(44 days)
The SunTech Medical 247 NIBP , Temperature, and Pulse Oximeter device is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, temperature, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities, clinics, physicians offices, and other subacute environments.
The 247 BP, Temperature and Pulse Oximeter device, a microprocessor based noninvasive blood pressure, predictive temperature and oxygen saturation measurement system, uses oscillometric signals to determine blood pressure, oral, rectal or auxiliary probes to determine temperature and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff. Deflation of the cuff is controlled by two valves. Implementation of Pulse Oximetry and temperature is achieved through the incorporation of OEM devices from companies with currently marketed products and accessories.
The provided text is a 510(k) summary for the SunTech Medical 247 NIBP, Temperature, and Pulse Oximeter device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study with specific acceptance criteria and detailed performance metrics as would be found in a multi-reader, multi-case (MRMC) study for an AI-powered diagnostic device.
Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC study effect size, standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory document.
However, I can extract information related to the device's validation against relevant standards.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that the device has been tested to applicable requirements of several standards, and these tests "have indicated passing results." However, it does not provide specific numerical acceptance criteria or performance metrics (e.g., accuracy, precision, sensitivity, specificity) within the text itself for blood pressure, temperature, or SpO2 measurements. The acceptance criteria for these types of devices are typically defined within the cited standards.
| Parameter/Characteristic | Acceptance Criteria (from standards) | Reported Device Performance |
|---|---|---|
| NIBP Performance | AAMI SP10: 2002 requirements | Passing results |
| General Safety | IEC 60601-1:1996 requirements | Passing results |
| Electromagnetic Compatibility | IEC 60601-1-2:2001 requirements | Passing results |
| Programmable Electrical Medical Systems | IEC 60601-1-4:2000 requirements | Passing results |
| Pulse Oximetry Performance | ISO 9919:1992 requirements | Passing results |
| Electronic Thermometer Performance | E1112-00:2006 requirements | Passing results |
| Functional Specifications | SunTech document # 99-0049-XX-FS requirements | Passing results |
Note: "Passing results" indicates that the device met the criteria specified in each standard, but the specific numerical thresholds and the exact performance achieved are not detailed in this summary.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
This type of information is typically found in the detailed test reports that are referenced but not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a measurement device, and its "ground truth" is typically established by comparison to other validated measurement devices or by using physical standards, not by expert consensus in the diagnostic sense.
4. Adjudication method for the test set:
- Not applicable. (See answer to #3.)
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a vital signs monitor and does not involve human readers interpreting images or data in the context of an AI-assisted diagnostic workflow.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a "standalone" system in the sense that its algorithms perform the measurements (NIBP, SpO2, temperature) without human intervention in the calculation process. However, a specific "standalone" study comparing algorithm-only performance to a human-in-the-loop scenario is not applicable here as it's a measurement device, not an AI diagnostic tool. Its performance is validated against established measurement standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for this type of measurement device is typically established against reference standards or calibrated instruments as defined by the cited standards (e.g., AAMI SP10 for NIBP, ISO 9919 for Pulse Oximetry, E1112 for thermometers).
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model in the sense of requiring a "training set" for diagnostic pattern recognition. Its underlying algorithms are based on established physiological principles and signal processing.
9. How the ground truth for the training set was established:
- Not applicable. (See answer to #8.)
Summary of what can be inferred from the document:
The SunTech Medical 247 device demonstrates its meeting of acceptance criteria by undergoing and passing tests against recognized international and national standards for medical devices and vital signs measurement. These standards define the acceptable performance limits for non-invasive blood pressure, pulse oximetry, and electronic thermometers. The 510(k) summary states that the device has "indicated passing results" for these tests, implying compliance with the performance and safety requirements outlined in the standards. The study mentioned is a series of compliance tests against these standards, not a clinical trial with a detailed statistical analysis of patient data in the context of an AI application.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).