(171 days)
The Natus Photic Stimulator is indicated for photic activation of the EEG study and in the generation of visual evoked potentials.
The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Photic Stimulator is used by trained medical staff in a medical environment to apply photic flashes to the patient during neurophysiology studies such as electroencephalographic (EEG) studies, where it is used as an activation to test photo-sensibility related to epilepsy.
The Natus Photic Stimulator is typically used by EEG technicians in the hospital environment in fixed, mobile or portable systems, and with patients of all ages. The lamp head assembly is mounted on an arm allowing easy placement at 30 cm away from the patient's face. The arm is ergonomically designed so that the lamp can be move and rotated in the direction of the patient using a handgrip on the lamp.
Trigger pulses applied to the trigger input of the Natus Photic Stimulator generate 1 millisecond photic flashes at specific frequencies, typically in the range of 0.5 Hz to 60 Hz by a white light emitting diode (LED) lamp. The basic operating mode consists of generating a single flash per trigger pulse applied. Flash intensity has a maximum range from 22,000 lux up to 75,000 lux measured at 30 cm from the LED lamp at the position of highest intensity and 3,520 lux to 12,000 lux calculated at 75cm. The frequency and intensity of the flash is controlled by the acquisition software.
It can also be used along with evoked potential devices for stimulating visual evoked potentials.
This document describes the Natus Photic Stimulator, a device used in neurophysiology studies. The information provided focuses on the device's technical specifications and compliance with regulatory standards, rather than clinical performance or AI integration.
Therefore, the following information regarding acceptance criteria and study details cannot be fully extracted as it pertains to clinical performance and AI, which are not the primary focus of this submission. The document primarily reports on technical and safety performance testing.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) akin to what would be provided for a diagnostic AI device. Instead, the "acceptance criteria" are compliance with various technical and safety standards.
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| Electrical Safety: | The Natus Photic Stimulator complies with: |
| IEC 60601-1: 2005, Am1: 2012 | Results indicate that the Natus Photic Stimulator complies with the applicable standards. |
| Electromagnetic Compatibility: | The Natus Photic Stimulator complies with: |
| IEC 60601-1-2: 2007 | Results indicate that the Natus Photic Stimulator complies with the applicable standards. |
| IEC 60601-2-40: 2016 | Results indicate that the Natus Photic Stimulator complies with the applicable standards. |
| Bench Performance Testing: | The Natus Photic Stimulator complies with its predetermined specifications and applicable standards, including: |
| Internal requirements | Results indicate that the Natus Photic Stimulator complies with its predetermined specifications and the applicable standards. |
| IEC 60601-1-6: 2010, Am1: 2013 | Verified for performance in accordance with internal requirements and the applicable clauses of the standards. |
| IEC 60601-2-40: 2016 | Verified for performance in accordance with internal requirements and the applicable clauses of the standards. |
| IEC 62366: 2007, Am1: 2014 | Verified for performance in accordance with internal requirements and the applicable clauses of the standards. |
| IEC 62471: 2006 | Verified for performance in accordance with internal requirements and the applicable clauses of the standards. |
| ANSI Z80.36-2016 | Verified for performance in accordance with internal requirements and the applicable clauses of the standards. |
2. Sample sized 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. The performance testing described is bench testing against technical and safety standards, not a clinical study on a patient population.
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 is not applicable as the submission describes device safety and performance testing against engineering standards, not a clinical evaluation requiring expert interpretation of ground truth in patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The performance testing involves engineering verification and validation, not clinical adjudication of patient cases.
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
There is no mention of AI assistance or a MRMC study in this document. This submission is for a photic stimulator, which is a hardware device for neurophysiology studies, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a hardware photic stimulator, and the performance testing focuses on its compliance with safety and technical standards as a standalone physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is compliance with established international and national technical, electrical, electromagnetic, usability, and photobiological safety standards (e.g., IEC 60601 series, IEC 62366, IEC 62471, ANSI Z80.36). This is verified through objective measurements and tests against those standards, not through clinical ground truth like pathology or expert consensus on patient outcomes.
8. The sample size for the training set
This is not applicable. This device is not an AI algorithm trained on data.
9. How the ground truth for the training set was established
This is not applicable. This device is not an AI algorithm trained on data.
§ 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).