(88 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety: Meets all requirements of EN 60601-1. | ConfoScan 2 Confocal Microscope found to meet all requirements of EN 60601-1. |
| Electromagnetic Compatibility: Meets all requirements of EN 60601-1-2. | ConfoScan 2 Confocal Microscope found to meet all requirements of EN 60601-1-2. |
| Programmable Electrical Medical Systems: Meets all requirements of EN 60601-1-4. | ConfoScan 2 Confocal Microscope found to meet all requirements of EN 60601-1-4. |
| Ophthalmic Instruments Fundamental Test Requirements & Methods: Meets all requirements of ISO 15004. | ConfoScan 2 Confocal Microscope found to meet all requirements of ISO 15004. |
| Light Energy Levels: Negligible amount of light energy transferred to the patient during normal examination (1-2 minutes). | Amount of light energy transferred to the patient during 1-2 minute examination found to be negligible. |
| Endothelial Cell Analysis Software Validation: Automatic cell density values comparable to results from at least two other commercially available specular microscopes. | 134 samples analyzed, and resulting automatic cell density values validated by comparison to two other commercially available specular microscopes. (The exact level of agreement/equivalence is not quantified in the summary, only that it was "validated"). |
| Substantial Equivalence: Same intended use and fundamental scientific technology as the predicate device (Tomey ConfoScan Confocal Microscope K972953). | "The results of this comparison demonstrate that the ConfoScan 2 Confocal Microscope device has the same basic technological characteristics as the predicate device and is equivalent to the marketed 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.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.