(173 days)
The software is intended for use by a trained/qualified MEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function by fusing a variety of magnetoencephalographic (MEG) and electroencephalographic (EEG) information with rendered images of either an idealized head model and an idealized magnetic resonance (MR) image or a subject's MR image based head model and the subject's MR images
The MaxInsight ™ software is a software-only product. It runs on a personal computer and requires no specialized hardware. It displays digitized MEG signals, topographic maps, etc. It displays electrical brain activity correlated to anatomical brain information, which is provided by means of either an idealized head model and an idealized MRI image or a subject's MRI image based head model and the subject's MRI images. These functions are all controlled and interpreted by the user. The MaxInsight software imports digital MEG and co-registered EEG data (in the Neuromag Functional Image File Format) and permits its visualization. The digitized MEG/EEG input is read from a file on the personal computer (or available across the network). The software also provides a report generator to transfer relevant information, such as patient and recording information, event information, topographic images and images of brain activity, to a printable document.
The provided text does not contain detailed information about the acceptance criteria and a specific study proving the device meets these criteria in the format requested. The document is a 510(k) summary for the MaxInsight™ Electroencephalograph Software, focusing primarily on demonstrating substantial equivalence to a predicate device.
Here's a breakdown of what is available and what is missing:
The document states:
- "Predetermined software development processes were employed in the design and testing of this software product, and validation testing was performed to ensure compliance with the product specifications."
- "The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device."
- "After analyzing both bench and clinical testing data, it is the precedes as not relies and Jang Solutions GmbH that the MaxInsight™ software is as safe and effective as the predicate devices, has few technological differences, and has no new indication for use, thus rendering it substantially equivalent to the data analysis package of the predicate devices."
However, these statements are general affirmations and do not provide the specific details requested in your prompt.
Missing Information:
- Specific Acceptance Criteria and Reported Device Performance Table: The document does not provide a table outlining specific performance metrics (e.g., accuracy, sensitivity, specificity, computational speed) that the device was tested against, nor does it report the device's performance results quantitatively.
- Sample Size for Test Set and Data Provenance: No information is given about the number of cases or patients used in any "clinical testing data" or "validation testing," nor their origin (country, retrospective/prospective).
- Number and Qualifications of Experts for Ground Truth: There is no mention of experts used to establish ground truth for a test set.
- Adjudication Method: No adjudication method is described.
- Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: There is no indication that an MRMC study was performed, nor any effect size regarding human reader improvement with AI assistance.
- Standalone Performance Study: While the device is software-only, "standalone performance" in the context of diagnostic accuracy metrics is not reported. The focus is on its function as a visualization tool; its "performance" is implicitly tied to its ability to display signals and images accurately as intended.
- Type of Ground Truth: The document does not specify the type of ground truth used for any testing (e.g., expert consensus, pathology, outcomes data).
- Sample Size for Training Set: Since this is not an AI/ML device in the modern sense (it's visualization software), there isn't a "training set" as conceptualized for machine learning algorithms.
- How Ground Truth for Training Set was Established: Not applicable given the nature of the device.
In summary, the provided 510(k) summary for K070358 focuses on demonstrating substantial equivalence of a medical imaging visualization software to a predicate device through general statements about software development processes and "bench and clinical testing data." It does not provide the detailed performance metrics, study designs, or ground truth methodologies typically found in submissions for devices that make diagnostic claims based on algorithmic analysis or where quantitative performance against a specific standard is required to prove effectiveness.
§ 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).