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510(k) Data Aggregation
(249 days)
CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for invivo viewing, axial cross-sectional, and three-dimensional imaging of anterior ocular structures. The device is indicated for visualizing and measuring and posterior ocular structures, including corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects.
CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. (Model 5000 only.)
CIRRUS HD-OCT is indicated as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
The CIRRUSTM HD-OCT is a computerized instrument that acquires and analyses crosssectional tomograms of anterior and posterior ocular structures (including cornea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, CIRRUS HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye).
The CIRRUS HD-OCT is offered in two models, Model 5000 and 500. In the CIRRUS HD-OCT Model 5000, the fundus camera is a line scanning ophthalmoscope. The CIRRUS HD-OCT Model 500 is similar to the Model 5000 except that it provides the fundus image using the OCT scanner only.
The acquired imaging data can be analyzed to provide thickness and area measurements of regions of interest to the clinician. The system uses acquired data to determine the fovea location or the optic disc location. Measurements can then be oriented using the fovea and/or optic disc locations. The patient's results can be compared to subjects without disease for measurements of RNFL thickness, neuroretinal rim area, average and vertical cup-to-disc area ratio, cup volume, macular thickness and ganglion cell plus inner plexiform layer thickness.
In addition to macular and optic disc cube scans, the CIRRUS HD-OCT 5000 also offers scans for OCT angiography imaging, a non-invasive approach with depth sectioning capability to visualize microvascular structures of the eye.
Anterior segment scans enable analysis of the anterior segment including Anterior Chamber Depth, Angle-to-Angle and automated measurement of the thickness of the cornea with the Pachymetry scan.
The provided text describes the 510(k) summary for the Carl Zeiss Meditec, Inc. CIRRUS HD-OCT with Software Version 10. The main study detailed is for corneal epithelial thickness measurements.
Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the statistical analyses performed, primarily focusing on repeatability, reproducibility, and agreement with manual measurements. The performance is reported in terms of these statistical metrics rather than predefined thresholds for acceptance.
Corneal Epithelial Thickness Measurements (Pachymetry Scans)
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Normal Eyes - Central Sector) | Reported Device Performance (Pathology Eyes - Central Sector) |
|---|---|---|---|
| Repeatability SD | Low standard deviation (SD) for repeated measurements. | 0.8 µm | 1.4 µm |
| Repeatability Limit | Low limit (2.8 x Repeatability SD). | 2.2 µm | 4.0 µm |
| Repeatability CV% | Low coefficient of variation. | 1.6% | 3.0% |
| Reproducibility SD | Low standard deviation (SD) across different operators/devices. | 1.1 µm | 1.8 µm |
| Reproducibility Limit | Low limit (2.8 x Reproducibility SD). | 3.2 µm | 5.1 µm |
| Reproducibility CV% | Low coefficient of variation. | 2.3% | 3.8% |
| Automated vs. Manual Agreement (Deming Regression) | Slope close to 1, Intercept close to 0. | Slope: 0.88 (95% CI: 0.71, 1.04) | |
| Intercept: 4.69 (95% CI: -3.65, 13.02) | Slope: 1.03 (95% CI: 0.95, 1.10) | ||
| Intercept: -2.46 (95% CI: -6.35, 1.43) | |||
| Automated vs. Manual Agreement (Bland-Altman Limits of Agreement) | Narrow limits of agreement around a mean difference close to 0. | Mean Difference: -1.59 µm (SD 1.77) | |
| Lower LOA: -5.05 µm | |||
| Upper LOA: 1.88 µm | Mean Difference: -1.17 µm (SD 2.98) | ||
| Lower LOA: -7.00 µm | |||
| Upper LOA: 4.67 µm |
Note: The table provides data for the "Central" sector as an example. The document provides detailed results for 25 different sectors.
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Normal Corneas (Group 1): 11 adult participants (one eligible eye per participant).
- Keratoconus/Post-LASIK (Group 2): 12 participants (one eligible eye per participant).
- Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study specifically conducted to determine repeatability, reproducibility, and agreement.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three masked graders.
- Qualifications of Experts: Not explicitly stated beyond "masked graders."
4. Adjudication Method for the Test Set
The document states: "To generate manually marked corneal epithelial thickness measurements, three masked graders reviewed images and manually performed measurements in the 25 sectors." It does not specify an adjudication method like 2+1 or 3+1; it simply mentions that three graders performed the measurements. The comparison is made between the automated measurement and these manual measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study focuses on the agreement between the device's automated measurements and manual measurements.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was done. The study specifically evaluated the "automated corneal epithelial thickness measurements" generated by the device's software. The comparison to manual measurements serves as a validation of this standalone algorithm's performance against human expert measurements.
7. Type of Ground Truth Used
The ground truth for the corneal epithelial thickness measurements was established by expert manual measurements performed by three masked graders. This serves as a reference standard to which the automated measurements were compared.
8. Sample Size for the Training Set
The document does not provide information about the sample size used for the training set of the algorithm. This study focuses on the clinical evaluation of the device in its final form.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set (if any) was established. The clinical evaluation described pertains to the performance validation of the already developed algorithm.
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