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The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.

The Meditron Contact Lens Ophthalmodynamometer is a classic Goldmann three-mirror examination contact glass that has been adapted with precision electronic sensors for continuous measurement of pressure applied to the eye. Electronic signals from the sensors are used to determine pressure values, which are then displayed on the device's LCD display.

The patient contact portion of the examination glass consists of a curved shell of acrylic plastic (PMMA) that is applied for a short period of time directly on the globe or cornea of the eye. PMMA is commonly used as a material in examination contact glasses having the same intended purpose.

The mirror angles are the same as the original Goldmann and predicate devices: 59/66/73 degrees.

The Meditron Contact Lens Ophthalmodynamometer is intended for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The summary states that "Repeatability and reproducibility of the device was determined under simulated use conditions." However, it does not provide specific details on:

• Sample size used for the test set: No number of devices or measurements is specified.
• Data provenance: It's unclear if this was prospective or retrospective data, or if any specific geographical region was involved in the "simulated use conditions." Given the manufacturer is German (Meditron GmbH), it's reasonable to infer the testing might have occurred in Europe, but this is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

• Number of experts: Not specified.
• Qualifications of those experts: Not specified.
• Role of experts: The ground truth for the "repeatability and reproducibility" study likely involved comparison to a reference standard or expected range for the force measurements. The summary states "All results of the study were within acceptable tolerances," implying a predetermined range for acceptable performance, but how these tolerances or the ground truth were established (e.g., by experts) is not detailed.
• The overall safety and effectiveness is tied to the expertise of the user, stating: "The user must be qualified in ophthalmic examination procedures, and must be familiar with all labeling and instructions for use associated with the device."

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The study description is very brief, simply stating that results were "within acceptable tolerances." This suggests a direct comparison to predefined benchmarks rather than an expert consensus/adjudication process for discrepancy resolution.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device's purpose is to measure applied force during an ophthalmic examination, not to interpret images or assist human readers in diagnosis in a way that would lend itself to an MRMC study comparing AI-assisted vs. unassisted human performance.

6. Standalone (Algorithm Only) Performance Study

The information provided implicitly describes standalone performance. The "repeatability and reproducibility" test assesses the device's inherent ability to consistently measure force under simulated conditions. There is no mention of human interaction or a "human-in-the-loop" component in this specific test. The device itself is designed to make a direct physical measurement.

7. Type of Ground Truth Used

The ground truth for the "repeatability and reproducibility" study seems to be based on predefined acceptable tolerances for force measurements. The exact method of establishing these tolerances (e.g., specific engineering specifications, clinical requirements, or comparison to an established reference dynamometer) is not detailed. It is not based on expert consensus, pathology, or outcomes data as these are not relevant to the performance metrics being evaluated (repeatability and reproducibility of force measurement).

8. Sample Size for the Training Set

No training set is mentioned. This device is a measurement instrument, not an AI/machine learning model that typically requires a training set. The "electronic sensors" and "calibration" implicit in such a device would be based on engineering principles and physical standards, not a data-driven training set.

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

Not applicable, as no training set is mentioned or implied for this type of device.

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