(139 days)
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.
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
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.
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided. No information about adjudication methods is present.
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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.
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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.
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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.
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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.
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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.
§ 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.