(27 days)
The Vital Signs Monitor models M3 and M3A (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).
The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.
The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both
M3 and M3A Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature), in a hospital, hospital type facilities environment and intra-hospital moves. The following lists the detailed features of the subject device.
- . LCD or LED display
- SpO2, Pulse Rate NIBP and fast TEMP measurement .
- Infrared ear temperature measurement
- Nellcor or EDAN SpO2 module .
- Display numeric and waveform information simultaneously .
- Nurse call feature .
- Built-in Lithium-ion Battery .
- . Suitable for adult, pediatric and neonate patients
- Visual and audible alarm .
- Trend graph review and record .
- USB data storage and review .
- Wired and wireless network capability .
The provided text describes the 510(k) submission for the Edan Instruments Vital Signs Monitor Models M3 and M3A. It confirms that the device is substantially equivalent to its predicate devices for non-invasive continuous monitoring of SpO2, NIBP, and temperature. However, the document does not contain specific acceptance criteria or detailed study results that prove the device meets such criteria.
The submission mentions "Verification and validation testing were conducted," and refers to "Software testing, Safety testing, Performance testing, Risk analysis, and Final validation," but it does not provide the quantitative or qualitative benchmarks used as acceptance criteria, nor does it present the results of these tests in detail.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, how ground truth was established) cannot be answered from the provided text.
Here's a summary of what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Not specified in document | Not specified in document |
| NIBP Accuracy | Not specified in document | Not specified in document |
| Temperature Accuracy | Not specified in document | Not specified in document |
| General Safety | Not specified in document | Not specified in document |
| Software Functionality | Not specified in document | Not specified in document |
Note: The document states that "Verification and validation testing were conducted" and implies these tests demonstrate substantial equivalence. However, it does not explicitly define the acceptance criteria or report the numerical results of these tests for specific performance metrics (e.g., SpO2 accuracy, NIBP accuracy, temperature accuracy).
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided document.
4. Adjudication method for the test set
- Not specified in the provided document.
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
- The device is a vital signs monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and is not mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the device's performance (standalone, as a medical device) was tested during verification and validation, but specific details or results of these standalone tests are not provided. The function of the device itself is the standalone performance, as it measures vital signs without human interpretation of raw data for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified in the provided document. For vital signs monitors, ground truth would typically involve comparison against reference measurement devices or established clinical methods (e.g., arterial line for NIBP, highly accurate thermometer for temperature, CO-oximetry for SpO2). However, specific methodologies are not detailed here.
8. The sample size for the training set
- This device is not described as an AI/ML device that requires a "training set." Therefore, this question is not applicable based on the provided text.
9. How the ground truth for the training set was established
- This device is not described as an AI/ML device that requires a "training set." Therefore, this question is not applicable based on the provided text.
§ 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).