(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.

[81 FR 87811, Dec. 6, 2016]