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The device is designed to detect and quantify the amount of aniseikonia of a patient. Aniseikonia is defined as a condition of binocular vision where there is a relative difference in the size and/or shape of the ocular image of the two eyes. If a significant amount of aniseikonia is detected in a patient, a new prescription (contact lenses and/or glasses) can be calculated to reduce the amount of aniseikonia.

This device is intended to assist in the detection and management of aniseikonia.

The device is based on an old technique called 'direct comparison eikonometry'. I.e. the two eyes are offered a different image and the subject needs to determine if there is a size imbalance between the two images. If there is an imbalance in size, the size 16 a one of the images is changed until the subject perceives the two images as equal in size. The extent in which one of the images needed to be changed in size is a measure for the amount of aniseikonia of the subject. In The Aniseikonia Inspector the separation between the two eyes is accomplished by holding a red and a green filter in front of the eyes. The images are created on a computer screen and they can be altered by using a computer periheral such as the keyboard.

The provided 510(k) summary does not contain information about acceptance criteria, device performance, study details, and related elements typically found in a clinical study report. The document describes the device, its intended use, and its substantial equivalence to a predicate device, but it lacks the specific data requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, and performance metrics based solely on the provided text. The document is primarily a notification of intent to market and a confirmation of FDA's substantial equivalence determination, rather than a detailed report of a performance study.

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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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