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CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in vivo 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.

CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

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.

This device is Prescription Use (Rx) only.

The CIRRUS™ HD-OCT Model 6000 is indicated for in-vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of anterior and posterior ocular structures. The clinical purpose of this device has not been modified as compared to the predicate.

CIRRUS 6000 uses the same optical system, architecture, and principle of operation as the previously cleared CIRRUS 5000 (K181534). CIRRUS 6000 has a 100 kHz scan rate for all structural and angiography scans. The primary impact of the higher acquisition speed is its impact on signal-to-noise ratio. The signal-to-noise ratio m the subject device is calibrated to match the specifications of the CIRRUS 6000 uses the same segmentation algorithms as the predicate device and therefore the segmentation results will be equivalent.

In addition to the acquisition speed change, CIRRUS 6000 also has a wider field of view (FOV) and has increased the number of fixation points to 21.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported precision summaries (Repeatability %CV and Reproducibility %CV and Limits) for various measurements on the CIRRUS HD-OCT 6000 (C6000) and the qualitative image quality results. The studies aim to demonstrate that the C6000 performs comparably to the predicate device, the CIRRUS HD-OCT 5000 (C5000), and that its image quality is clinically acceptable.

Since explicit numerical acceptance criteria (e.g., "Repeatability %CV must be < X%") are not directly stated in the text, I will present the reported performance as the evidence that these implicit criteria have been met. The table below summarizes key metrics where direct quantitative comparison is available.

| Metric (Measurement and Population) | Acceptance Criterion (Implicitly demonstrated by achieving results comparable to predicate and within
clinically acceptable ranges) | Reported Device Performance (CIRRUS HD-OCT 6000) |
|---|---|---|
| Ganglion Cell Thickness (Normal Subjects) | | |
| Average Thickness (µm) Repeatability %CV | Should be low, indicating consistent measurements | 0.5% |
| Average Thickness (µm) Reproducibility %CV | Should be low, indicating consistent measurements | 0.6% |
| Macular Thickness (Normal Subjects) | | |
| Central Subfield (µm) Repeatability %CV | Should be low, indicating consistent measurements | 0.4% |
| Central Subfield (µm) Reproducibility %CV | Should be low, indicating consistent measurements | 0.7% |
| ONH (Rim Area, Normal Subjects) | | |
| Rim Area (mm2) Repeatability %CV | Should be low, indicating consistent measurements | 4.9% |
| Rim Area (mm2) Reproducibility %CV | Should be low, indicating consistent measurements | 6.6% |
| RNFL Thickness (Average, Normal Subjects) | | |
| Average RNFL Thickness (µm) Repeatability %CV | Should be low, indicating consistent measurements | 1.2% |
| Average RNFL Thickness (µm) Reproducibility %CV | Should be low, indicating consistent measurements | 1.8% |
| Epithelial Thickness (Central, Normal Subjects) | | |
| Central (µm) Repeatability %CV | Should be low, indicating consistent measurements | 1.8% |
| Central (µm) Reproducibility %CV | Should be low, indicating consistent measurements | 3.8% |
| Pachymetry Thickness (Central, Normal Subjects) | | |
| Central (µm) Repeatability %CV | Should be low, indicating consistent measurements | 0.2% |
| Central (µm) Reproducibility %CV | Should be low, indicating consistent measurements | 0.4% |
| Angiography Image Quality (Overall) | Clinically Acceptable Overall Images should be high | 0.98 or above (C6000) vs 0.94 or above (C5000) |
| Raster Image Quality (Overall) | Clinically Acceptable Overall Images should be high | 1.00 (C6000) and 1.00 (C5000) |

Studies Proving Acceptance Criteria were Met:

The document describes two main clinical performance studies:

• CIRRUS 6000 Repeatability and Reproducibility (R&R) Study: This study quantified the precision of measurements from the C6000 for various ocular structures (Ganglion Cell Thickness, Macular Thickness, ONH, RNFL Thickness, Epithelial Thickness, Pachymetry Thickness) across different patient populations (Normal, Glaucoma, Retinal pathology, Cornea pathology). The results are presented in Tables 3 through 12, showing generally low %CV values for both repeatability and reproducibility, indicating good precision. The agreement between C5000 and C6000 was evaluated using Bland-Altman Limits of Agreement and Deming Regression analysis, suggesting that the measurements are comparable to the predicate device.

• CIRRUS 6000 Angiography Image Quality Study: This study assessed the image quality of OCTA scans from the C6000. It reported a high proportion of clinically acceptable overall images (0.98 or above for C6000), which was comparable to or better than the predicate C5000 (0.94 or above).

• CIRRUS 6000 Raster Image Quality Study: This study evaluated the image quality of raster B-scans from the C6000, reporting that the proportion of clinically acceptable overall images was 1.00 for all scan types, identical to the predicate C5000.

Detailed Information on the Studies:

2. Sample Sizes and Data Provenance

• CIRRUS 6000 Repeatability and Reproducibility (R&R) Study:

  • Total Subjects Enrolled: 117
  • Subgroups: 27 normal, 37 with glaucoma, 30 with retinal pathology, 23 with status post refractive surgery or with corneal pathology.
  • Disqualifications: 9 subjects (did not meet inclusion criteria or showed macular changes due to drusen).
  • Valid Scans Analyzed: 96.0% of C6000 and 94.9% of C5000 scans were valid.
  • Data Provenance: Prospective, multi-site study. Country of origin not specified, but typically multi-site studies for FDA submissions include US sites.

• CIRRUS 6000 Angiography Image Quality Study:

  • Total Subjects Enrolled: 110
  • Subgroups: 103 retinal diseased subjects, 7 normal subjects.
  • Disqualifications/Discontinuations: 7 normal subjects (did not meet inclusion/exclusion criteria), 11 (operator unable to acquire quality scans), 1 (unable to continue study visit), 2 (no C6000 scans acquired), 2 (did not return for second visit).
  • Valid Subjects with at least one OCT scan/FA/ICGA: 93. Only 92 subjects had at least one valid OCT scan.
  • Valid Scans Analyzed: 78.3% of C6000 and 77.2% of C5000 scans.
  • Data Provenance: Prospective, multi-site study. Country of origin not specified, but typically multi-site studies for FDA submissions include US sites.

• CIRRUS 6000 Raster Image Quality Study:

  • Total Subjects Enrolled: 68
  • Subgroups: 20 normal eyes, 48 with retinal disease.
  • Valid Scans Analyzed: 92.3% of C6000 and 91.3% of C5000 scans.
  • Data Provenance: Prospective, multi-site study. Country of origin not specified, but typically multi-site studies for FDA submissions include US sites.

3. Number of Experts and Qualifications for Ground Truth

• R&R Study: No external experts were used for establishing ground truth in the R&R study itself, as it focused on the device's internal precision metrics.
• Angiography Image Quality Study: Three independent reviewers from a reading center were used to grade OCTA scans on image quality and clinically relevant information. Their specific qualifications (e.g., years of experience, specific certifications) are not detailed in the provided text.
• Raster Image Quality Study: Three independent graders from a reading center were used to grade the raster B-scans on image quality and clinically relevant information. Their specific qualifications are not detailed in the provided text.

4. Adjudication Method for the Test Set

• R&R Study: Not applicable, as this study focused on precision of measurements rather than subjective grading requiring adjudication.
• Angiography Image Quality Study: The text mentions "three independent reviewers...graded...according to pre-determined grading criteria." It does not specify an adjudication method (e.g., 2+1, 3+1). It implies independent assessments were done, and the reported "Proportion of Clinically Acceptable Overall Images" likely reflects a consensus or majority opinion based on these independent grades, or an aggregate result.
• Raster Image Quality Study: Similar to the angiography study, "three independent graders...graded...according to pre-determined grading criteria." No explicit adjudication method is described.

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

• The document describes "qualitative image grading and agreement" studies (Angiography and Raster Image Quality Studies) that involved multiple readers. However, these appear to be primarily for assessing image quality and clinical relevance of the device outputs, rather than a direct MRMC comparative effectiveness study where human readers' diagnostic performance with and without AI assistance is measured.
• The studies compare the C6000's image quality to the C5000, and human readers grade these images. There is no mention of an effect size for how much human readers improve with AI vs without AI assistance. The device itself, the Cirrus HD-OCT, is an imaging device, not an AI-based diagnostic tool providing interpretations to assist human readers in the traditional sense of AI studies.

6. Standalone (Algorithm Only) Performance Study

• The document implies that the device's segmentation algorithms are the same as the predicate device and that "the segmentation results will be equivalent." It also states "ZEISS demonstrated non-clinical equivalency between the CIRRUS 6000 and CIRRUS 5000 scan data using a phantom retina, which shows the equivalency of the segmentation results as the segmentation algorithms are the same in both instruments."
• This suggests that an assessment of the algorithm's performance (particularly segmentation) was conducted indirectly by verifying equivalency to the predicate device's algorithms and demonstrating that the acquired data from the C6000 results in equivalent segmentation on a phantom. However, a specific "standalone" study rigorously evaluating the algorithm's performance on clinical data separate from the device's overall output is not explicitly detailed. The R&R study focuses on the precision of measurements derived from segmentations, which implies good algorithm performance.

7. Type of Ground Truth Used

• R&R Study: The "ground truth" here is the assumed true anatomical measurement for the precision calculation. The study methodology evaluates the variability within the device's measurements, not against an independent gold standard for the measurements themselves. The "truth" for this study is essentially the consistency and reproducibility of the device's own measurements.
• Angiography and Raster Image Quality Studies: The ground truth for these studies was established by "three independent reviewers from a reading center" who "graded the OCTA scans on image quality and clinically relevant information according to pre-determined grading criteria." This is expert consensus/grading on image quality and clinical relevance.

8. Sample Size for the Training Set

• The document does not provide information about the training set size for the segmentation algorithms. It explicitly states that the C6000 uses the same segmentation algorithms as the predicate device (C5000). This implies that the algorithms were trained previously for the C5000, and no re-training or new training set was required for the C6000 because the algorithms themselves have not changed.

9. How Ground Truth for Training Set was Established

• As mentioned above, the document states that the C6000 uses the same segmentation algorithms as the predicate device, the CIRRUS HD-OCT 5000 (K181534). Therefore, the training for these algorithms would have been established during the development and clearance of the predicate device. The current submission does not describe the ground truth establishment for the original training of these algorithms.

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