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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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