Search Results

The EyeStat is intended to measure and display the mechanically induced blink reflex. The device is intended to be used by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under the direct supervision of a medical professional.

The device is available for use on any patient as determined by the medical professional including adults and children.

The operating principle of the EyeStat device is that the application of a light puff of air (sterile food grade CO2) to the outer canthus of the eye acts as a stimulus that elicits a blink reflex. The puff of air is delivered while the patient's eyes are positioned within an eyepiece that allows the movement of the eye lid to be tracked using two high-speed cameras. The device uses software to evaluate the video frames containing the movement of the eyelid of the eye to which the puff of air was applied (ipsilateral) and detect the frame containing the initiation of a blink using image/video processing algorithms. The time associated with the video frame containing the initiation of the ipsilateral blink is then compared to the time associated with the application of the puff of air, and the difference represents the latency.

Here's an analysis of the acceptance criteria and study detailed in the provided text.

Based on the provided text, the device in question is the EyeStat, an "Evoked Response Mechanical Stimulator" intended to measure and display the mechanically induced blink reflex.

The available information describes the general performance testing and does not provide typical acceptance criteria in specific numerical thresholds (e.g., Sensitivity > X%, Specificity > Y%) for blink reflex measurements. Instead, the performance evaluations focus on the functionality and accuracy of the device's components and measurements.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Accuracy (Eye Lid Tracking): Not explicitly stated. The text only mentions "an expert reviewer" and does not provide the number of cases or data provenance.
• Precision: Not explicitly stated. The text reports "test-retest reliability of all measurements," but the sample size for patients or measurements is not given, nor is the data provenance.
• Pressure of Stimulus: The text mentions comparing the EyeStat's air pressures against a non-contact tonometer (reference device). It does not specify the sample size of these comparisons or their provenance.

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

• Accuracy (Eye Lid Tracking): "an expert reviewer" was used. No specific qualifications (e.g., years of experience, specialty) for this expert are provided.

4. Adjudication Method for the Test Set

• The text does not describe any specific adjudication method (e.g., 2+1, 3+1). For eye-lid tracking accuracy, it appears to be a direct comparison against a single expert's contouring, rather than a consensus approach.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not described. The provided text focuses on the device's intrinsic performance characteristics and comparison to elements of a predicate device but does not mention a study evaluating human readers' improvement with or without AI assistance.

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

• Yes, a standalone study was implicitly done for "Accuracy (Eye Lid Tracking)." The algorithm's eye-lid tracking performance was compared against an expert's contouring, which assesses the algorithm's capability independently of a human operator, at least for that specific function. The "Precision" testing also appears to be standalone, evaluating the device's inherent measurement consistency.

7. The Type of Ground Truth Used

• Accuracy (Eye Lid Tracking): Expert contouring/review served as the ground truth.
• Precision: The "ground truth" for precision is implicitly the device's own repeat measurements, aiming for high consistency.
• Pressure of Stimulus: A "non-contact tonometer device" (a reference device, K802419) was used for comparison, implying its measurements served as a benchmark for the stimulus pressure.

8. The Sample Size for the Training Set

• Not specified. The document does not provide any information about a training set or its sample size. This is common if the algorithm development process is not detailed, or if a specific "training set" in the machine learning sense was not explicitly defined or reported in the regulatory submission.

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

• Not applicable / Not specified. Since no information regarding a training set is provided, how its ground truth was established is also not detailed.

Ask a specific question about this device