(266 days)
The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).
The BRC software product is composed of the following major components: BRC The DRC software produisition Software and the BRC Neuromarker Analysis Software. Neuromarker Data Acquisition Software is used to collect the data gathered at BRC I he Nedromancer Data requisition protocols and equipment are utilized at each nechsed laboratory to ensure uniformity of collected data. The data is then transmitted to the DRC Central Analysis Facility where the Neuromarker Analysis Software is used to DIC Central Interfall Pagainst the Brain Resource International Database (BRID). The process the gatibled and againta from approximately 2,400 normative (i.e., without a database Currently contains ada cohol abuse, or serious medical condition) participants. The results of the processed data is compiled into an individualized report called the NeuroMarker Report.
The BRC Cognition Acquisition Software is one component of the BRC NeuroMarker The DRC Cognition Frequence is loaded on a computerized touchscreen system and used to gather cognitive patient performance information. This data is transmitted from used to gamer cogment person personal Analysis Facility for processing and formatting into report form (IntegNeuro Report).
The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).
Here's an analysis of the provided text regarding acceptance criteria and the study performed, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, no specific acceptance criteria or quantitative performance metrics are mentioned for the BRC Software Product. The document primarily focuses on establishing substantial equivalence to predicate devices, outlining the device description, intended use, and technological characteristics.
Therefore, the table would look like this:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that the BRC Neuromarker Analysis Software processes data against the Brain Resource International Database (BRID), which "currently contains data from approximately 2,400 normative (i.e., without a database Currently contains ada, cohol abuse, or serious medical condition) participants."
- Sample Size for Test Set: Although the document refers to this database as a "normative" one against which processed data is compared, it is not explicitly stated as a "test set" in the context of validating the device's performance against specific acceptance criteria. The 2,400 participants are described as providing a normative database for comparison, not as a dedicated test set for performance evaluation in the typical sense of a validation study.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the manufacturer is BRC Operations Pty. Ltd, located in Sydney, NSW, Australia, which might suggest data could originate from Australia or be internationally sourced for the "Brain Resource International Database." The data is described as being "collected at each network laboratory."
- Retrospective or Prospective: The document does not specify whether the data in the BRID is retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information about experts being used to establish a "ground truth" for a test set. The 2,400 participants are described as "normative" individuals without specific conditions, suggesting their data serves as a baseline for comparison rather than requiring expert labeling for a specific outcome.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is a "software product" for statistical evaluation of EEG/ERP, and the submission is focused on establishing substantial equivalence to predicate devices that are also software products for similar analysis.
6. Standalone (Algorithm Only) Performance Study
The document describes the BRC software product as performing "posthoc statistical evaluation" of EEG/ERP data by comparing it against a normative database. This implicitly describes the algorithm's standalone function (processing data and generating a report). However, the document does not report specific performance metrics from a standalone study, such as sensitivity, specificity, accuracy, or AUC. The focus is on the functional equivalence and comparison against normative data rather than a detailed performance validation against an adjudicated ground truth in a standalone study.
7. Type of Ground Truth Used
The "ground truth" for the comparison performed by the device is essentially the normative data from the Brain Resource International Database (BRID). This database contains data from "approximately 2,400 normative (i.e., without ... alcohol abuse, or serious medical condition) participants." The device compares incoming patient data against this established normative range. This is akin to using a healthy control group's data as a baseline for statistical comparison. It is not expert consensus, pathology, or outcomes data in the sense of labeling specific conditions.
8. Sample Size for the Training Set
The document mentions the Brain Resource International Database (BRID) is used for comparison and contains data from approximately 2,400 normative participants. While this database serves as a reference for the software's analysis, the document does not explicitly describe a separate "training set" in the context of machine learning model development. For statistical comparison against normative data, the entire normative database might be considered the "reference" or "training" data in a broader sense, but not a distinct training set for a classified model.
9. How the Ground Truth for the Training Set Was Established
For the normative database (BRID) of 2,400 participants, the "ground truth" or defining characteristic is that these participants are "without ... alcohol abuse, or serious medical condition." This suggests that participants were screened and confirmed to be "normative" based on their medical history and absence of specific conditions. The specific methods for establishing this "normative" status (e.g., clinical examination, diagnostic tests, self-reporting) are not detailed in the provided text.
§ 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).