 is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, Aespire, Aisys, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals. The Aisys CS2 supplies set flows of medical gases to the breathing system using electronic gas mixing. Interfaces to control the system include the touch screen, keypad and rotary controller on the main display unit. Selected gas flows are displayed as electronic flow indicators on the system display unit. The Aisys is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizer cassettes are available to give the user control of the system configuration. The Aisys CS systems are also available in pendant models. The system shall support a maximum of two-cylinder supply connections mounted inboard on the machine and supported by cylinder yokes. All models have O2. The Aisys CS comes with up to two optional gases (air, N2O). Safety features and devices within the Aisys are designed to decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures. The Aisys CS system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above cleared via K001814) and E-Gas Module (E-CAiOVX software revision 4.5 and above cleared via K051092). CARESCAPE Modules are also available for Aisys CS' (EsCAiO, E-sCAiOV cleared via K123195). The above modules can be physically integrated into the Anesthesia device, receive electronic power from the said device and communicate measured values to the said device for display on the system display unit. The anesthetic agent delivery for the Aisys CS2 is controlled via an anesthesia computer through user input from the central display. The vaporization technology is based upon the electronic vaporizer cleared as part of the Datex-Ohmeda Anesthesia Delivery Unit (ADU) cleared via K973985. An Aladin cassette (also cleared as part of K973895) or Aladin, is inserted into the active cassette bay. The cassette holds the agent to be delivered - Halothane. Enflurane. Isoflurane. Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys is designed to allow only one active cassette at a time. Per the user input into the main display, valves within the active cassette bay will open and allow agent to be delivered. The agent is mixed with gas from the FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient. The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aisys Anesthesia System. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Mode (Optional) and Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional) and Continuous Positive Airway Pressure / Pressure Support Ventilation (CPAP/PSV) Mode (Optional). Aisys CS2 also supports optional Pressure Control Ventilation - Volume Guarantee mode with spontaneous breath pressure support (SIMV PCV-VG) mode (Optional). Ventilator parameters and measurements are displayed on the system display unit. The system display unit is mounted to an arm on the top shelf of the Aisys CS. The arm is counter balanced and capable of moving vertically and/or horizontally, and also tilting the display, enabling the user to position the display to the most advantageous viewing position. The arm length is limited such that the display position is always within the footprint of the Aisys CS2 frame. The arm also supports the mounting of additional display units for a variety of patient monitors. Several frame configurations are available, including one that allows for the physical integration of the GE Monitors (cleared Carescape B850 via K092027 and B650 cleared on K102239). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Aisys CS frame. An additional option allows the monitor to be linked to the power supply of the Aisys CS2 such that when the Aisys CS2 is turned on, the monitor is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys CS.

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

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

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

Acceptance Criteria and Device Performance

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

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

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

Study Details

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

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

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

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

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

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

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

• MRMC Study: No, an MRMC study was not done. This device is an anesthesia system, not an AI-assisted diagnostic tool for human readers.

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

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

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

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

8. The sample size for the training set:

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

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

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

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

The GE Datex-Ohmeda Avance CS2 anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). They represent one of the systems in a long line of products based on the Datex-Ohmeda Excel. Aestiva, and Aespire Anesthesia Systems. Avance systems are to be used only by trained and qualified medical professionals trained in the administration of general anesthesia.

The Avance and Avance CS2 anesthesia systems supply set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the electronic controls on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance systems are equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames options including central brake or individual caster brakes, gases, and vaporizers are available to give the user control of the system configuration. The Avance systems are also available in pendant models. Avance systems are available with two or three gases, up to three vaporizer positions and up to three cvlinder connections. All models have O2. The Avance systems come with up to two optional gases (air, N2O).

The Avance systems accept Tec 6 Plus and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance systems are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance systems are available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the GE Compact Gas Airway Modules Series: M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above cleared via K001814) and E-Gas Compact Gas Airway Module (E-CAiOVX software revision 3.2 and above cleared via K051092) which can be physically integrated into the Avance, receive electronic power from the Avance and communicate measured values to the Avance for display on the system display unit. In addition to M-Gas and E-gas modules, the Avance CS- can utilize the GE CARESCAPE Respiratory Module (E-sCAiO, E-sCAiOV cleared via K123195).

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber. bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Control Ventilation (VCV), Pressure Control Ventilation (PCV) (optional), Synchronized Intermittent Mandatory Ventilation/Pressure Support (SIMV/PSV) (optional), Pressure Support Ventilation (PSVPro) (optional), Synchronized Intermittent Mandatory Ventilation-Pressure Control (SIMV-PC) (optional), Pressure Control Ventilation-Volume Guaranteed (PCV-VG) (optional), Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV), Pressure Control Ventilation-Volume Guaranteed with Pressure Support Ventilation (SIMV PCV-VG) (optional), and Volume Control Ventilation Mode for Cardiac Bypass Mode (optional). Ventilator parameters and measurements are displayed on the system display unit.

Several frame configurations are available, including one that allows for the physical integration of the GE Monitor Series (cleared Carescape B850 via K092027 and B650 cleared on K102239). These configurations also provide cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Avance frame. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Avance.

The provided text is a 510(k) summary for the GE Datex-Ohmeda Avance CS2 Anesthesia System. It details the device's description, intended use, and a comparison to a predicate device. However, it explicitly states that no clinical testing was required or conducted for the modifications made to this version of the device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them, as these are typically derived from clinical or comprehensive performance studies which were not performed in this case.

Specifically, the document states:

• "The modifications made to the GE Datex-Ohmeda Avance CS2 did not require clinical testing. The functionality of the modified features was completely evaluated by performing nonclinical tests of design verification and validation testing."

Without a clinical study or a study specifically designed to establish performance against acceptance criteria, I cannot fill out the requested table or provide details on sample sizes, expert involvement, ground truth establishment, or comparative effectiveness.

The only "testing" mentioned is nonclinical verification and validation testing, which includes:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation)

This nonclinical testing served to confirm that the changes made (primarily updated labeling to include the use of an optional CARESCAPE respiratory module) did not alter the fundamental scientific technology or indications for use, and that the device remained substantially equivalent to its predicate.

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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

The proposed Monitor B40V2 is a multi-parameter patient monitor that is developed based on the predicate Monitor B40V1 (K120598) platform. The proposed Monitor B40V2 provides additional support for optional modules (E-Entropy module (K061907) and CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) compared with predicate Monitor B40V1 (K120598). The proposed Monitor B40V2 is also compatible with CARESCAPE Respiratory modules (E-sCOV and EsCAiOV)(K123195) but with disabled spirometry function. The proposed Monitor B40V2 utilizes the existing 12 inch LCD display with an integrated keypad and a pre-configuration patient parameter measurement module. The proposed Monitor B40V2 will continue to interface with the optional E-MiniC (K052582) and Thermal Recorder with an extension rack. As with the predicate Monitor B40V1, the proposed Monitor B40V2 includes features and subsystems that are optional or configurable. The proposed Monitor B40V2 interfaces to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V1, the proposed Monitor B40V2 has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

This document describes the GE Monitor B40V2, a multi-parameter patient monitor. The primary focus of the provided text regarding acceptance criteria and studies is on the SpO2 accuracy performance for the neonatal patient population.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifically mentions an SpO2 accuracy performance study for the neonatal population. However, it does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges or statistical thresholds) within the provided text. It only reports that the study "demonstrated SpO2 accuracy performance."

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "Neonatal patient population" for the clinical study.
• Data Provenance: Not explicitly stated in the provided text regarding country of origin. The study was a "Clinical study of the GE SpO2 TruSignalV2 on Neonatal patient population." It is described as a prospective study since it was a "clinical study" performed "in accordance to ISO 14155-1, ISO14155-2, ISO9919 and FDA Guidance."

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

Not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

Not explicitly stated in the provided text.

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

No, an MRMC comparative effectiveness study was not done. The study described is a clinical study for SpO2 accuracy in neonates, not a comparison of human reader performance with and without AI assistance.

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

Yes, a standalone performance study was done. The clinical study was performed to demonstrate the "SpO2 accuracy performance of the TruSignal V2 technology on the neonate population," which implies an evaluation of the algorithm's performance independent of human interpretation.

7. The Type of Ground Truth Used

The ground truth for the SpO2 accuracy study would typically be established by a co-oximeter or a reference device known to precisely measure arterial oxygen saturation (SaO2) from blood samples. While not explicitly stated as "co-oximetry," clinical studies for SpO2 accuracy universally rely on such reference measurements.

8. The Sample Size for the Training Set

Not applicable/Not stated. The document refers to a clinical study for performance demonstration, not the training of an AI algorithm. The device primarily consists of a "TruSignal V2 algorithm" which is likely a fixed, developed algorithm, not one that undergoes continuous training in the context described.

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

Not applicable/Not stated. As above, this document describes performance testing of a developed algorithm, not the training phase.

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