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BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)).

BrainScope TBI provides a multi-parameter measure (CI)) to aid in the evaluation of concussion in patients between the ages of 13-25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days), in conjunction with a standard neurological assessment of concussion. The CI is computed from a multivariate algorithm based on the patient's electroencephalogram (EEG), augmented by neurocognitive measures and selected clinical symptoms.

The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical activity (EEG) to determine the likelihood of structural brain injury visible on head CT for patients between the ages of 18-85 years (have a GCS score of 13 – 15), have sustained a closed head injury within the past 72 hours (3 days) who are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.

BrainScope TBI provides a measure of brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment, in patients 18-85 years of age (have a GCS score of 13 - 15) who have sustained a closed head injury within the past 72 hours (3 days).

The BrainScope TBI device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope TBI 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.

BrainScope TBI also provides clinicians with quantitative measures of cognitive performance in patients 13-85 years of age to aid in the assessment of an individual's level of cognitive function. These measures interact with the CI and can be used stand alone.

BrainScope TBI 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.

BrainScope TBI (model: Ahead 500) 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 concussion / mild traumatic brain injury (mTBI). The BrainScope TBI includes a new multivariate classification algorithm that analyzes a patient's electroencephalogram (EEG), augmented by neurocognitive performance and selected clinical symptoms to compute a multi-modal index called the Concussion Index (CI). BrainScope TBI provides the healthcare provider with a multi-parameter measure to aid in the evaluation of concussion following a head injury within the past 72 hours (3 days). The BrainScope TBI (Ahead 500) retains all the capabilities of the predicate (BrainScope TBI, model: Ahead 400) including the Structural Injury Classification (SIC) and the Brain Function Index (BFI). It also contains configurable, selectable computerized cognitive performance tests and digitized standard clinical assessment tools intended to provide a multi-modal panel of measures to support the clinical assessment of concussion / mTBI.

Here's a breakdown of the acceptance criteria and the study details for the BrainScope TBI (model: Ahead 500) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 580 subjects
  • 229 matched controls
  • 144 healthy volunteers
  • 207 subjects who sustained closed head injury and were removed from play
• Data Provenance: The study was conducted across 10 US clinical sites, including High Schools, Colleges, and Concussion Clinics. The study design appears to be prospective, given it involved testing subjects at different time points and with specific inclusion/exclusion criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts used or their specific qualifications (e.g., "Radiologist with 10 years of experience") for establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, the document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to assess how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the Concussion Index (CI) algorithm.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done for the Concussion Index (CI). The reported sensitivity and specificity values are for the algorithm's performance in classifying concussions.

7. Type of Ground Truth Used

The clinical reference standard (ground truth) incorporated elements from guidelines published in the International Conference on Concussion in Sport (McCrory 2017; 2013) as well as the National Collegiate Athletic Association (NCAA) concussion policy. This suggests a clinical diagnosis/consensus-based ground truth, likely established by clinicians based on established guidelines and possibly direct observations or outcomes related to concussion (e.g., "removed from play"). It's not explicitly stated to be solely pathology or patient outcomes data, but rather a combination of clinical criteria.

8. Sample Size for the Training Set

The document states that the "cutoff (threshold) CI [was] derived from an algorithm development study that was independent of the validation study," but it does not provide the sample size for this algorithm development (training) study.

9. How the Ground Truth for the Training Set Was Established

The document implies that the ground truth for the "algorithm development study" (training set) would have been established using similar clinical criteria as the validation study, i.e., "consistent with similar changes seen in subjects with concussion," incorporating elements from the International Conference on Concussion in Sport guidelines and NCAA concussion policy. However, it does not explicitly detail the process for establishing ground truth for the training set.

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BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury within the past 72 hours (3 days), are between the ages of 18-85 years, have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion / mild traumatic brain injury (mTBI), and are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan.

The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical activity to determine the likelihood of structural brain injury visible on head CT. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.

BrainScope TBI provides a measure of brain function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment.

The BrainScope TBI device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope TBI 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.

BrainScope TBI 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.

BrainScope TBI also stores and displays electronic 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.

BrainScope TBI 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 mild traumatic brain injury (mTBI). It also contains configurable, selectable computerized cognitive performance tests and digitized standard clinical assessment intended to provide a multi-modal panel of measures to support the clinical assessment of concussion / mTBI. BrainScope TBI provides healthcare professionals with a set of validated and clinically accepted library of concussion / mTBI assessments.

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal acceptance criteria with numerical thresholds. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The performance data presented primarily confirms that the new modifications (cognitive performance tests, PECARN, wireless connectivity) work as specified and do not negatively impact existing functionalities.

Table of Acceptance Criteria (Inferred from Substantial Equivalence Claim) and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: 707 healthy individuals.
• Data Provenance: The document states that normative data was collected from "707 healthy individuals" for the cognitive tests. It does not specify the country of origin, but given the context of FDA submission, it is typically expected to be from a US-based population or a population generalizable to the US. It is a prospective collection for establishing normative data for the new cognitive tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set of the new cognitive performance tests. It refers to the new tests and RCI output being "well accepted in clinical practice," which implies expert consensus in the field, but no specific quantification of experts is provided within this document. For the EEG-based Structural Injury Classification (SIC), the ground truth is based on the visible injury on head CT, which is a clinical standard.

4. Adjudication method for the test set:

Not explicitly stated for the cognitive performance tests or the overall assessment of device modifications. Given the nature of normative data collection for cognitive tests, the "ground truth" is often statistical (e.g., population averages, standard deviations) rather than expert adjudication on individual cases for classification. For the SIC, the ground truth is based on head CT findings, which are objective imaging results.

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:

The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is described as an "adjunct to standard clinical practice" and "should not be used as a substitute for a CT scan," suggesting it provides additional information rather than directly assisting in CT interpretation by a reader.

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

Yes, the Structural Injury Classification (SIC) and Brain Function Index (BFI) are described as "EEG based algorithms" which "use brain electrical activity to determine the likelihood of structural brain injury visible on head CT." This implies a standalone algorithmic assessment of the EEG data, providing "Negative, Equivocal and Positive outputs" for SIC and a "statistical evaluation of the human EEG" for BFI.

7. The type of ground truth used:

• For Structural Injury Classification (SIC): Visible structural brain injury on head CT. This is a form of outcomes data or a clinical standard.
• For Cognitive Performance Tests: Normative data derived from a population of healthy individuals. This establishes a baseline for cognitive function.
• For QEEG parameters: Standards related to the accurate recording, measuring, analyzing, and displaying of brain electrical activity, as well as comparison to the predicate device's performance characteristics.

8. The sample size for the training set:

The document does not specify the sample size for the training set. It only mentions the "normative data collected from 707 healthy individuals" used to construct databases for the cognitive tests, which likely serves as a reference/validation set for these specific components. The EEG-based algorithms (SIC, BFI) were likely developed and trained on separate, larger datasets that are not detailed in this particular summary, as these algorithms are shared with the predicate device (BrainScope One).

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

The document does not provide details on how the ground truth for the training set was established for the core EEG algorithms (SIC, BFI) as these algorithms were already established and cleared under the predicate device (BrainScope One). For the new cognitive performance tests and PECARN, the ground truth for the "normative data" was established by collecting data from "healthy individuals," implying a healthy control group without known head injury or cognitive impairment.

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BrainScope One is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury within the past 72 hours (3 days), are between the ages of 18-85 years, have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion / mild traumatic brain injury (mTBI), and are being considered for a head CT. BrainScope One should not be used as a substitute for a CT scan.

The BrainScope One Structural Injury Classification ("SIC") uses brain electrical activity to determine the likelihood of structural brain injury visible on head CT. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.

BrainScope One provides a measure of brain function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment.

The BrainScope One device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope One calculates and displays raw measures for the following standard QEEG measures in the tive 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.

BrainScope One 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.

BrainScope One also stores and displays electronic 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 Modified BrainScope One is a portable, non-radiation emitting, point of care device intended to provide results and measures to support clinical assessments to aid in the diagnosis of concussion / mild traumatic brain injury (mTBI). It also contains configurable, selectable cognitive performance tests and digitized standard assessment forms. The combination of multi-modal, multi-parameter capabilities is intended to provide a panel of measures to further support the clinical assessment of head injury. BrainScope One provides healthcare professionals with a set of well-developed and researched concussion assessment tools.

The provided document focuses on the Modified BrainScope One's 510(k) submission, stating its substantial equivalence to a previously cleared predicate device, BrainScope One (K181179). Crucially, the document does not contain detailed information about specific acceptance criteria or the study data that proves the device meets these criteria for the initial clearance of the BrainScope One (K181179), which would have established these performance metrics.

Instead, this submission (K181785) relies on the performance data from the prior submission (K161068), stating "All clinical performance data from the Ahead 300 (K161068) submission still apply." To fully answer your request regarding Acceptance Criteria and supporting study, one would ideally need access to the K161068 submission document.

However, based on the provided text, I can infer and extract some relevant information, particularly concerning the Structural Injury Classification (SIC) component, as this is a key diagnostic output. The document reiterates the indications for use and confirms that the algorithm for Structural Injury Classification outputs "Negative, Equivocal and Positive."

Let's break down what can be inferred from the provided text for the Modified BrainScope One and its relation to the original BrainScope One (K181179), and where information is explicitly stated to be from a prior submission (K161068).

Inferred/Deduced Information from the Provided Document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, the most direct "performance" mentioned relates to the Structural Injury Classification (SIC). The document describes how the SIC outputs correspond to the likelihood of structural brain injury visible on head CT. While it doesn't give numerical criteria or reported performance values for each output (e.g., sensitivity, specificity), it defines what "Negative," "Positive," and "Equivocal" mean in the context of CT findings.

Note: The document explicitly states, "All clinical performance data from the Ahead 300 (K161068) submission still apply." This implies that the definitive numerical acceptance criteria and their met performance values for the SIC and BFI would be found in the K161068 submission, not in this one. This document focuses on demonstrating substantial equivalence based on minor modifications not affecting safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not provided in this document. It refers to a previous submission (K161068) for "All clinical performance data."
• Data Provenance: Not provided in this document (e.g., country of origin, retrospective/prospective). This information would be in the K161068 submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not provided in this document. This information would be in the K161068 submission.

4. Adjudication Method for the Test Set:

• Not provided in this document. This information would be in the K161068 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• Not explicitly stated in this document whether an MRMC study was performed. The device is intended as an "adjunct to standard clinical practice," implying human-in-the-loop assistance. However, the document does not provide details on comparative effectiveness studies showing improvement with AI assistance vs. without. The "Performance Data" section mentions "Pre-Specified analyses for the BFI... included a multinomial logistic regression analysis comparing the odds ratio of groups with differing levels of functional impairment... to a control group, as well as ANOVAs between these groups." This indicates statistical analysis of BFI, but not a direct MRMC comparative effectiveness study as described.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

• The Structural Injury Classification (SIC) is described as using "brain electrical activity to determine the likelihood of structural brain injury visible on head CT." This implies a standalone algorithmic output (Negative, Positive, Equivocal) based on EEG data. However, direct metrics (e.g., sensitivity, specificity, AUC) for this standalone algorithm's performance are not provided in this document. This information would be in the K161068 submission.

7. The Type of Ground Truth Used:

• For Structural Injury Classification (SIC): The ground truth reference is explicitly stated as "structural brain injury visible on head CT." This is an imaging-based ground truth.
• For Brain Function Index (BFI): The document mentions "assessments from conventional concussion symptom scales" and "differing levels of functional impairment" being compared to a control group. This suggests that for BFI, ground truth involved clinical assessment scales/scores indicating functional impairment.

8. The Sample Size for the Training Set:

• Not provided in this document. This information would be in the K161068 submission.

9. How the Ground Truth for the Training Set Was Established:

• Not provided in this document. This information would be in the K161068 submission.

Summary of Missing Information (Likely in K161068 and/or K181179 Submissions):

The current document (K181785) is for a "Modified BrainScope One" and states that "All clinical performance data from the Ahead 300 (K161068) submission still apply." Therefore, the specific numerical acceptance criteria, detailed study designs (sample sizes, provenance, expert qualifications, adjudication methods), and quantitative results proving initial device performance would be found in the K161068 and subsequent K181179 submissions. This document's purpose is to demonstrate that the modifications do not alter the existing safety and effectiveness, leveraging the data from the predicate.

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BrainScope One 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 (including concussion / mild Traumatic Brain Injury (mTBI)), and are between the ages of 18-85 years. The BrainScope One should not be used as a substitute for a CT scan.

The BrainScope One device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope One calculates and displays 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 BrainScope One 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 BrainScope One 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 BrainScope One 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 BrainScope One provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG).

BrainScope One 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.

BrainScope One also stores and displays electronic 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.

BrainScope One 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). It also contains configurable, selectable cognitive performance tests and digitized standard assessment forms intended to provide a panel of measures to support the clinical assessment of head injury. BrainScope One provides healthcare professionals with a set of well-developed and researched concussion assessment tools.

The provided text is a 510(k) summary for the BrainScope One device. It indicates that "No clinical or non-clinical performance data was submitted to support the device modification being made. All clinical performance data from the Ahead 300 (predicate) submission still apply."

Therefore, based on the provided text, I cannot provide details about the acceptance criteria and study proving its adherence for BrainScope One, as the document explicitly states that this information was not submitted for the BrainScope One, but rather refers to the predicate device (Ahead 300).

To answer your request thoroughly, I would need access to the 510(k) submission for the Ahead 300 (K161068), which is the predicate device the BrainScope One references for its clinical performance data.

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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

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.

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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:

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The Ahead® 100, consisting of two models, i.e., the Ahead® M-100 and the Ahead® CV-100, 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® 100 device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (qEEG) parameters from frontal locations on a patient's forehead. The Ahead® 100 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-100 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 analyzing and displaying brain electrical activity, and the function of storing and displaying MACE information.
The Ahead® 100 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® 100 is a prescription use device.

The Ahead 100 is a portable EEG system consisting of two models: the Ahead M-100 and the Ahead CV-100. As stated in the Indications for Use above, the only functional difference between the M-100 model and the CV-100 model is that the M-100 stores and displays an electronic version of the Military Acute Concussion (MACE) cognitive assessment and user-entered responses to the MACE questions in addition to all other device functionality as discussed below.

The Ahead 100 device is comprised of the following main components:

1. The Ahead 100 Handheld Unit
2. The Electrode Headset
3. The Patient Interface Cable
4. The Compact Flash Card (CF Card)

The Handheld Unit, Patient Interface Cable, and Electrode Headset interface together to facilitate the collection of EEG data from the patient. The Electrode Headset includes 8 wet gel electrodes integrated into a single use, disposable headset that allows for electrode placement over the following frontal locations: Fp1, Fp2, Fpz, AFz, F7, F8, A1, and A2 as defined by the standardized International 10-20 Electrode Placement System. The Patient Interface Cable connects the Electrode Headset to the Handheld Unit and contains a preamplifier that prepares the electrical signals measured by the Electrode Headset for processing by the Handheld Unit.

The Handheld Unit employs a color, touch-screen user interface and utilizes proprietary software to perform real-time analyses of the collected EEG data. Using the Handheld Unit, the user is able to review the raw EEG data, view spectral plots, and view a number of calculated quantitative EEG (qEEG) measures including Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension.

The software utilized by the Handheld Unit also processes the collected raw EEG to produce the final Ahead 100 classification. This data analysis includes filtering the raw EEG, performing artifact reduction, computation of a variety of qEEG features across specific frequency bands, normalization of these computed features, a quality check to identify potential outliers, integration of these features to determine the appropriate classification, and finally a graphical display of this classification to the user. The algorithm used to integrate the computed features and determine a classification was pre-established in a separate study, prior to validation in the B-AHEAD II study.

The Ahead 100 device provides one of two potential classifications of the patient's recorded EEG data:

1. "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." or,
2. "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 result does not establish the presence of a structural brain injury visible on head CT."

Acceptance Criteria and Device Performance for BrainScope AHEAD 100

1. Table of Acceptance Criteria and Reported Device Performance

Note: The clinical study "failed to meet the predefined primary endpoints" for specificity, though sensitivity was met.

2. Sample Size and Data Provenance for the Test Set

• Sample Size (Test Set): 552 subjects were included in the analysis of diagnostic accuracy per the intended use.
• Data Provenance: The study was a prospective, controlled, non-randomized, pivotal study conducted at 11 study sites in the US.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: 3 blinded neuroradiologists.
• Qualifications of Experts: Neuroradiologists (specific years of experience not mentioned).

4. Adjudication Method for the Test Set

• The final head CT readings were reviewed by a panel of 3 blinded neuroradiologists, and classification was determined by a majority of the panel. This implies a 3-reader consensus method, likely 2+1 or 3-reader agreement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• It is not explicitly stated that a Human-in-the-Loop MRMC comparative effectiveness study was done to measure human reader improvement with AI assistance. The study focuses on the standalone performance of the device against clinical classification (CT findings). The device is intended as an adjunct to standard clinical practice, suggesting it would be used by physicians, but the study design described does not quantify the improvement of human readers using the AI.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The provided acceptance criteria and performance results (sensitivity, specificity, PPV, NPV) are for the "Ahead 100 classification," which is the algorithm's output. The study design states, "All treating physicians were to be blinded to the output of the Ahead 100 device," indicating the device's output was assessed independently.

7. Type of Ground Truth Used

• The primary ground truth used was structural brain injury on CT scan (CT+), as determined by a panel of 3 blinded neuroradiologists.
• For subjects with GCS=15, the New Orleans Criteria (NOC) was used for truth assessment if a CT was not performed. If a CT was performed for such subjects, the CT results were used.

8. Sample Size for the Training Set

• The document states, "The algorithm used to integrate the computed features and determine a classification was pre-established in a separate study, prior to validation in the B-AHEAD II study." However, the sample size for this "separate study" (training set) is not provided in the given text.

9. How Ground Truth for the Training Set Was Established

• The document implies that an algorithm was developed and established prior to the pivotal B-AHEAD II study. However, how the ground truth for this separate study (training set) was established is not detailed in the provided text. It would likely have involved similar methods to the validation study (e.g., expert-adjudicated CT scans), but this is not explicitly stated.

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The ZOOM-100DC is used to measure and record the electrical activity of a patient's brain. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram (EEG) signals and by the calculation of standard quantitative EEG (qEEG) parameters.

The ZOOM-100DC records, measures and displays Electroencephalographic (EEG) waveforms which are digitized and processed.

The provided text describes a 510(k) premarket notification for BrainScope's ZOOM-100DC, an Electroencephalograph (EEG). The document focuses on demonstrating substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria based on diagnostic accuracy or clinical outcomes. Therefore, much of the requested information regarding study design, sample sizes, expert adjudication, and ground truth establishment is not present in the provided text.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in the sense of predefined performance targets for diagnostic accuracy or clinical utility. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and intended use. The "performance" assessment is based on this comparison.

The conclusion states that "Performance data demonstrate that the device performs equivalently to the predicate devices." This equivalence, rather than a specific numerical acceptance criterion, is the basis for substantial equivalence.

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

The document does not provide information on a test set, sample size, or data provenance from a clinical study for the ZOOM-100DC. The submission relies on a comparison of technical specifications and intended use against existing predicate devices, not on new clinical performance data from a specific study.

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 as there is no mention of a clinical study involving a test set that required expert-established ground truth.

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

This information is not provided as there is no mention of a clinical study involving a test set that required adjudication.

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

This information is not provided. The ZOOM-100DC is an electroencephalograph, not an AI-assisted diagnostic tool that would typically involve a multi-reader, multi-case study for comparative effectiveness with human readers.

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

This information is not provided. The device is an EEG recording and display system, not an algorithm that operates standalone for diagnostic purposes.

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

This information is not provided as there is no mention of a clinical study that required establishing 'ground truth' for diagnostic outputs. The device measures and records EEG signals and calculates qEEG parameters; its "performance" is assessed by its ability to perform these functions reliably and comparably to predicate devices.

8. The sample size for the training set

This information is not provided. As the submission is for an EEG device and not a machine learning algorithm requiring a "training set," this concept is not applicable in the context of this document.

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

This information is not provided. See point 8.

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