(525 days)
The Noncon Robo Pachy F&A is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea.
The Noncon Robo Pachy F&A specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo Pachy, K980357. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.
Konan NonCon Robo Pachy F&A: Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Konan NonCon Robo Pachy F&A are based on the agreement and variability of its analysis methods for corneal endothelial cell density, coefficient of variation, and percent hexagonality, when compared to manual and center methods. The reported performance is presented as the mean difference and 95% limits of agreement between these methods for agreement, and standard deviation (within-image) for variability.
Acceptance Criteria & Reported Performance Table:
| Parameter | Analysis Method Comparison | Acceptance Criteria (Implied) | Reported Device Performance (Mean Difference & 95% Limits of Agreement) | Reported Device Performance (Variability - Standard Deviation (within-image) as % of mean value) |
|---|---|---|---|---|
| Cell Density | Manual vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 0.06%, LoA: -0.78% to 0.9% | 1.14% (PC-Assist with redrawing) |
| Manual vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 0.00%, LoA: -2.3% to 2.3% | 0.78% (PC-Assist without redrawing) | |
| Center vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: -0.11%, LoA: -1.47% to 1.25% | 1.23% (Center Method) | |
| Center vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: -0.17%, LoA: 2.37% to 2.71% | ||
| Manual vs Center Method | Close agreement, narrow limits of agreement | Mean Diff: 0.16%, LoA: -1.1% to 1.42% | ||
| Coefficient of Variation | Manual vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 0.43%, LoA: -2.35% to 3.21% | 4.23% (PC-Assist with redrawing) |
| Manual vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 0.24%, LoA: -5.62% to 6.10% | 8.02% (PC-Assist without redrawing) | |
| Center vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 2.38%, LoA: -4.18% to 8.94% | 6.60% (Center Method) | |
| Center vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 2.18%, LoA: -4.18% to 8.94% | ||
| Manual vs Center Method | Close agreement, narrow limits of agreement | Mean Diff: -1.96%, LoA: -8.58% to 4.66% | ||
| Percent Hexagonality | Manual vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: -0.08%, LoA: -3.32% to 3.16% | 3.87% (PC-Assist with redrawing) |
| Manual vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 1.47%, LoA: -3.63% to 6.57% | 12.67% (PC-Assist without redrawing) | |
| Center vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 2.13%, LoA: -3.03% to 7.29% | 6.42% (Center Method) | |
| Center vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 3.67%, LoA: -3.13% to 10.47% | ||
| Manual vs Center Method | Close agreement, narrow limits of agreement | Mean Diff: -2.23%, LoA: -7.03% to 2.57% |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria thresholds. Instead, it presents the "Agreement Between Methods of Analysis" and "Variability Associated with the Analysis Methods" as performance data to demonstrate substantial equivalence to the predicate device. The implied acceptance is that the device's performance, as measured by these metrics, is comparable to, or an improvement on, the predicate device and clinically acceptable.
Additionally, the study explicitly states: "Agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with Percent Hexagonality 0.41, or Cell Density
§ 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.