(90 days)
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.
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).