(24 days)
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.
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.
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.
§ 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.