(85 days)
The Live View Panel is an accessory to EEG and PSG systems, intended to transmit EEG or PSG data to a remote location where the data can be viewed by a clinician to aid in diagnosis of epilepsies, sleep disorders, and other related disorders.
The Live View Panel is intended for use by medical personnel within a medical facility, clinic or nursing home, or outside a medical facility under the supervision of a medical professional. The Live View Panel is available for use on all patient populations, including adults and children as determined by the medical professional.
This device is not to be used to monitor life threatening situations.
This device is not to be used to control life supporting or life sustaining devices.
The Live View Panel (LVP) consists of several software components that allow remote viewing of digitized physiological waveforms and general patient information for the purpose of viewing EEG (electroencephalography) or PSG (polysomnography) patients in real time or in review. The software uses off-the-shelf and custom software components to manage multiple computer displays to facilitate the viewing of several patients simultaneously.
The Live View Panel consists of three software components. The Live View Panel Acquisition Interface Server (AIS) located on the acquisition system collects patient data from a recording machine and transmits this information over a network to a client machine. The Live View Panel client program receives this information and displays basic information in grid pattern along with other patients. The Live View Panel Monitor Controller program manages a bank of displays, each displaying a single patient. The Live View Panel grid mimics the physical locations of the monitors to allow the clinician manage and keep track of multiple patients displayed on the bank of displays.
The Live View Panel is software only and does not connect to the patient except through a cleared and currently marketed EEG or PSG device. A software module resides on the EEG or PSG device and sends patient data to a remote computer where another software module displays the data on an array of monitors. The software runs on off-the-shelf computers.
Regarding the Live View Panel (LVP) device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for a software accessory (Live View Panel) rather than a diagnostic device that outputs numerical performance metrics against specific acceptance criteria. Therefore, there isn't a traditional table of "acceptance criteria" and "reported device performance" in terms of clinical accuracy (e.g., sensitivity, specificity, AUC).
Instead, the acceptance criteria for this type of device are centered on demonstrating substantial equivalence to predicate devices by meeting functional, technical, and safety requirements. The "performance" is primarily about fulfilling its intended use as a data display and management system.
Here’s a conceptual table based on the information provided, focusing on its functional equivalence:
| Acceptance Criterion (Implied) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Functional Equivalence to Predicates | |
| Display electrical activity of the brain and other physiological signals on a monitor. | "Same" as predicate devices. |
| Device uses Windows™ on a 32-bit computer. | "Same" as predicate devices. |
| Display waveforms in acquisition and review. | "Same" as predicate devices. |
| Maximum number of waveforms on screen (64 EEG, 32 PSG). | "Same" as predicate devices. |
| Simultaneously view waveforms from multiple EEG/PSG instruments. | "Same" as predicate devices. |
| Variable waveform display duration. | "Same" as predicate devices. |
| Change waveform parameters (pattern, montage, amplifier conditions, AV induction). | "Same" as predicate devices. |
| Add, edit, delete on-screen events. | "Same" as predicate devices. |
| Measure vital signs (ECG, EMG, Respiration, etc.). | "Same" as predicate devices. |
| Display patient video along with waveforms. | "Same" as predicate devices. |
| Safety and Effectiveness | |
| Presents no new questions of safety and effectiveness. | "CONCLUSION: Based on the results of the Intended Use Comparison, the Technical Comparison, and Testing Data, it is believed that the Live View Panel (LVP) accessory presents no new questions of safety and effectiveness and, is substantially equivalent..." |
| Intended Use Equivalence | |
| Aids in diagnosis of epilepsies, sleep disorders, and other related disorders, as an accessory to existing EEG/PSG systems. | "The Live View Panel accessory improves upon the predicates' current capabilities for remote access and review of on-line or previously recorded acquisitions. This accessory does not change the indications for use for the devices which it is an accessory. This accessory is intended to aid in diagnosis of epilepsies, sleep disorders, and other related disorders." |
| For use by medical personnel in a medical facility, clinic, nursing home, or under supervision outside a facility. | "Same" as predicate devices. |
| For all patient populations. | "Same" as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Testing Data Testing included: Software testing." This indicates that the "study" for this device was primarily software verification and validation testing. There is no mention of a clinical test set involving patient data for the LVP itself in a diagnostic performance context. The device's function is to display data from already-cleared EEG/PSG devices, so its "performance" is about accurate rendering and transmission, not interpretative diagnostic accuracy.
- Sample Size for Test Set: Not applicable in the context of clinical data for diagnostic performance. The testing was of the software itself.
- Data Provenance: Not applicable in the context of clinical data for diagnostic performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Since the "study" was primarily software testing to ensure correct display and transmission of data, there was no need for expert ground truth establishment for diagnostic purposes. The ground truth for software testing would be the expected output of the software functions (e.g., if a waveform is supposed to appear in a certain location with certain characteristics, it does).
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above. Software testing relies on predefined specifications and expected outputs rather than expert adjudication of clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor would it be relevant for this specific device.
- The Live View Panel is an accessory for displaying existing EEG/PSG data; it is not an AI-driven diagnostic tool or an "AI assistant" that interprets data or makes diagnoses. Its purpose is to facilitate viewing, not to enhance human reader performance through AI.
- Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done.
- The Live View Panel is explicitly described as an accessory that facilitates human viewing of data. It does not perform any diagnostic or interpretive function independently ("algorithm only"). Its core function is to display data for a clinician.
7. The Type of Ground Truth Used
For the software testing that was performed, the "ground truth" would be the functional specifications and expected outputs of the software components. For example:
- Expected behavior of data transmission over a network.
- Expected graphical rendering of waveforms and patient information on various display configurations.
- Expected response to user interface interactions (e.g., changing parameters, adding events).
This is a technical "ground truth" rather than a clinical one (like pathology or expert consensus).
8. The Sample Size for the Training Set
Not applicable. The Live View Panel is a data display and transmission software, not a machine learning or artificial intelligence algorithm that requires a training set of data to learn patterns or make predictions.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for this device.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).