(41 days)
The Midmark Diagnostics IQmark® Vital Signs Monitor is intended to be used by clinicians and medically qualified personnel for monitoring adult, pediatric and neonatal patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature. In adults and pediatric patients, temperature is monitored orally, rectally, or at axillary sites. In neonates (to 1 month) temperature is monitored at axillary sites only.
The most likely locations for patients to be monitored are general medical locations, hospitals, and alternative care environments.
The Midmark Diagnostics IQmark® Vital Signs Monitor consists of the following three individual measurement Modules:
a. Noninvasive blood pressure (NIBP)
b. Pulse Oximeter
c. Temperature
In the Automatic or STAT Modes of operation, the NIBP Module automatically inflates an occluding cuff placed around the patient's arm or leg. It uses the oscillometric measurement technique to measure and record the patient's systolic and diastolic pressure as well as pulse rate. From these measurements the IQmark VSM also calculates the mean arterial blood pressure (MAP). Measurement results along with operator prompts and error messages are indicated on the front panel display. The frequency of NIBP determination can be selected by the operator at fixed times between one and ninety minutes. The Manual Mode of operation also covers a variety of clinical uses. A variety of reusable and disposable cuff types and sizes is available for adult, pediatric, and neonatal applications. The NIBP Module requires routine calibration and maintenance.
The Pulse Oximeter Module measures and records the patient's arterial oxyhemoglobin saturation by measuring the absorption of red and infrared light passing through tissue (SpO₂). Changes in absorption caused by pulsations of blood in the patient's vascular bed are used to determine arterial oxygen saturation and pulse rate. Oxygen saturation and heart rate are indicated on the front panel display. A bar graph display gives the user a pulse visual indication of waveform signal quality. An audible indicator can be enabled which automatically generates a sound each time the SpO2 sensor detects a pulse. The 1Qmark VSM utilizes the Masimo Set" oximeter. A variety of reusable and disposable sensor types and sizes is available for adult, pediatric and neonatal applications. These oximeter does not require routine calibration or maintenance.
The Temperature Module measures and records a patient's temperature in either the Predictive or Continuous Mode of operation using either oral (also used for axillary) or rectal probes. In the Predictive Mode, the thermometer's software predicts body temperature in about 15 seconds for oral and axillary temperatures. The IQmark VSM Temperature Module does not support Predictive Mode measurements for the rectal temperature probe. The default mode used by the IQmark VSM for oral temperature determinations is the Predictive Mode. The Continuous Mode is usually used for longer-term monitoring or when difficult situations prevent accurate patient temperature measurement in the Predictive Mode. Temperature probe covers are required and are available for the oral/axillary and rectal probes. The Temperature Module requires routine calibration and maintenance.
When the Alarm Setting Mode is activated, high and low alarm limits can be set (within specification and safety limits) for heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and SpO2.
Here's an analysis of the provided text regarding the Midmark Diagnostics IQmark® Vital Signs Monitor, focusing on acceptance criteria and supporting studies:
It's important to note that this document is a 510(k) Summary from 2007, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. It typically focuses on comparing the new device to existing ones rather than presenting full, detailed clinical study reports. As such, some of the requested information (like specific sample sizes for test sets, data provenance for clinical studies, number/qualifications of experts, adjudication methods, or MRMC studies) are not explicitly detailed in the provided summary as they would be in a comprehensive study report.
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (IQmark® Vital Signs Monitor) |
|---|---|---|
| NIBP Accuracy | +/- 5 mmHg, standard deviation no greater than 8 mmHg (CAS Medical 740 Series) | +/- 5 mmHg, standard deviation no greater than 8 mmHg |
| SpO₂ Accuracy (Adult) | 70-100%: ± 2 counts (CAS Medical 740 Series) | 70-100%: ± 2 counts |
| SpO₂ Accuracy (Neonatal) | 70-100%: ± 3 counts (CAS Medical 740 Series) | 70-100%: ± 3 counts |
| Temperature Accuracy (Continuous Mode) | ± 0.1 °C (± 0.2 °F), meet or exceeds ASTM E1112-00 (IVAC Model 2080 / Welch Allyn VSM) | ± 0.1 °C (± 0.2 °F), meet or exceeds ASTM E1112-00 |
| Temperature Accuracy (Predictive Mode) | + 0.6 °C (+ 1.0 °F) (IVAC Model 2080) | ± 0.6 °C (+ 1.0 °F) |
Study Details
Due to the nature of a 510(k) Summary, the provided text does not contain detailed clinical study reports with specific sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for clinical performance testing. The performance data is presented as meeting the same specifications as the predicate devices and relevant standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated in the 510(k) Summary. The document states that "The IQmark VSM has been tested for safety and efficacy" and "operational and performance specifications for each measurement module and for the IQmark Vital Signs Monitor as a system has been successfully verified and validated." However, specific sample sizes for human subject testing (if any were conducted for this submission beyond standard verification/validation) are not provided. The performance specifications are directly compared to predicate devices and industry standards (e.g., ANSI/AAMI SP10 for NIBP, ASTM E1112 for temperature).
- The Masimo Set™ oximeter module is mentioned, implying that its performance characteristics would be based on Masimo's established data, but details are not included here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated in the 510(k) Summary. The summary refers to "verification and validation testing, safety, and performance testing," but does not detail the methodology for establishing ground truth via expert consensus for these tests, especially for clinical accuracy measurements. Accuracy claims are often supported by comparison to a reference standard rather than expert consensus on a diagnosis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not explicitly stated. The testing described in the summary pertains to performance against established physical and electrical standards, and accuracy against reference measurements (e.g., direct blood pressure readings for NIBP, a reference thermometer for temperature, CO-oximeter for SpO2, which are typically considered the "ground truth" for these physiological measurements). Adjudication methods like 2+1 or 3+1 are more common in studies involving subjective interpretation (e.g., image reading) where expert consensus establishes ground truth.
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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. The IQmark® Vital Signs Monitor is a measurement device for physiological parameters (NIBP, SpO₂, Temperature, Pulse Rate). It is not an AI-based diagnostic tool that assists human readers/clinicians in interpretation, so an MRMC study comparing human performance with/without AI assistance would not be relevant in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance specifications listed (e.g., NIBP accuracy, SpO₂ accuracy, Temperature accuracy) represent the standalone performance of the device's measurement modules. These values are determined through testing the device itself against reference standards, independent of human interpretation or intervention beyond operating the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Standards and Industry Standards:
- NIBP: Likely comparison to a reference method (e.g., invasive arterial line measurement) or established simulation protocols as per ANSI/AAMI SP10.
- SpO₂: Likely comparison to multi-wavelength oximetry (Co-oximetry) measurements on blood samples, or controlled desaturation studies.
- Temperature: Comparison against precision reference thermometers in controlled environments, as per ASTM E1112-00 requirements.
- Reference Standards and Industry Standards:
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The sample size for the training set:
- Not applicable in the context of this 510(k) Summary. This device is hardware-based for physiological monitoring and does not employ machine learning algorithms that would typically require a "training set" in the sense of AI/ML models. Any internal calibration data or development data are not described as a "training set" in this document.
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How the ground truth for the training set was established:
- Not applicable. As a traditional physiological monitor, the device doesn't use a "training set" in the modern AI/ML sense. Its operational parameters and accuracy are based on known physics, engineering design, and adherence to established medical device standards.
§ 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).