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• 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:

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:

The clinical "acceptance criteria" for the device, in terms of diagnostic accuracy, would typically have been established during the clearance of the predicate device (Ahead 100), as this submission for Ahead 200 claims "substantial equivalence" based on using the "Same Harmony algorithm" and "Same fundamental technology." This document does not present a new clinical study to establish these criteria for the Ahead 200 itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document for the clinical performance of the classification algorithm. The document states that "All tests were conducted on the new model to establish substantial equivalence to the predicate (Ahead® 100, models M-100 and CV-100, DEN 140025)." These are primarily engineering and functionality tests. Any clinical performance data regarding the "Harmony" algorithm would likely be referenced in the predicate device's 510(k) (DEN 140025), which is not part of this input.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document as it focuses on engineering and functional testing for equivalence. For the clinical performance of the classification algorithm, ground truth (e.g., presence/absence of structural brain injury on head CT) would have been established for the studies that supported the predicate device's clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study in this document. The device is a "Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid," meaning it's intended to aid in evaluation, not directly replace or be compared in an MRMC setting with human readers. It's an algorithm generating a "classification" based on EEG, which is then used by a physician.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document mentions "Algorithm Performance" as a test that passed. The "BrainScope® Classification" (positive/negative) output by the device is described as "brain electrical activity consistent with no structural brain injury visible on head CT" or "brain electrical activity that may be present in both patients with or without a structural brain injury visible on head CT." This implies a standalone classification from the algorithm. However, quantitative performance metrics (e.g., sensitivity, specificity, PPV, NPV) of this standalone classification are not explicitly provided in this document. Any such data would likely be found in the original 510(k) for the predicate device, as this device uses the "Same Harmony algorithm."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "Indications for Use" mention "structural brain injury visible on head CT." This strongly implies that the ground truth for assessing the algorithm's performance (implicitly for the predicate device, as the algorithm is the same) was based on head CT scans.

8. The sample size for the training set

The document does not provide the sample size for the training set for the "Harmony" algorithm. This information would typically be part of the development and validation of the algorithm, likely detailed in the predicate device's 510(k) submission.

9. How the ground truth for the training set was established

The document does not provide this information. Given the ground truth type mentioned (structural brain injury visible on head CT), it would logically have involved interpretation of head CT scans.

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