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McKesson Cardiology™ Hemo is intended for complete physiological/hemodynamic monitoring. clinical data acquisition, medical image and data processing, and analytical assessment.

McKesson Cardiology™ Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, storing, storing, carrying, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.

McKesson Cardiology™ Hemo is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed.

User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses.

Use of the system is not intended for unattended patient monitoring or in situations where arrhythmia detection is required.

The McKesson Cardiology™ Hemo device is a hemodynamic monitoring system for monitoring vital signs, performing measurements and calculations, documenting procedure and patient data and interfacing to other systems and devices during and after procedures in the areas of in the areas of: cardiology, cardiac catheterization, electrophysiology, invasive radiology, and other areas where patient/procedural data management is needed.

McKesson Cardiology™ Hemo also acquires patient information from other hospital information systems and makes hemodynamic information available to them. It facilitates seamless interfacing with hospital information systems and cardiac image management, archiving and reporting systems.

McKesson Cardiology™ Hemo incorporates the FDA cleared the ARGUS PB vital signs monitoring device (K012226), manufactured by Schiller AG, which provides patient monitoring via:

• ECG leads .
• Invasive Blood Pressure (non-McKesson transducers) .
• SpO2 sensor .
• Non-invasive blood pressure (NIBP) cuff .
• . Temperature probe
• . Thermal Dilution Cardiac output temperature probe (connected to a non-McKesson Cardiac Output catheter)
• . CO2 (connected to non-McKesson cannulas or intubation tubes)

Disposables and accessories (transducers, cannulas and intubation devices) are not part of the McKesson Cardiology™ Hemo system, but are supplied by the end user facility as required.

McKesson Cardiology™ Hemo is composed of:

• A control and documentation unit (Information System) that is used for administration, . performing measurements, recording full disclosure, taking samples and entering procedure notes and overall data input and management of the patient and procedure data.
• A Clinical Unit that incorporates the 'Clinical System' and the 'Front-End' unit (which . incorporates the Schiller Argus PB device - K012226). The clinical unit is responsible for acquiring, analyzing and displaying patient vitals and other pertinent clinical data. The data is displayed on monitors.

The provided 510(k) summary for McKesson Cardiology™ Hemo does not contain detailed acceptance criteria or a specific study designed to prove the device meets such criteria in terms of analytical or clinical performance metrics. Instead, it focuses on general verification and validation and demonstrating substantial equivalence to predicate devices.

Here's an analysis based on the provided text, addressing your specific points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) for the device's functions. Therefore, a table for this cannot be created from the provided text.

The closest statement regarding performance is:
"Verification and validation testing was performed on McKesson Cardiology™ Hemo to ensure it met all specifications. The device was further validated to ensure that it performs as intended. Performance testing was conducted to verify compliance with specified design requirements and relevant safety standards such as: IEC 60601-1, IEC 60601-2-49 and IEC 60601-1-8. In all instances, McKesson Cardiology™ Hemo functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices."

This indicates general functional and safety compliance but does not provide quantitative performance data against specific acceptance criteria.

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

The document does not specify any sample sizes for test sets (e.g., number of patients, cases, or data points) or the provenance of any data used for testing (e.g., country of origin, retrospective or prospective). The performance data section broadly mentions "verification and validation testing."

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

The document does not mention using experts to establish ground truth for a test set. This type of information is usually associated with clinical performance studies or algorithm validation, which are not detailed here.

4. Adjudication Method for the Test Set

Since there is no mention of experts or a specific test set requiring ground truth establishment, there is no information on any adjudication method.

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

The document does not mention an MRMC comparative effectiveness study, nor does it discuss comparing human reader performance with or without AI assistance. The device is a physiological/hemodynamic monitoring system, not primarily an AI diagnostic tool that would typically undergo such a study for human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The document does not describe a standalone performance study in terms of specific algorithm outputs. The device is described as a system for monitoring, data acquisition, processing, and analytical assessment, implying a human user interacts with and interprets the displayed information. Its core function is to present data, not to make autonomous diagnostic decisions.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for any performance evaluation. Given the nature of the device (hemodynamic monitoring), ground truth would typically refer to validated physiological measurements, but no details are provided.

8. The Sample Size for the Training Set

The document does not mention a training set size. This indicates that the device might not heavily rely on machine learning or AI models that require distinct training and testing sets in the conventional sense for performance claims, or this information was not deemed necessary for this type of 510(k) submission focused on substantial equivalence to predicate devices that are also likely traditional monitoring systems.

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

Since there is no mention of a training set, there is also no information on how ground truth for a training set was established.

Summary of Device Evaluation Approach as described in the 510(k):

The McKesson Cardiology™ Hemo 510(k) relies primarily on demonstrating substantial equivalence to existing predicate devices (Medcon Ltd.'s Windsurfer and WITT BIOMEDICAL CORP Philips Xper Flex Cardio Physiomonitoring System/ Xper Information Management System).

The "Performance Data" section states: "Verification and validation testing was performed on McKesson Cardiology™ Hemo to ensure it met all specifications. The device was further validated to ensure that it performs as intended. Performance testing was conducted to verify compliance with specified design requirements and relevant safety standards such as: IEC 60601-1, IEC 60601-2-49 and IEC 60601-1-8. In all instances, McKesson Cardiology™ Hemo functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices."

This indicates that the "study" proving the device meets acceptance criteria was a general verification and validation (V&V) testing program focused on:

• Meeting design specifications.
• Functioning as intended.
• Complying with relevant safety standards (IEC 60601 series).
• Demonstrating that its technological characteristics and performance are comparable to the identified predicate devices, raising no new safety or effectiveness concerns.

Specific analytical or clinical performance metrics (e.g., accuracy of a specific measurement, diagnostic performance) and the details of studies to establish these are not provided in this summary. The FDA's clearance is based on the determination of substantial equivalence, implying that accepted methods for physiological monitoring are used and that the device performs comparably to already cleared devices.

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The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage of oxygen saturation in arterial blood (SpO2) and pulse rate in adult or adolescent patients during stress tests. The measurement cuff of the BP-200 plus in intended to be placed on the upper right arm of the patient. The BP-200 plus can be used for patients of both sexes and all races. The BP-200 plus should not be used with neonates.

The BP-200 plus, a microprocessor based non invasive blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical ear sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by a valve. The BP-200 plus has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.

The BP-200 plus is powered by an external power supply (input: 230/110 V; output: 9V dc), and as an option by using four "AA" rechargeable batteries (≥ 2500 mAh). The batteries must be recharged with an external battery charger.

The SCHILLER BP-200 plus is an automated non-invasive blood pressure monitor system with an oxygen saturation measurement option, intended for use as an adjunct to exercise stress testing devices. It measures and displays diastolic and systolic blood pressure, heart rate, percentage of oxygen saturation in arterial blood (SpO2), and pulse rate in adult or adolescent patients during stress tests. It is not to be used with neonates.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the BP-200 plus has satisfactorily passed all tests according to the listed standards. While quantitative acceptance criteria (e.g., specific error margins for blood pressure measurements) are not explicitly stated in the provided text, the reference to these standards implies that the device achieved compliance with their respective requirements.

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

The document does not explicitly state the sample size (number of patients) used for the clinical test set. The provenance of the data is implied to be clinical studies conducted in adherence to international standards. The country of origin of the data is not specified directly, but the device manufacturer is SCHILLER AG in Switzerland, and the standards are international (ANSI/AAMI, EN, ISO, European Society of Hypertension). The studies are clinical tests, and based on the context of premarket notification for a new device, they would be considered prospective in nature.

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

The document states that the measurements of the BP-200 plus were "compared with manual auscultatory measurements." This implies that human experts (e.g., trained medical professionals) performed the manual auscultatory measurements, which served as the ground truth. However, the number of experts, their qualifications, or any specific details about the individuals establishing the ground truth are not provided.

4. Adjudication Method for the Test Set

The document indicates that the BP-200 plus measurements were "compared with manual auscultatory measurements." This likely means that the manual measurements served as the reference standard. However, the specific adjudication method (e.g., if multiple human readers took manual measurements and how discrepancies were resolved, such as 2+1, 3+1, or none) is not 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

A MRMC comparative effectiveness study, particularly one involving AI assistance, is not described in the provided text. The device is a blood pressure monitor, not an AI-assisted diagnostic tool for image interpretation or similar tasks that would typically involve MRMC studies in this context. The comparison is between the device's automated measurements and traditional manual measurements.

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

Yes, the primary clinical test described is a standalone performance evaluation of the BP-200 plus device. The device's measurements (algorithm only, as it's an automated monitor) are compared against the gold standard of manual auscultatory measurements. There is no indication of a human-in-the-loop interaction where an operator's performance is 'assisted' by the device in the way an AI would assist a radiologist.

7. The Type of Ground Truth Used

The ground truth used for the clinical tests was manual auscultatory measurements. This is a well-established clinical standard for blood pressure measurement.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" or its sample size. As this device is a medical monitoring instrument and not an AI/machine learning algorithm that requires extensive data for model training in the conventional sense, the concept of a training set as understood in AI/ML is not directly applicable. The device's internal algorithms and calibration would have been developed and refined through engineering and validation processes, but these details are not specified as a "training set" in this context.

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

Since a "training set" in the context of AI/ML is not mentioned or implied for this device, information on how its ground truth was established is not applicable/provided. The development and calibration of the device's algorithms would have relied on engineering principles and potentially internal testing, but not explicitly on an external "training set" with established ground truth as described for AI models.

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The monitoring system ARGUS PB-2200 is for the monitoring of vital parameters such as:

Invasive blood pressure: systolic, diastolic and mean pressure
s and controller Brings and/or sidestream Invasive blood pressure. Systems, main and/or sidestream FIO2

lt will extend the functionality of the existing Argus PB-1000 system (K0122Z6).
The function and the promoter her PB-1000 and the visualisation unit AR It will extend the functionality of the existing Algust PB-1000 (PB-100) (PB-100)
The system comprises the parameter box PB-1000 and the visualisation unit ARGUS
(PBS) and th

The system compilses the parcined via a serial interface. PRO. The two units are connected via a serial intenated and calculated in the PB-2200. This All vital parameters and evaluations are registered and calouaced manager generally used
data is then transmitted to the visualisation unit ARGUS PRO or another generally us data is then transmitted to the visuallsation und monitored on the ARGUS PRO.
PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. PC via the serial interface. All data can be snown and monecessed power input (RS
The PB-2200 is operated using an internal battery and an external power input (RS
e and the The PB-2200 is operated using an internal battery alle an and the manate from the 232/12V), which is, like the data transmission, completely sop
visualisation unit. The ARGUS PRO is powered via the normal mains connection

230V/110V.
The system is intended for use in the intensive care unit, in the recovery room, in the The system is intended for ass internal transports.

The system comprises the Parameter Box PB-1000 and the Visualisation Unit AR-GUS PRO. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the PB-1000. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. The PB-1000 operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V.

The provided 510(k) summary for the ARGUS PB-2200 Monitoring System indicates that no specific acceptance criteria or a dedicated study proving performance against such criteria were explicitly presented in the document. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (ARGUS PB-1000 System, K012226) by showing that the ARGUS PB-2200 meets or exceeds various established safety and electromagnetic compatibility standards.

The key takeaway is that for this device, the "acceptance criteria" are the compliance with recognized medical device standards, and the "study" is the non-clinical testing performed against those standards.

Here's a breakdown of the requested information based on the provided text:

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

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

The document relates to non-clinical testing of the device against standards. There is no mention of a "test set" in the context of patient data or clinical performance. Therefore, sample size for a test set is not applicable (N/A) for this type of submission. The data provenance is related to in-house or contracted laboratory testing for compliance with international standards, likely performed in Switzerland (country of origin of SCHILLER AG). The testing is prospective in the sense that the device was actively tested against the standards.

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

Not applicable. This submission focuses on engineering and safety standards compliance, not on clinical performance evaluated by medical experts establishing ground truth from patient data.

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

Not applicable. There was no "test set" in the context of clinical data requiring adjudication.

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. This device is a vital signs monitor, not an AI-assisted diagnostic tool for interpretation by human readers.

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

The device is a monitoring system for vital parameters. Its "performance" is its ability to accurately measure and display these parameters and comply with safety standards. The non-clinical tests described are essentially "standalone" performance evaluations against specified engineering and safety criteria. There is no mention of an algorithm in the sense of a diagnostic or interpretive AI, therefore, no standalone algorithm performance study as typically understood in AI/ML medical devices.

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

For the non-clinical tests, the "ground truth" is established by the defined parameters and tolerances within the referenced international standards (e.g., specific voltage levels for ESD, frequency ranges for emitted radiation, and safety requirements for medical electrical equipment). The device's performance is compared directly against these established standard requirements.

8. The sample size for the training set

The document does not describe a "training set" as it is commonly understood for AI/ML models. This device is a hardware monitoring system, not an AI/ML product that undergoes a training phase with a dataset.

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

Not applicable. No training set for an AI/ML model was used or described.

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