(258 days)
The Marquette Eagle 3000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs. The option is provided for the printing of information by a paper recorder. Use of the Marquette Eagle 3000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal. Use of the Marquette Eagle 3000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel. Use of the Marquette Eagle 3000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.
The Marquette Eagle 3000 Patient Monitor is a patient monitoring system that is designed to be used to monitor a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, and end tidal carbon dioxide (EtCO2). PA Wedge is also available. The Eagle 3000 Patient Monitor is a factory configured or fixed-parameter patient monitoring device. Options which allow for the monitoring of invasive blood pressure and the printing of information by a paper recorder may be added to the basic monitor configuration at the factory prior to shipment to the customer. The Eagle 3000 Patient Monitor has NOT been designed as a modular patient monitoring device which allows the addition and deletion of monitoring parameters at the point-of-use. The Eagle 3000 Patient Monitor has NOT been designed as a transport monitor. Therefore, no battery power feature or option has been included with this device.
Marquette Electronics, Inc. did not provide quantifiable acceptance criteria or device performance in the provided 510(k) summary (K960272). The summary broadly states that "Comparative testing was done on the Eagle 3000 Patient Monitor and its predicate devices. Precision and accuracy testing was also performed. Test results indicate that the Eagle 3000 Patient Monitor provides an equivalent level or better in performance, when compared to the legally marketed predicate devices when tested to the accuracy requirements as specified in the contents of the premarket notification submission."
Therefore, I cannot populate the table or answer questions related to specific performance metrics, sample sizes, ground truth establishment, or expert involvement as this information is not present in the provided text.
Based on the available information:
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1. Table of acceptance criteria and the reported device performance:
Cannot be provided as this information is not present in the 510(k) summary. The summary only states that the device provides "an equivalent level or better in performance" compared to predicate devices. -
2. Sample sized used for the test set and the data provenance:
Not specified in the provided text. -
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 text. -
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified in the provided text. -
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. This device is a patient monitoring system, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned. -
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a patient monitoring system, not an algorithm, and it explicitly states its use "by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment," implying human interaction. -
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not specified in the provided text. The summary only mentions "Precision and accuracy testing" against "accuracy requirements as specified in the contents of the premarket notification submission." -
8. The sample size for the training set:
Not applicable. This is a traditional patient monitoring system, and the concept of a "training set" for an algorithm is not mentioned. -
9. How the ground truth for the training set was established:
Not applicable, as there is no mention of a training set.
§ 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.