(377 days)
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No
The summary describes a computer-based neurocognitive test battery that measures and calculates scores based on pre-defined tests and normative data. There is no mention of AI, ML, or any related concepts like training sets, test sets, or complex algorithms that learn from data to make predictions or classifications. The calculations mentioned (RCI, Validity Index, factor scores) are standard statistical methods, not indicative of AI/ML.
No.
The device is intended for assessment and management of concussion, providing objective measures of neurocognitive functioning, but it does not directly treat or cure the condition.
Yes
The device is explicitly stated as being intended "to aid in the assessment and management of concussion" and provides "objective measure of neurocognitive functioning as an assessment aid," which are characteristic functions of a diagnostic device.
Yes
The device description explicitly states that ImPACT and ImPACT Pediatric are "software-based tools" and a "computerized neurocognitive test battery." The summary focuses on the software's functionality, performance studies related to the test battery itself, and its use on a computer. There is no mention of any accompanying hardware components being part of the device submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that ImPACT and ImPACT Pediatric are "computer-based neurocognitive test batteries." They measure neurocognitive functioning through a series of tasks performed by the individual on a computer.
- Intended Use: The intended use is to "aid in the assessment and management of concussion" by providing "objective measure of neurocognitive functioning." This is a behavioral and cognitive assessment, not a test performed on a biological sample.
- Lack of Biological Sample Testing: There is no mention of collecting or analyzing any biological samples from the patient.
The device is a software-based tool for assessing cognitive function, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
ImPACT: ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59.
ImPACT Pediatric: ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT Pediatric is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 5-11.
Product codes (comma separated list FDA assigned to the subject device)
POM
Device Description
ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) and ImPACT Pediatric are computer-based neurocognitive test batteries for use as an assessment aid in the management of concussion.
ImPACT and ImPACT Pediatric are software-based tools that allows healthcare professionals to conduct a series of neurocognitive tests that provide data related to the neurocognitive functioning of the test taker. This computerized neurocognitive test battery measures various aspects of neurocognitive functioning including reaction time, memory, attention, and spatial processing speed. It also records symptoms of concussion in the test taker.
ImPACT and ImPACT Pediatric provide healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices. The devices are intended to be used as part of a multidisciplinary approach to concussion assessment and patient management.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
ImPACT: 12-59
ImPACT Pediatric: 5-11
Intended User / Care Setting
medical professionals qualified to interpret the results of a concussion assessment examination and aid in the management of concussion.
Description of the training set, sample size, data source, and annotation protocol
ImPACT - Standardization/Normative Database: The standardization sample consisted of 17,013 individuals who underwent baseline ImPACT testing. The older subjects represented teachers, coaches, school administrators, and adult athletes. Athletes who participated in the normative sample were participants in the following sports: Tackle football (males only), soccer (males and females), lacrosse (males and females), wrestling (males only), baseball (males only), softball (females only), swimming/diving (males and females), cheerleading (females only), crew/rowing (males and females), volleyball (males and females), track and field (males and females), field hockey (females only) and cross country (males and females). Sample was inclusive of minorities. Normative data were collected by research partners acknowledged in the user manual. All testing was completed by professionals who were specifically trained to administer the tests. These professionals consisted of Neuropsychologists, Psychologists and Neuropsychology/Psychology graduate students, Certified Athletic Trainers and Athletic Training Graduate Students and Nurses. All testing was completed in a supervised setting and data were later uploaded onto a secure HIPPA-compliant server. Data were deidentified and placed in a database for analysis. All participants in the resulting studies were English speakers and were not reported to have underlying intellectual or developmental data and were not currently concussed or suffering from any other medical condition that might affect their test performance.
ImPACT Pediatric - Normative Database: A large, age-stratified sample of children ages 5 through 12 years old that are representative of the intended use population were tested utilizing ImPACT Pediatric to generate normal score ranges for the test. The subjects were 915 children between the ages of 5 and 12 years from Children's Hospital of Atlanta – Atlanta, Georgia (312), Right Time Pediatrics – Annapolis, Maryland (230), Northern Michigan University – Marquette, Michigan (199), Mount Lebanon School District – Pittsburgh, Pennsylvania (94), Shift Concussion Management – Guelph, Ontario, Canada (80). ImPACT Pediatric tests were administered by a researcher, clinician, or educational professional trained in the use of ImPACT Pediatric. Tests were taken on an iPad 2 or above with the device flat on the table and instructions read out loud to the participant. Testing typically takes between 10 and 20 minutes. The children were instructed to respond by touching the screen with the pointing (first) finger of the hand that they write with. No "group testing" was conducted and all testing was done on a one-on-one basis.
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ImPACT:
1. Construct Validity: Abstracts from 4 published studies were provided:
* Iverson GL, Lovell MR, Collins MW. (2005) - Sample N=72 athletes (avg age 17.1, 83.8% male, 16.2% female) from high schools in PA. Comparison of ImPACT to Symbol Digit Modalities Test (SDMT). SDMT correlated 0.70 with Processing Speed and -0.60 with Reaction Time. PCFA confirms a three-factor solution of Speed/Reaction Time, Memory, and Total Symptoms.
* Maerlender A, Flashman L, (2010) - Sample N=54 varsity athletes from Dartmouth College (40 football, remainder non-contact sports). Correlational analysis relating ImPACT Composites and Neuropsychological domains. ImPACT showed good convergent and discriminant validity, correlating with expected experimental measures and traditional paper and pencil measures of memory and processing speed.
* Schatz P, Putz BO. (2006) - Sample N=30 college students (14 men, 16 women, non-varsity athletes, ages 18-23) from St. Joseph's University. Correlational analysis relating ImPACT Composites to Trail Making A-B.D-2 test and Digit Symbol from WAIS-R. ImPACT Reaction time significantly correlated with Trails A-B (.61, .44 respectively) and Digit Symbol from WAIS (.46). Digit Symbol also significantly correlated with ImPACT Processing Speed Index -.51.
* Allen BJ, Gfeller JD. (2011) - Sample N=100 students (56 females, 44 males, mean age 19.69) from a private university. Correlational analysis with ImPACT and NFL Battery (HVLT-R, BVMT-R, Trail Making Test A-B, COWA and Symbol Search and Digit Span Forward and Backward from the WAIS-III). Significant correlations (0.3 to 0.45 range) were obtained between many ImPACT composite scores and components of the NFL battery.
2. Reliability: Five published studies were provided, assessing test-retest reliability over various intervals (30 days to 2 years).
* Schatz (2013) - 30 days, n=25. ICCs: Verbal Memory 0.79, Visual Memory 0.6, Visual Motor Speed 0.88, Reaction Time 0.77.
* Cole (2013) - 30 days, n=44. ICCs: Verbal Memory 0.6, Visual Memory 0.5, Visual Motor Speed 0.83, Reaction Time 0.53.
* Nakayama (2014) - 0-45 days, n=85 & 0-50 days, n=85 & 45-50 days, n=85. ICCs ranged from 0.6 to 0.88 across different time intervals for various metrics.
* Elbin (2011) - 1 year, n=369. ICCs: Verbal Memory 0.62, Visual Memory 0.7, Visual Motor Speed 0.82, Reaction Time 0.71.
* Schatz (2010) - 2 years, n=95. ICCs: Verbal Memory 0.46, Visual Memory 0.65, Visual Motor Speed 0.74, Reaction Time 0.68.
Table 4 demonstrates relatively robust test-retest reliability of the ImPACT modules over a variety of time intervals up to two years.
3. Reliable Change Index (RCI): The ImPACT software calculates a RCI using the standard error of the difference score, indicating if a change in score is statistically reliable (not due to practice effects or measurement error) and clinically meaningful.
4. Validity Index: Identifies invalid baseline examinations based on sub-optimal performance on five subtests with published research cut-off values (e.g., X's and O's Total Incorrect > 30).
ImPACT Pediatric:
1. Development of Normative Database: N=915 children ages 5-12. Statistical analysis showed expected trend of older children performing better (faster with fewer mistakes). Significant gender differences were found for Word Memory scores (7-12 years) and Picture Match Average Taps (9-12 years).
2. Development of Factor Scores: Factor analysis on N=712 participants yielded a four-factor solution: attention and sequencing, word memory, visual memory, and reaction time. T-scores (mean 50, SD 10) were calculated for standardized comparison.
3. Reliable Change Index (RCI): Similar to ImPACT, the software calculates RCI to indicate changes not due to practice effects or measurement error.
4. Reliability: Unpublished clinical study of N=100 children (mean age 7.8 yrs) in youth soccer and hockey leagues. Test-retest reliability measured at one week and one month. Intraclass correlation coefficients (ICCs) for one week interval: 2 items showed poor stability (ICC= .46, .54), 5 adequate to good (ICC=.61 .63, .67, .71, .72) and 5 excellent (ICC=.79, 81, .82, .83, .89).
5. Construct Validity: N=83 participants ages 5-12 were given a modified battery of Wide Range Assessment of Memory and Learning-2 (WRAML-2) and Pediatric ImPACT. Significant correlations were revealed for 20 of 24 potential test comparisons. Pearson's correlation coefficients showed ImPACT Pediatric correlates significantly with relevant WRAML-2 subtests. Therefore, concurrent validity is considered adequate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Reliability coefficients (ICC, r) are provided in the Reliability section of the Summary of Performance Studies, and Pearson's correlation coefficients are provided in the Construct Validity section for ImPACT Pediatric).
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.
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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).
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§ 882.1471 Computerized cognitive assessment aid for concussion.
(a)
Identification. The computerized cognitive assessment aid for concussion is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. It is not intended as a stand-alone diagnostic device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed.
(2) Clinical performance data must be provided that demonstrates how the device functions as an interpretation of the current level of cognitive function in an individual that has recently received an injury that causes concern about a possible concussion. The testing must:
(i) Evaluate device output and clinical interpretation.
(ii) Evaluate device test-retest reliability of the device output.
(iii) Evaluate construct validity of the device cognitive assessments.
(iv) Describe the construction of the normative database, which includes the following:
(A) How the clinical workup was completed to establish a “normal” population, including the establishment of inclusion and exclusion criteria.
(B) Statistical methods and model assumptions used.
(3) The labeling must include:
(i) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function in a patient that has recently received an injury that causes concern about a possible concussion. The summary of testing must include the following:
(A) Device output and clinical interpretation.
(B) Device test-retest reliability of the device output.
(C) Construct validity of the device cognitive assessments.
(D) A description of the normative database, which includes the following:
(
1 ) How the clinical workup was completed to establish a “normal” population, including the establishment of inclusion and exclusion criteria.(
2 ) How normal values will be reported to the user.(
3 ) Representative screen shots and reports that will be generated to provide the user results and normative data.(
4 ) Statistical methods and model assumptions used.(
5 ) Whether or not the normative database was adjusted due to differences in age and gender.(ii) A warning that the device should only be used by health care professionals who are trained in concussion management.
(iii) A warning that the device does not identify the presence or absence of concussion or other clinical diagnoses.
(iv) A warning that the device is not a stand-alone diagnostic.
(v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.
0
DE NOVO CLASSIFICATION REQUEST FOR IMPACT AND IMPACT PEDIATRIC
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Computerized Cognitive Assessment Aid for Concussion. The computerized cognitive assessment aid for concussion is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. It is not intended as a stand-alone diagnostic device.
NEW REGULATION NUMBER: 882.1471
CLASSIFICATION: CLASS II
PRODUCT CODE: POM
BACKGROUND
DEVICE NAME: IMPACT AND IMPACT PEDIATRIC
SUBMISSION NUMBER: DEN 150037
DATE OF DE NOVO: AUGUST 11, 2015
CONTACT: IMPACT APPLICATIONS, INC. 2000 TECHNOLOGY DRIVE, SUITE 150 PITTSBURGH, PA 15219
INDICATIONS FOR USE
ImPACT:
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.
ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59.
1
ImPACT Pediatric:
ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.
ImPACT Pediatric is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 5-11.
LIMITATIONS
For prescription use only.
The safety and effectiveness of ImPACT for individuals under the age of 12 years and over the age of 59 years has not been established. The safety and effectiveness of ImPACT Pediatric for individuals under the age of 5 years and over the age of 11 years has not been established.
ImPACT and ImPACT Pediatric are intended be used by medical professionals qualified to interpret the results of a concussion assessment examination and aid in the management of concussion.
The devices are not intended to be used as a stand-alone diagnostic device.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) and ImPACT Pediatric are computer-based neurocognitive test batteries for use as an assessment aid in the management of concussion.
ImPACT and ImPACT Pediatric are software-based tools that allows healthcare professionals to conduct a series of neurocognitive tests that provide data related to the neurocognitive functioning of the test taker. This computerized neurocognitive test battery measures various aspects of neurocognitive functioning including reaction time, memory, attention, and spatial processing speed. It also records symptoms of concussion in the test taker.
ImPACT and ImPACT Pediatric provide healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices. The devices are intended to be used as part of a multidisciplinary approach to concussion assessment and patient management.
2
ImPACT
ImPACT (ages 12-59) is administered using the following sequence:
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- Demographics
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- Symptom Scale
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- Word Memory
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- Design Memory
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- X's and O's
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- Symbol Match
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- Color Match
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- Three Letters
An example of one of the tests, the Symbol Match, is shown below in Figure 1. This particular test evaluates processing speed, learning, and memory.
Figure 1: Example Symbol Match Task
Upon successful completion of the test battery, ImPACT generates a report with the following information:
Demographic Information
- Background Information and Native Language
- Education and Special Needs as reported by test taker ●
- Concussion and Sport Background ●
- . Medical Information as reported by test taker
ImPACT Composite Scores
- Verbal Memory Composite, Visual Memory Composite, Visual Motor Speed ● Composite, Reaction Time Composite, Impulse Control Composite, Total Symptom Score, Cognitive Efficiency Index (CEI)
3
Test Battery Modules
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Word Memory, Design Memory, X's and O's, Symbol Match, Color Match, Three Letters
Post-Concussion Symptom Checklist -
. Individual Symptom Scores
Graphic Representation of Composite Scores and Symptoms -
. Graphs depicting: Verbal Memory, Visual Memory, Visual Motor Speed, and Reaction Time Composite Scores, Total Symptom Score
Table 1 shows an example test score report, which identifies the overall composite score table for each cognitive area tested.
| Composite Scores | Percentile scores if available are listed in small type | |||
|---|---|---|---|---|
| Memory composite (verbal) | 82 | 49% | 57 | 30 OR |
- Impulse Control Composite >30 OR
- Word Memory Learning Pct Correct 1 Kontos, A.P., Elbin, R.J., Covasin, T., Larson, E. (2010), Exploring differences in neurocognitive concussion testing in African American and White athletes. Archives of Clinical Neuropsycholog, 25(8), 734-744.
" Shuttleworth-Edwards AB1, Whitefield-Alexander VJ, Radloff SE, Taylor AM, Lovell MR. Computerized neuropsychological profiles of South African versus US athletes: a basis for commentary on cross-cultural norming issues in the sports concussion arena. Phys Sportmed. 2009:37(4),45-52.
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The RCI is a statistical calculation to demonstrate the change in score is not due to expected test-retest variance. The RCI calculation provides additional information to the clinician in determining if the change in test scores is clinically meaningful and not solely due to measurement error and provides important information to the clinician both diagnostically and prognostically.
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- Validity Index. The ImPACT test battery provides an index designed to aid in identifying invalid baseline examinations. The validity index is based upon sub-optimal performance on the five subtests, which comprise the ImPACT test battery and include the published research cut-off values for each subtest:
- X's and O's Total Incorrect > 30 OR
- Impulse Control Composite > 30 OR
- Word Memory Learning Pct Correct