The Solar 7/8000 System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care.

Physiologic parameter data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, end tidal CO2, pulse oximetry, venous O2 saturation, Transcutaneous O2 and/or CO2, respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations. O2 and/or CO2 concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stored in the monitor from a variety of peripheral devices.

The Solar 7/8000 System is also intended to provide physiologic data over the UNITY™ network.

The Solar 7/8000 System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

Device Description

The Solar 8000 System includes four basic components:

Solar 8000 processing unit .
. a display (monochrome or color)
TRAM-rac housing .
acquisition module(s) .

The Solar 7000 System includes three basic components:

Solar 7000 monitor (integrated display and . processing unit) (monochrome or color)
TRAM-rac housing
. . acquisition module(s)

Optional Solar 7/8000 components include:

central station (K901072) .
. remote display
. remote control
writer (Direct Digital Writer/ PRN 50 Thermal . Recorder / Laser Printer)
. TRAM-Net hub
TRAM-Net interface adapter(s) .
SolarView Remote Display Controller .
Octanet connectivity device .
. Trend Memory Storage System

AI/ML Overview

This 510(k) summary (K993757) for the GE Marquette Medical Systems Solar 7/8000 System does not provide the detailed information required to fill out all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria. The document is primarily a summary for substantial equivalence to predicate devices, rather than a detailed report of performance testing against specific acceptance criteria.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria for specific performance metrics (e.g., accuracy, precision for each physiological parameter). Instead, it makes a general claim of equivalent performance to predicate devices.

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable metrics. The overarching acceptance criterion appears to be "as safe, as effective, and perform as well as the predicate devices."	The Solar 7/8000 complies with voluntary standards as detailed in Section 9 of the submission (which is not provided) and underwent various quality assurance measures. The conclusion states "The results of these measurements demonstrated that the Solar 7/8000 is as safe, as effective, and perform as well as the predicate devices."

Study Details

The provided text only offers high-level descriptions of "testing" and "validation" activities, rather than a specific study design or results.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document mentions "Software and hardware testing," "Safety testing," "Environmental testing," and "Clinical use validation," but no details on sample sizes for any of these tests are given. Data provenance (country, retrospective/prospective) is also not mentioned.
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. The document refers to "Clinical use validation" but does not detail how ground truth was established or if experts were involved for performance evaluation against a gold standard.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided. No information about adjudication methods is present.
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-assisted diagnostic tool that would typically involve human "readers" interpreting images or data with and without AI assistance in an MRMC study format. The focus is on the device's ability to accurately measure physiological parameters.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly detailed, but implied for certain components. The device is a patient monitor system that measures and displays physiological parameters. Its performance, by nature, is largely "standalone" in terms of its ability to acquire and process data. However, the exact methodology for evaluating the performance of individual algorithms (e.g., for arrhythmia detection, CO2 measurement) in isolation is not provided. "Software and hardware testing" would likely encompass such evaluations.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but inferred to be direct physical measurements and/or comparison to established reference devices. For physiological parameters like ECG, blood pressure, temperature, etc., ground truth would typically be established using highly accurate reference measurement equipment or controlled physical simulations, rather than expert consensus on interpretive data or pathology. The "Clinical use validation" would likely involve comparing the device's readings to established clinical standards.
The sample size for the training set:
- Not applicable/Not provided. This document predates modern AI/ML-driven device submissions where explicit "training sets" are common. While the device contains algorithms, the concept of a distinct 'training set' as understood in current AI development is not mentioned. The development process would have involved engineering design, calibration, and testing.
How the ground truth for the training set was established:
- Not applicable/Not provided. Similar to the point above, the concept of a 'training set' with established ground truth in the current AI/ML context is not applicable or detailed in this 1999/2000 document.

Summary of Missing Information:

The 510(k) summary provides a high-level overview of the device and its intended use, along with a general statement about compliance with voluntary standards and various quality assurance measures. However, it lacks specifics regarding:

Quantifiable acceptance criteria for any physiological parameter.
Detailed study designs, methodologies, or raw data from performance tests.
Sample sizes for validation or testing.
Specifics on how ground truth was established for any performance evaluation.
Information on expert involvement or adjudication.

This level of detail is typically found in the full 510(k) submission and supporting technical reports, not usually in the publicly available 510(k) summary. The document served its purpose at the time by demonstrating substantial equivalence to predicate devices based on its underlying technology and general testing practices.

Summary

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MAR 2 3 2000

Section 2 Summary and Certification

510(k) Summary of Safety and Effectiveness
Date:	November 1, 1999
Submitter:	GE Marquette Medical Systems8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Karen WebbSr. Regulatory Affairs SpecialistGE Marquette Medical SystemsPhone: (414) 362-3329Fax: (414) 362-2420
Device:	Trade Name: Solar 7/8000 System
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:

K900598 Marquette Tramscope System

K921669 Marquette SL Series Transport Remote Acquisition Module

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Device Description: The Solar 8000 System includes four basic components:

Solar 8000 processing unit .
. a display (monochrome or color)
TRAM-rac housing .
acquisition module(s) .

The Solar 7000 System includes three basic components:

Solar 7000 monitor (integrated display and . processing unit) (monochrome or color)
- TRAM-rac housing
. . acquisition module(s)

Optional Solar 7/8000 components include:

central station (K901072) .
. remote display
. remote control
writer (Direct Digital Writer/ PRN 50 Thermal . Recorder / Laser Printer)
. TRAM-Net hub
TRAM-Net interface adapter(s) .
SolarView Remote Display Controller .
Octanet connectivity device .
. Trend Memory Storage System

Intended Use:

The Solar 7/8000 System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained The intended use of the system is to monitor in its proper use. physiologic parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care.

The Solar 7/8000 System is also intended to provide physiologic data over the UNITY™ network.

The Solar 7/8000 System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

Technology:

The Solar 7/8000 employs the same functional technology as its predicate devices.

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Test Summary:

The Solar 7/8000 complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Solar 7/8000:

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

Conclusion:

The results of these measurements demonstrated that the Solar 7/8000 is as safe, as effective, and perform as well as the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2000

Ms. Karen Webb Sr. Regulatory Affairs Specialist GE Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223

Re: K993757 Trade Name: Solar 7/8000 System Regulatory Class: III Product Code: 74 DSI Dated: February 1, 2000 Received: February 2, 2000

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 legally 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, Druq, 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulatory action. In addition, FDA may publish further announcements 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

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Page 2 - Ms. Karen Webb

under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21CFR 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,

Megas Magneka

Image /page/4/Picture/7 description: The image contains a handwritten word that appears to be "far". The word is written in a cursive style with the letters connected. Below the word, there are two horizontal lines, which could be interpreted as an underline or a simple design element.

James E. Dillard III Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Unknown; 510(k) filed on November 1, 1999 510(k) Number (if known):

Solar 7/8000 System Device Name:

Indications for Use:

Physiologic parameter data includes: electrocardiogram, invasive blood pressure. noninyasive blood pressure, pulse, temperature, cardiac output, respiration, end tidal CO2 pulse oximetry, venous O2 saturation, Transcutaneous O2 and/or CO2, respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations. O2 and/or CO2 concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stored in the monitor from a variety of peripheral devices.

The Solar 7/8000 System is also intended to provide physiologic data over the UNITY™ network.

The Solar 7/8000 System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

	for Jim Dillard
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K993757

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

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.