(253 days)
The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length.
The analysis covers:
- · Cornea Thickness
- · Anterior Segment
o Anterior chamber width, depth, volume and angle parameters
o Lens Thickness - · Axial Length
The ANTERION is a diagnostic imaging device for the eye. The technology is based on swept-source optical coherence tomography (SS-OCT) technology. The device itself has two basic component groups:
· ANTERION Hardware (Imager/Base) with integrated forehead/ chin rest: The hardware includes imaging hardware (e.g., laser, LEDs, optics, detectors, hardware for spatial encoding) as well as a touch screen.
• ANTERION Software (V.1.5) (PC): The ANTERION Software includes the main user interface. The software allows for device control, such as selection of examination(s) and imaging parameter(s). The ANTERION software provides an interface for a Medical Image Management and Processing System.
The ANTERION hardware is separated in three parts: the Base (bottom part), the Imager (top part), and the Head Rest (forehead/chin rest).
For examinations, the patient places his/her head in the forehead/chin rest. The Head Rest is mechanically and electronically connected to the Base and controlled via a joystick. Within its stand, a stepper motor with additional mechanic parts and a controller board are placed, allowing the operator to move the motorized chin rest up or down for optimally positioning the patients' eye. An external fixation light is mounted at the forehead rest.
The Base mainly contains the power supply and PC connection of the device. In the Imager, the components for scanning, signal generation, and signal processing are contained.
The operator directly accesses two software modules, which are named AQM (acquisition module) and VWM (viewing module). The AQM allows selecting between examinations. The VWM shows acquired images, parameters, and reports.
The ANTERION device contains two imaging modalities, a scanning optical coherence tomography (OCT) modality and an infrared (IR) camera. The OCT modality allows for cross-sectional imaging and biometry, while the IR camera allows for en-face imaging of a patient's eve.
The ANTERION device provides four separate software functionalities (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App. (2) the Cornea App. (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements for the patient´s individual corneal geometry and corneal characteristics. The Cornea App provides tomographic data and parameters, such as corneal curvature and thickness. The Cataract App provides key measurements for cataract surgery planning, such as corneal thickness, anterior chamber depth and axial length. The Metrics App generates OCT images and scan parameters for the anterior chamber such as anterior chamber angle and volume. The four ANTERION Apps are locked/unlocked independently by a license mechanism for each App. The software implementation of these Apps is realized within the AQM and VWM.
The following modification has been applied to the device, subject of this 510(k):
- · Addition of the Epithelial Thickness Module (separate License in the Cornea App) with maps and parameters of the corneal epithelial and stromal thickness.
To function as intended, the ANTERION must be connected to a Medical Image Management and Processing system (MIMPS) with compatible interface. To date, HEYEX 2 / HEYEX PACS is the only available MIMPS with compatible interface.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The document describes a comparative study, implying that the acceptance criteria for the "ANTERION" device's new Epithelial Thickness Module were based on its precision (repeatability and reproducibility) and agreement with an existing legally marketed device, the "Cirrus HD-OCT 5000 with Anterior Segment Premier Module."
The acceptance criteria are implicitly defined by demonstrating similar or better precision and general agreement with the predicate device across various corneal epithelial thickness measurements and patient populations.
Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implicit, based on predicate device performance) | Reported ANTERION Performance |
|---|---|---|
| Precision (Repeatability SD) | ANTERION Repeatability SD values should be similar to or better than Cirrus HD-OCT 5000. (Cirrus repeatability SD range 0.67 µm to 2.01 µm, and 7mm Zone range 1.34 µm to 2.87 µm, for all populations and subgroups) | ANTERION repeatability SD values ranged 0.59 µm to 1.59 µm (except 7mm Zone parameters: 1.49 µm to 2.32 µm). Generally lower than Cirrus. |
| Precision (Reproducibility SD) | ANTERION Reproducibility SD values should be similar to or better than Cirrus HD-OCT 5000. (Cirrus reproducibility SD range 0.76 µm to 2.24 µm, and 7mm Zone range 1.34 µm to 2.87 µm, for all populations and subgroups) | ANTERION reproducibility SD values ranged 0.59 µm to 1.81 µm (except 7mm Zone parameters: 1.64 µm to 2.48 µm). Generally lower than Cirrus. |
| Precision (CV%) | ANTERION CV% should be similar to or better than Cirrus HD-OCT 5000. (Cirrus CV% range 1-5%, with Keratoconus Eyes up to 5.04%) | Most ANTERION CV%s were within or around 1-4% (range 0.90% to 3.47%, except Keratoconus Eyes up to 3.82%). Generally similar or better than Cirrus. |
| Agreement (Limits of Agreement & Deming Regression) | General agreement between ANTERION and Cirrus HD-OCT 5000, demonstrated by Limits of Agreement and Deming Regression Coefficients (95%CI for intercept including 0 and 95%CI for slope including 1). | General agreement shown, though ANTERION exhibited systematically slightly thicker measurements (mean difference 1.3 µm to 5.1 µm thicker). Deming Regression 95%CI for intercept included 0 and for slope included 1 for most parameters, with exceptions in certain subgroups. |
| Acquisition Acceptability Rate | Not explicitly stated as an acceptance criterion, but performance was measured. | Higher for ANTERION (83.0%) than Cirrus (66.3%) for all eyes. |
| Safety | No adverse events related to the device. | No adverse events reported. |
Study Details:
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Sample sizes used for the test set and data provenance:
- Total Subjects: 115 subjects
- 32 in Normal Cornea population (Group A)
- 82 in Abnormal Cornea population (Group B), further divided into:
- 25 Keratoconus subgroup
- 20 Contact Lens Wearer subgroup
- 18 Status Post-Keratorefractive Surgery subgroup
- 19 Dry Eye Disease subgroup
- Data from 32 Group A and 81 Group B participants were included in precision analyses.
- Data from 32 Group A and 80 Group B participants were included in agreement analyses.
- Provenance: Prospective, randomized precision and agreement clinical study conducted at one diverse clinical site in the United States.
- Scans per parameter/population: Vary (e.g., 285 scans for most Normal Cornea parameters, 725 for most Abnormal Cornea parameters). Each participant had 3 replicates per acquisition type, per configuration from three device-operator configurations.
- Total Subjects: 115 subjects
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study does not establish ground truth using experts in the traditional sense (e.g., radiologists interpreting images). Instead, it's a comparative effectiveness study where the ANTERION device's measurements are compared to those of a legally marketed predicate device (CIRRUS HD-OCT 5000). The "ground truth" implicitly refers to the measurements obtained by the predicate device, or rather, the comparison is made between the measurements of the two devices, not against an external expert-derived truth. Expertise was involved in operating the devices and assessing image quality by the operator, but not in establishing a separate "ground truth" for the measurements themselves.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated for the test set measurements. The study design involved "three replicates per acquisition type, per configuration" and "image quality was assessed by the operator after each acquisition." This suggests that the operators evaluated the quality of the individual scans, but there is no mention of an independent adjudication process for the actual thickness measurements or a consensus method for defining "ground truth" between multiple readers.
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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:
- This was a comparative effectiveness study involving multiple operators ("three operators") and multiple cases (115 subjects / ~114 study eyes). However, it was not an MRMC study focused on human reader improvement with/without AI assistance. This study compared measurements from one device (ANTERION) to another (CIRRUS HD-OCT 5000) for precision and agreement. The "ANTERION" device is an ophthalmic imaging and analysis device, and while it has "Apps" that perform analysis, the study focuses on the device's measurement performance rather than an AI component assisting human readers in diagnosis.
- Therefore, there is no effect size reported regarding human readers improving with/without AI assistance in this context.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the study primarily evaluates the standalone performance of the ANTERION device's measurement capabilities (specifically the Epithelial Thickness Module) against a predicate device. While human operators collected the images, the reported precision (repeatability and reproducibility) and agreement data are quantifications of the device's algorithmic measurement outputs. The "Cornea App" and its Epithelial Thickness Module perform the thickness calculations.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The study uses the measurements from a legally marketed predicate device (CIRRUS HD-OCT 5000) as the reference for comparison, rather than an independent "ground truth" like pathology or expert consensus. The aim is to show that the new device's measurements are sufficiently precise and agree with those from an established device.
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The sample size for the training set:
- The document does not provide information on the training set for the ANTERION device's algorithms. The study described is entirely focused on the clinical performance testing (test set) of the device.
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How the ground truth for the training set was established:
- As no information on the training set is provided, how its "ground truth" was established is also not available in this document.
§ 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.