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The Lifelines iEEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information. The Lifelines iEEG system also includes the display of a quantitative EEG plots, power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Lifelines iEEG is medical device used to acquire, display, archive, store and analyze EEG examinations. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of acquiring and presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The system software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.

The components of Lifelines iEEG are:

• Lifelines iEEG software:
  • . iEEG Centrum
  • . iEEG Review
  • iEEG Acquisition .
• Lifelines Trackit, Lifelines Ltd, 510(k)#K010460
• Lifelines Photic Stimulator, Lifelines Ltd, 510(k)# K101691 ●
• Off the shelf PC and medical grade power supply ●
• Off the shelf IP Video Camera ●

This 510(k) submission for the Lifelines iEEG 2.0 device primarily focuses on demonstrating substantial equivalence to a predicate device (Natus Medical, Inc., DG Nervus/NicoletOne, K964280) rather than presenting a standalone study with acceptance criteria for clinical performance. The documentation emphasizes software verification and validation, along with conformance to various IEC standards for safety and essential performance.

Therefore, many of the requested sections related to clinical study design, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not explicitly addressed in this document. The device is an EEG system for acquisition, display, archive, storage, and analysis of physiological signals, and the submission argues that it is substantially equivalent to existing, legally marketed devices.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics in terms of clinical accuracy (e.g., sensitivity, specificity for diagnostic tasks) are provided in this document. The submission focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and conformance to safety and performance standards.

The document highlights the following characteristics of the Subject Device (Lifelines iEEG):

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The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a digital EEG system to monitor the brain. The device is intended for use in a healthcare facility, clinical research environment, or in the home under the supervision of a qualified healthcare professional. The device is intended for use on all patient populations including pediatric.

The Intelligent Electroencephalogram (iEEG) device acquires and stores electrical activity of the brain and patient data. The iEEG can be used with other FDA cleared devices such as the BraiNet Kit (K043009) and Ives EEG electrode (K062880). The BraiNet Kit consists of the BraiNet Template (electrode cap), and Sub-dermal EEG Needle Electrodes and Cutaneous EEG Electrodes.

The iEEG consists of an iEEG transmitter module, a medical grade AC charging adapter/charging cable and an iEEG viewer/recorder software.

The wireless iEEG transmitter module provides an EEG electrode connection, electrode impedance (connection) status indicator(s), a single-user multi-function push button switch that provides power on/off, electrode impedance check. The wireless module is powered by an internal rechargeable energy source.

The AC charger module provides a convenient means to recharge the wireless module's internal energy source when not in use. The device is not intended to be charged when attached to the patient.

The iEEG viewer/recorder software provides, with the aid of host computer hardware and operating system, the ability to collect EEG electrode data from the wireless iEEG transmitter module, view EEG data, and record data to digital file. The iEEG viewer/recorder provides eight signal graphic display of selectable EEG montages (lead/electrode combinations). It also enables subject data entry (Name, DOB, ID number etc.) and control of EEG data recording to digital file.

The Intelligent Electroencephalogram (iEEG) is designed to be capable of usage and storage in hospital, clinic, and emergency room environments. The iEEG transmitter modules communicate with the computer by using Bluetooth wireless technology.

The provided 510(k) summary for the iEEG (Intelligent Electroencephalograph) device does not contain a dedicated section detailing acceptance criteria or the specifics of a study conducted to prove the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This type of submission relies on showing that the new device is as safe and effective as a legally marketed device, rather than proving performance against specific pre-defined acceptance criteria through a clinical study.

The submission primarily lists technological characteristics and benchmarks them against predicate devices. The "Performance Data" section briefly mentions:

"The device was tested to IEC 60601-1-1 for safety and IEC 60601-2 Electromagnetic Compatibility. The device was also evaluated to standard IEC 60601-2-26 for essential EEG performance specifications. The device with a suitable battery charger was evaluated to IEC 60601-1/A2:1995, IEC 60601-2-26 and applicable national requirements. All applicable tests according to the specified standards were completed and passed. Bench testing was performed and confirms that the device meets design requirements and specifications."

This indicates that various engineering and safety standards were met through bench testing, but these are not the "acceptance criteria" for a clinical performance study in the way implied by the request. There is no clinical study described with a test set, ground truth, or expert review for diagnostic performance.

Therefore, for the points requested by the user, most of the information is not available in the provided text.

Here's a breakdown of what can be inferred or explicitly stated based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• "The device was also evaluated to standard IEC 60601-2-26 for essential EEG performance specifications."
• "The device with a suitable battery charger was evaluated to IEC 60601-1/A2:1995, IEC 60601-2-26 and applicable national requirements."
• "All applicable tests according to the specified standards were completed and passed."
• "Bench testing was performed and confirms that the device meets design requirements and specifications." |
  | Technological Equivalence (Relative to Predicate Devices) | - Channels: 8 (Equivalent to Zoom-100, within range of Trackit)
• ADC Resolution: 16 bit (Same as Zoom-100 and Trackit)
• ADC CMRR: >115dB (Slightly better than predicates (>100dB), deemed "comparable performance")
• Input Impedance: 10MOhm (Same as Zoom-100, better than Trackit)
• Electrode Impedance Check: Yes (Same as predicates)
• Wireless Output: Bluetooth 2.4 GHz (Same as predicates)
• Data Format: edf (Equivalent to Trackit)
• Electrode Material: Standard off-shelf electrodes (Same as predicates)
• Battery: Rechargeable Lithium-Polymer (Equivalent to Lithium-Ion in predicates)
• Charger: Yes (Same as predicates)
• Hi Filter Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)
• Low Filter Settings: Ranges listed (Deemed "Same" to predicates)
• 60 Hz Filter: Yes (Same as predicates)
• Gain Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)
• Time Base Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)
• Display Montage: User selectable (Deemed "Same or clinically insignificant differences" to predicates) |

2. Sample size used for the test set and the data provenance

• Not Available. The document describes bench testing against engineering standards and comparison of technical specifications against predicate devices. It does not mention any clinical test set or patient data used to evaluate diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Available. No clinical test set or ground truth establishment based on expert consensus for diagnostic performance is described. The evaluation was based on conformance to engineering standards and comparison of technical specifications.

4. Adjudication method for the test set

• Not Applicable / Not Available. No clinical test set or adjudication method is described.

5. 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

• No. An MRMC comparative effectiveness study was not conducted or reported. The iEEG device is described as an "electroencephalograph" intended to acquire and store electrical activity for review by a medical professional, implying it is a data acquisition and display tool, not an AI-assisted diagnostic tool designed to improve human reader performance or automate diagnosis.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No. The device is not an algorithm for standalone diagnostic performance. It is a hardware/software system for acquiring and displaying EEG data for human review.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Not Available. For its "performance data," the device primarily refers to meeting engineering and safety standards (IEC 60601 series). For demonstrating substantial equivalence, its technical specifications were compared to those of already cleared predicate devices. There is no mention of a clinical ground truth (like expert consensus, pathology, or outcomes data) being established for evaluating diagnostic accuracy.

8. The sample size for the training set

• Not Applicable / Not Available. This device is an EEG acquisition and display system, not an AI/ML algorithm that requires a "training set" in the context of diagnostic performance. Any internal development or validation would be against technical specifications, not a clinical training set for an algorithm.

9. How the ground truth for the training set was established

• Not Applicable / Not Available. As noted above, there is no mention of a "training set" or corresponding ground truth.

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The Lifelines iEEG is a software system that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

• The Lifelines iEEG software allows display, archive, review and analysis of . physiological signals.
• Lifelines iEEG also includes the display of a quantitative EEG plot, power . spectrum, which is intended to help the user to monitor and analyze the EEG.
  This device does not provide any diagnostic conclusion about the patient's condition to the user.

Lifelines iEEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.
The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions. The two main components of Lifelines iEEG are iEEG Centrum and iEEG Review.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Lifelines iEEG device:

Based on the provided K123665 510(k) Summary, the Lifelines iEEG is a software system for managing and reviewing EEG examinations. It displays physiological signals and provides analysis features like FFT and Artifact Removal. Crucially, the document does not detail specific acceptance criteria or a study proving that the device meets such criteria in terms of clinical performance or accuracy thresholds. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on functional similarities and safety considerations.

The device does not provide any diagnostic conclusion and is intended for use by qualified medical practitioners who will exercise professional judgment. This implies that the software acts as a tool for presentation and analysis, rather than a diagnostic algorithm requiring performance metrics like sensitivity, specificity, or AUC.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific test set with a defined sample size for evaluating the clinical performance of the Lifelines iEEG in terms of diagnostic accuracy or other performance metrics. The comparison is primarily functional.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since there is no described test set for clinical performance evaluation, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

As there is no described test set requiring a ground truth, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

An MRMC study was not conducted or described in this 510(k) summary. The device's purpose is not to assist human readers in a diagnostic task that would be directly compared to unassisted reading, as it doesn't provide diagnostic conclusions or AI-driven interpretations beyond basic signal processing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document does not describe any standalone performance study in terms of diagnostic effectiveness for the algorithm itself. The device is a software system intended to be used by a qualified medical practitioner.

7. The Type of Ground Truth Used

Given the lack of a clinical performance study with acceptance criteria, no specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for performance evaluation.

8. The Sample Size for the Training Set

The document does not mention a training set or any deep learning/machine learning models that would require one. The functions described (re-montaging, band pass filtering, FFT analysis, Artifact Removal) are conventional signal processing techniques, not typically "trained" on data in the way AI algorithms are.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, this information is not applicable and not provided.

Summary of Device Evaluation Approach:

The K123665 submission for Lifelines iEEG primarily relies on demonstrating substantial equivalence to predicate devices based on functional characteristics and safety considerations stemming from standard signal processing methods. The key argument is that the Lifelines iEEG performs similar functions (display, archive, review, analysis of EEG signals) to the predicate devices, despite lacking the acquisition and specific spike/seizure detection functionalities. The safety and effectiveness are inferred from the use of conventional, industry-standard methods for signal processing, which are assumed to be similar enough to predicate devices such that the device does not raise new questions of safety or effectiveness. No specific clinical performance metrics or studies proving diagnostic accuracy are presented because the device's intended use is as a display and analysis tool, not a diagnostic aid providing conclusions.

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