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Cognivue testing is indicated as an adjunctive tool for evaluating perceptual and memory function in individuals aged 55-95 years old.

Cognivue provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of identifying a potential decline in cognitive function relative to baseline test performance of other age-normal adults, referring those adults for further testing where warranted, and monitoring changes in cognitive function over time.

Cognivue presents a series of visual stimuli and a wedge-shaped cursor. The display presents stimuli at varying signal strengths with a moving domain-specific target. The patient identifies the target location by moving the cursor using the rotatory mouse manipulandum. The patient is scored based on the timing and accuracy of the responses. Repeated trials of varying difficulty characterize the subject's performance in each of the tested functional domains.

Here's a breakdown of the acceptance criteria and the study that proves the CogniVue device meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

• Overall relationship: Deming regression showed Cognivue = -29.98 + 4.465 SLUMS with r = 0.71 (p=27 (impairment cut-off values), Cognivue related PPA = 86%, NPA = 50%, Accuracy = 0.86.
• For SLUMS ≥ 27 and Cognivue ≥ 75 (unimpaired cut-off values): PPA = 66%, NPA = 67%, Accuracy = 0.66. |

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Main Clinical Validation Test Set: 401 subjects.
   • Test-Retest Reliability Test Set: 358 subjects (a subset of the 401, those available for repeat testing).
   • Cut-off Determination Test Set (Training Set for Cut-offs): 92 subjects.
   • Data Provenance: The subjects were enrolled at 13 older adult independent living communities and adult programs for independent living seniors who are living at home. The study was prospective in its design, involving specific recruitment and protocol execution for the study. No explicit country of origin is stated, but given the FDA De Novo filing, it's highly likely the data is from the USA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The primary ground truth for classification was the St. Louis University Mental Status (SLUMS) Examination. While the SLUMS is a clinical tool administered by a "Tester," the text doesn't specify if this "Tester" is explicitly an "expert" (e.g., a neurologist or psychologist) or a trained administrator. Given that SLUMS scores have validated cut-off scores, it relies on the established validity of the SLUMS itself, rather than real-time expert consensus for each case. The study states "Tester #2 administration of the neuropsychological test battery," implying trained personnel administered the SLUMS.
   • The study used "licensed practitioners evaluating brain function" as the general user group for the device, implying that interpretation of SLUMS scores would typically fall under their purview.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • There was no adjudication method mentioned for establishing the ground truth (SLUMS scores). The SLUMS is a standardized psychometric test with established scoring rules and cut-offs.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No such MRMC comparative effectiveness study was conducted. The study design was a comparative study between the Cognivue device and a battery of non-reference standard tests (including SLUMS), not a study comparing human readers with and without AI assistance. The Cognivue is intended as an "adjunctive tool," meaning a clinician would use its output alongside other information, but the study did not quantify improvement of human performance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance assessment was done. The entire clinical validation focuses on the Cognivue device's output (an average score classified as impaired, intermediate, or unimpaired) and its agreement with the SLUMS examination and other neuropsychological tests. The device itself generates the score and classification automatically without real-time human interpretation or modification of its core output.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The primary ground truth used was a validated clinical psychometric scale: the St. Louis University Mental Status (SLUMS) Examination. This is a well-established cognitive screening tool with predefined cut-off scores for unimpaired, intermediate (mildly impaired), and impaired cognitive function. Secondary ground truth involved other established neuropsychological tests for construct validity.

7. The sample size for the training set:

   • The cut-off values for Cognivue (impaired, intermediate, unimpaired) were determined using a preliminary study of 92 subjects. This set of 92 subjects essentially served as a training set for calibrating the device's classification thresholds against the SLUMS.

8. How the ground truth for the training set was established:

   • For the 92 subjects used to establish the Cognivue cut-offs, the ground truth was established by administering the St. Louis University Mental Status (SLUMS) Examination. The SLUMS scores were then used to classify these 92 subjects into impaired, intermediate, and unimpaired categories based on their established cut-offs (e.g., >26 unimpaired,

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