(56 days)
The Geodesic Photogrammetry System is intended for use in recording precise locations of EEG electrodes in the Geodesic Sensor Net on a patient's head.
The GPS consists of a geodesic dome structure containing 11 mounted cameras, a steel supporting structure, a dedicated computer, and accompanying software. It is used with a Geodesic Sensor Net and any EGI Geodesic EEG system. It allows the user to record the locations of the dense array EEG electrodes on a patient's head. No part of the Geodesic Photogrammetry System touches the patient.
The provided text is a 510(k) summary for the Geodesic Photogrammetry System (GPS). It clearly states that comparative performance testing and clinical evaluations were NOT submitted as part of this 510(k). Therefore, the device's acceptance criteria and studies proving it meets those criteria, as typically understood in a clinical performance context, are not available in the provided document.
The document indicates that testing was conducted only for electrical safety and electromagnetic compatibility, and the GPS passed "all essential performance tests." However, it does not detail what these "essential performance tests" entailed in terms of specific acceptance criteria or how device performance against those criteria was measured.
Based on the provided information, I cannot complete the requested tables and sections related to the device's performance regarding its intended use.
Here's a breakdown of why based on the request requirements:
- 1. A table of acceptance criteria and the reported device performance: This information is not provided. The document states "Performance testing: Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." The "essential performance tests" mentioned are not elaborated upon with specific criteria or results relevant to the device's functional intended use (recording precise EEG electrode locations).
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as performance testing was not submitted.
- 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.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as no comparative effectiveness study was done, and this device is described as an accessory, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The 510(k) summary explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This indicates that the regulatory clearance for this device, at the time of this document, did not rely on studies demonstrating its performance in recording precise EEG electrode locations in a clinical setting against specific acceptance criteria. Instead, it seems to have been cleared based on technological characteristics being substantially equivalent to existing devices and adherence to electrical safety and electromagnetic compatibility standards.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).