(169 days)
Not Found
Yes
The description mentions "multinomial logistic regression analysis" in the performance studies section, which is a statistical method often used in machine learning for classification tasks. While not explicitly stating "AI" or "ML," this type of analysis suggests the use of algorithms to process and interpret the EEG data for classification (e.g., likelihood of structural injury).
No
The device aids in the evaluation and diagnosis of head injuries by assessing brain electrical activity and cognitive performance, but it does not treat or cure any condition.
Yes
The device aids in the evaluation of patients who have sustained a closed head injury and supports clinical assessments to aid in the diagnosis of concussion/mild traumatic brain injury (mTBI), which are diagnostic functions. It also uses brain electrical activity to determine the likelihood of structural brain injury visible on head CT.
No
The device description explicitly states it is a "portable, non-radiation emitting, point of care device" and 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." This indicates the device includes hardware components for recording and measuring EEG signals, in addition to software for analysis and display.
Based on the provided text, the BrainScope One device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The text describes BrainScope One as a device that records, measures, analyzes, and displays brain electrical activity (EEG) directly from the patient's forehead. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device description focuses on external measurement and analysis. The device is described as a "portable, non-radiation emitting, point of care device" that interacts with the patient externally to collect EEG data.
Therefore, BrainScope One falls under the category of a medical device that interacts with the body externally to collect physiological data, rather than an IVD which analyzes samples taken from the body.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found'.
Intended Use / Indications for Use
- 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.
Product codes (comma separated list FDA assigned to the subject device)
PIW, PKO, OLU
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
Indicated Patient Age Range
18-85 years
Intended User / Care Setting
Healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Pre-Specified analyses for the BFI (described in SAR for submission K161068) included a multinomial logistic regression analysis comparing the odds ratio of groups with differing levels of functional impairment, as determined by assessments from conventional concussion symptom scales, to a control group, as well as ANOVAs between these groups. Post-hoc analyses were performed to explore the relationship between conventional concussion symptom scales and the BFI, as well as the relationship between differing levels of functional impairment and the BFI.
All clinical performance data from the Ahead 300 (K161068) submission still apply.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BrainScope One (K181179)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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December 19, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
BrainScope Company Inc. Michael Singer CEO 4350 East West Hwy, Ste 1050 Bethesda. Maryland 20814
Re: K181785
Trade/Device Name: Modified BrainScope One Regulation Number: 21 CFR 882.1450 Regulation Name: Brain injury adjunctive interpretive electroencephalograph assessment aid Regulatory Class: Class II Product Code: PIW, PKO, OLU Dated: November 28, 2018 Received: November 28, 2018
Dear Michael Singer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181785
Device Name BrainScope One
Indications for Use (Describe)
• 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------- | ------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image is a logo for Brainscope. The word "BRAINSCOPE" is written in large, bold, blue letters. There are two horizontal blue lines above and below the word. The "O" in "SCOPE" is stylized to look like a brainwave. There is a registered trademark symbol to the right of the word.
4350 East-West Highway.Suite 1050.Bethesda.Maryland.20814
phone 240.752.7680
510(k) SUMMARY1
| Submitter: | BrainScope® Company, Inc.
4350 East West Highway Suite #1050
Bethesda, MD 20814
Phone: (240) 752-7680
Fax: (240) 752-7679
www.brainscope.com |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael E. Singer, Ph.D.
Chief Executive Officer
BrainScope Company, Inc.
Phone: (240) 752-7677
Fax: (240) 752-7679
Email: michael.singer@brainscope.com |
| Prepared By: | Sabyasachi Roy, Ph.D.
Director Regulatory Affairs, Quality Assurance &
Compliance |
| Device Proprietary Name: | Modified BrainScope One |
| Device Common Name: | Brain Injury Adjunctive Interpretive
Electroencephalograph Assessment Aid |
| Device Classification Name: | Brain Injury Adjunctive Interpretive
Electroencephalograph Assessment Aid |
| Classification Regulation: | 21 CFR § 882.1450 |
| Panel: | Neurology |
| Product Codes: | PIW, PKQ, OLU |
| Predicate Device: | BrainScope One (K181179) |
1 Prepared in accordance with 21 CFR § 807.87(h) and 21 CFR § 807.92(c).
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Image /page/4/Picture/0 description: The image shows the word "BRAINSCOPE" in a stylized, blue font. The letters are bold and slightly italicized, with horizontal lines above and below the word. The "O" in "SCOPE" is replaced by a graphic of brainwaves, and a registered trademark symbol is located in the upper right corner of the image.
Device Description:
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.
Indications for Use:2
The modified BrainScope One's Indications for Use are as follows:
- 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 (EEG 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: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of
Modified BrainScope One 510(k) Summary
2 The differences between the modified BrainScope One and its predicate (BrainScope One) do not alter the intended use of the device nor do they affect the safety and effectiveness of the predicates. The subject and predicate devices have the same overall intended use.
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Image /page/5/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BRAINSCOPE" in a bold, sans-serif font. There is a horizontal line above and below the word. The letter "O" in "SCOPE" is replaced with a stylized image of a brainwave. There is a registered trademark symbol to the right of the logo.
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 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.
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Image /page/6/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BRAINSCOPE" in a bold, sans-serif font. There are two horizontal lines under the word. The "C" in "SCOPE" is stylized to look like a brainwave pattern. There is a registered trademark symbol to the right of the word.
Table 1: Indications for Use Comparison to Predicate device
| Proposed Device:
Modified BrainScope One | Predicate:
BrainScope One | Comments |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| 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. | 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. BrainScope One should not be
used as a substitute for a CT scan. | Expanded to include
multi-modal and
multi-parameter
assessment. |
| 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. | 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. | Equivalent.
Combined for clarity. |
| BrainScope One provides a measure
of brain function (EEG 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 provides a
measure of brain function (EEG Brain
Function Index, (BFI)) for the
statistical evaluation of the human
electroencephalogram (EEG). | Equivalent.
Clarification of device
capabilities. |
| Proposed Device:
Modified BrainScope One | Predicate:
BrainScope One | Comments |
| 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. BrainScope One 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 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. BrainScope One 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. | Same |
| 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 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. | Same |
| BrainScope One 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 One 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. | Same |
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Image /page/7/Picture/0 description: The image is a logo for Brainscope. The logo is in blue and features the word "BRAINSCOPE" in large, bold letters. The "O" in "SCOPE" is stylized with a waveform graphic, and there are horizontal lines above and below the word. There is also a registered trademark symbol to the right of the word.
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Image /page/8/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "Brain" in a bold, sans-serif font, with a line above it. The word "Scope" is next to "Brain" and also in blue, with a line above and below it. There is a registered trademark symbol to the right of the word "Scope".
Comparison of Technological Characteristics with the Predicate Device:
The Modified BrainScope One incorporates additional clarification in the Indications for Use statement of its predicate (BrainScope One) to accommodate widely accepted definitions for "concussion" and "mild Traumatic Brain Injury (mTBI)". The core capabilities of the Modified BrainScope One and its fundamental scientific technology remain unaltered compared to the BrainScope One (predicate). The device modifications discussed do not alter the BrainScope One's safety or effectiveness and neither do they change its intended use compared to the predicate. The Modified BrainScope One is substantially equivalent to the predicate BrainScope One.
| Topic / Area | Proposed Device:
Modified BrainScope
One | Predicate:
BrainScope One | Comments |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------|
| Platform | Trimble T41 mobile
device, Android OS | Trimble T41 mobile
device, Android OS | Same |
| Processed
EEG
Bandwidth | 1kHz sampled data
with DC to 300Hz
bandwidth and 100Hz
sampled data with
0.67Hz to 43Hz
bandwidth | 1kHz sampled data
with DC to 300Hz
bandwidth and 100Hz
sampled data with
0.67Hz to 43Hz
bandwidth | Same |
| Common
Mode
Rejection
Ratio (CMRR) |