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The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents, and children patient populations for the following paramaters:

• Non-invasive blood pressure
• Impedance respiration .
• Invasive blood pressure .
• Temperature .
• Functional arterial oxygen saturation (SpO2) .
• End-tidal & inspired CO2 .
• ECG monitoring with arrhythmia & ST-segment
• 12-Lead resting ECG
• Cardiac output .

The Mortara Surveyor Patient Monitor is indicated for use in infants and neonatal patient populations for the monitoring of the following parameters:

• Non-invasive blood pressure ●
• Impedance respiration
• . Invasive blood pressure
• Temperature
• Functional arterial oxygen saturation (SpO2) ●
• End-tidal & inspired CO2 ●
• ECG monitoring with arrhythmia ●
• 12-Lead resting ECG .

The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Mortara Surveyor S12 and S19 are integrated multi-parameter patient monitors designed to be used by trained medical personnel within healthcare facilities on adult, adolescent, child, infant, and neonatal patient populations.

Surveyor S12 and S19 include color, touch screen displays which present patient demographics, physiological waveforms, numeric data, trends, status condition, with high, medium, and low warning alarms and technical messages. The monitor alerts of patient conditions with audible alarming through a speaker located within the device, visual alarms presented on the graphical user interface, and a visual LED alarm bar indicator on the front of the unit. The monitor provides a dedicated ON/OFF switch with AC power LED indication. Power is provided either from an external power supply connected to mains, or an internal lithium-ion battery. The Surveyor S12 has an 11.6" display and comes with an integrated 2 channel printer, while the Surveyor S19 has at 18.5"display and comes with an optional 2 channel printer.

The Surveyor S12 and S19 are intended for continuous monitoring in both bedside and portable applications and are manufactured in various fixed configurations. A Surveyor S12 or S19 may include the following parameters: 3, 5, or 10 Wire electrocardiography (ECG), 12 lead resting ECG, impedance respiration, non-invasive blood pressure (NIBP), up to two temperatures, functional arterial oxygen saturation (SpO₂), up to four invasive blood pressures (IBP), end-tidal & inspired CO2, and thermal dilution cardiac output.

The Surveyor S12 and S19 may be used as stand-alone monitors near the patient bedside, or during patient transport within a healthcare facility. When connected to the Mortara Surveyor Network, the Surveyor S12 and S19 can be part of a centralized monitoring system managed by the Surveyor Central Station (K131929) which can also send data to the Electronic Health Record. The Surveyor Central displays the aforementioned parameters including audible and visuals alarms.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text only explicitly mentions a clinical study for the neonatal non-invasive blood pressure (NIBP) readings.

• Neonatal NIBP Clinical Study Test Set:
  • Sample Size: Not specified in the provided text.
  • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the study was conducted to demonstrate safety and effectiveness for the neonatal patient population, implying prospective data collection specifically for this purpose.

For other parameters (e.g., ECG, SpO2), no specific test set sample sizes or data provenance are detailed. The substantial equivalence relies on compliance with various international standards, which typically involve testing against predefined datasets or clinical scenarios.

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not provided in the given text for any aspect of the device's evaluation. The clinical study for neonatal NIBP refers to the demonstration of safety and effectiveness, but it does not detail the method for establishing ground truth or the involvement of experts in that process.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least, not mentioned) for the Mortara Surveyor S12 and S19 Patient Monitor based on the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with standards, and a single clinical study for one specific parameter (neonatal NIBP).

6. Standalone Performance Study

Yes, a standalone performance study was done for the neonatal Non-Invasive Blood Pressure (NIBP) readings. A clinical study was conducted to demonstrate the safety and effectiveness of these readings. The wording suggests that the device's performance for this specific function was evaluated independently.

For other parameters (like ECG, SpO2, etc.), the document primarily references compliance with various IEC and ISO standards (e.g., IEC 60601 series), which typically involve standalone testing of the algorithm or device's performance against defined benchmarks or simulated signals. The results of these tests, however, are not explicitly provided in the summary.

7. Type of Ground Truth Used

For the neonatal NIBP clinical study, the type of ground truth used is not explicitly stated. However, clinical studies designed to demonstrate safety and effectiveness, as mandated by ISO 81060-2:2013 (which specifies clinical investigation of automated measurement type sphygmomanometers), typically rely on:

• Simultaneously obtained reference measurements: Often from an "expert" or gold-standard measurement method (e.g., invasive arterial blood pressure monitoring for NIBP), or highly accurate manual measurements by trained observers using auscultation. The standard sets strict requirements for how these reference measurements are taken and compared.

For other parameters, the ground truth would be established by the respective standards they comply with (e.g., standardized ECG waveforms for arrhythmia detection, calibrated SpO2 simulators, etc.).

8. Sample Size for the Training Set

This information is not provided in the text. The document describes a clinical study for neonatal NIBP for validation/testing, not for training. Given the device's nature as a physiological monitor relying on established algorithms and hardware, it's less likely to involve a "training set" in the machine learning sense for its core functionalities, but rather calibration and verification against known signals or reference measurements during development.

9. How Ground Truth for the Training Set Was Established

As no training set is described or implied in the provided text, information on how its ground truth was established is not applicable/not provided.

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The Surveyor S4 Mobile Monitor is indicated for use:

• The Surveyor S4 mobile monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG signals.
• The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.
• The Surveyor S4 mobile monitor is indicated for use in a clinical setting by a physician, or by trained personnel acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• The Surveyor S4 mobile monitor is indicated for use to acquire and output electrocardiographic data.
• The Surveyor S4 mobile monitor is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering real-time acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.
• The Mortara Li-Ion Battery Charger is intended for charging only the Mortara Rechargeable Li-Ion battery pack.

The Surveyor S4 incorporates wireless electrocardiographic technology to achieve real-time acquisition and RF transmission of simultaneous diagnostic quality 12-lead ECG data to a network access point while allowing the patient to be ambulatory. It provides a means to acquire and transmit 12-lead cardiac signals through the network access point to a compatible monitoring device where the signals are displayed. The Surveyor S4 Mobile Monitor allows the patient complete freedom of movement. Extended range can be obtained with additional network access points). The Surveyor S4 Mobile Monitor uses a similar patient cable as the T12S. The S4 requires use of a proprietary ECG patient cable for use with snap electrode hookups. The patient cables use the same wire as present Mortara predicate lead-form cables. The cable is unique to the S4 and is distributed as a device component with the device. The patient cable acquires a continuous ECG signal. A design option will allow the user to set the patient cable type in case of reduced lead (less than 12-lead) options. ECG patient cable is worn by the patient in a standard torso electrode hook-up, which connects to snap type electrodes. Utilizing a frequency range of 2400.96Mhz to 2482.56MHz. ECG data is acquired, processed and transmitted via a Wi-Fi wireless network comprised of one or more network access points. The wireless network is used for patient data transmission and for other system-level command / control and communication. The data network uses modulation / control schemes that share spectrum based on standard IEEE 802.11 Wi-Fi at 2.5GHz range. The Surveyor S4 includes data integrity checks and bi-direction protocols to provide robust data transmission. The device also includes a mechanism to inform the user through a compatible centralized monitor of various device states including low battery, lead quality issues, or out of range condition. It has a color, touch-screen display as the primary interface for user input and graphical display of physiological waveforms, measured parameters, demographic data and other status information. The unit operates with a set of single-use commonly available disposable, non-spillable batteries or from a specified rechargeable battery back that is compatible standards. The battery charger is capable of charging up to five multi-use (rechargeable) batteries at one time and prevents overcharging. The Surveyor S4 uses a touch screen user interface for operator interaction that allows control over the device via selection of menu items and icons as well as entry of relevant configuration. While in normal operation, the display will show other status information such as a battery level indicator, Wi-Fi Signal Strength and Central Station Slot information.

The provided text is a 510(k) premarket notification for the Mortara Surveyor S4 Mobile Monitor. It does not contain specific acceptance criteria, reported device performance data, details of a study proving the device meets acceptance criteria, or information on ground truth establishment, sample sizes for test/training sets, adjudication methods, or MRMC studies.

The document generally states that the device was tested against recognized standards and internal requirements, and that these tests demonstrated compliance and similar safety/effectiveness to predicate devices. However, it does not provide quantitative acceptance criteria or detailed results of these tests in a way that would allow for the direct completion of your requested table and study details.

Here's how to break down what is and isn't available based on your request:

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

• Not Available. The document lists the standards the device complies with (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-25, IEC 60601-2-27, IEC/EN 62304, IEC 62366). However, it does not specify quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity, measurement ranges with tolerances) for any performance aspect of the device (ECG signal acquisition, transmission, display). It also does not report specific device performance metrics against any such criteria. It only states, "Test results indicated that the Mortara Surveyor S4 Mobile Monitor complies with its predetermined specification" for software and EMC, and "test results indicated that the device complies with the predetermined requirements" for bench performance.

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

• Not Available. The document explicitly states:
  • "Performance Testing – Animal – Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor S4 Mobile Monitor."
  • "Performance Testing - Clinical - Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor S4 Mobile Monitor."
• This indicates that no clinical or animal test sets were used for performance evaluation that would necessitate a sample size or data provenance. The testing mentioned appears to be bench testing, software verification/validation, and electrical/EMC safety testing against 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 / Not Available. Since no clinical or animal test sets are mentioned, there would be no ground truth established by experts for such data. The device's function is explicit data acquisition and transmission, not interpretation or diagnosis.

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

• Not Applicable / Not Available. See above point.

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

• Not Applicable / Not Available. This device (Mortara Surveyor S4 Mobile Monitor) is a "radiofrequency physiological signal transmitter and receiver" designed for "acquiring and transmitting 12-lead cardiac signals." It does not involve AI assistance, diagnostic interpretation, or reader performance improvement. Its function is to provide the raw data to a compatible monitoring device.

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

• Not Applicable / Not Available. This device is a hardware module that acquires and transmits physiological signals. It does not have a standalone algorithm for diagnosis or interpretation in the way an AI algorithm would. Its "performance" refers to its ability to acquire and transmit signals according to specifications.

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

• Not Applicable / Not Available. As it's a signal acquisition and transmission device, "ground truth" in the diagnostic sense (e.g., for disease detection) is not relevant to its stated performance evaluation. Its performance is likely evaluated against signal integrity and transmission fidelity standards.

8. The sample size for the training set

• Not Applicable / Not Available. This device does not use machine learning or AI models that require a training set.

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

• Not Applicable / Not Available. See above point.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices through compliance with general safety and performance standards for hardware and software. It explicitly states that animal and clinical performance testing (which would typically involve test and training sets, ground truth, and expert review for diagnostic devices) were "not performed and are not necessary" for this device. Therefore, most of your requested detailed study information cannot be extracted from this text.

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The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for: 3 & 5 Lead ECG monitoring; 12 Lead ECG recording; real-time arrhythmia detection / alarming; QT measurement / alarming and ST measurements / alarming: impedance pneumography: noninvasive blood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure.

The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).

The device is indicated for adults, paediatrics and neonates.

The Tempus Pro is a multi-parameter vital signs monitor designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3&5 lead ECG monitoring, 12 lead ECG recording, real-time arrhythmia detection / alarming, QT measurement / alarming and ST measurements / alarming pulse oximetry, non-invasive blood pressure, sidestream capnometry, 2 channels of contact temperature, impedance respiration, up to 4 channels of invasive pressure and user configurable alarms.

In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a software system (called i2i) expected to be based in a facility far from the user e.g. a response centre facility. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset.

The provided text describes a 510(k) submission for the Tempus Pro Patient Monitor with Enhanced Features, specifically the addition of arrhythmia detection/alarming, QT measurement/alarming, and ST measurements/alarming.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the Arrhythmia detection, ST elevation, and QT interval measurements were evaluated in accordance with FDA guidance on arrhythmia detection and alarm, using the FDA recognized consensus standard EC57 (FDA Rec No: 3-118). However, it does not provide a specific table of acceptance criteria or quantitative performance metrics for these features. It only states: "A summary report demonstrating compliance with the guidance and associated standard is presented as part of this 510(k) submission." and "In each case the results of this testing confirmed that acceptance criteria defined by the relevant standard, or other appropriate reference document had been met."

Without access to the "summary report" or the full 510(k) submission, we cannot extract specific numerical acceptance criteria or reported device performance for the new features. The table below reflects the information that is available.

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

The document explicitly states that the evaluation was performed in accordance with "FDA guidance on arrhythmia detection and alarm" and "the FDA recognized consensus standard EC57 (FDA Rec No: 3-118), which defines methods of presenting results when testing against specified ECG databases."

However, the provided text does not specify the sample size (e.g., number of patients, number of ECGs) used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) of the ECG databases used. EC57 typically refers to standard databases like MIT-BIH Arrhythmia Database, but this is not explicitly stated in the provided text.

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

The document does not provide information on the number of experts used to establish ground truth or their specific qualifications for the test set. For standard ECG databases (like those referenced by EC57), ground truth is typically established by multiple expert cardiologists.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set. If standard ECG databases were used, the ground truth annotations would have been established prior to the device under test being evaluated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs without AI assistance. The focus of this 510(k) appears to be on the device's standalone performance in arrhythmia detection and measurement against established standards.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone study was done. The document states that "Arrhythmia detection and alarms, ST elevation and QT interval measurements... were evaluated in accordance with FDA guidance on arrhythmia detection and alarm... This guidance calls for use of the FDA recognized consensus standard EC57 (FDA Rec No: 3-118), which defines methods of presenting results when testing against specified ECG databases." This indicates the algorithm's performance was evaluated independently against pre-annotated databases, which is a standalone assessment.

7. Type of Ground Truth Used

The ground truth used would be expert consensus annotations as provided in the "specified ECG databases" referenced by the EC57 standard. These databases contain ECG recordings with validated annotations of arrhythmias and other cardiac events, established by a panel of cardiologists.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the algorithms. It is possible the algorithms were pre-trained and integrated, or that general ECG databases were used for training, but this is not detailed.

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

The document does not provide any information on how the ground truth for the training set was established. If standard ECG databases were used for training, the ground truth would have been established by expert consensus annotations within those databases.

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