Search Results

The Surveyor S2 is indicated for use:

· The Surveyor S2 is indicated for use in adult, adolescents, and children patient populations. The Surveyor S2 facilitates the monitoring of ECG signals.

· The Surveyor S2 is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.

· The Surveyor S2 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 S2 is indicated for use to acquire and output electrocardiographic data.

· The Surveyor S2 is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering realtime acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.

The Surveyor S2 is a patient-worn, battery-powered telemetry transmitter. The Surveyor S2 is intended to acquire ECG signals and transmits waveforms and corresponding status to a receiving S2 Communication Library. The S2 Communication Library, to be integrated in an external monitoring node for processing, exposes an API to obtain ECG signals and push session status, parameters and demographic information to the S2.

The ECG acquired signals are transmitted through the S2 communication Library to the Monitoring Node for further processing, presentation, storage, etc via the hospital/clinic wireless and wired network infrastructure. The Surveyor S2 is designed to be used within the existing network IT infrastructure.

The Surveyor S2 has a 2.8'' color display with a capacitive touch sensitive screen, allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and on-demand visual indication of the status of its connection to the monitoring node. The Surveyor S2 acquires and sends signals to the monitoring node where ECG signal processing and monitoring occurs. The Surveyor S2 displays ECG derived parameters (Heart Rate) and demographic data and monitoring state as received from the monitoring node through the S2 Communication Library.

The Surveyor S2 provides continuous data acquisition which can be visualized on the S2 itself for the ECG waveforms.

The Surveyor S2 utilizes ECG lead cables available in AHA or IEC, snap or clip, 4-wire Lead. ECG data delivered is 3-leads, lossless compressed, 2.5 µV LSB at 500 samples per second.

ECG data is augmented with electrode fail markers, lead identifications, hardware detected pacemaker spikes.

The provided text describes the Mortara Instrument Surveyor S2, a device for monitoring ECG signals, and compares it to its predicate device, the Surveyor S4. However, it does not include specific acceptance criteria or a study with detailed performance metrics. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone performance study against pre-defined acceptance criteria.

Therefore, many of the requested sections about acceptance criteria, clinical studies, and ground truth cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided. The document does not define specific quantitative acceptance criteria or provide a table of performance metrics. The comparison table focuses on technological characteristics and equivalence to the predicate, not on numerical performance against targets.

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

• Cannot be provided. The document states, "No clinical studies were utilized for the purpose of obtaining data," which implies no human test set was used for performance validation.

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

• Cannot be provided. As no clinical studies were performed, there was no need for experts to establish ground truth from a test set.

4. Adjudication method for the test set:

• Cannot be provided. As no clinical studies were performed, there was no ground truth adjudication.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states, "No clinical studies were utilized for the purpose of obtaining data."

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

• Yes, a standalone non-clinical performance assessment was done. The document states: "Performance testing for the Surveyor S2 includes software verification and validation test, software unit test, integration test, system test and testing to compliance standards for electrical and electromagnetic safety. Wireless coexistence testing and evaluation was performed following FDA Guidance, 'Radio Frequency Wireless Technology in Medical Device', and the device's immunity to proximity fields from radio frequency wireless communications equipment was validated."
  • Effect size of improvement: Not applicable, as this was not an MRMC study comparing human performance with and without AI.

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

• For non-clinical tests: The "ground truth" for the non-clinical tests (software, electrical, electromagnetic) would be defined by the specifications and expected behavior outlined in the various compliance standards (e.g., IEC 60601 series, ISO 10993 series, ISO 14971, IEC 62304, IEC 62366). The device's performance was compared against these established engineering and safety standards. There is no mention of clinical ground truth (e.g., expert consensus on ECGs, pathology, or outcomes).

8. The sample size for the training set:

• Not applicable / Cannot be determined. The document doesn't describe the development of an AI or algorithm that would require a "training set" in the traditional machine learning sense. The device is a physiological signal transceiver.

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

• Not applicable / Cannot be determined. As there's no mention of a training set for an AI/algorithm, this question is not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

CardioConfirm is intended to be used by qualified clinicians to finalize cardiology reports for adult and pediatric patients. To aid the clinician's interpretation of resting ECGs, CardioConfirm supports the display and onscreen measurement of ECG waveforms. CardioConfirm also supports the algorithmic comparison of serial adult ECGs and allows the user to edit the automatic comparison statements.

CardioConfirm is intended to be controlled by a host application that manages user authentication, user permissions, and secure persistent storage of the tests.

CardioConfirm is a software component that is embedded into a host application (e.g. EMR) as a Dynamic Link Library (DLL) or launched as an executable application. CardioConfirm allows the user to display, edit and finalize diagnostic cardiology ECG, Stress and Holter reports. A Clinician can open a diaqnostic cardiology test from a workstation application and pass it to CardioConfirm as a DICOM object for viewing or editing. CardioConfirm is able to open and edit diagnostic cardiology ECG, Stress and Holter reports from Mortara Instrument, Inc. devices and offers an optional version which can edit diagnostic cardiology ECG, Stress and Holter reports from multiple diagnostic cardiology equipment vendors.

CardioConfirm allows the clinician the ability to view, measure, and compare previously acquired resting ECGs as well as perform visual and textual serial comparison of acquired ECGs. With visual serial comparison, the clinician can view current and previous ECG's simultaneously superimposed on the screen. Textual serial comparison allows the clinician to enter or edit text that describes the significant differences between the ECG's. For adult ECG's the initial text can be generated by the VERITAS SERIAL COMPARISON algorithm. The algorithm generates comparative statements automatically on the basis of the VERITAS INTERPRETATION statements originally made by the Mortara acquiring devices, measurements and the ECG waveforms. The clinician can edit the patient demographics, previous measurements and interpretations and the serial comparison statements, and then sign final ECG reports.

The clinician can also view and edit stress and Holter reports that includes editing patient demographics, summary statistics and physician conclusions. The clinician can electronically sign both stress and Holter final reports in CardioConfirm and print final reports or generate PDF copies to store in the host application. If a physician wants to amend a previously finalized report with additional information, CardioConfirm has an option to perform amendments to final reports and store the updated test in the host application.

CardioConfirm is available in two versions. The standard version is intended to be used with tests generated by Mortara equipment. The professional version is intended to be used with tests generated by any equipment that produces DICOM 12-lead ECG Waveform and Encapsulated PDF objects.

I will provide the information based on the text provided, which focuses on the regulatory submission and comparison to predicate devices, rather than a detailed study protocol for performance. The document primarily describes the device and asserts its substantial equivalence based on non-clinical data. It explicitly states that clinical data was not required.

Here's the breakdown of the information you requested, based on the provided text:

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

The provided text does not list specific numeric acceptance criteria for device performance or corresponding reported performance metrics in the format typically used for studies determining efficacy or accuracy (e.g., sensitivity, specificity, F1-score). Instead, it implicitly defines "performance" through a comparison of technological characteristics with predicate devices and emphasizes software verification and validation. The "reported device performance" is framed as performing "as intended" and demonstrating "substantial equivalence."

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

The document makes no mention of a "test set" in the context of clinical or performance data for the device. The "non-clinical data" and "software verification and validation" (Section 7) refer to engineering and software testing, not a dataset of patient cases used to evaluate the diagnostic or comparison algorithm's performance against human experts or ground truth. Therefore, sample size, data provenance, retrospective/prospective nature are not applicable or provided.

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, as no clinical test set for evaluating diagnostic performance or algorithmic comparison accuracy is described in the provided text.

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

Not applicable, as no clinical test set is described.

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 done. The document explicitly states: "The subject of this premarket notification did not require clinical data to support substantial equivalence." (Section 7)

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

The document describes the device as providing "algorithmic comparison of serial adult ECGs" and mentions "The algorithm generates comparative statements automatically on the basis of the VERITAS INTERPRETATION statements originally made by the Mortara acquiring devices, measurements and the ECG waveforms." (Section 4). However, it does not provide performance metrics for this algorithm in a standalone capacity (e.g., sensitivity, specificity for identifying changes). It also states that users can "edit the automatic comparison statements" and "edit previously-signed interpretations," indicating that the device is intended for human-in-the-loop use. No standalone performance study as such is detailed.

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

For the "VERITAS SERIAL COMPARISON algorithm" mentioned (which generates initial comparative statements), the ground truth for its development or internal validation is not explicitly stated. Given the context, it would likely be based on consensus interpretations by cardiologists or a similar expert review of ECG changes, but this is not specified in the document. For the overall device, the "ground truth" for its acceptance criteria revolved around demonstrating functional equivalence to existing devices and proper software engineering practices, rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

The document does not mention a "training set" in the context of a machine learning or AI model that would typically require one for statistical performance evaluation. The "VERITAS SERIAL COMPARISON algorithm" implicitly refers to an algorithmic component, but details on its development data (training set) are not provided.

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

Not applicable, as no "training set" is documented, nor is the establishment of its ground truth described.

Ask a specific question about this device

The Surveyor S4 Mobile Monitor is indicated for use:
• The Surveyor S4 Mobile Monitor is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals.
The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own.
• The Surveyor S4 processes Heart Rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm.
• The Surveyor S4 can deliver data from a 3/5-lead cable and diagnostic 12-lead ECG data to a receiving Surveyor Central station
• The Surveyor S4 Mobile Monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure.
• The Surveyor S4 Mobile Monitor is indicated for use in adults, adolescents and children.
• The Surveyor S4 Mobile Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.

The Surveyor™ S4 Mobile Monitor is a battery operated patient worn transceiver that communicates via IEEE 802.11 Wi-Fi technology to the Surveyor™ Central Station (K131929) which is the primary monitoring display and alarm source.
The Surveyor S4 transmitter has a touch sensitive, color display allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and Surveyor Central Station slot information. The Surveyor S4 can display physiological waveforms, measured parameters, demographic data and other status information. The Surveyor S4 acquires, filters, and processes ECG or ECG and SpO2 parameters and sends filtered signals and parameters to the Surveyor Central Station where alarm processing and annunciation occurs.
The Surveyor Central is designed to communicate with the Surveyor S4 within a healthcare facilities Wi-Fi network infrastructure. The Surveyor Central provides primary monitoring of telemetry patients when used with the Surveyor S4. The central station displays numeric values, waveforms, alarm generation and management, data storage, individualized patient management, report generation and printing functionality.
The Surveyor S4 provides continuous data acquisition which can be visualized on the S4 itself for the following parameters:

• o Electrocardiography (ECG) including heart rate and ECG waveforms
• · Saturation percentage of peripheral oxygen (SpO2), including SpO2 plethysmogram waveform, pulse rate, and signal quality index.
• o No alarm status or processing information of ECG or SpO2 is shown on the Surveyor S4 device.
• o The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias, by utilizing Mortara VERITAS™ ECG algorithm and sends ECG data packets, including arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole to the Surveyor Central Station for alarm processing and annunciation.
• o The Surveyor S4 utilizes proprietary ECG lead cables available in AHA or IEC, snap or clip, 3-Lead, 5-Lead, and diagnostic 12 Lead configurations.
• o The Surveyor S4 processes SpO2 percentage, pulse rate and signal quality through the Mortara SpO2 algorithm and sends data packets for SpO2 to the Surveyor Central Station for alarm processing and annunciation.
• o Multiple SpO2 sensor styles allow connection of adults, adolescents, and children. SpO2 sensors are specified for use with the Surveyor S4 and available through Mortara Instrument.

The device in question is the Mortara Surveyor S4 Mobile Monitor. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for acceptance criteria. However, it does mention one basic clinical study for SpO2 compliance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding device performance for the entire device. It states that software verification and validation testing was conducted, and the device was designed and tested for compliance with specific standards (listed below). The only specific performance claim related to a study is for SpO2.

Note: The FDA 510(k) summary typically establishes substantial equivalence, often by demonstrating adherence to recognized standards and comparing to predicate devices, rather than presenting full clinical trial results and specific acceptance criterion tables for every feature. The statement "The study met the requirements of ISO 80601-2-61-2011 Clause 201.12.1" is the most direct mention of acceptance criteria being met.

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

The document states: "A basic pulse oximeter clinical study was conducted to demonstrate the Surveyor S4 Mobile Monitor SpO2 compliance to IEC 80601-2-61."

• Sample Size for Test Set: Not specified for the SpO2 clinical study.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided for the SpO2 clinical study or any other part of the evaluation. For a pulse oximeter study conforming to ISO 80601-2-61, ground truth is typically established by comparing the device's SpO2 readings against co-oximeter readings from arterial blood samples, with interpretation often overseen by a qualified physician or clinical team, but details are absent here.

4. Adjudication Method for the Test Set

This information is not provided.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document describes a "basic pulse oximeter clinical study" for SpO2 compliance and otherwise focuses on engineering testing against standards and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

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

For the SpO2 functionality, a standalone clinical study was done as "A basic pulse oximeter clinical study was conducted to demonstrate the Surveyor S4 Mobile Monitor SpO2 compliance to IEC 80601-2-61." This evaluates the algorithm's performance directly against established ground truth.

For ECG aspects (Heart rate, ST segment deviation, arrhythmias using VERITAS™ ECG algorithm), the document states the device "was designed and tested for compliance with the applicable clauses of... ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm, ST segment measurement algorithms, ventricular fibrillation algorithm, and irregular rhythm (atrial fibrillation) algorithm." This standard specifically outlines methods for standalone algorithm performance testing, implying such testing was conducted to demonstrate compliance. However, specific performance metrics or detailed study descriptions are not provided in this summary.

7. The Type of Ground Truth Used

For the SpO2 clinical study, the ground truth would typically be established using co-oximetry from arterial blood samples, as dictated by the ISO 80601-2-61 standard for pulse oximeter accuracy testing. This involves comparing the device's SpO2 readings with direct measurements of oxygen saturation in arterial blood. While not explicitly stated, adherence to the standard implies this methodology.

For the ECG algorithms (Heart Rate, ST-segment, arrhythmia detection), ground truth for compliance with ANSI/AAMI EC57:2012 would typically be established by expert consensus of cardiologists or other qualified medical professionals reviewing annotated ECG recordings. This could also involve comparison against known, validated datasets or simulated waveforms. Again, the specific details are not provided in this summary but are implied by the standard.

8. The Sample Size for the Training Set

The document does not provide information regarding the training set sample size for any of its algorithms (VERITAS™ ECG algorithm or Mortara SpO2 algorithm). This submission focuses on the performance of the final, developed device and algorithm.

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

The document does not provide information on how the ground truth for the training set was established. As this is a 510(k) submission for substantial equivalence, such details about algorithm development and training data are typically not included unless specifically requested or if it's a novel AI device requiring detailed algorithm transparency.

Ask a specific question about this device

The H3+ Holter recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from adult, adolescent, pediatric, infant and neonate patient populations for a maximum recording time of 14 days in a hospital, clinic or home environment. The H3+ performs no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system which will analyze the recorded data. The H3+ data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The H3+ Holter Recorder is not a life-supporting device.

The H3+ Holter Recorder is part of a Holter Analysis system. The H3+ Holter Recorder provides multiple channels of continuous multi-day ECG data recording and pacemaker spike detection markers.

The H3+ Holter Recorder is extremely small and lightweight. The H3+ includes a display that allows the clinician to confirm patient identification, preview the waveform, and check the quality of lead connections during patient hook-up. The H3+ also has a patient activated event button which allows the insertion of event marks into the recorded data if directed by the clinician.

The H3+ uses a single battery and stores acquired data in digital form on internal, non-volatile memory. Stored data is then imported for analysis at a compatible Holter analysis system [ e.g. HScribe (K004017) or Vision (K945985)]. The recorded data will remain in memory until it has been cleared by the clinician.

The data provided by H3+ to the Holter Analysis system is used by trained medical personnel to assist in the diagnosis of patient conditions.

The provided text describes the H3+ Holter Recorder (K152626) and its substantial equivalence to a predicate device. However, a detailed study proving the device meets specific acceptance criteria with reported performance metrics is not included in this document. This submission primarily focuses on demonstrating substantial equivalence to a previous version of the H3+ Holter Recorder (K043010) by outlining technological characteristics and compliance with standards.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in a table format with reported device performance for specific clinical metrics. Instead, it compares the current device (H3+ version 3.0.0) with its predicate device (H3+ version 2.09) across various technical specifications. The changes are largely related to increased recording duration, updated standards compliance, and minor hardware modifications. The statement "The H3+ was designed and tested for compliance with the applicable clauses of the following standards" implies that meeting these standards serves as the acceptance criteria for technical performance, but no specific performance values are reported against them in this document.

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 primarily focuses on technical and regulatory compliance. It does not mention any specific sample size for a test set or clinical data. It explicitly states in Section 5, item 5: "The subject of this premarket notification did not require clinical data to support substantial equivalence." This implies that the testing performed was primarily non-clinical, focusing on engineering validation and adherence to standards. Therefore, information on data provenance (country, retrospective/prospective) is also not available.

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)

Since no clinical data or clinical test set was required for this submission, there is no information regarding the number of experts or their qualifications used to establish ground truth for a test set. The device's output (ECG data) is intended to be reviewed by "trained medical personnel for the purpose of forming a clinical diagnosis," suggesting that human experts interpret the device's output, but this is not part of the device's acceptance criteria study in this document.

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

As no clinical test set requiring adjudication was used for this submission, there is no information on any adjudication method.

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 Holter recorder, which acquires, records, and stores ECG data. It explicitly states the device "performs no analysis by itself." Therefore, it does not incorporate AI and no MRMC comparative effectiveness study with or without AI assistance was performed or would be relevant to this device's function.

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

The H3+ Holter Recorder is a data acquisition and recording device. It "performs no analysis by itself." Therefore, there is no standalone algorithm performance to report. Its function is to capture data that will then be analyzed by a separate Holter analysis system, with the final interpretation by trained medical personnel.

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

For the technical performance evaluations mentioned (e.g., related to standards compliance), the "ground truth" would be established by the definitions and requirements specified within those engineering and medical electrical equipment standards. For instance, frequency response or signal resolution are directly measurable against predefined norms. Since no clinical claims were made or clinical data was required for this submission, there is no ground truth related to clinical diagnoses (expert consensus, pathology, or outcomes data) established or reported for the device itself.

8. The sample size for the training set

Since this device does not perform analysis and does not incorporate AI or machine learning algorithms, there is no training set used for the device itself.

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

As there is no training set for this device, information on how its ground truth was established is not applicable.

Ask a specific question about this device

The XScribe/Q-Stress device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device is intended for use in adult, adolescent, and children patient populations. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician.

The device may interface with equipment for pulmonary function testing and other devices, including a treadmill or ergometer for dynamic exercise evaluation, as well as non- invasive blood pressure equipment, functional arterial oxygen saturation (SpO2) equipment, and computer communications equipment.

The device is not intended to be used as a vital signs physiological monitor.

The XScribe / Q-Stress device is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules. The device is able to generate risk scoring via recognized protocols. The device is capable of obtaining a resting ECG with automatic interpretation. The device can interface with equipment for pulmonary evaluation. The device has several built in exercise protocols for connection and control of exercise equipment such as treadmills and ergometers. The device supports measurement of non-invasive blood pressure. The device can output analog ECG signals or digital QRS trigger signals for synchronizing an external device. The device supports a touch screen interface as well as a keyboard / mouse interface and a wired remote control unit. The device will store a complete record of diagnostic quality test data from which the user can generate and review stress test reports. The device can function as standalone workstation or can connect via network to a database server allowing for remote review capabilities. The device can communicate with electronic record keeping systems to obtain work lists and patient data, and to provide test result reports.

This document is a 510(k) premarket notification for the Mortara Instrument, Inc. XScribe and Q-Stress Stress Exercise Testing Systems. It asserts substantial equivalence to a predicate device, XScribe II (K022618).

The crucial point for the request is that this submission explicitly states that clinical data was NOT required or used to support substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, test set details (sample size, provenance, ground truth experts, adjudication), MRMC studies, standalone performance, or training set details because no such studies were performed or are presented in this document for the purpose of demonstrating substantial equivalence.

The document primarily relies on non-clinical data, software verification and validation, and compliance with applicable electrical and medical device standards to establish substantial equivalence.

Here's how I can address the prompts based on the provided text:

Acceptance Criteria and Study for DEVICE PERFORMANCE (Based on Available Information):

Since no clinical study data is provided in this 510(k) submission to demonstrate the device meeting performance acceptance criteria in a clinical setting against a ground truth, the "acceptance criteria" here refer to the engineering and regulatory compliance criteria used for a 510(k) submission based on substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable / Not Provided for Clinical Performance. The submission explicitly states: "The subject of this premarket notification did not require clinical data to support substantial equivalence."
• For the non-clinical software and hardware testing, the specific sample sizes or data provenance (e.g., number of test cases, simulated data characteristics) are not detailed in this summary. These would typically be found in the full testing reports which are not part of this public summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable / Not Provided. As no clinical performance study was conducted or presented to establish ground truth for clinical outcomes, no such experts were involved for this purpose in this submission.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided. No clinical performance study requiring adjudication was presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. The document explicitly states that clinical data was not required or utilized for this submission. Therefore, no MRMC study was conducted.

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

• Not Applicable / Not Provided as a distinct clinical study. The device "acquires, processes, records, archives, and outputs electrocardiographic data" and performs "ST analysis and ventricular ectopic beat detection." While these are algorithmic functions, their standalone performance in a clinical diagnostic context (e.g., sensitivity/specificity for detecting certain conditions) is not quantified or presented in this 510(k) submission through a dedicated study with clinical ground truth. The V&V activities would assess the technical correctness of these algorithms.

7. The Type of Ground Truth Used:

• For the non-clinical testing, the "ground truth" would be the engineering specifications, regulatory standards, and expected behavior of the software and hardware components. This is not clinical ground truth (e.g., pathology reports, expert consensus on patient diagnosis).
• For clinical performance, no ground truth was established or used, as no clinical study was performed.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. This device is largely based on known physiological principles and signal processing, and it is asserting substantial equivalence to an existing predicate. The nature of this 510(k) (not a novel AI/ML device relying on extensive data training for a diagnostic claim) means that a "training set" in the context of machine learning model development is not relevant or disclosed here. Its processing capabilities are likely rule-based or parametrically driven from established algorithms.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable / Not Provided. See point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

The Ambulo 2400 Ambulatory Blood Pressure Monitor is indicated for use in adult & pediatric patient populations; it is not indicated for use with neonates.

The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults and pediatric patients, using the oscillometric method on a cuffed arm.

The Ambulo 2400 is a compact, lightweight, non-invasive ambulatory blood monitoring system. The Ambulo 2400 can measure systolic and diastolic blood pressure and pulse rate over and pulse rate over a 24 hour period. It is easily configured and individually-fitted for each patient by a physician or health care professional. Measurements are automatically captured, without medical supervision, by the Ambulo 2400 and later downloaded to a computer for analysis and interpretation by a physician.

The provided text is a 510(k) premarket notification for the Ambulo 2400 Ambulatory Blood Pressure Monitoring System. It describes the device, its intended use, and the testing performed to demonstrate its safety and effectiveness.

However, the document does not contain specific acceptance criteria or detailed results of a study proving the device meets those criteria in the format requested. It mentions performance testing and compliance with various standards but lacks the quantitative data needed to complete the requested table and detailed study information.

Therefore, I cannot provide a complete answer to your request based on the provided text. The document refers to "predetermined requirements" and "predetermined specification" for performance and software testing but does not explicitly state what these are in numerical terms or provide the specific results that would fill out your table.

Based on the available information, here's what can be inferred and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text in a quantifiable manner (e.g., specific accuracy ranges for blood pressure). The document mentions compliance with standards like IEC 80601-2-30:2009+A1:2013 for automated non-invasive sphygmomanometers, which would contain the acceptance criteria.
• Reported Device Performance: Not numerically reported in the provided text. The document states that "Test results indicated that the Mortara Ambulo 2400 complies with its predetermined specification" and that it "performs as well as or better than the predicate device," but no actual performance numbers are given.

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

• Sample Size: Not specified. The document only states "Performance Testing - Clinical: The Ambulo 2400 was evaluated for clinical performance to demonstrate safety and effectiveness."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• This information is not available in the provided text.

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

• This information is not available in the provided text.

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:

• The Ambulo 2400 is an automated blood pressure monitor, not an AI assistance tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device type.

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

• Yes, implicitly. The device is an automated blood pressure monitor. Its primary function is to measure blood pressure without continuous human intervention during the measurement period. The "Performance Testing - Clinical" would evaluate this standalone performance.

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

• For an automated blood pressure monitor, the "ground truth" in clinical performance testing would typically be reference measurements taken simultaneously by a validated, highly accurate manual method (e.g., auscultation by trained observers) or another highly accurate automated device. The document does not specify the ground truth methodology used for its clinical testing.

8. The sample size for the training set:

• Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. The device measures physical parameters.

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

• Not applicable as this is not an AI/machine learning device.

In summary, while the document confirms that clinical performance testing was conducted and that the device complies with predetermined specifications and relevant standards, it lacks the specific quantitative data and detailed methodology to answer most of your detailed questions regarding acceptance criteria and study particulars.

Ask a specific question about this device

The Monitoring Waveform Viewer is indicated for use as follows:

The Monitoring Waveform Viewer is a software component utilized within another software application.

The Monitoring Waveform Viewer performs the following:

• Display of data generated by multi-parameter patient monitoring systems continuously producing waveforms and parameters.
• Display of reported alarm states produced by such monitoring systems.
• Display of static waveforms for review of existing data, with the possibility to activate a magnification tool. The magnification tool will enlarge the signal located under the magnification icon.
• Perform measurements with the support of a caliper tool (providing horizontal/time measurements and vertical/signal amplitude measurements). The caliper tool can be activated when the Monitoring Waver displays still waveforms.
• Provide selected waveform episodes to the host application for printing or inclusion in the patient record.

The Monitoring Waveform Viewer:

• Is not a primary or secondary alarm device.
• Does not provide a user interface for acknowledging or silencing active alarms.
• Does not generate audible or visual (flashing) notifications of active alarms.

The Monitoring Waveform Viewer does not provide any support for implementing an application that is part of an alarm system.

The Monitoring Waveform Viewer is a software component that includes a system for reviewing snapshots of monitoring data and offers a measurement module with user controlled calipers and magnifier glass.

Medical device data or information system applications may utilize the Monitoring Waveform Viewer software component that includes a stand-alone executable module that functions as a host application. The Monitoring Waveform Viewer is organized as a drawing surface with three areas:

• a parameters area located at the bottom of the window, .
• a parameter waveform area located at the right and
• . a main waveform area.

The parameters area is dedicated to report the values of parameters not associated with displayed waveforms. The parameter waveform area is dedicated to report the values of parameters associated to the displayed waveforms.

The application supports several numerical parameters such as: ECG (electrocardiogram), ART (arterial pressure), PA (pulmonary artery invasive blood pressure), ICP (intracranial pressure), IABP (intra-aotic balloon pump pressure), RR (respiration rate), EtCO2 (end tidal carbon dioxide), SpO2 (oxygen saturation), etc.

The Monitoring Waveform Viewer receives data parameters and waveforms supplied from multi-parameter patient monitoring systems. The Monitoring Waver is able to display alarm states by highlighting the corresponding parameter box. The Monitoring Waveform Viewer operating in near real time mode supports alarm priorities of High Priority, Medium Priority, and Low Priority.

The Monitoring Waveform Viewer allows the user to right-click over any ECG lead or the ECG parameter box to activate a context menu for selecting the ECG gain and displayed leads. The user is able to select a list of active (with data) ECG leads received from the host application. It also allows the user to select gains of 5, 10, 20 and 40mm/mV. The Monitoring Waveform Viewer provides a caliper tool for performance amplitude and interval measurements on the displayed traces. The caliper can be placed anywhere on the waveform display area.

The provided document is a 510(k) notification for the Mortara Monitoring Waveform Viewer, a software component. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria in the typical sense of diagnostic metrics (e.g., sensitivity, specificity).

However, based on the Performance Testing: Software Testing section, we can infer some aspects related to acceptance criteria and the "study" that proves the device meets those criteria.

Here's an attempt to extract the requested information, understanding that this is a software component and not a diagnostic device with traditional performance metrics:

Acceptance Criteria and Device Performance for Mortara Monitoring Waveform Viewer

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a software component for viewing and measuring waveforms, the "acceptance criteria" are related to its functional and performance specifications. Since specific quantitative thresholds are not provided in the document beyond a general statement of compliance, the table below represents the implicit criteria and reported performance.

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

• Sample Size: Not explicitly stated. The document mentions "test results." For software testing, the "sample size" would typically refer to the number of test cases executed. This information is not provided.
• Data Provenance: Not specified. The testing was conducted internally by Mortara Instrument, Inc. It's likely simulated or recorded patient data was used, but the origin (e.g., country, retrospective/prospective) is not detailed.

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

• Number of Experts: Not applicable or not specified. For functional software testing, "ground truth" often refers to the expected output of the software for given inputs, which is derived from the software's specified requirements. There is no mention of external human experts establishing ground truth for evaluating the software's performance on patient data, as this is a viewing and measurement tool, not a diagnostic one. The accuracy of measurements would likely be benchmarked against known values or manual measurements on the displayed data, rather than expert consensus on a clinical outcome.
• Qualifications of Experts: Not applicable or not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since expert consensus on clinical diagnoses is not explicitly used to establish ground truth for this type of device, an adjudication method for conflicting expert opinions is not relevant or described. The "adjudication" in this context would likely be comparing software output to predetermined correct outputs based on specifications.

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

• MRMC Study: No. The document does not describe an MRMC study. The device is a "viewer" and "measurement tool," not a diagnostic AI intended to assist human readers in interpretation that would typically warrant an MRMC study. The focus is on the software component's ability to accurately display and measure, not on improving human diagnostic accuracy.

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

• Standalone Performance: Yes, in essence. The "Software Testing" and "Performance Testing – Bench" sections describe the device's performance as software. This testing evaluates the algorithm (software component) independently against its predetermined specifications for display, measurement, and functionality. There is no human-in-the-loop performance described beyond the general statement that "The data and analysis provided by the Monitoring Waveform Viewer is reviewed, confirmed, and used by trained medical personnel." The performance tests themselves assess the software's outputs directly.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this software component would be based on its functional specifications and expected outputs. For display features, it would be whether the waveforms and parameters are displayed correctly and accurately represent the input data. For the caliper tool, ground truth would be the known accurate measurements of simulated or recorded waveforms. This is essentially "specification-based verification" or "expected output" rather than clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a software component for viewing and measurement; it does not appear to employ machine learning or AI that would require a "training set" in the conventional sense. The software is developed based on deterministic algorithms and rules.

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

• How Ground Truth was Established: Not applicable, as there is no "training set" for this type of software component. Its functionality is based on direct programming logic and specifications rather than learning from data.

Ask a specific question about this device