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.

AI/ML Overview

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:

Acceptance Criteria (Implied)	Reported Device Performance
1. Image Quality of Anterior Segment Structures	Overall, the ANTERION shows superiority in image quality compared to each of the three CIRRUS scans. Specifics shown in Figure 1 indicate a higher percentage of "Good" image quality ratings for ANTERION across all evaluated structures (Cornea/Conjunctiva, Anterior Lens Surface, Iris, Angle, Scleral Spur) compared to CIRRUS scan types (CCN, CAC, CAG). For example, for Cornea/Conjunctiva, ANT showed 83.3% "Good" vs. 52.6% for CCN. This demonstrates ANTERION is at least similar to, and often superior, in image quality.
2. Ability to Identify Abnormality in Anterior Segment (compared to slit lamp reference)	Overall, the ANTERION shows superiority compared to each of the three CIRRUS scans in identifying the abnormality in reference with the slit lamp examination. Figure 2 graphically represents this, showing higher percentages of "Match" (agreement with slit-lamp) for ANTERION (ANT) across various predefined abnormalities (e.g., cornea pterygium, corneal inlay, corneal transplant, trabeculectomy bleb, peripheral iridotomy, glaucoma drainage device) compared to CIRRUS scan types (CAC, CAG/CCN). This indicates ANTERION offers an equal or superior ability in identifying each pre-specified abnormality compared to CIRRUS.
3. Visualization of Key Anatomical Structures	The ANTERION's ability to visualize key anatomical structures was similar to or better than CIRRUS. (This is a conclusion drawn from the image quality assessment where individual structures' visibility was graded).

Study Details:

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.
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."
Adjudication Method for the Test Set:
- Method: Majority rule was applied to get consensus from the three independent graders.
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.
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.
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.
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.
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.

Summary

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November 5, 2021

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Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 226 1st Street Bonita Springs, Florida 34134

Re: K211817

Trade/Device Name: Anterion Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: September 24, 2021 Received: September 27, 2021

Dear Lena Sattler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211817

Device Name

ANTERION

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Descriptive Use (Part 21 CFR 601 Subpart D)
Over-The-Counter Use (21 CFR 601 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, sans-serif font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square to the left of the first line and to the right of the second line.

510(K) SUMMARY

Date Prepared

June 10, 2021

SPONSOR/510(K) OWNER/ MANUFACTURER

Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany Telephone: +49 6221 / 64 63 0 Facsimile: +49 6221 / 64 63 62 Email: aschoess@hdeng.de Establishment Registration No.: 8043762

OFFICIAL CONTACT PERSON

Lena Sattler Orasi Consulting, LLC. 226 1st Street Bonita Springs, FL 34134 Telephone: (440) 554-3706 Facsimile: (866) 904-4315 E-mail: lena@orasiconsulting.com

COMMON/USUAL NAME

Optical Coherence Tomography

PROPRIETARY OR TRADE NAMES

ANTERION

CLASSIFICATION INFORMATION

Regulation Number:	21 CFR 886.1570
Classification name:	Ophthalmoscope
Device Class:	II
Common name:	Optical Coherence Tomography
Product Codes, Name:	OBO (Tomography, Optical Coherence)
Medical Specialty:	Ophthalmic
Classification Panel:	Ophthalmic Device Panel

Heidelberg Engineering GmbH

Traditional 510(k): ANTERION

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PREDICATE DEVICE

Visante OCT (K051789), Carl Zeiss Meditec Inc.

REFERENCE DEVICE

CIRRUS HD-OCT 5000 (K150977), Carl Zeiss Meditec Inc.

INDICATIONS FOR USE

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

GENERAL DEVICE DESCRIPTION

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).

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.

Heidelberg Engineering GmbH

Traditional 510(k): ANTERION

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SUBSTANTIAL EQUIVALENCE

The Substantial Equivalence Summary tables below illustrate the comparisons of the ANTERION to the predicate device and the reference device.

The imaging function of the ANTERION is similar to the anterior imaging function of the predicate device Visante OCT (K051789) and the reference device CIRRUS HD-OCT 5000 (K150977) in intended use and technological characteristics.

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Image /page/6/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, sans-serif font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square to the left of the first line and to the right of the second line.

SUBJECT DEVICE	PREDICATE DEVICE	REFERENCE DEVICE	Discussion
ANTERION	Visante OCT (K051789)	CIRRUS HD-OCT 5000 (K150977)
The ANTERION is a non-contactophthalmic imaging and analysisdevice for the eye. It is intendedfor visualization of the anteriorsegment.	The Visante™ OCT is a non-contact, highresolution tomographic and biomicroscopicdevice indicated for the in vivo imaging andmeasurement of ocular structures in theanterior segment, such as corneal andLASIK flap thickness.	The CIRRUS™ HD-OCT is a non-contact,high resolution tomographic andbiomicroscopic imaging device intended forin-vivo viewing, axial cross-sectional, andthree-dimensional imaging of anterior andposterior ocular structures. The device isindicated for visualizing and measuringanterior and posterior ocular structures,including cornea, retina, retinal nerve fiberlayer, ganglion cell plus inner plexiformlayer, macula, and optic nerve head. TheCIRRUS normative databases arequantitative tools indicated for thecomparison of retinal nerve fiber layerthickness, macular thickness, ganglion cellplus inner plexiform layer thickness, andoptic nerve head measurements to adatabase of normal subjects. The CIRRUSOCT Angiography is indicated as an aid inthe visualization of vascular structures ofthe retina and choroid. The CIRRUS HD-OCT is indicated as a diagnostic device toaid in the detection and management ofocular diseases including, but not limited to,macular holes, cystoid macular edema,diabetic retinopathy, age-related maculardegeneration, and glaucoma.	Similar. All devicessupport imaging of theanterior segment of theeye.

INTENDED USE/INDICATIONS FOR USE STATEMENT CHART

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TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART

(*specific data for the Anterior Segment module of CIRRUS HD-OCT 5000)

	SUBJECT DEVICEANTERION	PREDICATE DEVICEVisante OCT (K051789)	REFERENCE DEVICECIRRUS HD-OCT 5000(K150977)	Discussion
Device classificationname	Optical Coherence Tomographer(OCT)	Optical Coherence Tomographer(OCT)	Optical Coherence Tomographer(OCT)	Same
Main Technology	Swept Source OCT Technology	Time Domain OCT Technology	Spectral Domain OCTTechnology	The OCT technologiesare different, but theresulting images showcomparable structures
SupportingTechnologies	Infrared Camera	Video camera	Infrared Camera	Similar. Their mainusage is to support aproper OCTacquisition.
OCT center wavelength	1310 nm	1310 nm	750 nm	Similar. The OCTwavelength of theANTERION andVisante OCT areintended for anteriorsegment imaging. TheCIRRUS HD-OCT5000 is optimized forposterior segmentimaging but can alsobe used to createanterior segment
	SUBJECT DEVICEANTERION	PREDICATE DEVICEVisante OCT (K051789)	REFERENCE DEVICECIRRUS HD-OCT 5000(K150977)	Discussion
				images using a speciallens module.
OCT axial resolution	<10 um (tissue)	18 um (in tissue)	5 um (in tissue)	Similar
OCT lateral resolution	30 um	60 um	20 um - 45 um*	Similar
Scan length	5 - 16.5 mm	10 mm – 16 mm	9 mm - 15.5 mm*	Similar
Scan depth (in tissue)	8 mm	3 mm; 6 mm	2 mm; 2.9 mm; 5.8 mm*	The ANTERIONprovides imagesshowing the fullanterior segmentincluding the posteriorlens.
Number of A-Scansper B-Scan	256; 512; 768; 1024	128; 256; 512	1024; 2048*	Similar
A-scan rate	50,000 Hz	2,000 Hz	27,000/68,000 Hz	The OCT technologyused in the Visantecannot provide highA-Scan rates
Number of B-Scans	1-65	1; 2; 3; 4; 8; 16	1-24*	Adjustable in alldevices.
Scan Pattern	Line, Volume, Arc, Radial	Line, Line Raster Scan	Line, Line Raster Scan, Radial	Similar
Scan Center	Adjustable	Not adjustable	Not adjustable	The ANTERIONprovides moreflexibility in definingthe scanned area.
	SUBJECT DEVICEANTERION	PREDICATE DEVICEVisante OCT (K051789)	REFERENCE DEVICECIRRUS HD-OCT 5000(K150977)	Discussion
Tracking	Available	Available	Not available for anteriorsegment imaging	Tracking improves theability to correlateacquired B-Scans toeach other and enablesscanning of largerareas.
Number of averagedScans per B-Scan/	1; 2; 4; 8	1; 4	20*	All devices providesome sort of scanaveraging.
IR camera image size(px)	768 x 576	No information found	1280 x 1024	Differences in thecamera specificationsare not relevant
Patient/ User Interface
Patient groups	No restrictions regarding patientgroups	No restrictions regarding patientgroups	No restrictions regarding patientgroups	Same
Dilation of pupilrequired?	No	No	No	Same
Eye contact required?	No	No	No	Same
Fixation light	Internal, external	Internal, external	Internal, external	Same
Working position	Upright sitting position of thepatient, using chin rest andforehead rest	Upright sitting position of thepatient, using chin rest andforehead rest	Upright sitting position of thepatient, using chin rest andforehead rest	Same
User Interface	Joystick for user to move andalign device, device has GUI(Graphical user interface) fordisplay and analysis of data	Graphical user interface for userto move and align device, devicehas GUI for display and analysisof data	Graphical user interface for userto move and align device, devicehas GUI for display and analysisof data	All systems provide adisplay attached to thedevice, showing a GUIto supervise and
SUBJECT DEVICEANTERION	PREDICATE DEVICEVisante OCT (K051789)	REFERENCE DEVICECIRRUS HD-OCT 5000(K150977)	Discussion
			control the acquisitionand analyze the data.

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NON-CLINICAL PERFORMANCE SUMMARY

Software documentation was provided, and software verification and validation was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Documentation regarding cybersecurity was submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and an overall risk assessment regarding security and safety of the device was conducted due to ISO 14971:2007.

Laser safety testing for the light sources used in ANTERION was provided and showed that the requirements according to FDA recognized standards IEC-60825-1:2007 and ANSI Z80.36:2016 were fulfilled.

Biocompatibility of the device was demonstrated by cytotoxicity testing and chemical analysis according to ISO 10993-5:2009 and ISO 10993-18:2005. respectively, and supported by biocompatibility assessment according to 10993-1:2018.

Tests for electrical safety (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012) and electromagnetic radiation (EC 60601-1-2 Edition 4.0 2014-02) were performed with the Anterion device and passed the relevant requirements of the applied standards.

CLINICAL EVALUATION

A prospective, clinical study was conducted at a single clinical site in the United States to compare the clinical performance of the ANTERION Imaging App between the ANTERION and the CIRRUS HD-OCT 5000 devices. 87 participants age 22 or older meeting eligibility criteria in at least one eye were enrolled into two study cohorts, the "Normal Anterior Segment group" (without abnormality present in the anterior segment of the eye) and the "Abnormal Anterior Segment group" (those anterior segment abnormalities identified with the slit lamp exam such as glaucoma and corneal surgeries). One eye of each subject was selected to be the study eye, (randomly determined when both eyes were eligible).

The following endpoints were evaluated:

The image quality grade of the acquired images. ●
Agreement in identification of abnormality between the B-Scan images using the ● slit lamp examination as the reference.

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An eye examination was performed to determine study eligibility, then inclusion and exclusion criteria were assessed. The anterior segment abnormalities and a primary Abnormality of Interest (AOI) were identified during the eye examination by the investigator (when applicable). The device order and the acquisition type order was randomized.

Imaging was performed by the site operators based on randomization

The first acceptable scans were sent to the Reading Center for grading. Each grader graded each image for image quality and for identification and assessment of abnormality (if applicable). The images were presented to three independent graders, who were blinded to the subject identification, population allocation, eye examination results and to each other's grading results. Majority rule was applied to get consensus. For each device and acquisition type (if applicable), three qualified graders graded the OCT images for quality into categorical groups (1 = poor, 2 = fair, 3 = good).

In each image the visibility of following structures was assessed:

Cornea/Conjunctiva ●
Iris (temporal/nasal) ●
Anterior Lens Surface
. Scleral Spur (temporal/nasal)
. Angles (temporal/nasal)

The graders also graded for presence or absence of pre-defined key abnormalities, specified on the grading form.

Eighty-seven subjects were enrolled in this study. Thirty-four in the Normal Anterior Segment population and fifty-three in the Abnormal Anterior Segment population.

The mean age was 45.7 ± 16.1 years overall, with the Abnormal Anterior Segment population subjects being older. The study population gender distribution was 67.9% male and 32.1% female. Sixty-seven percent (67%) were not Hispanic or Latino, 34% were Caucasian and 42% African American. The study eyes were fairly equally distributed between right and left eyes (51% right, 49% left).

To compare the image quality of the ANTERION and the CIRRUS devices, key anatomical structures were evaluated for image quality (Good/Fair/Poor) by the independent Reading Center by three masked graders.

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Figure 1 below summarizes the structure image quality for all study eyes of the effectiveness analysis population. Overall, the ANTERION shows superiority in image quality compared to each of the three CIRRUS scans.

Image /page/13/Figure/3 description: The image is a set of bar charts that show the image quality of different structures in the eye, including the cornea/conjunctiva, anterior lens surface, iris, angle, and scleral spur. The image quality is measured using four categories: good, fair, poor, and no acceptable scans. The bar charts show the percentage of scans that fall into each category for each structure. For example, for the cornea/conjunctiva, 83.3% of scans are rated as good using the ANT scan type, while 52.6% of scans are rated as good using the CCN scan type.

FIGURE 1: IMAGE QUALITY OF EACH STRUCTURE BY DEVICE AND SCAN TYPE

Heidelberg Engineering GmbH

Traditional 510(k): ANTERION

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Image /page/14/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, sans-serif font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square on the left side of the first line and on the right side of the second line.

The slit lamp examination, as well as the OCT imaging as assessed by the Reading Center, have been assessed for the presence or absence of the predefined abnormalities. Figure 2 below illustrated the comparison among the different OCT scan types, using the slit lamp results as the reference. Overall, the ANTERION shows superiority compared to each of the three CIRRUS scans in identifying the abnormality in reference with the slit lamp examination.

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Image /page/15/Figure/2 description: This image contains multiple bar charts that show the percent of frequency of different eye conditions. The eye conditions include cornea pterygium, cornea corneal inlay, cornea corneal transplant, cornea corneal scar, conjunctiva trabeculectomy bleb, iris nasal peripheral iridotomy, iris temporal peripheral iridotomy, angle nasal glaucoma drainage device, and angle temporal glaucoma drainage device. Each bar chart shows the percent of frequency for match, no match, UNA, and NAS. The x-axis of each bar chart shows ANT, CAC, and CAG/CCN.

FIGURE 2: OCT ABNORMALITY IDENTIFICATION USING SLIT LAMP IDENTIFICATION AS REFERENCE BY DEVICE AND SCAN TYPE

Heidelberg Engineering GmbH

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Image /page/16/Picture/1 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, sans-serif font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a dark red square to the left of the first line and to the right of the second line.

There were no adverse event occurring during the course of the study.

The results of this study illustrated that when using OCT to visualize the anterior segment, ANTERION's overall OCT image quality and ability to visualize key anatomical structures on OCT images was similar to or better than CIRRUS for all scan patterns and all subject populations. Furthermore, using the slit lamp examination as a reference, the results indicate that ANTERION offers an equal or superior ability in identifying each pre-specified abnormality as compared to CIRRUS. Therefore, the study results support substantial equivalence of ANTERION and the CIRRUS 5000 with Anterior Segment Premier Module in regard to image quality, the ability to discern key anatomical structures, and the ability to identify various anterior segment abnormalities.

CONCLUSION

Comparison of intended use, technological characteristics, and clinical performance data as well as evaluation of non-clinical testing support substantial equivalence of the ANTERION subject device to the predicate and reference devices.

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.