(160 days)
The Ahead 300 is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-85 years. The Ahead 300 should not be used as a substitute for a CT scan.
The Ahead 300 device is intended to record, measure, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The Ahead 300 calculates and displays raw measures for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user.
A negative Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT.
A positive Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT.
An equivocal Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.
The Ahead 300 provides a measure of brain function Index, (BFI)) for the statistical evaluation of the human electroencephalogram(EEG).
The Ahead 300 also provides clinicians with quantitative measures of cognitive performance to aid in the assessment of an individual's level of cognitive function. These measures do not interact with any other device measures, and are stand alone.
The Ahead 300 also stores and displays electronic versions of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.
The Ahead 300 is a portable, non-invasive, non-radiation emitting, point of care device intended to provide results and measures to support clinical assessments and aid in the diagnosis of traumatic brain injury (TBI).
The Ahead 300 is a product of the continual technological evolution of the BrainScope Ahead 200 device. The device platform is essentially identical, and the core capability of the Ahead 300 remains the same as the Ahead 200. Both devices provide an algorithmbased structural injury classification of head injured patients using EEG features. The Ahead 300's accuracy is improved over the Ahead 200. The Ahead 300 also incorporates functions performed by additional legally marketed predicate devices, including an overall assessment of functional brain injury utilizing EEG, and two wellaccepted cognitive performance tests.
While the document mentions that "The co-primary endpoints, as defined by sensitivity and specificity of the study device classification distinguishing CT+ from CT-, successfully exceeded the performance goals, and demonstrated significantly improved performance over Ahead 200," it does not explicitly provide the numerical acceptance criteria or the reported device performance for sensitivity and specificity. It suggests these were successfully met and improved upon the predicate device (Ahead 200).
Therefore, a table of acceptance criteria and reported device performance cannot be generated with the provided information.
However, based on the clinical performance data section, some information regarding the study can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| Sensitivity | "Exceeded performance goals" | "Significantly improved performance over Ahead 200" |
| Specifcity | "Exceeded performance goals" | "Significantly improved performance over Ahead 200" |
| NPV | Successfully demonstrated | Successfully demonstrated |
| Repeatability | Successfully demonstrated | Successfully demonstrated |
| Reproducibility | Successfully demonstrated | Successfully demonstrated |
Note: The document states that the co-primary endpoints (sensitivity and specificity) "successfully exceeded the performance goals" and demonstrated "significantly improved performance over Ahead 200". However, the specific numerical values for these performance goals and the achieved performance of the Ahead 300 are not provided in this excerpt.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 720 adults
- Data Provenance: The document does not explicitly state the country of origin. It mentions "The B-AHEAD III validation trial" and prior "B-AHEAD II validation trial," implying clinical trials. It does not state if the data was retrospective or prospective, but the term "validation trial" typically suggests prospective data collection for evaluating performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing the ground truth. It only states that the ground truth for "structural injury" was "visible on head CT."
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It focuses on the device's standalone performance compared to the predicate device (Ahead 200) and other predicates' functionalities.
6. Standalone Performance Study
Yes, a standalone study was done. The "Clinical Performance Data" section describes a "B-AHEAD III validation trial" where the device classification distinguished "CT+ from CT-". This indicates the algorithm's performance independent of human interpretation for the structural injury classification. The document also states "The Ahead 300's accuracy is improved over the Ahead 200," further suggesting standalone comparison.
7. Type of Ground Truth Used
The primary ground truth used for the "Structural Injury Classification" was "structural brain injury visible on head CT."
8. Sample Size for the Training Set
The document does not provide the sample size for the training set. It only mentions the sample size for the validation trial (test set) of 720 adults.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for the training set was established. It only refers to the "B-AHEAD III validation trial" which is implied to be the test set, and mentions the ground truth for structural injury classification was based on head CT findings.
§ 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
(a)
Identification. A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.
(2) The device parts that contact the patient must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety.
(4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).
(5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use.
(6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output (
e.g., use in appropriate patient population, or for appropriate clinical decision).(7) The labeling and training information must include:
(i) A warning that the device is not to be used as a stand-alone diagnostic.
(ii) A detailed summary of the clinical performance testing, including any adverse events and complications.
(iii) The intended use population and the intended use environment.
(iv) Any instructions technicians should convey to patients regarding the collection of EEG data.
(v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.
(vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result.