Search Results

QMAPP® is intended for use by professional healthcare providers for physiological/hemodynamic monitoring. The system may be used to display and analyze surface ECG (Electrocardiogram), respiration, invasive pressures, pulse oximetry (SpO2), End tidal CO2 (EtCO2), fractional flow reserve (FFR), non-invasive blood pressure (NiBP), surface body temperature, cardiac output and intra-cardiac ECG. QMAPP® provides also clinical data acquisition, medical image/data processing and analytical assessment. QMAPP® is intended for use in the areas of, but not limited to cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology. QMAPP® can be used standalone and in networked environments. The system is intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or send to other devices, such as physiological monitoring system, information management systems, image acquisition/storage devices and other medical devices.

The QMAPP® system offers a complete physiological/hemodynamic monitoring and reporting system. The system is built from three units: an Amplifier, Live Monitoring CPU and Reporting CPU. The Amplifier Unit has various sensors connected with the patient, e.g. ECG, SpO2 and NiBP. The Amplifier Unit is connected to the Live Monitoring CPU via a dedicated Ethernet connection. The acquired patient information can be visualized on a Live Monitoring CPU. Typically located in the technical room. A software application executed on the Live Monitoring CPU can visualize the patient information. Also the Amplifier Unit can be controlled, i.e. most importantly, to set acquisition and filtering parameters for the different sensors, by the Live Monitoring CPU. Optionally the Monitoring unit can be connected via a dedicated Ethernet connection to a Reporting CPU, typically located in the technical room. On the Reporting CPU a database is installed which facilitates data storage and retrieval. A software application executed on the Reporting CPU serves as a patient data management system. It can e.g. be used for analysis, calculation and reporting in various representations of patient information.
The QMAPP® system, can operate standalone or it can be part of a typical hospital network infrastructure. The latter offers the possibility to send or receive information from and to other devices. The software has several communication modules, based on HL7 or DICOM protocols to interface with third party equipment/systems.
• The QMAPP® system works with 3rd party 510(k) cleared SpO2 module (Covidien Nellcor, K083325), NiBP module (CAS Medical Systems, MAXNIBP ND+, e.g. used in FDA cleared device CAS Medical Systems, 740 Select, K150620) and EtCO2 sensors e.g. used in FDA cleared device CLEO Patient Monitor, K142244.

The provided FDA 510(k) Clearance Letter for the QMAPP® System describes the device, its intended use, and a summary of non-clinical tests conducted to support its substantial equivalence. However, the document does not contain the specific details required to fully address your request regarding acceptance criteria and the comprehensive study that proves the device meets them.

Here's a breakdown of what can and cannot be extracted from the provided text, and where the requested information is missing:

Information Present in the Document:

• Overall Device Performance: The "NON-CLINICAL TESTS" section lists various characteristics on which "Bench testing" was carried out, implicitly suggesting these are areas where performance was evaluated. The "Referenced Standards and Performance Testing" section explicitly states that the QMAPP® system "meets the requirements of following performance Standards."
• Study Type: The studies mentioned are "Bench testing," "Usability Testing," and "Software verification and validation testing." The clearance is based on a "Traditional 510(k)" and relies on "non-clinical data."
• Ground Truth Type (for non-clinical testing): For the performance characteristics listed (ECG, Heart rate, SpO2, NiBP, IBP, Cardiac Output, Intra cardiac ECG, Skin Temperature, ECG impedance for Rate of respiratory effort, Measurement accuracy), the "ground truth" would be established by the physical standards and reference systems used during bench testing for each specific measurement. For example, a calibrated heart rate simulator would provide the ground truth for heart rate accuracy.
• Sample Size for Training Set: Not explicitly mentioned, but the document refers to a "software verification and validation testing," implying a dataset (likely synthetic or previously collected) was used.
• How Ground Truth for Training Set was Established: Not explicitly mentioned.

Missing Information (Crucial for your request):

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and adherence to recognized standards. It does not present a detailed study report with specific acceptance criteria, reported performance against those criteria, or the methodology of how "ground truth" was established for clinical or test datasets in the manner you've requested for an AI/ML context.

The QMAPP® system is a physiological/hemodynamic monitoring system, not specifically an AI/ML device that requires a comparison of algorithmic output against expert consensus on a test set, multi-reader multi-case studies, or standalone algorithm performance. The "clinical data acquisition, medical image/data processing and analytical assessment" mentioned are functions of the system, but the document does not elaborate on an AI/ML component with associated performance metrics.

Based on the provided text, here is what can be inferred and explicitly stated, with clear indications of missing information for your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the QMAPP® system was tested against and "meets the requirements of following performance Standards." These standards themselves contain detailed acceptance criteria for various parameters. The table below excerpts the performance characteristics mentioned in the "SUBSTANTIAL EQUIVALENCE SUMMARY TABLE" and "NON-CLINICAL TESTS" sections. Crucially, the document does not provide the specific numerical acceptance criteria (e.g., minimum accuracy percentages, maximum deviations) or the actual measured performance values against those criteria in a consolidated table. Instead, it states that the device "meets the requirements" of the listed standards and has "Accuracy" values which are the specifications for the device itself, not acceptance criteria of a study.

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

• Sample Size for Test Set: Not specified. The document only mentions "Bench testing," "Usability Testing," and "Software verification and validation testing." These are typically performed in a lab environment.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. Given it's bench testing, actual patient data provenance is not directly relevant for the stated tests, but the data used for software verification and validation testing (if involving patient data) is not detailed.

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

• Number of Experts & Qualifications: Not applicable/not specified. For bench testing of physiological monitoring devices, the "ground truth" comes from calibrated testing equipment and reference signals, not expert human interpretation in the way, for example, a radiology AI would be evaluated. The "Software verification and validation testing" is also not described as relying on expert review of a patient dataset for ground truth.

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

• Adjudication Method: Not applicable/not specified. This methodology is typically used when comparing an algorithm's output to human expert interpretations, which is not the type of testing described for this physiological monitor.

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

• MRMC Study: Not applicable. The QMAPP® system is described as a physiological/hemodynamic monitoring, data acquisition, and analytical assessment system. It is not presented as an AI-assisted diagnostic tool designed to improve human reader performance in interpreting images or complex clinical scenarios.

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

• Standalone Performance: The described "Bench testing" and "Software verification and validation testing" can be considered "standalone" in the sense that they evaluate the device's inherent measurement and processing capabilities without a human in the loop for interpretation, but for a physiological monitor, the ultimate "human-in-the-loop" is the clinician using the displayed information. The document does not describe an AI algorithm that operates entirely independently to make a diagnosis or prediction in the same way an AI for image analysis might.

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

• Type of Ground Truth: For the "Bench testing" of physiological parameters, the ground truth would be established by calibrated reference standards and simulated physiological signals. For instance, a signal generator provides a known ECG waveform or blood pressure reading, and the device's measurement is compared to this known input.

8. The sample size for the training set

• Sample Size for Training Set: Not specified. The document mentions "Software verification and validation testing," which would involve a dataset, but its size is not detailed. There is no mention of a "training set" in the context of an AI/ML model, as the device is not presented as such.

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

• How Ground Truth for Training Set was Established: Not specified. If a "training set" was used for software validation (e.g., for signal processing algorithms), the ground truth would likely be established through
  • Synthetic data: Ground truth is known by design.
  • Previously validated physiological data: Data collected with highly accurate reference devices, where the "truth" for various physiological parameters is established by the reference device's measurements.

In summary: The FDA 510(k) clearance document for the QMAPP® System confirms that the device meets relevant performance standards through non-clinical bench testing and software validation. However, it does not provide the detailed acceptance criteria and study particulars, particularly those related to expert-adjudicated test sets, MRMC studies, or specific AI/ML training/testing methodologies, because the device is presented as a traditional physiological monitor, not an AI-powered diagnostic system.

Ask a specific question about this device

QMAPP® is intended for use by professional healthcare providers for physiological/hemodynamic monitoring. The system may be used to display and analyze surface ECG (Electrocardiogram), respiration, invasive pressures, pulse oximetry (SpO2), end tidal CO2 (EtCO2), fractional flow reserve (FFR), non-invasive blood pressure (NiBP), surface body temperature, cardiac output and intra-cardiac ECG.

QMAPP® is intended to be used on the patient population of adults. QMAPP® is not intended for neonatal/infant, pediatric and adolescent patients.

OMAPP® provides also clinical data acquisition, medical image/data processing and analytical assessment.

QMAPP® is intended for use in the areas of, but not limited to cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology.

OMAPP® can be used standalone and in networked environments. The system is intended for patient/procedural data management, such as documentation, logging, rending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or send to other devices, such as physiological monitoring system, information management systems, image acquisition/storage devices and other medical devices.

The QMAPP® system offers a complete physiological/hemodynamic monitoring and reporting system. The system is built from three units: an Amplifier, Live Monitoring CPU and Reporting CPU. The Amplifier Unit has various sensors connected with the patient, e.g. ECG, SpO2 and NiBP. The Amplifier Unit is connected to the Live Monitoring CPU via a dedicated Ethernet connection. The acquired patient information can be visualized on a Live Monitoring CPU, typically located in the technical room. A software application executed on the Live Monitoring CPU can visualize the patient information. Also the Amplifier Unit can be controlled, i.e. most importantly, set acquisition and filtering parameters for the different sensors, by the Live Monitoring CPU. Optionally the Monitoring unit can be connected via a dedicated Ethernet connection to a Reporting CPU, typically located in the technical room. On the Reporting CPU a database is installed which facilitates data storage and retrieval. A software application executed on the Reporting CPU serves as a patient data management system. It can be used for analysis, calculation and reporting in various representations of patient information.

The QMAPP® system, can operate standalone or it can be part of a typical hospital network infrastructure. The latter offers the possibility to send or receive information from and to other devices. The software has several communication modules, based on HL7 or DICOM protocols to interface with third party equipment/systems.

The QMAPP® system works with 3rd party 510(k) cleared devices: SpO2 module, (Covidien Nellcor, K083325), NiBP module (CAS Medical Systems, MAXNIBP ND+, e.g. CAS Medical Systems, 740 Select, K150620) and EtCO2 sensors, e.q. CLEO Patient Monitor, K142244.

The provided text describes the regulatory clearance of the QMAPP® system, a physiological/hemodynamic monitoring device. However, it does not contain specific acceptance criteria with reported device performance values or detailed study information typically found in a clinical study report.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and adherence to recognized performance standards. It mentions various non-clinical and usability tests, but doesn't provide specific numerical acceptance criteria or test results against those criteria.

Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.

Acceptance Criteria and Device Performance Study for QMAPP® System

The QMAPP® system underwent various non-clinical (bench) and usability testing, as well as validation against recognized performance standards to demonstrate its safety and effectiveness and establish substantial equivalence to predicate devices. The document does not explicitly state specific numerical acceptance criteria for each measurement type nor does it provide the exact reported device performance values against such criteria. Instead, the conclusion states that the system "meets the requirements of following performance Standards" and that "the non-clinical data support the safety of the device and the hardware and software verification and validation testing demonstrate that the QMAPP® system should perform as intended in the specified use conditions."

For the Non-Invasive Blood Pressure (NiBP) measurement, a clinical validation was carried out following IEC 81060-2:2009, which pertains to clinical validation of automated measurement type for non-invasive sphygmomanometers. However, the results of this clinical validation or specific acceptance criteria met are not detailed.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria and reported performance values are not explicitly provided in the document, the table reflects the types of tests conducted and the standards met, rather than direct numerical comparisons.

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

• Test Set Sample Size: The document does not specify a sample size for the bench tests or the usability testing. For the NiBP clinical validation, no specific sample size is mentioned, only that clinical validation was carried out.
• Data Provenance: The document does not specify the country of origin of the data for any of the tests. It also does not explicitly state if the data was retrospective or prospective. Given the nature of bench and usability testing, these would typically be prospective tests conducted in a controlled environment. The NIBP clinical validation, by its nature, would involve prospective patient data.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: The document does not specify the number of experts used for any part of the testing or for establishing ground truth, and it does not mention the use of experts to establish 'ground truth' in the context of diagnostic accuracy.
• Qualifications of Experts: Since no experts are explicitly mentioned in this context, their qualifications are not provided.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth as it focuses on physiological monitoring, which typically relies on direct measurement validation against reference standards rather than expert reader interpretation.

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

An MRMC comparative effectiveness study was not mentioned or implied in the provided text. The device is a physiological/hemodynamic monitor, not an AI-assisted diagnostic tool designed to improve human reader performance. Therefore, there is no discussion of human readers improving with AI assistance.

6. Standalone (Algorithm Only) Performance

The testing described (bench testing, compliance with performance standards, software verification) essentially validates the standalone performance of the QMAPP® system in its capacity as a physiological/hemodynamic monitor. The document confirms that "the QMAPP® system should perform as intended in the specified use conditions," indicating standalone functionality and accuracy.

7. Type of Ground Truth Used

• For ECG, SpO2, IBP, Temperature, Heart Rate, Respiratory Effort, Cardiac Output: The ground truth would typically be established by comparing the device's measurements against calibrated reference instruments or established measurement methods in a laboratory or clinical setting (bench testing).
• For NiBP: The ground truth for the clinical validation would have been established through a reference measurement method as defined by the IEC 81060-2 standard (e.g., auscultatory method with a trained observer using a mercury sphygmomanometer or an equivalent validated reference device).
• For Software: Ground truth is established by functional and performance specifications that the software is designed to meet.

8. Sample Size for the Training Set

The document does not mention a training set size because it is not describing a machine learning or AI algorithm that requires a training phase. The QMAPP® system is a monitor, and its functionality is validated through traditional engineering and clinical performance testing, not via model training.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set for a machine learning model, this question is not applicable.

Ask a specific question about this device