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The Lifelines Photic Stimulator is indicated for photic activation of the EEG during an EEG study and in the generation of visual evoked potentials.

The Photic Stimulator is a device for generating short-duration flashes of white light by means of a solid-state LED (light emitting diode). The flashes are controlled from a host PC and typically occur over a repetition rate of between 1 and 60Hz.

This document is a 510(k) summary for the Lifelines Photic Stimulator, which is a medical device for generating flashes of white light used in EEG studies and for generating visual evoked potentials.

The provided text does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other clinical outcomes. Instead, it focuses on demonstrating substantial equivalence to a predicate device (EB Neuro, S.P.A. Model BE Plus / AURA-LTM64 Amplifier) based on intended use, technological characteristics, and design.

Therefore, many of the requested sections about acceptance criteria, study details, and performance metrics cannot be directly extracted from this document as they are not present. This type of submission relies on the established safety and effectiveness of a predicate device rather than presenting new clinical performance data.

Here's an analysis based on the information available:

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

The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for a clinical outcome. Instead, the acceptance criteria for the 510(k) submission are based on demonstrating substantial equivalence to a predicate device. This involves matching or demonstrating comparable characteristics in:

Study Description:
The "study" presented here is a comparison to a legally marketed predicate device (EB Neuro, S.P.A. Model BE Plus / AURA-LTM64 Amplifier, K053606) to demonstrate substantial equivalence, rather than a clinical trial or performance study on humans or specialized test sets. The report asserts that the Lifelines Photic Stimulator is similar to the predicate device in intended use, technological characteristics, and design. The FDA's letter confirms substantial equivalence based on this comparison.

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

Not applicable. This is not a study that involved a "test set" of patient data in the conventional sense. The "test" here was a comparison of device specifications and safety standards against a predicate device.

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)

Not applicable. Ground truth for clinical performance was not established as there was no patient-based clinical study. The "ground truth" for the submission was the regulatory safety and performance standards met by the predicate device and the new device's adherence to relevant safety standards.

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

Not applicable. There was no clinical test set requiring adjudication.

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

Not applicable. This device is a photic stimulator, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This device is hardware and does not involve an algorithm for standalone performance evaluation in the context of AI.

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

The "ground truth" in this context is the established safety and effectiveness profile of the predicate device, as well as adherence to relevant international and national safety standards (e.g., EN/IEC 60601-1, IEC 60825-1) for medical electrical equipment and light hazard protection.

8. The sample size for the training set

Not applicable. This device submission does not involve machine learning or a "training set."

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

Not applicable. This device submission does not involve machine learning or a "training set."

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