(377 days)
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 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.
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.
This response summarizes the acceptance criteria and supporting studies for the ImPACT and ImPACT Pediatric devices, as detailed in the provided document.
Acceptance Criteria and Device Performance
The acceptance criteria for ImPACT and ImPACT Pediatric are primarily demonstrated through the establishment of their psychometric properties: construct validity, test-retest reliability, and the development of a robust normative database. The device performance is reported through the results of various peer-reviewed studies and clinical data supporting these properties.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Outcome Demonstrated | Reported Device Performance (Summary) |
|---|---|---|
| Construct Validity | Demonstrate the device measures what it purports to measure (e.g., specific cognitive functions). | ImPACT: Significant correlations with traditional neuropsychological measures (SDMT, WAIS-R, NFL Battery components) for processing speed, reaction time, memory. Demonstrated good convergent and discriminant validity. |
| ImPACT Pediatric: Significant correlations (20/24 potential comparisons) with WRAML-2 subtests (e.g., Story Memory, Design Recall), indicating it measures important aspects of memory. | ||
| Test-Retest Reliability | Demonstrate consistent results over time for multiple administrations. | ImPACT: Robust test-retest reliability with ICCs generally ranging from 0.46 to 0.88 across various intervals (30 days to 2 years) for Verbal Memory, Visual Memory, Visual Motor Speed, and Reaction Time. |
| ImPACT Pediatric: ICCs ranging from 0.46 to 0.89 across test modules (e.g., Word List, Memory Touch, Stop & Go) over one-week intervals, indicating adequate to excellent stability for most. | ||
| Normative Database | Establish a representative database to compare patient performance against "normal" population. | ImPACT: Standardization sample of 17,013 individuals (ages 10-59 years, diverse gender/age breakdown). Data collected by trained professionals in supervised settings. |
| ImPACT Pediatric: Normative database of 915 children (ages 5-12 years) from multiple clinical sites (Atlanta, Annapolis, Marquette, Pittsburgh, Guelph, ON). Age-stratified, considering gender differences. | ||
| Reliable Change Index (RCI) | Provide a statistical calculation to determine if a change in score is clinically meaningful and not due to measurement error or practice effects. | ImPACT: RCI calculation provided to indicate clinically significant improvement, reducing adverse impact of measurement error. |
| ImPACT Pediatric: RCI calculated to highlight score changes not due to practice effects or measurement error, displayed in red on reports. | ||
| Validity Index | Provide an index to identify invalid baseline examinations. | ImPACT: Algorithm-based index identifies invalid tests based on sub-optimal performance on specific subtests (e.g., X's and O's Total Incorrect > 30, Word Memory Learning Pct Correct |
§ 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.