(144 days)
• The Ahead® 200, consisting of two models, i.e., the Ahead® CV-200, 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, but should not be used as a substitute for a CT scan. This device is to be used for this purpose in patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-80 years.
· A negative BrainScope® Classification may correspond to brain electrical activity consistent with no structural brain injury visible on head CT in patients presenting as a mild traumatic brain injury, within 24 hours of injury.
· A positive BrainScope® Classification corresponds to brain electrical activity that may be present in both patients with or without a structural brain injury visible on head CT. A positive BrainScope® Classification does not establish the presence of a structural brain injury visible on head CT.
· The Ahead® 200 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® 200 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.
• The Ahead® M-200 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) cognitive assessment and user-entered responses to the MACE questions. There is no interaction between EEG-related functionality, including and displaying brain electrical activity, and the function of storing and displaying MACE information.
· The Ahead® 200 is intended for use by physicians, or under the direction of a physician, who have been trained in the use of the device.
• The Ahead® 200 is a prescription use device.
BrainScope® Ahead® 200 is a Brain Injury Adjunctive The Interpretive Electroencephalograph Assessment Aid, Class II device. It is a portable, non-sterile, non-invasive, non-radiation emitting, point of care, electroencephalogram (EEG) device and is intended to provide an objective assessment of brain electrical activity associated with traumatic brain injury (TBI). This 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.
The BrainScope® Ahead® 200 is comprised of two hardware components: the Handheld Device and the disposable Electrode Headset with patient application supplies. The main software components of the Ahead 200 are the application software and the BrainScope Algorithm Library (BSAL). The Ahead® 200 has two models: (1) the Ahead® M-200, which is intended for use by the military, and (2) the Ahead® CV-200, which is intended for civilian use. The Ahead® M-200 and the Ahead® CV-200 have the same indications for use and intended uses with the exception that the Ahead® M-200 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) and user-entered responses to the MACE questions. There is no interaction between EEG-related functionality, including analyzing and displaying brain electrical activity, and the function of storing and displaying MACE information. The Ahead® M-200 and the Ahead® CV-200 have identical technological characteristics except that the Ahead® M-200 contains the additional MACE feature, i.e., an electronic version of the paper and pencil based MACE.
This document is a 510(k) premarket notification for the BrainScope Ahead 200 device, asserting its substantial equivalence to a predicate device, the BrainScope Ahead 100. It focuses on device specifications, safety, and performance comparisons rather than detailed clinical acceptance criteria and a definitive study demonstrating them.
Here's an analysis based on the provided text, outlining the limitations due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC) for the Ahead 200 device. Instead, it focuses on verifying that the Ahead 200 functions as intended and is comparable to its predicate device. The performance data presented are primarily engineering and safety tests:
| Design Verification Test | Result |
|---|---|
| Software (including User Interface) Verification Testing | Pass |
| Hardware Verification | Pass |
| System Performance and Functionality | Pass |
| Algorithm Performance | Pass |
| Packaging Testing | Pass |
| Basic Safety and Essential Performance (IEC 60601-1, 3rd ed.) including PEMS clause 14 for Software | Pass |
| Electromagnetic Compatibility | Pass |
| Biocompatibility | Pass |
| Reliability | Pass |
The document asserts the "Algorithm Performance" passed, and that the "Harmony" classification algorithm used is the same as the predicate device, implying its performance is at least equivalent. However, specific performance metrics (sensitivity, specificity) of this algorithm are not provided in this document.
Similarly, electrical hardware specifications are compared, suggesting functional acceptance criteria for components:
| Electrical Hardware Feature | Ahead® 200 Performance | Comparable Predicate Ahead® 100 Performance | Note (Indicating improvement or equivalence) |
|---|---|---|---|
| Common Mode Rejection Ratio (CMRR) |
§ 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.