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The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as:

• ECG: Heartrate, Respiration Rate ・
• Invasive Blood Pressure: systolic, diastolic and mean pressure -
• Temperature: temperature ー
• Non Invasive Blood Pressure: systolic, diastolic and mean pressure -
• CO2, etCO2 and CO2ins -
• SpO2: SpO2 and pulse rate -

There is alarm handling for all parameters except temperature.

The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input.

The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as: ECG, Invasive Blood Pressure, Temperature, Non Invasive Blood Pressure, CO2, etCO2, CO2ins, SpO2, and pulse rate. There is alarm handling for all parameters except temperature. The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input. The system is intended for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

The provided document is a 510(k) summary for the SCHILLER AG Argus LCM Monitoring System, comparing it to predicate devices. It states that the device is "as safe and effective as" the predicate devices and passed relevant electrical safety and software quality tests. However, it does not contain the specific information requested about acceptance criteria and a study proving those criteria are met in the format of the output.

Specifically:

• Acceptance Criteria and Reported Device Performance Table: The document lists standards passed for various components (e.g., IEC 60601-1 for System, IEC 60601-2-2 for ECG). However, it does not provide specific acceptance criteria values (e.g., accuracy +/- X%) or numerical reported device performance against those criteria. Instead, it generally states "All tests are passed" or refers to compliance with standards.
• Sample size and data provenance for test set: Not available. The document states "B2 Clinical Tests: n.a." (not applicable), indicating no clinical tests were performed for this submission. The non-clinical tests mentioned are electrical safety and software quality.
• Number of experts and qualifications for ground truth: Not applicable, as no clinical study with ground truth established by experts is described.
• Adjudication method for test set: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable, as the device is a monitoring system and the performance evaluation focuses on hardware components and electrical safety, not an algorithm's standalone diagnostic performance.
• Type of ground truth used: Not applicable, as no clinical study is described. The "ground truth" for the non-clinical tests would be the specifications and requirements of the standards themselves.
• Sample size for training set: Not applicable, as no machine learning algorithm development is described in detail that would require a 'training set'. The software quality section refers to software requirements, development, verification, validation, and testing, but not in the context of a machine learning model.
• How ground truth for training set was established: Not applicable.

Therefore, since the document pertains to a medical device submission primarily focused on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, the requested clinical study-centric details are not present.

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The CAS 740 Series Vital Signs Monitor is indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients, in the care of health professionals.

The CAS 740 Monitor is a replacement monitor based on the existing 9303 Vital Signs Monitor, and the CAS 9001 or 9002 EMS monitors. The 740 are primarily a repackaging of these monitors. The primary parameter is non-invasive blood pressure, which is included in all models. Blood pressure measurement is based on oscillometric technology. The additional two parameters are pulse oximetry and temperature. A purchaser has pulse oximetry choices that include modules manufactured by Masimo, Nellcor or Nonin. The temperature parameter utilizes predictive technology from SureTemp (Welch Allyn Inc.). The monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, features include an easily replaceable Nickel Metal Hydride rechargeable battery pack, wireless infrared printer communication, and many more.

The provided document describes the CAS 740 Series Monitor, a vital signs monitor, and details its equivalence to predicate devices, not an AI/ML powered device. Therefore, the questions related to AI/ML specific studies, such as multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for training sets, are not applicable.

However, the document does provide information regarding acceptance criteria and a study for the Non-Invasive Blood Pressure (NIBP) component.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that the clinical studies for NIBP were conducted in accordance with AAMI SP10:2002. The AAMI SP10 standard (now ISO 81060-2) typically requires a minimum of 85 subjects for clinical validation to ensure a statistically robust evaluation of NIBP device accuracy. The document does not specify the exact number of subjects or the country of origin, nor whether the data was retrospective or prospective, beyond stating "clinical studies."

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

For Non-Invasive Blood Pressure measurements validated against a standard like AAMI SP10, the "ground truth" is typically established by simultaneously taken reference blood pressure measurements (e.g., intra-arterial measurements or trained auscultatory measurements using a mercury sphygmomanometer) by qualified healthcare professionals. The document does not specify the exact number or qualifications of these professionals beyond implying adherence to the AAMI SP10 standard, which mandates specific protocols for reference measurements.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method in the context of expert consensus, as this is not typically applicable for NIBP accuracy studies where direct physiological measurements serve as the reference. Adherence to AAMI SP10 implies a standardized method for obtaining reference measurements.

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

No. This is not applicable as the CAS 740 Series Monitor is a vital signs monitor and not an AI/ML powered device requiring interpretation of medical images or data by multiple readers.

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

Yes, for the Non-Invasive Blood Pressure component, standalone performance was assessed. The document states: "CAS has tested and demonstrated ND Plus performance equivalent to the NB module in bench test simulations." This refers to the algorithm's performance in simulation without human interaction to interpret the NIBP readings. Additionally, the clinical studies, while involving patients, assess the device's ability to accurately measure blood pressure on its own.

7. The Type of Ground Truth Used

For the Non-Invasive Blood Pressure (NIBP) component, the ground truth was based on reference blood pressure measurements obtained according to the AAMI SP10:2002 standard during clinical studies. These are direct physiological measurements.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/ML algorithm. The NIBP measurement relies on oscillometric technology and algorithms that were likely developed and refined using physiological data, but the term "training set" with specific size is not mentioned for this type of device.

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

As there is no mention of a "training set" in the AI/ML context, this question is not directly applicable. The underlying algorithms for oscillometric NIBP would have been developed and validated against a combination of empirical data and theoretical models of blood pressure oscillations, with accuracy verified through extensive testing against established reference methods.

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The 2120is Maternal/Fetal Monitoring System is intended for monitoring fetal and maternal vital signs: fetal heart rate; fetal heart rate high/low/poor signal quality alarms; maternal uterine activity; heart/pulse rate, blood pressure, nondiagnostic maternal ECG and %SpO2. Optional fetal movement detection is available.

A Corometrics 2120is Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). Fetal movement detection and fetal heart rate alarm options (user selectable high/low and poor signal quality alarms) are available.

A Corometrics 2120is Maternal/Fetal Monitoring System is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with these monitor configurations are summarized as follows:

NOTE: Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms.

Blood Pressure: The monitor is intended for use in the non-invasive monitoring of maternal blood pressure (NBP). This monitor is not intended for use in the neonatal or pediatric blood pressure monitoring.

Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of maternal functional oxygen saturation of arterial hemoglobin (MSpO2).

Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of the maternal heart/pulse rate. Additionally, an MECG waveform "snapshot" may be displayed and printed.

NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.

Bed-to-bed surveillance is available when 2120is Series Monitors are networked together.

The 2120is Maternal/Fetal Monitoring System consists of the following features/options that can be available in multiple configurations:

• fetal heart rate (via Doppler Ultrasound of FECG)
• maternal uterine activity (via intrauterine pressure catheter or tocotransducer
• fetal movement detection
• maternal non-invasive blood pressure (clinician prompted or automatic)
• maternal pulse oximetry
• maternal heart/pulse rate (MECG) and ECG waveform "snapshot"

The 2120is is a full-featured maternal/fetal monitor. The device is also capable of providing bed-to-bed surveillance when multiple 2120is monitors are connected via an Ethernet network. The monitor is also capable of acting as a bedside terminal to the QS system. In this capacity, the 2120is monitor provides the features of a standard PC QS bedside terminal.

The provided text describes the 510(k) summary for the Corometrics Model 2120is Maternal/Fetal Monitor. It outlines the device description, intended use, and indicates that the device's technology is the same as its predicate devices. However, the document does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the way typically found for AI/ML-based medical devices.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through:

• Compliance with voluntary standards: This is a common approach for traditional medical devices.
• Internal validation processes: Requirements specification review, code inspections, software and hardware testing, safety testing, environmental testing, and final validation.

Therefore, the requested information cannot be fully provided as the submission does not contain details about:

• A table of acceptance criteria with reported performance metrics like sensitivity, specificity, or AUC.
• Sample sizes for test sets, data provenance, or expert ground truth establishment for performance evaluation.
• Adjudication methods, MRMC studies, or standalone algorithm performance.
• Training set details or ground truth establishment for a machine learning model.

This is consistent with the nature of a 510(k) submission for a non-AI/ML device where the focus is on demonstrating substantial equivalence to a legally marketed predicate through adherence to standards and robust internal development/testing processes, rather than a prospective clinical performance study with specific metrics.

Summary of what can be extracted/inferred:

• Compliance with voluntary standards.
• Successful completion of internal validation steps: Requirements specification review, Code inspections, Software and hardware testing, Safety testing, Environmental testing, Final validation.
  The reported performance is that the device "is as safe, as effective, and performs as well as the predicate device" (Corometrics Model 2120is Maternal/Fetal Monitor and Masimo SET® Pulse Oximetry). |
  | 2. Sample size for test set and data provenance | Not applicable/not provided. The submission focuses on device engineering, safety, and functional testing rather than a clinical performance study with a test set of patient data for an algorithm. |
  | 3. Number of experts and qualifications for ground truth (test set) | Not applicable/not provided. |
  | 4. Adjudication method (test set) | Not applicable/not provided. |
  | 5. MRMC comparative effectiveness study and effect size | No. This is not an AI/ML device, so such a study is not relevant or performed. |
  | 6. Standalone (algorithm only) performance study | No. This is a hardware monitor, not an algorithm. |
  | 7. Type of ground truth used | For the functional and safety testing, the "ground truth" would be established by engineering specifications, regulatory standards, and expected physiological responses, verified through direct measurement and comparison to known accurate instruments (e.g., during calibration and validation for SpO2 or NIBP). |
  | 8. Sample size for the training set | Not applicable/not provided. This is not an AI/ML device that requires a "training set" in the machine learning sense. |
  | 9. How the ground truth for the training set was established | Not applicable/not provided. |

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The indications for use for the Passport 2™ include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3 or 5 lead measurements
• Heart Rate derived from selected sources (SpO2, ECG, IBP, NIBP)
• Blood Oxygenation (SpO2 )* measurement/waveform
• ST Segment Analysis
• . . Lethal Arrhythmia Detection
• Non Invasive Blood Pressure (NIBP) measurement
• . Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites
• Respiration Rate/ waveform derived from ECG or CO2
• CO2 . Inspired and end tidal mainstream/waveform
• Temperature measurement via YSI 400/700 series probes
  The target populations are adult, pediatric and neonate with the exception of the Lethal Arrhythmia Detection and ST Segment Analysis for which the target populations are adult and pediatric only. The monitor is intended for use in the health care facility setting.
  The Passport 2 has the capability of interfacing with Datascope's Gas Module II, displaying the measurements of Anesthetic Gases, O3, N2O, and CO2.

• The Passport 2 monitors the SpO2 parameter via the Masimo SET® 2000 Pulse Oximeter Technology and Accessories (K990966). The Masimo SET® 2000 Pulse Oximeter Technology and Accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO,) and pulse rate (measured by an SpO2, sensor) and are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities. mobile, and home environments.

Passport 2 is a transportable, multi-parameter physiological monitor designed to monitor ECG, Heart Rate derived from selected source (SpO2, ECG, IBP and NIBP), SpO2 level, ST Segment (adult and pediatric only), Arrhythmia (adult and pediatric only), Blood Pressure (both Invasive and Non-Invasive), Respiration Rate (derived from ECG or CO2), CO2 and Temperature, and for adult, pediatric, and neonatal patients who are under the care of a physician, within the confines of a health care facility.
The Passport 2 can display measurements of five Anesthetic Gases (Halothane, Enflurane, Isoflurane, Sevoflurane, and Desflurane), O2, No O, and CO2 via connection to the stand alone Gas Module II ( K974903). The optional MediCO2 Microstream™ CO2 module (K964239), which uses the Oridion Microstream™ CO2 provides EtCO2, FiCO2 and Respiration Rate monitoring.
The optional built-in recorder provides hard copies of all digital data and waveforms as well as Tabular & Graphic Trend Information. Through its Comm Port the Passport 2 can communicate with the Visa Central Station (K913576), Gas Module II (K974903), Defibrillator (K930548), a Hospital's Nurse Call System or a Remote Color Display.

The provided 510(k) summary for the Datascope Passport 2™ Vital Signs Monitor describes its intended use and general performance testing, but it does not contain specific acceptance criteria tables nor detailed studies proving the device meets those criteria.

Instead, the document primarily:

• Identifies legally marketed predicate devices to establish substantial equivalence.
• States that the device has undergone "extensive safety and performance testing" to ensure it "meets all functional requirements and performance specifications" and complies with various industry standards (e.g., ANSI/AAMI EC13, IEC 60601-1 series).
• Mentions that certain components (NIBP system, SpO2 system, CO2 module, Gas Module II) are identical to or incorporate technology from previously cleared devices, making their performance substantially equivalent by reference.

Therefore, many of the requested details about specific acceptance criteria and the studies proving their achievement are not explicitly present in the provided text.

However, I can extract and infer information where possible based on the text provided.

Acceptance Criteria and Device Performance

The document does not provide a table of specific numerical acceptance criteria for each physiological parameter (e.g., accuracy range for NIBP, arrhythmia detection sensitivity/specificity) and the reported performance. It only states that the device was tested to "meet all functional requirements and performance specifications."

For example, for Non-Invasive Blood Pressure (NIBP), it notes:

• Acceptance Criteria (Implied): The NIBP measurement system used in the Passport 2 is the same as that used in Datascope's Accutorr Plus NIBP monitor (K983575). Therefore, the implied acceptance criteria would be those met by the Accutorr Plus, likely conforming to standards like ANSI/AAMI SP-10.
• Reported Device Performance: Not explicitly stated for Passport 2, but stated to be "identical" to the Accutorr Plus NIBP monitor.

Similarly, for SpO2:

• Acceptance Criteria (Implied): The SpO2 measurement system is the same as that used in the Masimo SET 2000 Pulse Oximeter (K974903 and K990966). The implied acceptance criteria would be those met by the Masimo SET 2000, likely conforming to standards like ISO 80601-2-61.
• Reported Device Performance: Not explicitly stated for Passport 2, but stated to be "identical" to the Masimo SET 2000 Pulse Oximeter.

For other parameters (ECG, Arrhythmia, Respiration Rate, CO2, Temperature), the document states that the Passport 2 was tested to comply with relevant standards (e.g., ANSI/AAMI EC13 and EC 11, AAMI ECAR-1987, EN 864-1997, EN 865-1997, IEC 60601-2-27, IEC 60601-2-30). However, the specific performance values (e.g., error margins, sensitivity/specificity rates) are not quantified in this summary.

Detailed Study Information (Based on Available Text)

Since no specific studies are detailed within this 510(k) summary, the following points are based on what can be inferred or stated as not provided:

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

   • Not provided in this summary. The document broadly states that the device "meets all functional requirements and performance specifications" and complies with various standards. For NIBP and SpO2, it refers to the performance of previously cleared devices whose technology is incorporated.

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 in this summary. Details on specific test subjects (number, age, health status) or the nature of data (retrospective/prospective, origin) for any performance testing are absent. The primary testing mentioned is "safety and performance testing" which generally implies in-house verification and validation, possibly against simulators or human subjects for certain parameters, but details are missing.

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 provided in this summary. Ground truth establishment, if applicable to the device's functions (e.g., for arrhythmia detection comparison), is not discussed. For vital sign monitors, ground truth is typically established by reference devices or calibrated instruments.

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

   • Not provided in this summary. Adjudication methods are typically relevant for subjective assessments or expert consensus in interpretation tasks, which are not detailed here for a vital signs monitor.

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 vital signs monitor, not an AI-assisted diagnostic tool that involves "human readers" interpreting "cases" or "effect sizes of human improvement with AI." Its function is direct physiological measurement and display.

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

   • Yes, implied. The device itself is a standalone monitor that performs measurements (e.g., ECG, NIBP, SpO2) and algorithms (e.g., arrhythmia detection, ST segment analysis) without requiring human interpretation for its core function. Testing would focus on the accuracy and reliability of these algorithms against reference standards. The summary states "Final testing for the monitor included various performance tests designed to ensure that the device meets all functional requirements and performance specifications." This directly points to standalone performance testing.

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

   • Implied by device type. For vital signs monitors, ground truth is typically established using:
     • Reference standard instruments: For parameters like SpO2 (e.g., co-oximetry), NIBP (e.g., invasive arterial line measurement or a highly accurate reference NIBP device), Temperature (calibrated thermometer).
     • Standardized waveforms/inputs: For ECG feature detection (e.g., arrhythmia detection, ST segment analysis), validated databases of ECG signals or simulated signals with known characteristics may be used.
   • Explicit details are not in the summary.

8. The sample size for the training set:

   • Not applicable/Not provided. This document describes a traditional medical device, not a machine learning or AI-based system that uses a "training set" in the context of data-driven model development. The algorithms for vital sign processing in this device would have been developed through engineering principles, signal processing, and physiological modeling, not through training on large datasets in the modern AI sense.

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

   • Not applicable/Not provided. As stated above, there is no "training set" in the AI/ML sense described for this device.

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