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LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic (EEG) studies. It always has to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The product must be used only by qualified personnel (physicians or technicians of neurophysiopathology) for the execution of EEG exams in a professional environment.

LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic(EEG) studies. It is to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation.

The LED PHOTIC Systemis managed by the EEG system software for setting some parameters, IC, and the power supply called LED PHOTIC IC POWER is an integral part of the LED PHOTIC System.

The provided text describes the regulatory clearance for a medical device called "LED PHOTIC System" and its comparison to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) premarket notification summary for a Class II medical device, which is an accessory for EEG studies to provide photic stimulation. The performance testing mentioned focuses on safety standards (electrical safety, usability, EMC compliance, photobiological safety), not on accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML device evaluations.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance: The document only lists safety standard compliance, not performance criteria for diagnostic accuracy or similar AI/ML metrics.
• Sample size used for the test set and the data provenance: No such testing is described for diagnostic performance. The safety tests would have their own sample sizes (e.g., number of units tested) but these are not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic performance study described.
• Adjudication method for the test set: Not applicable.
• 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: Not applicable, as the device is a photic stimulator, not an AI/ML diagnostic aid.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable (no AI/ML algorithm mentioned).
• How the ground truth for the training set was established: Not applicable.

The "Performance Testing" section only states:

• The LED PHOTIC System was tested and found compliant to the following safety standards:
  • IEC 60601-1:2005+A1:2012: Medical Electrical safety
  • IEC 60601-1-6:2010+A1:2013: Usability
  • IEC 60601-2:2014: EMC Compliance
  • IEC 62471:2006: Photobiological Safety

This submission is about establishing substantial equivalence to a predicate device (Lifelines Photic Stimulator K101691) primarily based on shared intended use, similar operational principles, and compliance with general medical device safety standards. It is not an evaluation of an AI-driven system.

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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):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission details non-clinical performance data, primarily software verification and validation, and conformance to electrical safety and EMC standards. There is no mention of a test set derived from patient data for evaluating clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there is no described clinical test set or ground truth establishment based on expert consensus for clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no described clinical test set or adjudication process for clinical performance.

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 MRMC comparative effectiveness study was done regarding the Lifelines iEEG device improving human reader performance. The device is an EEG system for acquisition and analysis, not an AI-assisted diagnostic tool that interprets EEG data for the user. Its quantitative EEG plots (power spectrum) are intended to help the user monitor and analyze the EEG, but it explicitly states: "This device does not provide any diagnostic conclusion about the patient's condition to the user."

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

No standalone performance study (in a diagnostic sense) was conducted or reported. The device's primary function is to acquire, display, and provide tools for analysis to a human expert, not to perform independent diagnostic interpretations. The document states it "does not provide any diagnostic conclusion." The non-clinical performance data focuses on the technical aspects of the software and hardware components.

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

Not applicable for clinical performance evaluation as described in this document. The "ground truth" in the context of the reported non-clinical performance data would be the expected behavior of the software and hardware according to its design specifications and relevant international standards.

8. The sample size for the training set

This information is not provided. The device is an EEG acquisition and analysis system, not a machine learning model that would typically have a distinct "training set" of clinical data for learning diagnostic patterns.

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

This information is not provided as there is no described training set for a machine learning model with established ground truth.

Summary of Device and Performance Context:

The Lifelines iEEG 2.0 is an electroencephalograph (EEG) system intended for qualified medical practitioners trained in electroencephalography. It allows for the acquisition, display, archive, storage, and analysis of physiological signals, including quantitative EEG plots (power spectrum).

The submission argues for substantial equivalence to the predicate device (DG Nervus/NicoletOne) by detailing similarities in intended use, users, population, use environment, regulation, and core principles of operation (signal processing, montage, filtering, data plotting).

The main differences noted are:

• Lifelines iEEG does not offer automated spike and seizure detection, which the predicate device does. The applicant argues these are "nice-to-have features that are not essential to an EEG system."
• Lifelines iEEG supports fewer EEG channels (up to 128 software, 32 hardware) compared to the predicate (up to 512).
• Lifelines iEEG includes the OLT product code for quantitative EEG, and supports its own proprietary (.ieeg) recording type.
• Lifelines iEEG includes wireless communication and video camera support as added features not present in the predicate.
• Minor differences in channel equivalent input noise, frequency band, filter ranges, and sampling rates between the subject and predicate device.

The "study" described is primarily a non-clinical performance evaluation consisting of:

• Software Verification and Validation
• Immunity Verification
• Third-party testing for conformance with IEC 60601-1:2005 (basic safety and essential performance)
• Third-party testing for conformance with IEC 60601-1-2:2007 (electromagnetic compatibility)
• Checklist testing for IEC 62304:2006 (Medical Device Software Life Cycle Processes)
• Checklist testing for IEC 62366:2007 (Usability Engineering)
• Third-party testing for conformance with IEC 60601-2-26:2002 (Particular requirements for the safety of electroencephalographs)

The absence of clinical performance data and acceptance criteria for diagnostic accuracy is consistent with the device's stated indications for use, which explicitly state it "does not provide any diagnostic conclusion about the patient's condition to the user." Its primary role is as a tool to aid qualified practitioners in their analysis.

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