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The ConfoScan 2 Confocal Microscope is intended for use in the precise display and digital storage of images of the corneal layers (endothelium, descemet's membrane, stroma, bowman's membrane, and epithelium) and corneal components (endothelial cells, stromal keratocytes, nerve fibers, basalar and superficial cells). The microscope is also used for optical pachymetry, post-surgery interface evaluation, endothelial cell analysis, haze detection, foreign bodies, corneal dystrophies, keratoconus, keratitis, and trauma.

The ConfoScan 2 Confocal Microscope is indicated for use as a diagnostic tool for observation of the cell layers of the anterior parts of the eye.

The Nidek Technologies Srl ConfoScan 2 Confocal Microscope is a fully digital, corneal confocal microscope that allows a user to view and image human corneal layers in vivo. The confocal arrangement consists of one slit that illuminates the tissue and a second slit that filters the reflected light from unfocused layers. The user can view, magnify, measure, and photograph scparate layers of the transparent structures and tissues of the cornea. One examination records 350 different images.

The ConfoScan 2 microscope is supplied with a Quartz Halogen light source and a scauning slit, suitable for performing ophthalmic examination. The system includes a 15-inch LCD S-VGA Monitor and a Personal Computer, which incorporates the dedicated NAVIS software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ConfoScan 2 Confocal Microscope:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the way one might see for a diagnostic accuracy study. Instead, the performance evaluation focuses on compliance with established standards and equivalence to a predicate device.

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

• Test Set Sample Size: For the "Endothelial Cell Analysis Software Validation," 134 samples (extracted from corneal images) were used.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective.

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

The document does not explicitly state the number of experts used to establish ground truth for the "Endothelial Cell Analysis Software Validation," nor their qualifications. The validation involved "comparison to the results of two other commercially available specular microscopes," implying these microscopes (and their inherent cell analysis methods) served as a reference or "ground truth surrogate," rather than a distinct panel of human experts.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The validation was a comparison against other commercially available devices.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The performance evaluation focuses on device-to-standard compliance and device-to-device comparison for the endothelial cell analysis software. There is no mention of human readers improving with or without AI assistance.

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

Yes, a standalone evaluation of the algorithm's performance was done for the "Endothelial Cell Analysis Software Validation." The ConfoScan 2 Confocal Microscope's software analyzed 134 samples and produced automatic cell density values, which were then compared to other commercial devices. This is a standalone assessment of the algorithm's output.

7. The Type of Ground Truth Used

For the "Endothelial Cell Analysis Software Validation," the ground truth was based on the results obtained from two other commercially available specular microscopes. This suggests a comparative reference standard, rather than a definitive "true" value derived from pathology or long-term outcomes. For the other tests (electrical safety, etc.), the "ground truth" was compliance with harmonized standards.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for training the ConfoScan 2 Confocal Microscope's software or any algorithms.

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

The document does not provide information regarding how the ground truth for any potential training set was established.

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The Tomey "ConfoScan" Confocal Microscope is intended for use in carrying out a visualization of the cell layers of the anterior parts of the eye.
The Tomey "ConfoScan" Confocal Microscope is intended for use as a diagnostic tool for looking at the cell layers of the anterior parts of the eye.

The Tomey "ConfoScan" Confocal Microscope is a scanning slit microscope system that is used to carry out a visualization of the cell layers of the anterior parts of the eye. The prime attributes of a Confocal Microscope include both improved contrast and spatial resolution over more conventional microscopy. The improved image rendition is accomplished in the Tomey "ConfoScan" Confocal Microscope by the introduction conjugate scanning slits into the viewing and illuminating light paths of the microscope. By illuminating and viewing an object through restricted apertures, it is possible to eliminate the contributions of scattered light from other regions in the object plane that can degrade contrast and spatial resolution.

The provided text describes the Tomey ConfoScan Confocal Microscope, but it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria are provided in terms of performance metrics (e.g., sensitivity, specificity, accuracy, resolution targets). The document highlights characteristics of the ConfoScan and compares them to predicate devices, implying these characteristics are accepted by virtue of being similar or equivalent to already approved devices.

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