FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The 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 anterior and posterior ocular structures, including cornea, retina, 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, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. The 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.

Device Description

The CIRRUSTM 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 employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this noninvasive 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 four models, Model 4000, 400, 5000 and 500. In the CIRRUS HD-OCT Models 4000 and 5000, the fundus camera is a line scanning ophthalmoscope. The CIRRUS HD-OCT Models 400 and 500 are similar to the Models 4000 and 5000 except that they provide 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, neuro-retinal 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 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.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the Carl Zeiss Meditec Inc. Cirrus HD-OCT with Software Version 8.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating repeatability and reproducibility of measurements, and comparability between the new device (CIRRUS HD-OCT with Software Version 8, specifically Models 4000 and 5000) and the predicate device (Visante OCT). Specific acceptance criteria are not explicitly stated as numerical targets in quantifiable terms for all parameters. Instead, the study aims to show that the new device's measurements are consistent and comparable to the predicate device. The tables report the demonstrated performance rather than predefined acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance (Inferred from the study's objective to demonstrate comparability, repeatability, and reproducibility):

Measurement Parameter	Acceptance Criteria (Inferred)	CIRRUS 4000 Reported Performance (Repeatability SD/CV% / Reproducibility SD/CV%)	CIRRUS 5000 Reported Performance (Repeatability SD/CV% / Reproducibility SD/CV%)	Comparison to Visante OCT (Mean Difference / 95% LOA)
Anterior Chamber Scans (Normal Cornea Group)	Demonstrates repeatability, reproducibility, and comparability to predicate.	See Table 1	See Table 2	See Table 7
CCT	Low SD, CV% for repeatability/reproducibility; Small mean difference and narrow LOA compared to Visante.	Repeatability SD: 8.806 / 1.619%; Reproducibility SD: 9.514 / 1.750%	Repeatability SD: 9.749 / 1.774%; Reproducibility SD: 11.897 / 2.165%	C4000: 9.4 (16.4); 95% LOA: -23.3, 42.1
Angle to Angle	Low SD, CV% for repeatability/reproducibility; Small mean difference and narrow LOA compared to Visante.	Repeatability SD: 0.187 / 1.517%; Reproducibility SD: 0.265 / 2.150%	Repeatability SD: 0.171 / 1.423%; Reproducibility SD: 0.300 / 2.494%	C4000: 0.665 (0.395); 95% LOA: -0.126, 1.456
ACD	Low SD, CV% for repeatability/reproducibility; Small mean difference and narrow LOA compared to Visante.	Repeatability SD: 0.066 / 2.291%; Reproducibility SD: 0.068 / 2.366%	Repeatability SD: 0.034 / 1.199%; Reproducibility SD: 0.046 / 1.601%	C4000: -0.067 (0.077); 95% LOA: -0.220, 0.087
Pachymetry Scans (Normal Cornea Group)	Demonstrates repeatability, reproducibility, and comparability to predicate.	See Table 1	See Table 2	See Table 7
Center Pachymetry	Low SD, CV% for repeatability/reproducibility; Small mean difference and narrow LOA compared to Visante.	Repeatability SD: 3.359 / 0.635%; Reproducibility SD: 3.719 / 0.703%	Repeatability SD: 1.197 / 0.226%; Reproducibility SD: 1.628 / 0.308%	C4000: 1.4 (4.1); 95% LOA: -6.8, 9.7
... (Other Pachymetry Zones)	Similar criteria as Center Pachymetry.	See Table 1 (various values)	See Table 2 (various values)	See Table 7 (various values)
Anterior Chamber Scans (Corneal Pathology Group)	Demonstrates repeatability, reproducibility, and comparability to predicate in pathological cases.	See Table 3	See Table 4	See Table 8
CCT	Similar criteria as Normal Cornea.	Repeatability SD: 10.023 / 1.923%; Reproducibility SD: 14.069 / 2.699%	Repeatability SD: 12.061 / 2.267%; Reproducibility SD: 18.951 / 3.561%	C4000: 8.2 (20.0); 95% LOA: -31.7, 48.2
... (ATA, ACD, Pachymetry Zones)	Similar criteria.	See Table 3	See Table 4	See Table 8
Pachymetry Scans (Post-LASIK Group)	Demonstrates repeatability, reproducibility, and comparability to predicate in post-LASIK cases.	See Table 5	See Table 6	See Table 9
Center Pachymetry	Similar criteria.	Repeatability SD: 1.793 / 0.385%; Reproducibility SD: 2.000 / 0.430%	Repeatability SD: 1.784 / 0.383%; Reproducibility SD: 2.068 / 0.445%	C4000: 2.2 (5.9); 95% LOA: -9.6, 14.0
Angle Study (Glaucoma Suspects/Patients)	Demonstrates repeatability, reproducibility, and comparability to predicate for angle measurements.	See Table 10	See Table 11	See Table 12
TISA 500 Nasal (Wide Angle to Angle Scan)	Low SD, CV% for repeatability/reproducibility; Small mean difference and narrow LOA compared to Visante.	Repeatability SD: 0.020 / 13.590%; Reproducibility SD: 0.032 / 21.484%	Repeatability SD: 0.025 / 16.801%; Reproducibility SD: 0.030 / 19.614%	C4000: Not directly provided for TISA (Only for AC Angle)
AC Angle Nasal (Wide Angle to Angle Scan)	Low SD, CV% for repeatability/reproducibility; Small mean difference and narrow LOA compared to Visante.	Repeatability SD: 4.128 / 11.479%; Reproducibility SD: 4.626 / 12.862%	Repeatability SD: 3.427 / 9.475%; Reproducibility SD: 4.861 / 13.442%	C4000: -1.887 (7.155); 95% LOA: -16.196, 12.422
... (Other angle measurements)	Similar criteria.	See Table 10	See Table 11	See Table 12

Study Details:

Sample sizes used for the test set and data provenance:
- Anterior Chamber and Pachymetry Scans:
  - Normal Cornea group: 46 subjects (Group 1)
  - Post-LASIK group: 40 subjects (Group 2)
  - Corneal Pathology group: 45 subjects (Group 3)
  - Age Range (all groups): 25 to 69 years.
  - Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "non-significant risk clinical study," implying prospective data collection in a clinical setting.
- Angle Study:
  - Angle Study: 27 subjects, ranging from 43 to 77 years (mean 62 years).
  - Specific eye counts per measurement type:
    - 26 eyes for Wide Angle-to-Angle scan
    - 27 eyes for HD Angle scan
  - Data Provenance: Not explicitly stated (e.g., country of origin). Described as a "non-significant risk clinical study," implying prospective data collection.
- OCT Angiography: Series of case studies. No specific sample size is provided beyond "case studies."
Number of experts used to establish the ground truth for the test set and their qualifications:
- Anterior Chamber and Pachymetry Scans: No external experts were used for "ground truth" in the sense of an adjudicated diagnosis. The study focused on comparing measurements between devices and assessing repeatability/reproducibility. The predicate device (Visante OCT) served as the reference for comparability. One operator acquired data on the Visante OCT. Three operators acquired data on the CIRRUS HD-OCT devices.
- Angle Study: The study focused on device measurement comparison, repeatability, and reproducibility. One operator acquired data on the Visante OCT. Three operators acquired data on the CIRRUS HD-OCT devices. The study population had a variety of angle configurations (Grade II to Grade IV) as assessed by gonioscopy using the Shaffer method, but the gonioscopy results themselves were not used as a direct "ground truth" for individual measurement values from the OCT devices.
- OCT Angiography: The "findings demonstrate that the CIRRUS OCT Angiography... can give non-invasive three-dimensional information regarding retinal microvasculature." This was compared with "fluorescein angiography images." The number and qualifications of experts interpreting either the OCTA or fluorescein angiography images for these case studies are not specified in the provided text.
Adjudication method for the test set:
- Anterior Chamber and Pachymetry Scans: Not applicable for establishing ground truth, as the study focused on device measurement comparison and repeatability/reproducibility across devices and operators. Measurements were generated by "manual placement of software tools."
- Angle Study: Similar to the above, not applicable for establishing "ground truth" through adjudication. Measurements were generated by "manual placement of software tools (Angle tool; TISA tool)" by the operators who acquired the data.
- OCT Angiography: Not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance was not explicitly reported or performed in the provided text. The study primarily focused on the device's technical performance (repeatability, reproducibility, and agreement with a predicate device) rather than its impact on human reader diagnostic accuracy with or without AI. The device itself (CIRRUS HD-OCT with Software Version 8) is an imaging and measurement device, not explicitly an "AI" diagnostic tool in the context of human-in-the-loop performance measurement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, the primary studies for Anterior Chamber, Pachymetry, and Angle measurements assessed the standalone performance of the device's measurement algorithms by evaluating their repeatability, reproducibility, and agreement with predicate device measurements. These measurements are generated by the device's software (e.g., "manual placement of software tools" by an operator, but the calculation is still algorithmic). The OCT Angiography section also mentions the device's ability to provide information on microvasculature without human "in-the-loop" interpretation for the basic image generation. However, it's not described as an "AI algorithm" in the common sense of diagnosing from images.
The type of ground truth used:
- Anterior Chamber, Pachymetry, and Angle Studies: The "ground truth" was effectively the measurements obtained from the predicate device (Visante OCT). The purpose was to show substantial equivalence and comparability, not to determine diagnostic accuracy against an independent, gold-standard clinical pathology or outcome.
- OCT Angiography: Comparisons were made with fluorescein angiography images. Fluorescein angiography is a clinical gold standard for visualizing retinal and choroidal vasculature.
The sample size for the training set:
- The document does not provide information on the training set size. The studies described are validation studies for the device's technical performance and comparability to a predicate. The device incorporates "proprietary algorithms" and "normative databases," which would have been developed using some form of training data, but details about this training data are not included in the provided 510(k) summary.
How the ground truth for the training set was established:
- Not described in the provided text. As mentioned above, the 510(k) summary focuses on the validation studies, not the development or training of any underlying algorithms or normative databases. The "normative databases" would inherently rely on data from "normal subjects," but the specifics of their ground truth establishment are not given.

Summary

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.