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The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents, and children 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 & 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 'Bed to Bed communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station.

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 Survevor 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, noninvasive 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 Survevor Network, the Survevor 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.

The new Surveyor S12, S19, V3.0.1 has added Wireless LAN capability and a Bedside-to-Bedside (B2B) feature that allows remote viewing of monitors when connected to a Surveyor Central Station

The Mortara Surveyor Patient Monitor is a multi-parameter patient monitor that was submitted to the FDA for 510(k) clearance (K173765) as substantially equivalent to its predicate devices, the Surveyor S12 and S19 Patient Monitor v2.0.0 (K161517) and Philips MX800 Patient Monitor (K161531). The new features added were Wireless LAN capability and a Bedside-to-Bedside (B2B) feature that allows remote viewing of monitors when connected to a Surveyor Central Station.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table detailing acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) for parameters like ECG, NIBP, SpO2, etc. Instead, it relies on compliance with recognized consensus standards. The "Reported Device Performance" in this context refers to the device's adherence to these standards and the assertion of substantial equivalence based on the technological characteristics being identical or equivalent to the predicate devices and the successful completion of non-clinical software verification and validation.

The "Comparison Matrix to Predicate Device" (Table 12-1) is the closest thing to reported device performance, showing that fundamental parameters and their measurement methods are identical or equivalent to the predicate.

For example, for physiological parameters, the comparison matrix shows:

• NIBP: Measurement Method, Units, and Mode are "Identical" to predicate. Cuff sizes are "Identical".
• Respiration: Measurement Method, Signal origin, and Rate Resolution are "Identical". Bandwidth is "Equivalent" (0.17 to 3.3 Hz for the subject device vs. 0.3 to 2.5 Hz for Predicate 2).
• IBP: Measurement Method and Pressure sources are "Identical". Product Configurations for IBP are "Identical".
• Temperature: Measurement Method and Probe Type are "Identical".
• SpO2: Measurement Method, Algorithm (Mortara SpO2, Nellcor OxiMax), and Parameters are "Identical" to Predicate 1.
• CO2: Method, Sampling configurations, and Measurements are "Identical". Algorithm is "Equivalent" (Veritas for subject device vs. Oridion Microstream for Predicate 2).
• ECG: 12 Lead ECG module and 3/5-wire ECG cable set are "Identical". ECG input impedance is "Equivalent" (>2.5 MOhm at 10 Hz for subject device vs. >2 MOhm for Predicate 2). 3/5 wire ECG lead fail detection is "Identical".

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

The document explicitly states that non-clinical software verification and validation testing was conducted. There is no mention of a clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective data) for evaluating the overall device performance for physiological monitoring. The focus of the submission for the new features (Wireless LAN and B2B) is on software validation and compliance with electrical safety and EMC standards.

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

Since no clinical test set is described, there's no information about experts establishing ground truth in the context of physiological parameter accuracy or clinical efficacy. The substantial equivalence relies on comparison to predicate devices and adherence to engineering standards.

4. Adjudication Method for the Test Set

As there is no described clinical test set for performance evaluation, there is no adjudication method mentioned for such a test set.

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

No MRMC comparative effectiveness study was done or is mentioned in the provided document. The device's clearance is based on substantial equivalence to existing devices and non-clinical testing of new features.

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

The assessment focused on non-clinical software verification and validation, which can be considered a form of standalone performance evaluation for the software components, particularly for the new Wireless LAN and B2B features, as well as the underlying algorithms for physiological parameters.

Compliance with standards such as AAMI ANSI EC 57:2012 Testing And Reporting Performance Results Of Cardiac Rhythm And ST-Segment Measurement Algorithms suggests that the cardiac rhythm and ST-segment measurement algorithms would have undergone standalone testing against reference waveforms, but specific details of this testing (e.g., sample size, specific performance metrics against referenced ground truth) are not provided in this summary.

7. The Type of Ground Truth Used

For the software verification and validation, the ground truth would likely be established through:

• Reference standards and specifications: For electrical safety, EMC, and alarm systems (e.g., IEC 60601 series).
• Internal engineering specifications: For the functionality of the Wireless LAN and B2B features, ensuring they perform as designed.
• Simulated data or known test conditions: For cardiac rhythm and ST-segment measurement algorithms (implied by adherence to AAMI ANSI EC 57:2012), where known arrhythmias or ST-segment changes are used as ground truth.
• Comparison to predicate device performance: The core physiological monitoring components are claimed to be "Identical" or "Equivalent" to already cleared devices, suggesting their performance has a history of acceptable use based on previously established ground truths (though not detailed here).

For the new features (Wireless LAN, B2B), the "ground truth" would be the successful and secure transmission/display of data as specified by the system design.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This type of information is typically associated with AI/ML-based devices, which is not highlighted as the primary mechanism for the core physiological monitoring functions or the new features of this device.

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

As no training set is mentioned, no information on how its ground truth was established is available.

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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 Mortara Surveyor Patient Monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor Patient Monitor facilitates the monitoring of: 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 a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Mortara Instrument, Inc. Surveyor Patient Monitoring System (S12 and S19) is a portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output. Models within the Mortara Surveyor family come in two different sized viewing areas (11.6" and 18.5") and offer selected monitoring features.

The provided text describes the Mortara Surveyor Patient Monitor (S12 and S19) and aspects of its performance testing for its 510(k) submission. However, it does not include detailed acceptance criteria or the specific study data that would allow for a table of acceptance criteria versus reported device performance. It mainly states that the device "complies with its predetermined specification" and is "substantially equivalent to the predicate device" based on various tests.

Based on the provided document, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This specific table cannot be constructed from the provided text. The document repeatedly states that test results indicated the device "complies with its predetermined specification" for various categories (Software, Electrical Safety, EMC, Bench Performance). It does not, however, spell out what those predetermined specifications (acceptance criteria) were, nor does it provide quantitative performance data to report against those criteria.

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

The document does not specify any sample sizes for test sets. It mentions "Software Testing," "Electrical Safety Testing," "Electromagnetic Compatibility Testing," and "Performance Testing - Bench" but does not detail the number of cases or samples used in these tests. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned, as no clinical study data is presented.

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

This information is not provided. No clinical study was performed, and therefore, no experts were needed to establish ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical test set requiring expert ground truth was performed, no adjudication method is mentioned.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Patient Monitor." This implies the device doesn't involve human interpretation that would be enhanced by AI, making an MRMC study irrelevant in this context.

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

While the device itself is an "algorithm only" in the sense that it's a physiological monitor, the document does not describe a standalone algorithm performance study in the way this question typically implies (e.g., for AI/ML devices). Instead, it refers to "Software Testing" and "Performance Testing - Bench" which validated the device's adherence to its predetermined specifications. No specific performance metrics or studies analogous to those for AI algorithms are detailed.

7. The Type of Ground Truth Used

For the specific testing mentioned (Software, Electrical Safety, EMC, Bench Performance), the ground truth would inherently be based on the device's predetermined specifications and engineering standards. For example, for electrical safety, the "ground truth" is compliance with applicable electrical safety standards. For software, the "ground truth" is that the software performs according to its design requirements. This is not "expert consensus," "pathology," or "outcomes data" as typically thought of in diagnostic imaging or clinical decision support.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this device's submission description. The described device is a physiological monitor, not an AI/ML-driven device that typically undergoes a "training" phase with data.

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

Not applicable, as no training set is mentioned.

Summary of what is present:

• Device Description: The Mortara Surveyor Patient Monitoring System (S12 and S19) is a portable patient monitor for ECG, Respiration, NIBP, Temperature, SpO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG, and cardiac output.
• Intended Use: For knowledgeable healthcare professionals in a healthcare facility for continuous monitoring in stationary or portable applications, indicated for adult & pediatric patient populations.
• Performance Testing Categories (general statements of compliance):
  • Software Testing
  • Electrical Safety
  • Electromagnetic Compatibility Testing (EMC)
  • Performance Testing - Bench (functional, environmental, vibration/shock)
• Missing from the document:
  • Specific quantitative acceptance criteria.
  • Specific quantitative reported device performance data.
  • Sample sizes for any tests.
  • Data provenance.
  • Details on ground truth establishment if clinical data were used (which they weren't for performance).
  • MRMC or standalone algorithm studies (as the device is not presented as an AI/ML diagnostic system).

This document mainly focuses on engineering and regulatory compliance as opposed to detailed clinical performance metrics typically found in submissions for AI/ML diagnostic aids.

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