(265 days)
The iM60 monitor monitors parameters such as ECG (3-lead, 5-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) and Expired CO2. 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 iM70 monitor monitors parameters such as ECG (3-lead, 5-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.
iM60/iM70 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.
iM60 is outfitted with a 10.4-inch display screen, iM70 is I 2.1-inch, as well as an equally large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses.
iM60 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP, TEMP, ECG, RESP, EtCO2, IBP and C.O..
iM70 Patient Monitor has parameter modules including SpO2 with EDAN SpO2 module or Nellcor SPO2 module, NIBP with EDAN NIBP module or Omron M3600, TEMP, ECG, RESP, EtCO2, C.O., IBP, AG.
The provided document is a 510(k) summary for the Edan Instruments iM60 and iM70 Patient Monitors. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a specific study proving the device meets them.
The document states:
- "Verification and validation testing was done on the Patient Monitor. This premarket notification submission demonstrates that Patient Monitor is substantially equivalent to the predicate device."
- "The iM60 and iM70 Patient Monitors... have the same or similar performance specifications."
However, it does not provide a table of acceptance criteria and reported device performance directly within this document, nor does it describe a specific study (e.g., clinical trial or comparative effectiveness study) with details about sample sizes, ground truth establishment, or expert involvement.
The "Test Summary" section lists general quality assurance measures applied:
- Software testing
- Hardware testing
- Safety testing
- Environment test
- Risk analysis
- Final validation
These are general categories of testing and do not provide the specific performance metrics or the details of a study that would be needed to answer the questions thoroughly.
Therefore,Based on the provided K131971 510(k) summary, the following information can be extracted or is explicitly stated as not available within this document:
Acceptance Criteria and Device Performance
The document does not explicitly state specific numerical acceptance criteria for performance metrics nor does it provide a table of reported device performance against such criteria. It relies on the assertion that the new devices have "the same or similar performance specifications" as the legally marketed predicate devices (Edan Instruments iM50 and iM80, K113623).
Study Details
1. A table of acceptance criteria and the reported device performance:
- Not provided in this document. The submission relies on demonstrating "substantial equivalence" to predicate devices, implying that the performance is "the same or similar" to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in this document. The document mentions "Verification and validation testing" but does not detail the nature of these tests, including sample sizes or data provenance.
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 provided in this document. No information about expert involvement in establishing ground truth for any test set is given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided in this document. No details on adjudication methods for any test set are mentioned.
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/Not provided. This device is a patient monitor, not an AI-assisted diagnostic tool typically evaluated with MRMC studies comparing human reader performance. The document does not describe any such study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not provided in this document. While performance testing would inherently involve standalone device performance, the document does not detail specific "standalone" studies in the context of typical AI device evaluation. It states "Software testing," "Hardware testing," and "Final validation" were performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided in this document. The method for establishing ground truth for any testing is not described.
8. The sample size for the training set:
- Not provided in this document. Information about a "training set" (implying machine learning/AI development) is not mentioned. The device is described as a patient monitor performing continuous monitoring of physiological parameters.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. No training set for an AI/ML algorithm is mentioned.
In summary: The K131971 document is a 510(k) summary demonstrating substantial equivalence for patient monitors. It lists general testing categories but lacks specific details on performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement, which are typically found in more detailed clinical or performance studies.
§ 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.