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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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