(55 days)
The IQvitals and IQvitals System is intended to be used by clinicians and medically qualified personnel for measuring adult and pediatric patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arterial hemoglobin (SpO2), temperature and weight.
Patient information such as name, age, height, pain score etc. can be entered manually.
The IQvitals and IQvitals System are patient monitors intended to be used by clinicians and qualified medical personnel for spot check monitoring of noninvasive blood pressure (NIBP), pulse oximetry (SpOz), temperature and for the IQvitals device, weight.
Patient Record information, such as height, respiration rate and pain level, can be manually entered by clinicians via the user interface.
The provided text describes a medical device, the IQvitals and IQvitals System, and its substantial equivalence determination by the FDA. However, it does not contain any information about acceptance criteria or a specific study proving the device meets those criteria, as understood in the context of an AI/ML medical device.
Here's why and what information is available:
The document is a 510(k) summary for a "Patient Physiological Monitor." This type of device relies on established physiological measurement principles, not AI/ML algorithms. The performance testing described is focused on validating the accuracy and reliability of these standard physiological measurements against established norms and a predicate device.
Therefore, many of the requested points, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," and "training set details," are not applicable to this document as it pertains to the evaluation of an AI-powered medical device.
Here's a breakdown of what information can be extracted or inferred from the provided text, and where the requested information is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail numerical targets in the provided text. The general acceptance criterion is "substantially equivalent" to the predicate device. For specific parameters, compliance with "requirements and procedures" and "standards" is mentioned.
- Reported Device Performance:
Parameter Reported Performance Non Invasive Blood Pressure (NIBP) Tested in accordance with requirements and procedures; results indicated compliance with predetermined requirements and substantial equivalence to the predicate. Temperature Tested in accordance with requirements and procedures; results indicated compliance with predetermined requirements and substantial equivalence to the predicate. SpO2 Tested in accordance with requirements and procedures; results indicated compliance with predetermined requirements and substantial equivalence to the predicate. Pulse Rate Tested in accordance with requirements and procedures; results indicated compliance with predetermined requirements and substantial equivalence to the predicate. Display Tested or evaluated. Electrical Tested or evaluated. Environmental Tested or evaluated. Software Tested or evaluated. Biocompatibility Tested or evaluated.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. (The context strongly suggests physiological measurements, likely from human subjects, but details are not provided).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or similar. The "ground truth" for physiological measurements would typically be established by validated reference instruments or methods.
4. Adjudication method for the test set
- Not Applicable. Not an AI/ML device seeking consensus on interpretations.
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. This is not an AI-assisted interpretation device. The study type would be a typical performance validation study for a medical monitor.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physiological monitor, not an AI algorithm. Its performance is its "standalone" output of physiological parameters.
7. The type of ground truth used
- The "ground truth" for physiological measurements would involve reference standards or established, validated methods for measuring NIBP, temperature, SpO2, and pulse rate (e.g., invasive blood pressure monitoring for NIBP accuracy, reference thermometers, co-oximeters for SpO2 calibration). These are implied by the statement "tested in accordance with requirements and procedures, and test results indicated that the device complies with the predetermined requirements."
8. The sample size for the training set
- Not Applicable. This device does not use a training set in the context of AI/ML.
9. How the ground truth for the training set was established
- Not Applicable. This device does not use a training set in the context of AI/ML.
Study Information (General)
The study described is a performance testing and comparison to a predicate device to establish substantial equivalence.
- Study Type: Non-clinical areas thoroughly tested or evaluated against "standards and the predicate." This implies a series of bench tests, simulations, and likely human clinical studies (though details are not provided) to measure accuracy, precision, and reliability of the physiological measurements.
- Predicate Device: Well@Home System (K040012).
- Conclusion: "Based upon a comparison of devices and performance testing results, the IQvitals and IQvitals System is substantially equivalent to the predicate device."
§ 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).