(219 days)
Use of the Marquette Solar 9000 Anesthesia Information Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal.
Use of the Marquette Solar 9000 Anesthesia Information 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 personnel.
Use of the Marquette Solar 9000 Anestheaia Information Monitor is intended for operating room (OR), post ansethesia 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 Solar 9000 Anesthesia Information Monitor is a patient monitoring system that is designed to display patient physiciosical data that is received from the Marquette Electronic's Tram-Net (Unity) network, Tram individual and multi-parameter data acquisition modules (K900540). and other compatible modules, as referenced within the Premarket Notification Submission.
The data and information these modules acquire includes. but is not limited to: Electrocardlingraphy (ECG) information. QRS and antivitymia detection. heart rate calculation, ST-segment analysis, cardiac output, wedge determination, and systolic, diastolic, and mean pressure measurements. Additional data and information that these modules acquire includes: respiratory rate detection and computation, detection of a no breath (or apneic) period. respiratory and ansethesia gas perameters, ventilation perameters, pulse oximetry values, piethysmograph values, and temperature measurements. The Solar 9000 Anesthesia Information Monitor is designed to display ECG and pressure and respiratory waveforms generated from the network and the various acquisition modules.
The operator uses the system to interact with the scauired data via a color display device. This interaction includes: selecting which waveforms or parameters are displayed, display and review of trended data, silencing alarms, adjusting parameter alarm levels, or printing selected data.
The provided text describes a medical device, the "Marquette Solar 9000 Anesthesia Information Monitor," and its regulatory submission (K954852). However, it does not contain any information about acceptance criteria, study design, or device performance data derived from a study.
The document is a 510(k) Summary of Safety and Effectiveness, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria. While it lists various parameters the device monitors, it doesn't provide actual performance metrics or a study demonstrating these metrics meet predefined criteria.
Therefore, I cannot fulfill your request for the following sections based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method: Not available.
- 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 available. This device is not an AI-assisted diagnostic tool in the sense of image interpretation, but rather a patient monitoring system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available. (This device is a traditional monitoring system, not an AI/ML model requiring a training set in the typical sense).
- How the ground truth for the training set was established: Not available.
The document primarily focuses on:
- Manufacturer and contact information
- Device names and classification codes
- Identification of legally marketed predicate devices
- A general description of the device's functionality and the types of physiological data it acquires and displays.
- Intended use, including patient populations, environments, and users.
To answer your questions, specific performance data from a verification and validation study would be required, which is not included in this 510(k) summary.
§ 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.