(404 days)
Comen Multi-Parameter Patient Monitor models C50, C60, C80 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be made available to the user from the monitor.
The monitor models monitor parameters such as ECG (3-lead, 5-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both.
The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans.
The monitor models are not designed for home use, and are restricted to be used on one patient at a time.
COMEN Multi-Parameter Patient Monitor Models C50, C60 and C80 obtain and display physiological data of the patient including waveforms and numerical data in real time. COMEN C series can be custom confiqured to monitor electrocardiograph (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), respiration (RESP) or temperature (TEMP). These physiological signals are converted into digital data and displayed.
For each parameter, COMEN C series examine the data for alarm conditions and present them on the display. COMEN C series have audio alarming function that may raise the user's attention of system error or as dictated by the physiological parameter settings.
COMEN C series are capable of storing data trends for retrospective review and sending serial port signal to printer for report printing.
Here's an analysis of the provided 510(k) summary regarding the COMEN Multi-Parameter Patient Monitor (K112877) and its acceptance criteria and study information:
Based on the provided document, the device is a multi-parameter patient monitor. The summary emphasizes that the device is deemed "substantially equivalent" to predicate devices, which implies that its performance is expected to be similar or within acceptable ranges of previously cleared devices. However, the document does not explicitly state specific numerical acceptance criteria (e.g., accuracy percentages or error margins) for each physiological parameter, nor does it provide a table of reported device performance against such criteria. Instead, it refers to compliance with various international standards as the basis for proving safety and effectiveness.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
As mentioned above, the document does not explicitly list specific numerical acceptance criteria or a table of device performance. Instead, it relies on compliance with various international standards, which inherently contain their own performance and safety requirements. The document states:
- "COMEN C series meet the following standards: IEC 60601-1-2, IEC 60601-2-30, IEC 60601-2-27, EN1060-1, EN1060-3, EN1060-4, EN60601-2-49, EN 60601-1, AAMI EC13, ISO10993-1, ASTM E1112-00, ISO 9919, ISO 80601-2-56."
Meeting these standards would mean the device implicitly meets the performance and safety criteria outlined within each respective standard for various parameters (ECG, NIBP, SpO2, Respiration, Temperature). For example:
* IEC 60601-2-27: Specific requirements for the safety and essential performance of electrocardiographic monitoring equipment.
* EN1060-1, EN1060-3, EN1060-4: Non-invasive sphygmomanometers (blood pressure monitors).
* ISO 9919 / ISO 80601-2-61 (relevant for SpO2, although ISO 9919 is older): Requirements for pulse oximeter equipment.
* AAMI EC13: Cardiac monitors.
* ASTM E1112-00: Electronic thermometers.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide information on sample sizes for test sets or data provenance. It states: "A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operation." This implies internal testing but no specific details are given about the subjects or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts or ground truth establishment in the context of a specific test set. The validation is primarily based on compliance with international standards through non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for a test set, as no dedicated clinical test set is elaborated upon.
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 MRMC comparative effectiveness study was done or mentioned. This device is a diagnostic/monitoring tool, not an AI-assisted interpretation system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone monitor. The "testing was conducted to validate the systems overall operation" refers to its standalone performance in accordance with the listed standards. However, the document does not explicitly detail specific "algorithm only" performance data separate from the overall system validation based on standards compliance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests performed, the "ground truth" would be the reference values or established methodologies defined within each of the international standards (e.g., standard blood pressure cuffs for NIBP accuracy checks, calibrated temperature probes for TEMP accuracy, defined ECG signals for ECG performance). No clinical ground truth (like pathology or outcomes data) is mentioned as the basis for testing.
8. The sample size for the training set
The document does not mention any training set or associated sample size. This type of device (a multi-parameter patient monitor) typically relies on engineering design, calibration, and validation against established physiological signal processing principles and standard test procedures outlined in the relevant IEC/ISO standards, rather than machine learning training sets.
9. How the ground truth for the training set was established
As no training set is mentioned, this information is not applicable and not provided.
Summary of Key Takeaways from the document K112877:
- Acceptance Criteria: Based on adherence to a comprehensive list of international safety and performance standards (e.g., IEC 60601 series, EN1060 series, AAMI EC13, ASTM E1112-00, ISO 9919, ISO 80601-2-56). Specific numerical performance data against these criteria is not detailed in the summary.
- Study Type: Non-clinical bench testing and risk analysis to demonstrate compliance with the listed standards and overall system operation validation.
- No Clinical Studies: The summary explicitly states "Discussion on Clinical Tests Performed: Not Applicable." This means no human subject trials or clinical performance evaluations were conducted or provided in this 510(k) submission to assess the device's accuracy or effectiveness in a patient population.
- Ground Truth: For non-clinical testing, ground truth would be established by the physical or simulated reference values and methods specified within the compliance standards.
- No AI/Machine Learning Aspects: The device is a traditional multi-parameter patient monitor, and there is no indication of AI, machine learning, training sets, or comparative effectiveness studies involving human readers and AI assistance.
§ 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).