(58 days)
The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). 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.
iM50 :
The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature
( Quick TEMP. 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 arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
iM50 /iM80 Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
iM50 Patient Monitor can monitor parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP.
iM80 Patient Monitor can monitor parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP, C.O. and AG.
The above is the maximum configuration for iM50 and iM80, the user may select different monitoring parameters in according with the requirement.
iM50 is outfitted with a 8.4-inch display screen, iM80 is 15-inch, as well as an equal large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses. Besides, iM80 supports software upgrade online and networking.
iM50 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP, CO2, IBP and Quick Temp.
iM80 could be configured with three different NIBP modules, one is EDAN NIBP module, one is Omron NIBP module, the other is Suntech NIBP module; Omron NIBP module used in iM80 is the same to that used in BX-10, which has been cleared by K032857 in April.21.2003. Suntech NIBP module is cleared by FDA in K032363
CO2 module and Nellcor SpO2 module used in iM50 and iM80 are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.
Arrhythmia and ST segment Analysis used for ECG diagnoses in iM80 is the same to that in PC ECG which has been cleared by FDA under K102854 and K092010
The provided 510(k) summary for the Edan Instruments Patient Monitor (Models iM50 and iM80) does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and study proving device performance.
This document is a traditional 510(k) summary, which generally focuses on establishing substantial equivalence to predicate devices rather than providing exhaustive clinical study details. It refers to various internal tests but does not elaborate on their methodologies or results in a way that directly answers your questions.
However, I can extract the information that is present and note where the requested details are missing.
Here's what can be gathered from the provided text:
Acceptance Criteria and Device Performance Study for Edan Instruments Patient Monitor (Models iM50 and iM80)
The provided 510(k) summary does not explicitly state acceptance criteria in a table format with corresponding reported device performance metrics. Instead, it broadly claims that the device has "the same or similar performance specifications" as its predicate devices, implying that it meets the performance established by those already cleared devices.
The document mentions that "Verification and validation testing was done on the Patient Monitor" to demonstrate substantial equivalence. This testing includes:
- Software testing
- Hardware testing
- Safety testing
- Environment test
- Risk analysis
- Final validation
However, no specific study details, quantitative results, or acceptance criteria for these tests are provided in this summary. The summary focuses on comparing the new device's features and operational principles to predicate devices.
Missing Information Details:
1. A table of acceptance criteria and the reported device performance:
* Not available in the provided text. The document states "have the same or similar performance specifications" as predicate devices, but does not list these specifications or the new device's performance against them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not available in the provided text. The summary mentions "testing," but no details on sample size, data type, or origin are given.
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):
* Not available in the provided text. There is no mention of experts or ground truth establishment for testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not available in the provided text. There is no mention of adjudication methods.
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:
* Not applicable and not available in the provided text. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement with AI would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not explicitly detailed in the provided text for specific performance metrics. While "Software testing," "Hardware testing," "Safety testing," and "Final validation" are listed, the specifics of these tests and whether they constitute a "standalone" performance assessment (beyond basic functionality) are not explained. The general statement of "same or similar performance specifications" suggests standalone functions are expected to meet predicate device levels.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not available in the provided text. The document does not specify how ground truth was established for its testing.
8. The sample size for the training set:
* Not applicable and not available in the provided text. This is a traditional patient monitor, not an AI/machine learning device that would typically have a "training set" in the context of algorithm development for complex pattern recognition.
9. How the ground truth for the training set was established:
* Not applicable and not available in the provided text. (See point 8).
In summary, the provided 510(k) submission focuses on demonstrating substantial equivalence through a comparison of features, operating principles, and general performance specifications to legally marketed predicate devices. It does not include the detailed clinical study data, performance metrics, and methodological specifics you've requested beyond general statements of testing being performed. Such detailed information would typically be found in the complete 510(k) submission, not necessarily in the summary intended for public disclosure.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.