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The AA-1 System is indicated for the treatment of amblyopia using an interactive computerized program in patients 9 years or older suffering from amblyopia.
The Vision Treatment System is indicated for the treatment of amblyopia using and The Vision Treatment System is mateated to: and older suffering from amblyopia.

The device is a computerized interactive device that provides the user with a series of linear images oriented in vertical and horizontal planes on a video imaging screen that is designed to identify and correct visual dysfunction from reduced visual acuity by re-training the eye to utilize its optimal visual response in gaining an increased awareness of visual acuity through a series of training sessions. The device analyzes the patient's visual acuity deficiencies and sets a program for the user to increase the demand on the visual system resulting in an improvement of visual acuity. The device pre-programs a series of visual stimuli tasks and takes the patient through a series of interactive functions in identifying various objects on the video screen, and helps to provide an environment that increases visual response.

The Neurovision AA-1 System for the Treatment of Amblyopia is indicated for the treatment of amblyopia in patients 9 years or older.

1. Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and data provenance:

• Test Set Sample Size: The document does not specify the exact number of subjects in the test set. It mentions "subjects who completed the study with the long term follow-up three month visit."
• Data Provenance: Prospective, randomized, and controlled clinical investigation. The country of origin of the data is not explicitly stated.

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

Not applicable. The study evaluated the device's ability to directly improve visual acuity, which is a measurable physiological outcome, rather than relying on expert interpretation of diagnostic images or data for ground truth.

4. Adjudication method for the test set:

Not applicable. Visual acuity improvement was measured directly.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This study was a clinical investigation evaluating the direct effect of the device on patient visual acuity, comparing it to a placebo control group.

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

Yes, a standalone study was essentially performed in the sense that the device itself (the computerized program) was the intervention being evaluated. The "human-in-the-loop" was the patient interacting with the device, but the performance being measured was the patient's visual acuity improvement as a direct result of the device's treatment program, not the device's diagnostic accuracy independently.

7. The type of ground truth used:

Visual acuity measurements (lines of visual acuity) objectively assessed before and after treatment, and after a 3-month rest period.

8. The sample size for the training set:

Not applicable. This device is a treatment system, not a diagnostic algorithm that requires a training set in the typical machine learning sense. The "program" within the device analyzes patient deficiencies and sets a program, implying an internal logic or pre-programmed rules rather than a trained AI model based on a training dataset.

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

Not applicable, as there was no explicit training set for a machine learning model. The device operates based on a "pre-programmed analysis of visual debilitation from amblyopia and a computerized software program that had analyzed the visual defect and carried the subjects through a series of sequential treatments designed to improve visual resolution capability." This suggests a rule-based or empirically derived program rather than one trained on a dataset with established ground truth.

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