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.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

પાડ

510(k) Summary

SUMMARY DATE:		AUG 09 2013
Monday May 13, 2013
510K SUBMITTER:
Neurotronics, Inc.3600 NW 43rd Street, Suite F1Gainesville, FL, 32606		Phone: 352.372.9955Fax : 815.550.2871
Primary Contact:
Name: David PezetEmail: david.pezet@neurotronics.com	Title: Quality ManagerPhone: 352.372.9955 Ext 355
Establishment Registration Number:1063925

DEVICE TYPE (COMMON NAME):

Non-Normalizing Quantitative Electroencephalograph Software

PROPRIETARY NAME OF THE DEVICE:

Live View Panel (LVP)

{1}------------------------------------------------

CLASSIFICATION:

Product Code:

Product Code	Device	Regulation Description	Regulation Number
GWQ	Full-Montage StandardElectroencephalograph	Electroencephalograph	882.1400

Subsequent Product Code:

ProductCode	Device	RegulationDescription	RegulationNumber
OLZ	Automatic Event Detection Software ForPolysomnograph WithElectroencephalograph	Electroencephalograph	882.1400
OLV	Standard Polysomnograph WithElectroencephalograph	Electroencephalograph	882.1400
OLT	Non-Normalizing QuantitativeElectroencephalograph Software	Electroencephalograph	882.1400

PREDICATE DEVICES

Submitter/Holder	Device Name	Model	510(K)
Nihon Kohden America, Inc.	Nihon Kohden EEG-1200A SeriesNeurofax	EEG-1200A	K080546
Neurotronics, Inc.	Polysmith Sleep System	NTI5498	K062943
Nihon Kohden Corp.	PSG-1100 Sleep Diagnostic System	PSG-1100	K120888
Nihon Kohden America, Inc.	Nihon Kohden EEG-1200A with JE-120A Multi Channel ElectrodeJunction Box	JE-120A	K113117

{2}------------------------------------------------

DESCRIPTION

Image /page/2/Figure/4 description: The image shows a diagram of a system with multiple components. On the left side, there are four acquisition stations connected to a network switch. The data from the network switch is then transmitted to two live view panel (LVP) stations, each with its own network switch. Additionally, the data is sent via the internet to branch locations.

{3}------------------------------------------------

INTENDED USE

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.

{4}------------------------------------------------

PREDICATE COMPARISON

Intended Use Comparison

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.

Technical Comparison

The Live View Panel contains a subset of features found in the predicate. The device's main function is to facilitate the viewing of multiple patients' data from a location physically removed from the patient area. The Live View Panel extends the predicates' ability to view recordings remotely by providing an intuitive interface to manage multiple recordings. Therefore Neurotronics believes the Live View Panel is substantially equivalent to the Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction Box (K113117), Nihon Kohden EEG-1200A Series Neurofax (K080546), PSG-1100 Sleep Diagnostic System (K120888), and Polysmith Sleep System, Model NTI5498 (K062943).

Live View Panel	EEG Predicates(K113117, K080546)	PSG Predicates(K062943, K120888)
Display Electrical activity of the brain and otherphysiological signals on a monitor	Same	Same
Device uses Windows™ on a 32-bit computer	Same	Same
Display waveforms in acquisition and review	Same	Same
Maximum number of waveforms on screen is 64(EEG) and 32 (PSG)	Same	Same
Simultaneously view waveforms from multipleEEG/PSG instruments connected to a networkand display values from external instruments	Same	Same
Variable waveform display duration	Same	Same
Change waveform parameters (pattern, montage,amplifier conditions, AV induction)	Same	Same
Add, edit, delete on screen events	Same	Same
The device can measure vital signs (includingECG, EMG, Respiration, ocular motility, SpO2,and CO2)	Same	Same
Display patient video along with waveforms	Same	Same
For use by medical personnel in a medicalfacility, physician's office, laboratory, clinic, ornursing home	Same	Same
Any patient population including adults andchildren as determined by a trained professional	Same	Same

{5}------------------------------------------------

PERFORMANCE DATA

. Testing Data Testing included: Software testing

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 to the features provided by the Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction Box (K113117), Nihon Kohden EEG-1200A Series Neurofax (K080546), Polysmith Sleep System, Model NTI5498 (K062943), and PSG-1100 Sleep Diagnostic System (K120888).

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure embracing a bird, often interpreted as representing the department's mission of protecting and promoting the health of Americans. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 9, 2013

Neurotronics, Inc. c/o Mr.David Pezet Quality Manager 3600 NW 43td Street, Suite Fl Gainesville, FL 32606

Re: K131415

Trade/Device Name: Live View Panel Regulation Number: 21 CFR 882.1400 Regulation Name: Standard polysomnograph with electroencephalograph Product Code: OLV, GWQ, OLZ, and OLT Dated: June 16, 2013 Received: June 17, 2013

Dear Mr. Pezet:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing

{7}------------------------------------------------

Page 2 - Mr. David Pezet

practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Indications for Use

510(k) Number (if known): K131415

Device Name:

Indications For Use:

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.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sian Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number ________________________________________________________________________________________________________________________________________________________________ K131415

Page 1 of 1

Regulation Number and Section

§ 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).