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The Cirrus™ HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Databases is indicated for in-vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of anterior and posterior ocular structures.

The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial crosssectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retinal nerve fiber layer, macula, and optic disc. The Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL) and Macular Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer and the macula in the human retina to a database of known normal subjects. It is intended for use 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 Cirrus™ HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of anterior and posterior ocular structures (including cornea, retina, retinal nerve fiber layer, macula, and optic disc). It emplovs 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.

Here's a breakdown of the acceptance criteria and study details for the Cirrus HD-OCT device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The device's performance was evaluated across several key areas: Retinal Nerve Fiber Layer (RNFL) repeatability and reproducibility, retinal segmentation accuracy, retinal segmentation precision, agreement of retinal thickness measurements with a predicate device (Stratus OCT), and central corneal thickness measurements (CCT) repeatability, reproducibility, and agreement with ultrasound pachymetry.

Table 1: Acceptance Criteria and Reported Device Performance

• AMD: 85.7% (60/70)
• Diabetic Retinopathy: 95.2% (40/42)
• VRI Disorder: 96.4% (27/28)
• Other Retinal Disease: 86.3% (44/51)
• Macular Edema: 96.4% (27/28)
• No Retinal Disease: 100.0% (37/37)
  512x128 Scans:
• AMD: 86.1% (62/72)
• Diabetic Retinopathy: 97.6% (41/42)
• VRI Disorder: 89.3% (25/28)
• Other Retinal Disease: 88.5% (46/52)
• Macular Edema: 93.1% (27/29)
• No Retinal Disease: 100.0% (40/40) |
  | Retinal Segmentation Accuracy (ILM Layer) | Software and hand-segmentations agreed for 100% of A-scans within specified tolerances. | 200x200 Scans:
• AMD: 97.1% (68/70)
• Diabetic Retinopathy: 95.2% (40/42)
• VRI Disorder: 92.9% (26/28)
• Other Retinal Disease: 98.0% (50/51)
• Macular Edema: 100.0% (28/28)
• No Retinal Disease: 100.0% (37/37)
  512x128 Scans:
• AMD: 98.6% (73/74)
• Diabetic Retinopathy: 95.2% (40/42)
• VRI Disorder: 96.3% (26/27)
• Other Retinal Disease: 98.1% (51/52)
• Macular Edema: 96.6% (28/29)
• No Retinal Disease: 100.0% (40/40) |
  | Retinal Segmentation Precision (CSMT Repeatability) | Low standard deviation for central subfield macular thickness measurements. | Repeatability SD (µm) with Cirrus 4.0 MTA with Fovea Placement:
• AMD: 6.3
• DR: 9.8
• VRI Disorder: 5.4
• Other: 7.5
• ME: 7.9
• No Disease: 2.2
  Significantly improved with Fovea Placement and Registration compared to Cirrus 3.0 MTA alone. |
  | Agreement of Retinal Thickness with Stratus OCT | Demonstrate and explain the mean difference, acknowledge non-interchangeability. | Mean Difference Cirrus – Stratus (µm) for Central Subfield:
• AMD: 53.6 (SD: 35.0)
• Diabetic Retinopathy: 40.0 (SD: 47.1)
• VRI Disorder: 43.8 (SD: 35.9)
• Other: 41.7 (SD: 47.1)
• Macular Edema: 45.5 (SD: 45.3)
• Normal: 59.4 (SD: 11.7)
  Non-interchangeable; better for qualitative comparison. |
  | CCT Repeatability and Reproducibility | Not explicitly stated as acceptance criteria, but demonstrating low variability. | Repeatability SD: 4.08 µm
  Repeatability Limits: 11.42 µm
  Reproducibility SD: 4.23 µm
  Reproducibility Limits: 11.84 µm |
  | CCT Agreement with Ultrasound Pachymetry | Demonstrate and explain the mean difference and consistency with other OCT devices. | Mean difference (Cirrus CCT - Ultrasound pachymetry CCT): -9.06 µm (SD: 5.63).
  Consistent with other OCT devices (e.g., Visante OCT is ~15.1 µm thinner than ultrasound). |

Study Details

The provided document describes several clinical evaluations rather than a single overarching study. Here's a breakdown for each:

1. RNFL Repeatability and Reproducibility Study

• Sample Size (Test Set): 32 normal subjects.
• Data Provenance: In-house study, likely US (not explicitly stated, but common for domestic manufacturers). Retrospective/Prospective not specified, but the nature of the study (inter-visit, inter-instrument) points to prospective data collection for this specific evaluation.
• Number of Experts & Qualifications: Not applicable or specified, as this focuses on objective measurement variability.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No.
• Standalone Performance: Yes (algorithm/device performance in measurement).
• Type of Ground Truth: N/A for repeatability/reproducibility; focuses on consistency of device measurements.
• Training Set Sample Size: N/A (this study evaluates the device's measurement consistency, not an AI model).
• Training Set Ground Truth: N/A.

2. RNFL Agreement with Stratus OCT Study

• Sample Size (Test Set): 130 subjects (normal and patients).
• Data Provenance: Not explicitly stated, but the reference to "a recent study" and the nature of the publication suggests a clinical research setting, likely academic and possibly multi-site. The reference mentions "Poster 4628, ARVO 2008," indicating an academic presentation.
• Number of Experts & Qualifications: Not applicable for establishing ground truth as it's a comparison of device measurements.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No.
• Standalone Performance: Yes (comparing two devices' standalone measurements).
• Type of Ground Truth: N/A; comparing measurements from two different OCT systems.
• Training Set Sample Size: N/A.
• Training Set Ground Truth: N/A.

3. Retinal Segmentation Accuracy and Precision Study

• Sample Size (Test Set): Both eyes of 370 subjects. One eye chosen as the "study eye." Subjects classified into 6 pathology groups (AMD, DR, VRI, Other Retinal, Macular Edema, No Retinal Pathology).
• Data Provenance: Four sites, location not specified (likely US, given the sponsor). Retrospective/Prospective not explicitly stated, but the controlled scanning protocol suggests prospective data collection for this evaluation.
• Number of Experts & Qualifications: Not explicitly stated, but "hand-segmentations" imply expert manual delineation. No specific qualifications are listed.
• Adjudication Method: Not explicitly stated, but since agreement was defined as software and hand-segmentations being within a certain micron range, there was a defined metric for evaluating agreement.
• MRMC Comparative Effectiveness Study: No.
• Standalone Performance: Yes (algorithm's ability to segment layers).
• Type of Ground Truth: "Hand-segmentations" by experts. This serves as the reference standard for evaluating the automatic segmentation algorithm's accuracy.
• Training Set Sample Size: N/A (this study evaluates the segmentation algorithm, not AI training specific to this device).
• Training Set Ground Truth: N/A.

4. Retinal Thickness Measurements: Agreement with Stratus Study

• Sample Size (Test Set): N=63 (AMD), N=39 (Diabetic Retinopathy), N=45 (VRI Disorder), N=53 (Other), N=35 (Macular Edema), N=48 (Normal) - total not explicitly summed but likely combined from the larger 370 subject cohort, or a subset.
• Data Provenance: Implied same as the Retinal Segmentation study (four sites, likely US, prospective-like data collection).
• Number of Experts & Qualifications: Not applicable for establishing ground truth, as it's a comparison of device measurements.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No.
• Standalone Performance: Yes (comparing two devices' standalone measurements).
• Type of Ground Truth: N/A; comparing measurements from two different OCT systems.
• Training Set Sample Size: N/A.
• Training Set Ground Truth: N/A.

5. Central Corneal Thickness (CCT) Measurements Study

• Sample Size (Test Set): Phase I: 28 subjects; Phase II: 22 subjects (different subjects). For CCT vs. Ultrasound: 50 eyes.
• Data Provenance: In-house study (likely US). Prospective data collection for both phases.
• Number of Experts & Qualifications: Not applicable for establishing ground truth for CCT measurements.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No.
• Standalone Performance: Yes (device measurement performance).
• Type of Ground Truth: N/A for repeatability/reproducibility. For CCT vs. Ultrasound, ultrasound pachymetry serves as a comparative reference, but not explicitly stated as "ground truth" for CCT itself in the same vein as expert pathology.
• Training Set Sample Size: N/A.
• Training Set Ground Truth: N/A.

6. RNFL and Macula Normative Databases

• Sample Size (Test Set): RNFL: 284 subjects (aged 19-84); Macula: 282 subjects (aged 19-84).
• Data Provenance: Seven sites, location not specified (likely multi-center within the US or potentially international, but typical for normative data collection). Prospective.
• Number of Experts & Qualifications: Not explicitly stated, but the subjects would have been confirmed "normal" by qualified clinicians, typically ophthalmologists or optometrists.
• Adjudication Method: N/A for normative database collection directly.
• MRMC Comparative Effectiveness Study: No.
• Standalone Performance: Not applicable, as this is the collection and analysis of normative data, not an algorithm's performance against it.
• Type of Ground Truth: Clinically determined healthy/normal status of subjects.
• Training Set Sample Size: N/A, this is the data from which normative ranges are derived or "trained" for comparison.
• Training Set Ground Truth: "Known normal subjects" based on clinical assessment.

Summary of AI Specifics:

The provided document describes the performance of an optical coherence tomography (OCT) device and its inherent algorithms for retinal layer segmentation and thickness measurement. It does not explicitly mention the use of "AI" in the modern sense of machine learning or deep learning models, nor does it present an "AI vs. no AI assistance" comparative effectiveness study for human readers. The algorithms described are more in line with traditional image processing and segmentation techniques. Therefore, questions related to AI effect size, AI training set specifics, and AI ground truth are not directly answered by this 2009 submission.

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