(194 days)
The Solar 8000M System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in the use of the equipment. The Solar 8000M is a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment. The Solar 8000M System is capable of monitoring electrocardiogram, non-invasive pressure, pulse, invasive blood pressure, blood temperature, cardiac output, respiration, pulse oximetry, venous O2 saturation, Transcutaneous O2 and CO2 respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O2 and 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 8000M System is also intended to provide physiologic data over the UNITY Tu network. The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.
The Solar 8000M System includes the following basic components: Solar 8000M processing unit a display TRAM-rac housing acquisition module(s) keypad and/or remote control Additional, optional components include: Clinical Information Center (central station) Remote display digital writer or printer TRAM-Net interface adapter(s) Octanet connectivity device Remote Alarm Box
This submission describes a patient monitoring system and does not contain detailed performance metrics or specific acceptance criteria in the format typically seen for algorithm-based devices. Therefore, I cannot extract all the requested information for acceptance criteria and a study that proves the device meets them.
However, I can provide information based on the available text:
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported device performance values. The "Test Summary" only lists the types of tests performed.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for any "test set" in the context of an algorithm's performance. It mentions "Clinical use validation" but provides no details on the number of patients, data origin, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided. The submission focuses on hardware and system functionality, not algorithmic interpretation requiring expert ground truth.
4. Adjudication Method:
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. This submission is about a patient monitoring system, not an AI-assisted diagnostic tool.
6. Standalone Performance:
The document does not describe standalone (algorithm-only) performance in the sense of a diagnostic algorithm without human intervention. The device's function is to display and store physiological data for healthcare practitioners.
7. Type of Ground Truth Used:
The concept of "ground truth" as it applies to diagnostic algorithms (e.g., pathology, expert consensus) is not relevant to this submission. The "ground truth" for a patient monitor would be the actual physiological readings, which are measured directly by the device's sensors. The document states "performance testing" was done, implying comparison against expected physiological values or established calibration standards for each parameter monitored.
8. Sample Size for the Training Set:
This information is not applicable. The device described is a physiological patient monitor, not an AI/ML algorithm that undergoes a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for an AI/ML algorithm.
Summary of available information related to performance and testing:
Acceptance Criteria (Implicit and general, not specific metrics):
- Safety: The device is as safe as the predicate device.
- Effectiveness: The device is as effective as the predicate device.
- Performance: The device performs as well as the predicate device.
- Compliance: The device complies with voluntary standards.
- Functionality: Adherence to requirements (via requirements reviews, design reviews, unit, integration, and final acceptance testing).
- Environmental Robustness: Successful environmental testing.
Study/Testing Information:
The document mentions a "Test Summary" with the following quality assurance measures and testing:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
- Environmental testing
- Clinical use validation
Conclusion from the Submission:
"The results of these measurements demonstrated that the Solar 8000M System are as safe, as effective, and perform as well as the predicate device."
Predicate Device: K993757 Solar 7/8000 System
In essence, this 510(k) submission establishes substantial equivalence to a predicate device based on similar technology and comprehensive quality assurance testing, rather than an AI-specific performance study with detailed acceptance criteria and ground truth analysis.
§ 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.