(169 days)
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.
| Acceptance Criterion (Inferred from Indication for Use) | Reported Device Performance (Inferred from Indication for Use) |
|---|---|
| Structural Injury Classification (SIC) - Negative: | Likely corresponds to patients with no structural brain injury visible on head CT. |
| Structural Injury Classification (SIC) - Positive: | Likely corresponds to patients with a structural brain injury visible on head CT. |
| Structural Injury Classification (SIC) - Equivocal: | May correspond to structural brain injury visible on head CT, or may indicate the need for further observation or evaluation. |
| Brain Function Index (BFI): | Provides a measure for statistical evaluation of EEG, aiding in head injury evaluation as part of a multi-modal, multi-parameter assessment. (No specific numerical performance stated in this document). |
| QEEG Parameters: | Calculates and displays raw measures for Absolute and Relative Power, Asymmetry, Coherence, and Fractal Dimension. (No specific numerical performance stated in this document). |
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.
§ 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.