(247 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, temperature, and arrhythmia analysis. 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.
The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with specific acceptance criteria and their fulfillment.
Here's a breakdown of what can be extracted and what is missing:
The document states:
- "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."
This indicates that some form of testing was performed, but the specifics requested in your prompt (like actual acceptance criteria values, reported performance, sample sizes, ground truth details, etc.) are not included in this summary.
Therefore, I cannot populate the table or answer most of the questions based on the provided text.
However, I can extract the following limited information:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated with numerical values. The summary only mentions "accuracy requirements as specified in the contents of the premarket notification submission."
- Reported Device Performance: "Equivalent level or better in performance, when compared to the legally marketed predicate devices." No specific numerical performance metrics are provided.
-
Sample size used for the test set and the data provenance: Not available in the provided text.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the provided text.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available in the provided text.
-
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 monitor, not an AI diagnostic algorithm, and the summary does not describe an MRMC study or AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated, as the nature of the "testing" is only broadly described as "comparative testing" and "precision and accuracy testing." Given it's a monitor, its performance is inherently "standalone" in its measurement capabilities, but specific details are missing.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in the provided text.
-
The sample size for the training set: Not applicable. This is a 1996 device and summary, and it's a patient monitor, not an AI/ML algorithm that requires a "training set" in the modern sense.
-
How the ground truth for the training set was established: Not applicable for the same reasons as point 8.
§ 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.