(433 days)
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.
| Acceptance Criteria (via referenced standards & device specs) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|
| Electrocardiograph (ECG) | Tested via Bench Testing; Meets IEC 60601-2-27:2016 |
| ECG Resolution | 24 bit |
| ECG Input impedance | > 2.5 MOhm |
| ECG Common mode rejection | > 100 dB |
| ECG Sampling frequency | 2 – 32 KHz |
| ECG Channels | 12 |
| Heart Rate | Tested via Bench Testing; Meets performance standards |
| HR Method | QRS detection |
| HR Range | 15 – 300 bpm |
| HR Accuracy | ± 2% |
| Respiration Effort | Tested via Bench Testing; Meets performance standards |
| Respiration Method | Impedance Pneumography |
| Respiration Resolution | 1/min |
| Respiration Range | 0 – 150 / Min |
| Respiration Channels | 1 |
| Non-Invasive Blood Pressure (NiBP) | Tested via Bench Testing; Meets IEC 80601-2-30:2018 |
| NiBP Method | Oscillometric (CAS Max module) |
| NiBP Range | 15 - 260 mm Hg |
| NiBP Accuracy | ± 5 mm Hg |
| Oxygen Saturation (SpO2) | Tested via Bench Testing; Meets ISO 80601-2-61:2017 |
| SpO2 Method | Nellcor Oximax |
| SpO2 Range | 1 - 100% |
| SpO2 Accuracy | ± 1% |
| SpO2 Channels | 1 |
| Invasive Blood Pressure (IBP) | Tested via Bench Testing; Meets IEC 60601-2-34:2011 |
| IBP Method | Pressure transducer |
| IBP Accuracy | ± 2 mm Hg or ± 1 % |
| IBP Range | -30 - 320 mm Hg |
| IBP Channels | 4 |
| Skin Temperature | Tested via Bench Testing; Meets ISO 80601-2-56:2017 |
| Skin Temp Method | Thermistor, YSI compatible |
| Skin Temp Range | 20° – 45° C (68° – 113° F) |
| Skin Temp Accuracy | ± 0.1° C (± 0.18° F) |
| Skin Temp Channels | 2 |
| Cardiac Output | Tested via Bench Testing; Meets performance standards |
| CO Method | Thermo Dilution and (calculated) FICK |
| CO Range | 0.1 – 20 L |
| CO Accuracy | ± 0.1 L |
| End Tidal CO2 (EtCO2) | Tested via Bench Testing; Meets performance standards |
| EtCO2 Method | Low flow Side stream |
| EtCO2 Resolution | 0.1 mm Hg (0-49), 0.2 mm Hg (49-152) |
| EtCO2 Accuracy | 0-40 mmHg, ± 2 mmHg; 41-70 mmHg, ± 5%; 71-100 mmHg, ± 8%; >101 10% |
| Intra cardiac ECG | Tested via Bench Testing; Meets performance standards |
| Intra Cardiac ECG Method | Electro Physiology catheter |
| Intra Cardiac ECG Resolution | 24 Bit |
| Intra Cardiac ECG Input impedance | > 2.5 MOhm |
| Intra Cardiac ECG Common mode rejection | > 100 dB |
| Intra Cardiac HR range | 15 – 300 bpm |
| Intra Cardiac Sampling frequency | 2 - 32 kHz |
| Intra Cardiac Channels | 8, 16 or 32 (bipolar) Channels |
| Other General Performance | |
| Electromagnetic compatibility (EMC) | Meets IEC 60601-1-2:2014 |
| Electrical safety testing | Meets AAMI/ANSI EC 60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 |
| Mechanical safety testing | Meets AAMI/ANSI EC 60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 |
| Software verification and validation testing | Conducted |
| Usability Testing | Conducted |
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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).