Search Results

An Electroencepahlogram (EEG) electrode array intended for use in the ER, ICU and OR for recording of STAT EEGs in patients of 18 years of age and older.

StatNet EEG Headpiece

The provided text is a 510(k) premarket notification letter from the FDA to HydroDot, Inc. regarding their StatNet, Models: 3100, 3110 device. This document primarily focuses on regulatory approval and does not contain the detailed technical information required to answer your request about acceptance criteria and device study results.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets or how their ground truth was established.

The letter simply states that the FDA has reviewed the 510(k) and determined the device to be "substantially equivalent" to legally marketed predicate devices for its intended use as an EEG electrode array. It outlines general regulatory requirements but does not delve into the specific technical studies or performance metrics that underpinned this determination.

Ask a specific question about this device

StatNet is intended for the storage, distribution to any of several work stations, viewing, interpretation and annotation of X-ray of coronary anatomy that have been obtained in coronary catheterization laboratories and written on DICOM-3 CD-ROM media.

StatNet is a network of image display, processing, and archiving modules composed of general purpose, personal computer level, digital hardware; commercial, general purpose digital communication hardware; general purpose operating systems and communications software; medical image analysis and processing software developed by others; and proprietary software modules developed by GORCA that integrate the preceding components into a complete system. Images enter the network on DICOM-3 CD-ROM media.

The provided text describes a PACS system called StatNet and compares its features to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria for device performance, nor a study proving it meets such criteria. The document is a 510(k) summary, which focuses on device description and comparison to predicates for regulatory clearance, not performance validation studies against specific acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance, as this information is not present in the provided text.

Ask a specific question about this device