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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.1.2.4) (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. Placed within the stand are a stepper motor with additional mechanical parts and a controller board, 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 eye.

The ANTERION device provides four separate software applications (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App (cleared under K211817), (2) the Cornea App, (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements paraments 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 the 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.

This submission is to seek clearance for the Metrics App, Cataract App and Cornea App.

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.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the ANTERION device (K230897).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a table format with specific thresholds for each parameter. Instead, it presents extensive "Repeatability and Reproducibility" data (precision analyses) from two clinical studies (B-2018-3 and B-2018-5). The implication is that the demonstrated precision values meet the internal acceptance criteria for the device's performance.

Therefore, the table below will present the reported device performance, which is implicitly what the device "met" to achieve clearance. It's important to note that specific numerical acceptance thresholds are not explicitly defined in the provided text. The reported values are the performance demonstrated by the device in the studies.

Table 1: Reported Device Performance (Repeatability and Reproducibility)

Note regarding Acceptance Criteria: The document states, "The device met all pre-determined acceptance criteria" under "Non-Clinical Performance Testing". For clinical performance, it states, "Results of the clinical performance testing demonstrate a favorable clinical performance profile that supports a determination of substantial equivalence." This implies that the demonstrated repeatability and reproducibility values, as detailed in the tables, were considered acceptable for the device's intended use. Specific numerical thresholds for each parameter are not provided.

2. Sample Size Used for the Test Set and Data Provenance

The provided text details the sample sizes for the clinical studies which serve as the test sets for the device's performance.

• Study Protocol B-2018-3:

  • Sample Size:
    • Group A (open angle): 29 participants completed, data from 25 for precision analyses (225 scans). 27 for agreement analyses.
    • Group B (narrow angle): 27 participants completed, data from 27 for precision analyses (234 scans). 26 for agreement analyses.
    • Total enrolled: 30 Group A, 28 Group B.
  • Data Provenance: Single clinical site in the United States. The study was prospective, observational clinical study.

• Study Protocol B-2018-5:

  • Sample Size: 176 participants enrolled, 172 completed.
    • Group A (normal anterior segment): 27 participants.
    • Group B (cataract): 33 participants.
    • Group C (corneal abnormalities): 45 participants (38-43 for specific parameters in precision analysis tables).
    • Group D (post-keratorefractive surgery): 29 participants (28-29 for specific parameters).
    • Group E (pseudophakic/aphakic eyes): 41 participants (39-40 for specific parameters).
    • Scans: Varied per parameter and group, ranging from ~243 to 378 scans for precision analysis.
  • Data Provenance: Single clinical site in the United States. The study was prospective, observational clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set.

It mentions:

• "Manual correction of ANTERION segmentation and manual editing of the scleral spur and angle recess points were performed as needed" for Protocol B-2018-3.
• "Manual correction of ANTERION segmentation was performed by an independent reading center and manual placement of the angle recess points were performed" for Protocol B-2018-5.

While it mentions manual correction and an "independent reading center," it does not specify the number of experts, their specialty (e.g., ophthalmologists, optometrists, or technicians), or their years of experience for establishing this ground truth.

4. Adjudication Method for the Test Set

The document mentions "Manual correction of ANTERION segmentation and manual editing of the scleral spur and angle recess points were performed as needed" and "Manual correction of ANTERION segmentation was performed by an independent reading center and manual placement of the angle recess points were performed."

However, it does not describe a formal adjudication method (e.g., 2+1, 3+1, majority vote, etc.) for resolving disagreements among multiple readers or for establishing the final "ground truth" if multiple experts were involved in these manual corrections. It implies that a single "manual correction" was applied, but the process for achieving a single corrected state from potentially multiple reviewers or iterations is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a standard MRMC comparative effectiveness study was not performed as described for AI assistance.

The studies compared the ANTERION device's measurements not to human readers' performance, but to other devices (CIRRUS HD-OCT 5000 and Pentacam AXL) for accuracy and to itself for precision (repeatability and reproducibility). The ANTERION is an imaging and measurement device, not an AI-assisted diagnostic tool that aids human readers in interpretation. Therefore, a study of how human readers improve with AI vs without AI assistance is not applicable in the context described.

The studies assessed the ANTERION's ability to consistently and accurately measure ophthalmological parameters.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The performance results presented (Repeatability and Reproducibility) for the ANTERION device represent its standalone performance as a measurement device. The reported CV% values reflect the device's inherent precision in generating these measurements.

While manual corrections of ANTERION segmentation were performed in the studies, this was described as a step in processing the acquired images to enable measurements, rather than human "interpretation" of the algorithm's output for diagnostic purposes in a human-in-the-loop scenario. The repeatability and reproducibility are derived from the measurements produced by the device, sometimes after such manual adjustments. The overall goal was to demonstrate the consistent and accurate measurement capability of the device rather than a diagnosis assistance system.

7. The Type of Ground Truth Used

The ground truth for the clinical performance assessment appears to be based on:

• Comparison to legally marketed devices: The studies performed "agreement analyses" with CIRRUS HD-OCT 5000 and Pentacam AXL, implying these served as reference or comparative ground truth for measurement accuracy. The details of these agreement analyses (e.g., Bland-Altman, Deming regression) are mentioned, but the specific numerical outcomes of these agreement analyses are not provided in the excerpt.
• Manual correction by experts/independent reading center: For measurements derived from image segmentation (e.g., angle parameters, corneal thickness, chamber depth), "manual correction of ANTERION segmentation" and "manual placement of the angle recess points" were performed. This suggests that the ground truth for these segmented features was established by manual review, presumably by qualified personnel, even though their qualifications are not specified.

Therefore, the ground truth is a combination of comparison to established ophthalmic devices and expert manual correction/review of segmented images. It is not pathology or outcomes data.

8. The Sample Size for the Training Set

The provided document describes the clinical studies for device validation/testing. It does not provide information on the sample size used for the training set of the ANTERION's algorithms. As a measurement device rather than an AI diagnostic algorithm in the typical sense, it's possible that its internal algorithms rely on established physical/optical models and calibration, not necessarily a large-scale "training set" of images in the machine learning context. However, if machine learning was used for segmentation, the training set details are not provided.

9. How the Ground Truth for the Training Set Was Established

Since no information is provided about a "training set" or the use of machine learning for its algorithms, there is no information on how the ground truth for any hypothetical training set was established.

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The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization of the anterior segment.

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/Basis) 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 (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 PC software additionally stores, receives, and displays the acquired data.

The ANTERION hardware is separated in three parts: the Basis (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 Basis and controlled via a ioystick. Placed within the stand are a stepper motor with additional mechanical parts and a controller board, 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 Basis 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, while the IR camera allows for en-face imaging of a patient's eye.

The Imaging App, the subject of this submission, is the foundation of the ANTERION platform, and focuses on the high-resolution visualization of the entire anterior segment, from the anterior surface of the cornea to the posterior surface of the lens.

The Imaging App delivers swept-source OCT images that allow visualization of anterior segment pathologies and evidence of surgical interventions, e.g. keratoplasty, LASIK, implanted IOLs, and phakic lenses.

Here's a breakdown of the acceptance criteria and study details for the ANTERION device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document focuses on establishing substantial equivalence rather than explicit quantitative acceptance criteria with pass/fail thresholds. However, the study aims to demonstrate that the ANTERION's performance is similar to or better than the predicate and reference devices in key areas.

Here's a table summarizing the implicit acceptance criteria (demonstrated similarity or superiority) and the reported device performance:

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 87 participants (34 in "Normal Anterior Segment group", 53 in "Abnormal Anterior Segment group"). One eye per subject was selected.
   • Data Provenance: Prospective, single clinical site in the United States.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • Number of Experts: Three independent graders were used for image quality and abnormality identification.
   • Qualifications: "Qualified graders" are mentioned. No specific experience (e.g., "radiologist with 10 years of experience") is provided, but they were described as "masked" and "independent."

3. Adjudication Method for the Test Set:

   • Method: Majority rule was applied to get consensus from the three independent graders.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Was it done? Yes, effectively. The study compared the ANTERION device to the CIRRUS HD-OCT 5000 device using multiple graders and multiple cases, assessing both image quality and abnormality identification.
   • Effect size of human readers improve with AI vs. without AI assistance: This study does not directly measure the improvement of human readers with AI assistance. Instead, it compares the device's performance (ANTERION) against a comparator device (CIRRUS) for diagnostic imaging purposes. Human graders (experts) were used to evaluate the output of both devices and establish ground truth, not to assess AI assistance to human readers.

5. Standalone (Algorithm Only) Performance:

   • The study evaluates the ANTERION imaging app as a diagnostic device, which produces images and potentially analyses thereof. The assessment of image quality and abnormality identification was performed by human graders viewing the images produced by the device. It is not explicitly stated whether the ANTERION has an "algorithm only" mode that provides automated diagnoses without human review, but the clinical evaluation method suggests a focus on the quality of the images provided for human interpretation rather than fully automated standalone performance.

6. Type of Ground Truth Used:

   • For Abnormality Identification: The slit lamp examination performed by the investigator was used as the reference (ground truth) for identifying abnormalities.
   • For Image Quality and Visibility of Structures: Expert consensus (majority rule of three masked graders) was used to grade image quality and visibility of structures on the OCT images from both devices.

7. Sample Size for the Training Set:

   • The document does not provide information on the sample size used for the training set for the ANTERION device's algorithms or software. The clinical study described is a test set evaluation.

8. How the Ground Truth for the Training Set Was Established:

   • The document does not provide this information. The clinical study details focus solely on the evaluation of the device's performance using a test set.

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The RTVue XR OCT Avanti with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician. The RTVue XR OCT Avanti with Normative Database is also a quantitative tool for the comparison of retinal nerve fiber layer, and optic disk measurements in the human eve 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.

The RTVue XR OCT Avanti with AngioVue Software is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The RTVue XR OCT Avanti is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and measurement of the retinal nerve fiber layer and optic disc with micrometer range resolution as a tool and aid in the diagnosis and management of retinal disease. Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disc structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL, GCC and outer retinal thickness and total retinal thickness are thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE.

The RTVue XR OCT Avanti is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The computer has a graphic user interface for acquiring and analyzing the image. The line-scan camera operates at approximately 70,000 A-lines per second.

The RTVue XR OCT Avanti offers three scan types: Retina, Glaucoma, and Cornea. For the cornea and anterior eye scans, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM auxiliary attachment (Cornea Anterior Module). The CAM software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina.

With the normative database (NDB), the RTVue XR OCT Avanti can compare the measured data from the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to the normative database. The device will provide the analysis information to he used as a clinical reference to aid in the diagnosis and management of ocular diseases.

The RTVue XR OCT with AngioVue™ has an additional software module to aid in the visualization of vascular structures of the retina and choroid using a motion-contrast techniques without the need for intravenous dyes.

This document does not contain the detailed acceptance criteria or a study proving the device meets specific performance criteria in a quantitative manner as typically presented for AI/ML device submissions. This is a 510(k) summary for a medical device (RTVue XR OCT Avanti with AngioVue Software) filed in 2016, which predates the FDA's specific guidance for AI/ML medical devices.

The submission focuses heavily on demonstrating substantial equivalence to a predicate device (Optovue, Inc. RTVue XR OCT, K120238) rather than presenting a performance study with detailed acceptance criteria and corresponding results for the AngioVue software module.

However, based on the provided text, here's an attempt to answer your questions, highlighting the limitations of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for the AngioVue software's performance in visualizing vascular structures. Instead, the performance is described qualitatively by comparing AngioVue scans with fluorescein angiography images.

2. Sample size used for the test set and the data provenance

The document states: "In case examples of a variety of retinal diseases, RTVue XR OCT Avanti with AngioVue Software cube scans were compared with fluorescein angiography images." This implies a qualitative comparison using a case series, rather than a formal, statistically powered test set with a specified sample size.

• Sample size: Not specified. The phrase "case examples" suggests a small, illustrative set of cases, not a statistically robust sample.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the document. The ground truth appears to be implicitly established by "fluorescein angiography images," which are a recognized clinical standard for vascular visualization. It's not stated whether these images were reviewed by experts for an adjudicated ground truth for the purpose of this submission.

4. Adjudication method for the test set

Not explicitly stated. The comparison was made against "fluorescein angiography images," which serve as a reference. There is no mention of a formal expert adjudication process (e.g., 2+1, 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study is not mentioned in this document. The focus is on the device's capability to visualize structures, not on how its assistance improves human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The "AngioVue software module" is described as providing "visualization of vascular structures." The performance discussed ("can give non-invasive three-dimensional information") refers to the output of the algorithm. Therefore, the visualization capability of the algorithm itself was assessed, but not against quantitative standalone performance metrics like sensitivity/specificity for detecting specific pathologies. The comparison to fluorescein angiography implies a standalone assessment of the image output.

7. The type of ground truth used

The ground truth used for comparison with the AngioVue images was fluorescein angiography images. This is an established clinical imaging modality for visualizing retinal and choroidal vasculature.

8. The sample size for the training set

The document does not provide any information about a training set or its sample size. This is typical for submissions of this era and type, where the software functionality is described as a "visualization aid" rather than a classification or diagnostic algorithm requiring extensive training data disclosures. The motion correction technology (MCT) is proprietary, and its development (which would involve data for "training" or optimization) is not detailed.

9. How the ground truth for the training set was established

Since there is no mention of a training set, the method for establishing its ground truth is also not provided.

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