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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 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.

Device Description

The Solar 9500 is a patient monitoring system that is designed to display patient physiological data that is received from the GE Medical Systems' Tram-net network and individual and multi-parameter 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 Medical System'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 capability 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-GE platforms via the Enterprise network.

The Solar 9500 system was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

AI/ML Overview

The provided text is a 510(k) summary for the GE Medical Systems Information Technologies Solar 9500 Information Monitor. It describes the device, its intended use, and states that its safety and effectiveness are based on demonstrating substantial equivalence to predicate devices and compliance with voluntary standards.

However, the document does not contain specific acceptance criteria, numerical performance metrics, or details of a study that directly proves the device meets such criteria. Instead, it relies on the concept of "substantial equivalence" to predicate devices and adherence to general quality assurance measures and safety/environmental testing.

Therefore, most of the requested information cannot be extracted from this document as it does not detail a specific performance study with quantitative results, ground truth establishment, or sample sizes for testing or training sets.

Here's what can be extracted based on the provided text, with clear indications where information is not available:

Acceptance Criteria and Study Details for Solar 9500 Information Monitor

Information Category	Details from Document (if available)
1. Acceptance Criteria & Reported Performance	Not explicitly stated as numerical acceptance criteria for a new performance test. The document states: "The results of these measurements demonstrated that the Solar 9500 is as safe, as effective, and performs as well as the predicate devices." This implies that the 'acceptance criteria' were met by demonstrating substantial equivalence to predicate devices and compliance with voluntary standards. No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the Solar 9500 itself for each physiological parameter.
2. Sample size and data provenance (test set)	Not available. The document does not describe a specific clinical performance test with a defined test set sample size or data provenance. The assessment relies on substantial equivalence and general safety/performance testing.
3. Number of experts and qualifications (ground truth for test set)	Not applicable/available. No specific expert-adjudicated ground truth for a test set is described. The device's performance is assumed to be equivalent to predicate devices which would have undergone their own validation.
4. Adjudication method (test set)	Not applicable. No specific adjudication method is described for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study	No, not described. The document does not mention an MRMC study or any comparison of human readers with/without AI assistance. The device is a patient monitor, not an AI diagnostic tool for image interpretation.
6. Standalone (algorithm only without human-in-the-loop) performance study	*Not explicitly described as a standalone performance* study with quantitative metrics.** The document states "Software and hardware testing" and "Safety testing" were done, which would involve the device operating in a standalone capacity, but no detailed performance results are provided. The device's function is to display physiological data, not provide an automated diagnosis.
7. Type of ground truth used	Not applicable/available. The document does not refer to a specific "ground truth" as would be used in a diagnostic algorithm performance study (e.g., pathology, outcomes data). The device measures and displays physiological parameters, whose accuracy would be validated against established medical reference standards or predicate devices.
8. Sample size for the training set	Not applicable/available. This device is a patient monitor, not a machine learning model that undergoes a "training set" in the common sense of AI development.
9. How ground truth for the training set was established	Not applicable/available. (See point 8).

Summary of Study Described:

The document describes the "Solar 9500 Information Monitor," a patient monitoring system. The overarching "study" or assessment demonstrating its safety and effectiveness is primarily based on substantial equivalence to legally marketed predicate devices. This means that the device's technological characteristics, intended use, and performance are considered equivalent to devices already approved by the FDA (specifically, the Solar 9500 Information Monitor, K030575, is listed as a predicate device, although this seems to be a typo and likely refers to its own 510(k) rather than a separate predicate device).

The document states that the Solar 9500 "employs the same functional technology as the predicate devices." In addition, the device underwent various quality assurance measures during its development:

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

The conclusion drawn from these activities is that the Solar 9500 "is as safe, as effective, and performs as well as the predicate devices." This avoids the need for a de novo clinical trial with specific performance metrics and dedicated ground truth establishment for each measurable parameter, as the equivalence to already-approved devices serves as the basis for clearance.

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K Number

K030575

Device Name

MODIFICATION TO SOLAR 9500 INFORMATION MONITOR

Manufacturer

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

Date Cleared

2003-03-21

(25 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K990068

Intended Use

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

Device Description

The Solar 9500 system was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

AI/ML Overview

The provided 510(k) summary for the Solar 9500 Information Monitor does not contain information regarding specific acceptance criteria for performance benchmarks or a detailed study proving the device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device based on similar technology and general compliance with voluntary standards and internal quality assurance measures.

Therefore, most of the requested information cannot be extracted directly from the provided text.

Here is a summary of what information is explicitly stated or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative metrics or specific performance thresholds.	The document states: "The results of these measurements demonstrated that the Solar 9500 is as safe, as effective, and performs as well as the predicate devices." This is a qualitative statement of performance relative to the predicate, rather than precise metrics.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified.
Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. The document mentions "Software and hardware testing," "Safety testing," and "Environmental testing" but does not detail the nature of these tests, including the data used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. The provided information does not describe any MRMC studies or a comparison of human reader performance with or without AI assistance. The device is a patient monitor, not an AI-assisted diagnostic tool in the sense of image analysis.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: The document describes "Software and hardware testing" and "Final validation," implying standalone testing of the device's functions. However, specific performance metrics for an "algorithm only" component (like a specific arrhythmia detection algorithm's sensitivity/specificity) are not provided. The device as a whole is tested, which inherently includes its algorithms.

7. Type of Ground Truth Used

Type of Ground Truth: Not specified in detail. The testing mentioned ("Safety testing," "Environmental testing," "Software and hardware testing," "Final validation") typically involves comparing device outputs to known inputs or reference standards, but how the "ground truth" for specific physiological parameters or arrhythmia detection was established is not detailed. For a patient monitor, this would typically involve calibrated measurement devices or expert interpretation of physiological signals.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not specified. The document describes a patient monitoring system, which typically uses established algorithms and signal processing techniques rather than a "training set" in the machine learning sense from a specific dataset. Device development involves engineering, testing against specifications, and validation, not necessarily a machine learning training phase on a large dataset.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable/not specified, as there is no mention of a traditional machine learning "training set."

Summary of Device Rationale and Testing:

The 510(k) summary for the Solar 9500 Information Monitor relies on demonstrating substantial equivalence to a predicate device (K990068, also a Solar 9500 Information Monitor from GE Medical Systems).
The "Test Summary" section states that the device complies with voluntary standards (as detailed in Section 9, which is not provided here) and that the following quality assurance measures were applied:

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

The conclusion is that these measures "demonstrated that the Solar 9500 is as safe, as effective, and performs as well as the predicate devices." This indicates that the primary "study" proving performance is the comparison to the predicate device and adherence to internal quality assurance processes and relevant voluntary standards. There are no specific quantitative acceptance criteria or detailed performance studies presented in this summary document beyond this qualitative statement of equivalence.

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K Number

K990068

Device Name

SOLAR 9500 INFORMATION MONITOR

Manufacturer

GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN

Date Cleared

1999-07-14

(187 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K954852,K921669

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 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.

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 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.

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