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The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses.

The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral LED fixation lamps. It consists of a headset and a main body with an ultrasonic transmitter. Two ultrasonic receivers are imbedded in the center nosepiece of the headset. The patient wears the headset and looks at three orange LED fixation lamps in the main body as they light up in succession. As the patient follows the lights from side to side, the device measures the degree of head movement from the center light against a target angle of 40° and a standard deviation. Eye movement is extrapolated to fill the remaining vision angle. The calculated ratio of head/eye movement is used to determine the shape of the peripheral and central fields of the progressive spectacle lenses.

Here's a breakdown of the acceptance criteria and study information for the Varilux® VisionPrint™ System (VPS) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined "acceptance criteria" against which the device performance was measured. Instead, it describes characteristics of the device's performance in a clinical study. The performance described focuses on the reproducibility and correlation of the VPS measurements.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 175 presbyopic patients.
• Data Provenance: The document does not explicitly state the country of origin. It is a "clinical study," implying prospective data collection for the purpose of the submission. The date of the 510(k) summary (December 19, 2003) and the FDA approval date (July 2, 2004) suggest recent data for that period.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The provided summary does not mention the use of experts to establish ground truth for the test set. Instead, it uses a comparator device (Polhemus Fastrak) as a reference for comparison.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication process as external experts were not used to establish ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The study focused on the device's internal consistency and its correlation with another measurement device, not on how human readers' performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented is for the standalone device. The VPS is an "Eye Movement Monitor" that measures eye and head movement; the study describes its measurements directly, not its impact on human performance. It is a measurement device, not an interpretative AI.

7. The Type of Ground Truth Used

The "ground truth" for the comparative analysis was the measurements obtained from an "electromagnetic sensor -- the Polhemus Fastrak." This serves as a reference standard to demonstrate the accuracy or agreement of the VPS's measurements.

8. The Sample Size for the Training Set

The document does not mention a "training set" or "training data." The VPS is described as an ultrasonic measurement device, not an AI/machine learning algorithm requiring a distinct training phase. The clinical study described appears to be a validation or performance evaluation study of the device itself.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set or AI algorithm requiring ground truth for training is explicitly described.

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