(71 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.
The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement.
The following lists the detailed features of the subject device.
- LCD or LED display
- SpO2, Pulse Rate NIBP and TEMP measurement
- T2 or TH or F3000 module for Temp 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
Here's an analysis of the provided text regarding the acceptance criteria and study for the Edan Instruments Vital Signs Monitor Models M3 and M3A:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria and corresponding reported device performance values are not explicitly stated in a clear, tabulated format for the SpO2, NIBP, or TEMP measurements. The submission focuses on substantial equivalence to predicate devices and adherence to general safety standards rather than detailed performance metrics.
The document states:
- "The differences between the subject devices and predicate devices do not affect the basic design principle, usage, effectiveness and safety of the subject devices. And no question is raised relating to the safety and effectiveness." (Page 3)
- "Verification and validation testing were conducted on the Vital Signs Monitor Models M3 and M3A. This premarket notification submission demonstrates that Vital Signs Monitor Models M3 and M3A is substantially equivalent to the predicate device, and without any changes of the intended use compared to the predicate version." (Page 3)
The key acceptance criterion mentioned is substantial equivalence to predicate devices (Edan Instruments Inc.: M3 and M3A Vital Signs Monitor K120144, and The Kendall Company: K003313). The performance is implied to be at least equivalent to these predicate devices.
The only specific performance testing mentioned with regard to a standard is:
- "Clinical Electronic Thermometers testing for the newly added F3000 Temperature Module pursuant to the guidance 'Guidance on the Content of Premarket Notification [510(K)] Submission for Clinical Electronic Thermometers' dated Mar. 1993." (Page 2)
Without the detailed results of this thermometer testing, a quantitative table cannot be constructed from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a specific sample size used for a test set or the data provenance (e.g., country of origin, retrospective/prospective).
The document mentions "Verification and validation testing were conducted," but details on these tests, including sample sizes, subjects, or data sources, are absent. The "Clinical test: Clinical testing is not required" statement indicates that no human subject clinical trials were deemed necessary for this 510(k) submission, relying instead on non-clinical testing and equivalence to predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that "Clinical testing is not required," the concept of "ground truth established by experts" for a test set using patient data is not applicable in this context. The evaluation was primarily based on non-clinical performance against standards and comparison to predicate devices.
4. Adjudication Method for the Test Set
As there was no explicit clinical test set requiring expert ground truth, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical testing is not required" and focuses on substantial equivalence and non-clinical testing. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a vital signs monitor, which is inherently a standalone measurement device that provides physiological parameters (SpO2, NIBP, TEMP). It collects and displays data directly. The provided text, however, focuses on its safety and performance relative to predicate devices and standards, rather than a specific "standalone performance study" in the context of an AI algorithm. If we interpret "standalone" as the device operating independently to deliver its intended measurements, then the entire submission implicitly supports its standalone performance. However, there's no separate study specifically labeled as "standalone performance" for an AI algorithm, as this device does not appear to primarily be an AI-driven diagnostic.
7. Type of Ground Truth Used
The primary "ground truth" implicitly relied upon for this submission is:
- Standards: Adherence to established non-clinical electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and thermometer testing standards.
- Predicate Device Performance: The demonstrated safety and effectiveness of the legally marketed predicate devices (K120144 and K003313). The new device's performance is asserted to be "the same or similar performance specifications" as these predicates.
8. Sample Size for the Training Set
The provided text does not mention or imply the existence of a training set. This is consistent with the device being a vital signs monitor primarily evaluated through non-clinical testing and comparison to predicates, rather than a machine learning or AI-driven diagnostic device that would typically involve a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, there is no information on how its ground truth would have been established.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).