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The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Heatthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.

The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.

The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow networkbased applications to open windows and display information on other networked monitors.

The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.

The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

The Spacelabs Spacelabs Healthcare Qube Compact Monitor (91390) (Qube) is a component of the Spacelabs Medical Patient Monitoring System. The monitor accepts and displays parameter information, waveform and numeric data, and alarm conditions including arrhythmia information received from the same family of modules as its predicate, the Spacelabs Medical Model 91370 Patient Monitor.

The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Heatthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.

The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.

The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow networkbased applications to open windows and display information on other networked monitors.

The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.

The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

The provided text describes the Spacelabs Healthcare Qube Compact Monitor (91390) and its 510(k) premarket notification. However, it does not describe acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning algorithm. The document pertains to a medical device (patient monitor) and its regulatory clearance based on substantial equivalence to a predicate device. The performance testing outlined focuses on electrical safety, electromagnetic compatibility, software validation, usability, and alarm systems, which are standard for such medical devices, not for AI algorithm performance.

Therefore, for aspects related to AI/ML specific criteria (like ground truth, expert consensus, MRMC studies, sample sizes for training/test sets for an algorithm, and improvement with AI assistance), the information is not present in the provided document.

Here's an analysis based on the information available in the provided text:

Acceptance Criteria and Device Performance (Based on available information)

Study Details (Based on available information for a medical device, not an AI algorithm)

The document describes performance testing for a medical device (patient monitor), not a study for an AI/ML algorithm. Therefore, many of the requested AI/ML-specific details are not applicable or not present.

1. A table of acceptance criteria and the reported device performance: (Provided above)

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

   • The document does not specify sample sizes for any of the performance tests (e.g., number of units tested, duration of tests, or amount of data used for software validation).
   • Data provenance is not mentioned. These are typical engineering and regulatory compliance tests performed on the device itself.

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

   • This concept of "ground truth" and "experts" as in AI/ML is not applicable to the type of device testing described. The tests are against established engineering standards and internal specifications, not a clinical "ground truth" adjudicated by medical experts.

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

   • Not applicable as this is not a study assessing human or AI interpretation against a clinical ground truth.

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 study was conducted or mentioned, as this device is a patient monitor, not an AI-assisted diagnostic tool.

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

   • Not applicable. The device itself is the system; there is no separate "algorithm only" performance reported in the context of an AI.

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

   • Not applicable in the AI/ML sense. The "ground truth" for the device's performance is adherence to established engineering and medical device safety standards (e.g., IEC standards, internal specifications).

8. The sample size for the training set:

   • Not applicable. This document is for a medical monitor, not an AI/ML algorithm that requires a training set.

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

   • Not applicable.

In summary, the provided K120616 document is a 510(k) summary for a patient monitoring device, demonstrating its substantial equivalence to a predicate device through adherence to recognized performance, safety, and electromagnetic compatibility standards. It does not involve artificial intelligence or machine learning algorithms and therefore does not contain information on "acceptance criteria" or "study" as one would expect for an AI/ML-based medical device.

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Conditions to be screened, monitored, treated or diagnosed.
Patient conditions indicated by abnormalities in various physiologic parameters,
including ECG waveform, respiratory effort, invasive and noninvasive blood
pressure measurements, temperature, cardiac output, and pulse oximeter (SpO₂)
readings.
Prescription use only.
Yes. Caution statement is provided in the introductory page of the Patient Care
Management System which includes the operating instructions for this Module.
Parts of body applied to.
Specific to the physiologic parameter being monitored, accessories may be applied
externally to the chest and limbs or invasively into the blood stream.
Frequency of use.
Frequency as directed by physician.
Physiological purpose.
In conjunction with clinical findings, a screening and diagnostic tool for use in:
assessing electrical activity of the heart in order to detect abnormal cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations; monitoring respiratory effort to detect abnormal respiration events such as high and low respiration rates and episodes of apnea; continuous monitoring of invasive pressure signals to detect abnormal events such as high and low pressure; episodic monitoring of noninvasive pressure signals to detect abnormal events such as high and low pressure; continuous monitoring of temperature signals to detect abnormal events such as high and low body temperature; monitoring of the patient's pumping ability of the heart and various hemodynamic values to detect abnormal flow volumes; and noninvasive, continuous monitoring of pulse oxygen saturation signals in order to detect desaturation due to abnormal pulmonary/circulatory functions.

The Spacelabs Medical Multiparameter Module 91496 with Option N is a slim, lightweight singular modular unit that, when used in conjunction with a ilght Care Medical Patient Care Management System (PCMS), provides the capability to acquire various common physiologic data in a clinical setting. The Module 91496 is the primary interface to the patient being monitored. The Module 91496 is capable of acquiring and processing ECG, respiration, invasive and noninvasive blood pressure, temperature, cardiac output and SpO2 parameters for a single patient. The Module 91496 accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical PCMS monitor via SDLC communications. The PCMS monitor will provide the display capabilities for the care provider. Option N utilizes Nellcor Puritan Bennett OxiMax oximetry and sensors and OxiMax-compatible adapter cables.

The provided text describes a Special 510(k) for the Spacelabs Medical Multiparameter Module 91496 with Option N. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in a quantitative way that would allow for a table of acceptance criteria and performance, or the other requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.).

The document focuses on:

• Identification of the device and submitter.
• Device description and intended use.
• Comparison to predicate devices (K972502 and K012891).
• A general statement about testing: "The Module 91496 was validated through rigorous testing that, in part, support the compliance of the Module 91496 to applicable standards. Additionally, the software for the Module 91496 was developed following a robust software development process and was fully specified and validated. Safety testing has been performed by third party agencies to ensure the device complies with applicable industry and safety standards."
• FDA's 510(k) clearance letter.
• Detailed indications for use.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or the other specific details about study design, ground truth, and sample sizes, because this information is not present in the provided text.

The document states that the device was "validated through rigorous testing that, in part, support the compliance of the Module 91496 to applicable standards," but it does not specify which standards, what the acceptance criteria within those standards were, or how the device performed against them. It also does not provide details about specific clinical studies or performance data.

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QUEST is designed to provide ECG information and data to qualified medical personnel for the purpose of assessing the patient's cardiac response to exercise. It is to be used in hospitals, clinics, or physician offices by a qualified and licensed physician, or by trained staff under the direct supervision of that physician.

Stress-test or exercise electrocardiography is used a) when the diagnosis of coronary artery disease is suspected, b) to determine the physical performance characteristics of a patient, c) for post myocardial infarction assessment, or d) for cardiac rehabilitation. The test involves the recording of the electrocardiogram during dynamic or, occasionally, isometric exercise. Disease assessment is most prominent in adult patients. The diagnostic value of exercise testing primarily concerns either ST segment depression present in myocardial ischemia, or elevation seen in infarcts (in comparison to P-Q segment as the isoelectric line). In addition, it is important to consider the patient's blood pressure response and physical symptoms.

This instrument is not intended to interpret any exercise test results but is to be used as an aid for the physician to determine normal or abnormal response of the patient to exercise.

QUEST is not intended for long term monitoring of patient ECG signals. Specifically, it does not substitute for recommended cardiac monitoring devices recognized by AAMI EC13, especially in the area of alarms.

This instrument (OUEST) provides a method of collecting a multichannel ECG for dynamic evaluation of exercise performed by the patient. In order to provoke myocardial ischemia, the degree of stress must be sufficient to exceed the critical level of the patient's myocardial oxygen demand. The specificity of ST changes in identification of ischemia increases with the degree , time of onset, and when more than one electrocardiograph lead exhibits the abnormality. These patients can walk on a treadmill in which the speed and elevation can be adjusted (automatically or manually) to suit a variety of graded exercise protocols, or pedal an electronically braked bicycle ergometer. If the test subject is unable to walk, isometric exercise can be performed using a handheld dynamometer, or injecting the patient with heart rate stimulants to stress the myocardial system and then use this instrument's monitoring capability. It is operated from a standing position with design consideration given to ergonomic heights, viewing access of the information display, and control functions. It is cart based, with wheels, to provide easy movement. It can be used in conjunction with echocardiography, nuclear imaging, or pulmonary gas exchange equipment by providing ECG trigger signals and/or treadmill speed and grade levels.

This instrument can also serve as an adult resting interpretive electrocardiograph with the addition of Burdick's resting interpretive program.

The OUEST with T-Wave Alternans Option is intended for the measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing.

The presence of Microvolt T-Wave Alternans as measured by the QUEST with T-Wave Alternans Option in patients with known or suspected ventricular tachyarrhythmia, or who are at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The OUEST with T-Wave Alternans Option should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests. The interpretive results of the Alternans Report Classifier software should be reviewed by a qualified physician.

The predictive value of T-Wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.

*Microvolt T-Wave Alternans is defined as T-wave alternans which a) is measured from high-resolution multi-segment sensors, b) is present in leads X, Y, Z, VM, or two adjacent precordial leads, c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, d) is at least three standard deviations greater than the background noise level, e) has an onset heart rate of below 110 beats per minute, and f) is sustained for all heart rates above the onset heart rate.

The Quest Exercise Stress System is a computer based electrocardiograph (ECG) exercise stress test system designed for use with both treadmill and bicvcle eraometer exercise protocols. The Quest Exercise stress system provides real time ECG waveforms and calculations to qualified medical personnel while providing automatic or manual control of the exercise equipment.

The Quest Exercise Stress System with T-wave alternans option provides measurement of T-wave alternans measurement in addition to the functions of the ECG. The Alternans Report Classifier software used with the Twave alternans option provides a preliminary assessment of the alternans report data.

The provided text is a 510(k) summary for the Spacelabs Burdick Quest Exercise Stress System with the addition of Cambridge Heart's Alternans Report Classifier software. It describes the device, its indications for use, and specifications, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification (510(k)) to the FDA, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance validation studies with specific acceptance criteria and outcome metrics.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance details, training set sample size, or how ground truth for training was established.

The document states: "Quest with the addition of the Alternans Report Classifier software is substantially equivalent to the currently marketed QUEST system." This is the core "proof" presented in a 510(k) submission: that the new device (or modification) is as safe and effective as a legally marketed predicate device. The specifications listed are descriptive, not performance targets with associated test results.

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The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Ultraview™ Waveform Pager System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient-monitoring network. The Waveform Paging System supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.

The Spacelabs Medical Ultraview™ Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor.

The Spacelabs Medical Ultraview™ Waveform Pager System provides caregivers within a clinical environment the ability to remain mobile and be notified when an alarm event occurs. Typically, alarm notification by the pager occurs within 4-8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.

The administration module allows convenient assignment of patients to caregivers from any location on the network, including WinDNA-enabled Universal Clinical Workstations. Patient status updates can also be scheduled for dispatch to the pager on a repeating basis if desired.

This system is not a replacement for the primary alarm notification system. The delivery of pages cannot be guaranteed or verified. The Waveform Paging System is intended to augment alarm notification. It is not intended or designed to replace monitoring personnel, good clinical judgment, or to be used in place of bedside and remote alarm notification, or the Alarm Watch function of the monitor.

The device subject to this submission is Model 91841. Each Spacelabs Medical Ultraview™ Waveform Pager System consists of a Server which collects and formats data from the monitoring network, a Transmitter which broadcasts the information to the mobile caregiver, and a Receiver which receives the broadcast and displays the formatted information.

The provided document, K992749, is a 510(k) Safety and Effectiveness Summary for the Spacelabs Medical Ultraview™ Waveform Pager System. It does not contain detailed information about specific acceptance criteria or an explicit study proving device performance against those criteria in the way a modern clinical validation study would be presented for an AI/ML device.

Instead, it relies on a comparison to predicate devices and general performance claims. Here's a breakdown of the available information based on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a formal table of acceptance criteria with specific quantifiable metrics. However, key performance characteristics are mentioned as a comparison to predicate devices and as functional requirements.

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

The document does not specify a scientific study with a defined test set sample size or data provenance in the way a modern clinical validation for AI/ML would.

Instead, it states: "The Spacelabs Medical Ultraview™ Waveform Pager System will be subject to extensive safety and performance Final testing for the system testing prior to release includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." (Page 2)

This suggests internal engineering and functional testing rather than a clinical study with patients or a specific dataset.

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

Not applicable, as no external "test set" and corresponding "ground truth" established by experts for performance evaluation are described. The testing described is internal and functional.

4. Adjudication method 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. The device is a secondary alarm notification system, not an AI-assisted diagnostic tool that would involve human readers interpreting data.

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

The device is a system for relaying information, not an algorithm that performs analysis. Its core function is to transmit data, and its performance would be judged on the speed and accuracy of that transmission, effectively a "standalone" system in terms of its notification function. However, this is not in the context of an AI/ML algorithm.

7. The type of ground truth used

For functional performance related to alarm notification time and data display, the "ground truth" would likely be derived from:

• System logs/measurements: Actual time taken for a page to be sent and received following an alarm event on a patient monitor.
• Visual inspection: Verification that the correct patient ID, alarm parameters, and waveform snapshot are accurately displayed on the pager device.
• Predicate device comparison: Functional equivalence to the legally marketed predicate devices (K973527 Data Critical Corporation's Cardio-Pager System and K971868 Marquette Medical Systems Impact Pager System) formed the primary basis for regulatory clearance.

8. The sample size for the training set

Not applicable. The device is not an AI/ML system that requires a "training set."

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

Not applicable.

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Physiological purpose. An accessory to an SpO2 monitoring system for use in noninvasive, continuous monitoring of oxygen saturation for the detection of desaturation due to abnormal pulmonary/circulatory function in adult, pediatric or infant population by the standard photoelectric pulse of oximetric technique.

As an accessory to a pulse oximeter monitoring module in a Spacelabs Medical Patient Care Information System (PCIS), a Spacelabs Medical Disposable SpO2 sensor provides the means to noninvasively acquire SpO2 signals from the patient's fingertip or for the continuous monitoring of pulse saturation signals.

The SpO2 sensor converts optical signals into electrical signals from common monitoring sites. The acquired signals are transferred via an adapter cable to a pulse oximeter monitor for subsequent display, review, and editing by the care provider.

Sensors are available for specific monitoring sites, including the fingertip and foot, and are sized to meet various adult, pediatric and infant patient needs.

I'm sorry, but relevant information is not found in the provided text to generate a response. The document mostly focuses on the regulatory aspects of the device, such as its classification, predicate devices, and FDA approval, rather than detailed performance study data.

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The Spacelabs Medical Ultraview Digital Telemetry System, when used in conjunction with a Spacelabs Medical PCMS Patient Monitor or Ultraview Care Network, provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST segment deviations are detected.

The Ultraview Digital Telemetry System also provides a means for the episodic monitoring of noninvasive blood pressure (NIBP) signals to detect abnormal events such as high and low blood pressure. The System also provides a means for both continuous and episodic monitoring of pulse blood oxygen saturation signals in order to detect desaturation caused by abnormal pulmonary/circulatory functions.

The Spacelabs Medical Ultraview Digital Telemetry System Models 90343 and 90347 are intended for use with either adult or neonatal patient populations in a hospital environment. When the NIBP option is selected in the Model 90343 configuration, the NIBP feature is to be used with adult patient populations only.

The Ultraview Digital Telemetry System is a multiple parameter system which provides the capability for wireless central station monitoring of patients within hospitals or medical center facilities. This telecommunications feature converts bedside monitors to telemetry operation and works with a portable monitor for the transport of telemetricallymonitored patients to allow for the remote programming and data retrieval of clinical parameters specific to patient populations, clinical protocols, or operating preferences. Physiological parameters supported by the System are the acquisition and monitoring of electrocardiographic signals (ECG), pulse oximetric oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) parameters, based upon the System configuration options selected by the clinician.

The devices subject to this submission are the Models 90343, 90347, and 90478. Each Ultraview Digital Telemetry System configuration consists of a battery-operated Telemetry Transmitter, a Receiver Module, and an antenna system. The Ultraview Digital Telemetry Multi-Parameter Transmitter Model 90343 is a wideband VHF unit that provides 5electrode ECG and continuous or episodic SpO2 monitoring capabilities, with an optional noninvasive blood pressure (NIBP) interface when connected to a Spacelabs Medical Model 90217Ambulatory Blood Pressure (ABP) Monitor (K855127). The Ultraview Digital Telemetry ECG Transmitter Model 90347 is identical to the Model 90343 with the SpO2 measurement function and ABP communications capabilities removed.

The Ultraview Digital Telemetry System interfaces to a patient using standard accessories including ECG electrodes and lead wires, NIBP hoses and cuffs, SpO2 cables and sensors, and adapter cables to connect these accessories to the Transmitter. The telemetry system sends raw ECG vectors or preprocessed SpO2 and NIBP data, based upon the capability of the selected Transmitter, to the VHF version of the Model 90478 Modular Receiver via a diversity antenna system.

The Modular Receiver collects and processes parameter specific physiologic data for alarm generation and display of numeric values and waveforms on a Spacelabs Medical Patient Care Management System (PCMS) Monitor or Ultraview Care Network via SDLC communications. The monitor provides the display, review, editing and analysis capabilities for the care provider. Hard copy records may be provided by the wide variety of Spacelabs Medical printers and recorders that can be interfaced by either Ethernet or SDLC communications.

Here's an analysis of the provided text regarding the Spacelabs Medical Ultraview™ Digital Telemetry System, focusing on acceptance criteria and study information:

Based on the provided text, a detailed breakdown of acceptance criteria and a study proving device performance is not explicitly present in the format requested. This document is a 510(k) Safety and Effectiveness Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics against a ground truth.

However, I can extract the information that is available and highlight what is missing based on your request.

Missing Information/Why it's not present:

• Detailed Acceptance Criteria Table: The document describes the intended function of the device (detecting abnormal cardiac rhythms, NIBP events, SpO2 desaturation), but it does not specify quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy percentages) that the device must meet for each function.
• Reported Device Performance (Quantitative): Since quantitative acceptance criteria are not stated, reported performance metrics are also absent. The document asserts that the device will be subject to extensive testing and will meet functional requirements and specifications, but it doesn't provide the results of such tests here.
• Sample Size for Test Set, Data Provenance, Ground Truth Establishment for Test Set: There is no mention of a specific test set, its size, the origin of data, or how ground truth was established for this device. The document relies on substantial equivalence to predicate devices which presumably have undergone such testing.
• Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth (Test Set): These are all related to a specific clinical or performance study that is not detailed in this 510(k) summary. The document does not describe such studies for the Ultraview Digital Telemetry System.
• Sample Size for Training Set, Ground Truth Establishment for Training Set: As this is a traditional medical device (not explicitly AI/ML software), the concept of a "training set" in the context of machine learning is not applicable here. Even if it involved some algorithms, the document does not elaborate on a training phase or 'training data' in the modern AI sense.

Information that can be extracted or inferred:

1. A Table of Acceptance Criteria and the Reported Device Performance

Explanation: The "acceptance criteria" listed above are inferred from the stated "Indications for Use" and the "Testing" section. The document does not provide specific quantitative thresholds (e.g., "detect with 90% sensitivity"). The "Reported Device Performance" column reflects the statements made in the document about the device's design and planned testing, not actual performance data for this submission.

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. This document emphasizes substantial equivalence to existing predicate devices rather than presenting data from a new, specific clinical trial for this device.

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

• Not specified. (No specific test set or ground truth establishment described for this device in the provided text).

4. Adjudication method for the test set:

• Not specified.

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 mentioned. This document describes a medical device, not a diagnostic AI system for medical image interpretation or a system that "assists human readers" in an interpretable way in the context of MRMC studies.

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

• The device is a "multiple parameter system which provides the capability for wireless central station monitoring." It performs automated detection of physiological events. Its intended use implies "standalone" detection for the parameters it monitors, but no specific "standalone performance study" in the modern sense (e.g., comparing algorithm output to human interpretation) is described as part of this submission. The device itself is the "standalone" component doing the monitoring and detection.

7. The type of ground truth used:

• Not explicitly stated for the new device. For predicate devices, it would typically involve clinical diagnosis, validated reference measurements, or expert clinical review for arrhythmia detection. This document implies that the device's functional integrity will ensure it aligns with the expected physiological measurements, rather than comparing its diagnostic output against a 'ground truth' in a clinical study for this 510(k).

8. The sample size for the training set:

• Not applicable/Not specified. This document describes a hardware/software system for physiological monitoring, not an AI/Machine Learning model that undergoes a training phase in the typical sense.

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

• Not applicable/Not specified. (See point 8).

Summary of the Study (Based on 510(k) statement):

The "study" described in the 510(k) summary is not a detailed clinical trial with quantified results, but rather a declaration of planned and ongoing testing.

• Device Under Review: Spacelabs Medical Ultraview™ Digital Telemetry System (Models 90343, 90347, 90478).
• Purpose of Testing: To ensure the device meets all its functional requirements and performance specifications, and complies with applicable industry and safety standards (e.g., ANSI/AAMI EC13 and AAMI ECAR-1987).
• Nature of Testing: "Extensive safety and performance testing prior to release," including "various performance tests" and "safety testing... performed by third party agencies."
• Conclusion: The submission concludes that the device "is as safe and effective as its predicate devices and raises no new issues," implying that the planned testing will confirm this.

In essence, this 510(k) submission primarily leverages the concept of substantial equivalence to predicate devices. It describes the device's functional capabilities and the commitment to conduct testing to ensure it performs as intended and meets relevant safety standards, rather than presenting the results of a specific, comprehensive clinical study.

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The Spacelabs Medical 90519 Anesthesia Delivery System provides intermittent or continuous gas inhalation for adults and children (neonatal and pediatric). It allows the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anesthetic agents: Halothane, Isoflurane, Enflurane, or Sevoflurane, It provides safe and accurate gas flows to maintain patient respiration during anesthesia, and incorporates a ventilator, an oxygen monitor, and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anesthesia machine. It is recommended for use only by trained physicians, in the operating room or similar surgical environments.

The Spacelabs Medical 90519 Anesthesia Delivery System is designed to deliver anesthetic gases in a controlled hospital environment. The System incorporates a valveless patient circuitry design which offers very low resistance during spontaneous breathing since it allows for the ebb and flow of natural breathing gases. Oxygen, nitrous oxygen, and air are supplied to the gas distribution system for mixing with the selected anesthetic agent and delivery to the patient through the ventilation system. Another circuit separately provides for the cycling of patient expiration gases. The operator may select from two operating modes options: in manual mode the patient can be ventilated manually via a hand bag or the patient can breathe spontaneously; alternately, the controls can be set so that the patient is continually ventilated by the device. The control settings provide ease of use for both pediatric and adult patient populations in that the System may be set by the anesthesiologist for the appropriate tidal volume range based on patient needs. The System uses standard, commercially-available anesthesia system accessories appropriate to meet the needs of the clinician and patient. The delivery of gases is time cycled, volume controlled, pressure limited, and monitored for alarm states and error messages. Additional user-selectable convenience features include a hold switch to permit the temporary cessation of mechanical (continual) ventilation to facilitate the taking of imagery (e.g. x-rays) and a "sigh" switch to provide extra volume above the set tidal volume at a defined interval to allow for the more complete expiration of carbon dioxide.

The provided text describes the Spacelabs Medical 90519 Anesthesia Delivery System and its 510(k) submission. However, it does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested. The document focuses on establishing substantial equivalence to a predicate device (the Falcon Anaesthesia System) and mentions general safety and performance testing.

Therefore, many of the requested details cannot be extracted directly from the given text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

The document states: "The Spacelabs Medical 90519 Anesthesia Delivery System has been subject to extensive safety and performance testing, to ensure that the device meets all its functional requirements and performance of specifications."

However, it does not provide a table specifying exact acceptance criteria (e.g., specific thresholds for flow rates, pressure limits, or accuracy of gas mixing) nor does it report the quantitative results or performance metrics from these tests. It only mentions that the device is designed to meet general safety requirements and industry standards.

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 does not specify the sample size for any test set or provide details on data provenance (country, retrospective/prospective).

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

This information is not provided in the document. The testing described is for an anesthesia delivery system, which typically involves engineering and safety evaluations against specifications and standards, rather than expert-derived ground truth as might be seen for diagnostic imaging devices.

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

This information is not provided in the document.

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 document describes a medical device for anesthesia delivery, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related comparative effectiveness is not relevant and not mentioned.

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

This is an anesthesia delivery system, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

The document describes "safety and performance testing" against "functional requirements and performance of specifications" and "applicable industry and safety standards." The ground truth for such device testing would typically be the pre-defined engineering specifications and regulatory standards themselves, verified through direct measurement and testing, rather than expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or predictive AI.

8. The sample size for the training set

This document describes a physical medical device, not a machine learning model. Therefore, the concept of a "training set" with a specified sample size is not applicable.

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

As in point 8, this is not applicable to the described physical medical device.

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The Spacelabs Medical Integrated Multiparameter Module 90496 is intended for use with the PCMS to acquire, monitor. and process various clinical parameters from adult or neonatal/infant populations in any type of clinical environment other than home use. Physiologic parameters that may be monitored include cardiac activity, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2), and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.

Patient conditions indicated by abnormalities in various physiologic parameters, including ECG waveform, respiratory effort, invasive and noninvasive blood pressure measurements, temperature, cardiac output, and pulse oximeter (SpO2) readings.

In conjunction with clinical findings, a screening and diagnostic tool for use in:

• assessing electrical activity of the heart in order to detect abnormal cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation, as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations:
• monitoring respiratory effort to detect abnormal respiration events such as high and low respiration rates and episodes of apnea:
• continuous monitoring of invasive pressure signals to detect abnormal events such as high and low pressure;
• episodic monitoring of noninvasive pressure signals to detect abnormal events such as high and low pressure;
• continuous monitoring of temperature signals to detect abnormal events such as high and low body temperature;
• monitoring of the patient's pumping ability of the heart and various hemodynamic values to detect abnormal flow volumes; and
• noninvasive, continuous monitoring of pulse oxygen saturation signals in order to detect desaturation due to abnormal pulmonary/circulatory functions.

The Integrated Multiparameter Module 90496 is a slim, lightweight singular modular unit that. when used in conjunction with a Spacelabs Medical Palient Care Management System (PCMS), provides the capability to acquire various common physiologic data in a clinical setting.

The Module is the primary interface to the patient being monitored. The Module is capable of acquiring and processing ECG, respiration, invasive and noninvasive blood pressure, temperature, cardiac output, and SpO2 parameters for a single patient. The Module accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical monitor via SDLC communications. The monitor will provide the display capabilities for the care provider.

I am sorry, but the provided text does not contain the specific details about acceptance criteria, device performance, and study results in the format requested. The document is a 510(k) summary for a medical device (Spacelabs Medical Integrated Multiparameter Module 90496), which outlines:

• Submitter's Name and Company Information
• Device Name and Classification (Arrhythmia Detector and Alarm, Noninvasive Blood Pressure Measurement System, Oximeter, etc.)
• Predicate Device(s)
• Device Description
• Intended Use (acquiring, monitoring, and processing various clinical parameters)
• Comparison of Technological Characteristics (comparing to predicate devices, noting similarities in design, components, storage technology, and energy source, and differences in feature sets and hardware packaging)
• Testing (mentions extensive safety and performance testing, compliance to standards like IEC 601.1, ANSI/AAMI EC11 and EC13, AAMI ECAR-1987, and ANSI/AAMI SP-10 for accuracy testing)
• FDA Clearance Letter (K972502)
• Indications for Use (patient conditions indicated by abnormalities in various physiologic parameters)

While the document states that "Final testing for the system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications" and mentions compliance with specific standards for "accuracy testing" (e.g., ANSI/AAMI SP-10 for blood pressure), it does not provide:

1. A specific table of acceptance criteria and reported device performance values.
2. Details about sample sizes for test sets, data provenance (country, retrospective/prospective).
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
6. Explicit confirmation or details of a standalone algorithm-only performance study.
7. The specific type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to predicate devices under the 510(k) pathway, which typically involves showing that the new device is as safe and effective as a legally marketed device, often through a combination of design characteristics, intended use, and adherence to recognized performance standards, rather than disclosing detailed clinical study results with acceptance criteria and statistical performance metrics in this summary.

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