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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.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Not Explicitly Stated for all, but Inferred from Standards)	Reported Device Performance (from Clinical Study for Neonatal NIBP)
Neonatal NIBP Safety & Effectiveness	Compliance with ISO 81060-2:2013 and ISO 14155:2011	Clinical study conducted to demonstrate safety and effectiveness
Other Parameters (ECG, SpO2, etc.)	Compliance with various IEC/ISO standards (e.g., IEC 60601 series, ISO 9919, etc.)	Not explicitly detailed in the provided text

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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K Number

K123556

Device Name

MORTARA SURVEYOR PATIENT MONITOR

Manufacturer

MORTARA INSTRUMENT, INC.

Date Cleared

2013-03-22

(123 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K060135,K090556,K100127,K012226

Intended Use

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.

Device Description

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.

AI/ML Overview

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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