The Solar@ 9500 Information Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The Intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients, in high acuity areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. Physiologic data includes electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, anesthetic gas concentrations and mixed venous oxygen saturation, as summarized in the Solar® 9500 Operator's Manual. The monitoring parameters are contained in Appendix B under Technical Specifications.

The Solar® 9500 Information Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital INTRAnet data via a Web Browser at the point-of-care.

Device Description

The Solar 9500 is a patient monitoring system that is designed to display patient physiological data that is received from the GE Marquette Medical Systems' Tram-net network and individual and multiparameter data acquisition modules.

The Solar 9500 Information Monitoring System is comprised of four basic components: the processing unit, color display, Tram modules(s), and Tram-rac housing. Optional components include a remote display.

The Solar 9500 utilizes the GE Marquette's Unity Ethernet LAN allowing communication with monitoring, clinical information and cardiology products. An additional Ethernet connection is provided for connection to the hospital Enterprise Network. The Enterprise network connection allows the user access to the hospital INTRAnet, through an embedded Web Browser on the Solar 9500. This web browsing capabliity enables the user to log on to the hospital INTRAnet directly from the monitor allowing access to information such as patient history, up-to-the-minute lab results and cath reports. Data can also be accessed from non-Marquette platforms via the Enterprise network.

AI/ML Overview

The provided 510(k) summary for the Solar 9500 Information Monitor is a premarket notification for a patient monitoring system. It declares substantial equivalence to predicate devices but does not include a detailed study proving the device meets specific acceptance criteria in the manner requested (e.g., a clinical validation study with specific performance metrics like sensitivity, specificity, or accuracy. It's a physiological monitor, not an AI/CADe device).

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported device performance metrics like sensitivity/specificity, or details about ground truth establishment, expert adjudication, or MRMC studies, as these types of studies are not described in the provided document.

Here's an explanation of what the document does describe in relation to device performance and safety:

1. A table of acceptance criteria and the reported device performance:

Not provided in this document. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than reporting specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy (common in AI/CADe devices). The device monitors physiological parameters, and its performance is typically assessed through validation of its ability to accurately measure and display these parameters, not through traditional diagnostic performance metrics like sensitivity or specificity.
The document states, "The Solar 9500 complies with the voluntary standards as detailed in Section 9 of this submission." However, Section 9 (which would list these standards and likely contain the detailed test results and acceptance criteria) is not included in the provided text.

2. Sample sized 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 summary does not describe any specific clinical test set, patient data, sample sizes, or data provenance. The "Test Summary" refers to internal quality assurance measures (requirements review, code inspections, software/hardware testing, safety testing, environmental testing, final validation) rather than a clinical trial or performance study involving a specific patient dataset.

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 applicable/Not provided. Since there's no described clinical test set requiring ground truth establishment (as would be for an AI/CADe device interpreting images or other complex data), information about experts and their qualifications is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not provided. No adjudication method is mentioned as there is no test set described for performance evaluation based on expert interpretation.

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:

No MRMC study was done or mentioned. This device is a patient physiological monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and effects on human readers are not relevant in this context and are not discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided in the context of diagnostic algorithms. This device is a standalone monitor. Its "performance" refers to its accuracy in measuring physiological parameters, not to its performance as a diagnostic algorithm to be compared with human interpretation of its output in a standalone vs. human-in-the-loop manner. The "Test Summary" describes various internal validation tests that relate to the device's standalone functional integrity and safety.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable/Not provided for diagnostic ground truth. For a physiological monitor, accuracy is typically validated against known reference standards (e.g., a precise gas analyzer for CO2 measurement, an invasive pressure catheter for blood pressure, or a calibrated temperature probe for temperature). The document does not specify the ground truth methods used for validating the accuracy of each physiological parameter.

8. The sample size for the training set:

Not applicable/Not provided. This document describes a patient monitoring system, which typically does not involve machine learning models with "training sets" in the same way an AI/CADe device would. The software development included "Requirements specification review," "Code inspections," "Software and hardware testing," "Safety testing," "Environmental testing," and "Final validation." These are traditional software and hardware engineering validation steps, not machine learning model training.

9. How the ground truth for the training set was established:

Not applicable/Not provided. As there is no described training set for a machine learning model, the establishment of its ground truth is not discussed.

In summary, the provided 510(k) summary for the Solar 9500 Information Monitor is a regulatory filing focused on demonstrating "substantial equivalence" of a general patient monitoring system to previously cleared predicate devices. It relies on internal quality assurance, safety testing, and compliance with voluntary standards, rather than detailing clinical studies with specific performance metrics, test sets, or ground truth establishment typically found in submissions for AI/CADe devices. This type of submission is common for non-AI medical devices where equivalence in design, materials, and intended use is the primary pathway to market clearance.

Summary

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510(k) Summary of Safety and Effectiveness

Date:

January 7, 1999

GE Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223 USA

Contact Person:

Submitter:

Karen Webb Requiatory Affairs Specialist GE Marquette Medical Systems Phone: (414) 362-3329 Fax: (414) 355-3790

Trade Name: Device:

Solar 9500 Information Monitor

Common/Usual Name:

Patient monitor

Classification Names:

21 CFR 868.1400 Analyzer, Gas, Carbon Dioxide, Gaseous-Phase

21 CFR 868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Conc.) 21 CFR 868.1620 Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

21 CFR 868.1690 Analyzer, Gas, Nitrogen, Gaseous-Phase (Anesthetic Conc.)

21 CFR 868.1700 Analyzer, Gas, Nitrous Oxide, Gaseous-Phase, (Anesthetic Conc.)

21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase

21 CFR 868.2375 Breathing Frequency Monitor

21 CFR 870.1025 Detector and Alarm, Arrhythmia

21 CFR 870.1100 Monitor, Blood Pressure, Indwelling

21 CFR 870.1130 Noninvasive Blood Pressure Measurement System

21 CFR 870.1100 Blood Pressure Alarm

21 CFR 870.1425 Programmable Diagnostic Computer

21 CFR 870.2340 Electrocardiograph

21 CFR 870.1435 Monitor, Cardiac Output, Thermal (Balloon Type Catheter)

21 CFR 880.2910 Monitor, Temperature (with probe)

21 CFR 870.2300 Monitor, Cardiac (Incl. cardiotachometer & rate alarm)

21 CFR 870.2700 Oximeter, Pulse
Predicate Devices:

K954852 Solar 9000 Anesthesia Information Monitor

K921669 Marquette SL Series Transport Remote Acquisition Module

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Device Description:

Intended Use:

The Solar 9500 Information Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients, in high acuity areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive Physiologic data includes electrocardiogram, invasive blood care, care, pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, anesthetic gas concentrations and mixed venous oxygen saturation, as summarized in the Solar 9500 Operator's Manual. The monitoring parameters are contained in Appendix B under Technical Specifications.

The Solar 9500 Information Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital INTRAnet data via a Web Browser at the point-of-care.

This information can be displayed, trended, stored, and printed.

Technology:

The Solar 9500 employs the same functional technology as the predicate devices.

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Test Summary:

The Solar 9500 complies with the voluntary standards as detailed in The following quality assurance Section 9 of this submission. measures were applied to the development of the Solar 9500:

Requirements specification review �
Code inspections .
Software and hardware testing .
Safety testing .
Environmental testing .
Final validation .

Conclusion:

The results of these measurements demonstrated that the Solar 9500 ls as safe, as effective, and performs as well as the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird, with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 1999

Ms. Karen Webb GE Marquette Medical Systems, Inc. 8200 West Tower Avenue Milwaukee, WI 53223

K990068 Re: Solar 9500 Information Monitor Regulatory Class: III (three) Product Code: 74 MHX Dated: January 7, 1999 Received: January 8, 1999

Dear Ms. Webb:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Karen Webb

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if Known): Unknown; 510(k) filed on January 7, 1999

Solar® 9500 Information Monitor Device Name:

Indications For Use:

The Solar@ 9500 Information Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The Intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients, in high acuity areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal Physiologic data includes electrocardiogram, invasive blood pressure, intensive care. noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, anesthetic gas concentrations and mixed venous oxygen saturation, as summarized in the Solar® 9500 Operator's Manual. The monitoring parameters are contained in Appendix B under Technical Specifications.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Daula Tiller

Regulation Number and Section

§ 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.