The CenterVue COMPASS is intended for taking digital images of a human retina without the use of a mydriatic agent and for measuring retinal sensitivity, fixation stability and the locus of fixation. It contains a reference database that is a quantitative tool for the comparison of retinal sensitivity to a database of known normal subjects.

Device Description

The CenterVue COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the acquisition of images of the retina, as well as the measurement of retinal threshold sensitivity and the analysis of fixation. The device works with a dedicated software application, operates as a standalone unit, integrates a dedicated tablet, a joystick, a push-button and is provided with an external power supply. COMPASS operates in non-mydriatic conditions, i.e. without the need of pharmacological dilation and is intended for prescription use only.

The Centervue COMPASS device operates on the following principles:

An anterior segment alignment system is included, which uses two infrared LEDs with a centroid wavelength of 940 nm and two cameras, whereas the former illuminate the external eye by diffusion and the latter allow a stereoscopic reconstruction of the pupil's position, used for automated alignment purposes via pupil tracking;
An infrared imaging system captures live monochromatic images of the central retina over a circular field of view of 60° in diameter, by an horizontal line from an infrared LED with a centroid wavelength of 850 nm and by an oscillating mirror which scans the line to uniformly illuminate the retina; such images are in turn used for auto-focusing purposes and to track eye movements, providing a measure of a patient's fixation characteristics and allowing active compensation of the position of perimetric stimuli;
A concurrent color imaging system allows the capture of color images of the central retina over a circular field of view of 60° in diameter, using a white LED and a blue LED combined to obtain a white light illuminating the retina by the same scan mechanism;
A fixation target projecting onto the retina a fixation target obtained from a green LED;
A stimuli projector, projecting onto the retina white light Goldmann stimuli at variable intensity and allowing measurements of threshold sensitivity at multiple locations, according to a patient's subjective response to the light stimulus projected at a certain location.

The COMPASS device interacts with the patient by directing infrared, white, blue and green wavelength illumination into the patient's eye and by recording a patient's confirmation that a certain light stimulus has been perceived or not.

AI/ML Overview

Here's an analysis of the acceptance criteria and the supporting study for the CenterVue COMPASS device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter (K150320) primarily focuses on establishing "substantial equivalence" to predicate devices, rather than explicit numerical acceptance criteria for clinical performance that might be found in a performance goal document for a novel device. However, the clinical study serves to demonstrate this equivalence. The key performance comparison is between the CenterVue COMPASS and the Humphrey HFA-II.

Acceptance Criteria (Implied for Substantial Equivalence to HFA-II)	Reported Device Performance (CenterVue COMPASS)
Equivalence in retinal threshold sensitivity measurements for both normal and pathological subjects compared to the Humphrey HFA-II.	Mean differences in thresholds between COMPASS and HFA-II in both subject groups (normal and pathological) were found to be equivalent to those reported for the Humphrey HFA between SITA Standard and full threshold.
No significant adverse events during clinical testing.	No adverse event was reported during the study.

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

Test Set Sample Size:
- 200 normal subjects
- 120 subjects with pathology affecting the visual field (specifically glaucoma)
- Total: 320 subjects
Data Provenance: The document does not explicitly state the country of origin. It indicates the manufacturer is in Padova, Italy, and the study was conducted to support FDA clearance in the USA, suggesting the study likely occurred in conjunction with the manufacturer's operations or clinical sites. The study is presented as prospective clinical testing ("Measurements have been obtained...").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not specify the number of experts or their qualifications for establishing the "ground truth" for the test set (i.e., whether subjects were truly "normal" or had "glaucoma"). It only states that subjects were categorized as "normal" or with "pathology affecting the visual field (in particular glaucoma)." This implies a clinical diagnosis was used, but the specific process or number of experts for this diagnosis is not detailed.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in terms of expert review or consensus. The study compares the performance of the COMPASS directly to the predicate device (Humphrey HFA-II) on the same subjects, rather than assessing the COMPASS's ability to classify against a pre-established ground truth determined by multiple experts.

5. 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, an MRMC comparative effectiveness study was not done. This device is primarily a diagnostic instrument for measuring retinal sensitivity and imaging, not an AI-assisted diagnostic aid for interpretation by human readers. The clinical study compares the device's measurements to another device, not human performance.

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

Yes, the clinical study presents data on the standalone performance of the CenterVue COMPASS device in measuring retinal threshold sensitivity. It directly compares the measurements obtained by the COMPASS to those obtained by the Humphrey HFA-II. The device operates as a standalone unit for acquiring images and measuring retinal sensitivity.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurement of retinal threshold sensitivity as determined by the accepted standard, the Humphrey HFA-II. The study aims to demonstrate that the COMPASS's measurements are "equivalent" to those of the HFA-II, specifically that the mean differences in thresholds are comparable to known differences within the HFA-II platform (SITA Standard vs. full threshold). The classification of subjects as "normal" or with "glaucoma" would have been based on clinical diagnosis, implicitly serving as a form of "expert consensus" or "clinical diagnosis" ground truth for subject selection, but not for the specific performance metric being evaluated (threshold sensitivity differences).

8. The Sample Size for the Training Set

The document describes a "reference database" that was developed to serve as a quantitative tool for comparison of retinal sensitivity to known normal subjects.

Reference Database Sample Size: 200 eyes of 200 normal subjects.
The age range of this population was 20 - 86 years (50.6 ± 15.2).

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

The ground truth for the "training set" (referred to as the "reference database" in the document) was established by obtaining threshold sensitivity data from 200 subjects confirmed to be "normal." The specific criteria or expert qualifications for determining "normalcy" are not detailed in this summary, but it implies a clinical assessment of individuals free from visual field pathology. The perimetric settings used to gather this data are listed (24-2 grid, 4-2 strategy, Goldmann III stimulus, etc.).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2015

CenterVue S.p.A. Mr. Roberto Gabriotti QA/RA Manager via San Marco, 9h 35129 Padova, Italy

Re: K150320

Trade/Device Name: COMPASS Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC, HPT Dated: May 15, 2015 Received: Mav 20, 2015

Dear Mr. Gabriotti:

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. 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 statutes and regulations administered by other Federal agencies.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -A

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: OMB No. 0910-0120

510(k) Number K150320

Device Name

COMPASS

Indications for Use (Describe)

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

▽ Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Jan C. Callaway -S
2015.06.19
12:17:42 -04'00'

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Image /page/3/Picture/0 description: The image features the logo for "centervue." Above the text, there is a stylized eye graphic. The eye is made up of small yellow and gray cubes arranged in a semi-circular shape, with a black circle representing the pupil. The text "centervue" is written in a lowercase, sans-serif font, with the "vue" portion in yellow.

510(k) Summary in accordance with 21 CFR 807.92

Device Name:	CenterVue COMPASS
Type of submission:	Traditional
Date of submission:	2 February 2015
Manufacturer:	CENTERVUE SPAVia San Marco 9H35129 Padova - ITALY
510(k) Owner:	CENTERVUE SPAVia San Marco 9H35129 Padova - ITALY
PhoneFax	+39 049 7396 147+39 049 7396 148
510(k) submitter and contact	Mr. Roberto GabriottiCentervue S.p.A.Manager of Quality and Regulatory AffairsVia San Marco 9H, 35129 Padova - ITALYPhone: +39 049 7396 147Fax: +39 049 7396 148Email: roberto.gabriotti@centervue.com
FDA Product Code:	МУС; HPT
FDA Regulation Number:	21 CFR 886.1570; 886.1605
FDA Classification Name:	Ophthalmoscope, laser, scanning; Perimeter, Automatic, Ac-powered
Common Name:	Ophthalmoscope; Perimeter
FDA Panel:	Ophthalmology
FDA Classification:	Class II
FDA Identification:	An ophthalmoscope is an AC-powered or battery-powered devicecontaining illumination and viewing optics intended to examine themedia (cornea, aqueous, lens, and vitreous) and the retina of the eye.A perimeter is an AC-powered or manual device intended todetermine the extent of the peripheral visual field of a patient. Thedevice projects light on various points of a curved surface, and thepatient indicates whether he or she sees the light
Indications for Use:	The CenterVue COMPASS is intended for taking digital images of ahuman retina without the use of a mydriatic agent and for measuringretinal sensitivity, fixation stability and the locus of fixation. It containsa reference database that is a quantitative tool for the comparison ofretinal sensitivity to a database of known normal subjects.

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Image /page/4/Picture/0 description: The image shows the logo for Centervue. The logo features a stylized eye made up of yellow squares, with a black pupil in the center. Below the eye is the word "centervue" in a lowercase, sans-serif font.

DEVICE DESCRIPTION

The Centervue COMPASS device operates on the following principles:

An anterior segment alignment system is included, which uses two infrared LEDs with a centroid ● wavelength of 940 nm and two cameras, whereas the former illuminate the external eye by diffusion and the latter allow a stereoscopic reconstruction of the pupil's position, used for automated alignment purposes via pupil tracking;
An infrared imaging system captures live monochromatic images of the central retina over a circular field of view of 60° in diameter, by an horizontal line from an infrared LED with a centroid wavelength of 850 nm and by an oscillating mirror which scans the line to uniformly illuminate the retina; such images are in turn used for auto-focusing purposes and to track eye movements, providing a measure of a patient's fixation characteristics and allowing active compensation of the position of perimetric stimuli;
. A concurrent color imaging system allows the capture of color images of the central retina over a circular field of view of 60° in diameter, using a white LED and a blue LED combined to obtain a white light illuminating the retina by the same scan mechanism;
· A fixation target projecting onto the retina a fixation target obtained from a green LED;
. A stimuli projector, projecting onto the retina white light Goldmann stimuli at variable intensity and allowing measurements of threshold sensitivity at multiple locations, according to a patient's subjective response to the light stimulus projected at a certain location.

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Image /page/5/Picture/0 description: The image shows a stylized logo. The logo is a sphere that is partially deconstructed, with yellow squares arranged around a black circle. The yellow squares are arranged in a grid-like pattern, and the black circle is located in the center of the sphere. The background is white.

centervue

TECHNICAL SPECIFICATIONS

FundusPerimetry:

Projection field: 30° (radius)
. Background luminance: 31.4 asb
Maximum luminance:
Dynamic range:
Stimulus size:
Stimulus duration: 200 ms
Fixation control: 25 Hz automated retinal tracking

FundusImaging:

Field of view:
60° (diameter) • Sensor resolution: 5 MPixel (2592x1944)

10000 asb

Goldmann III

0 - 50 dB

Light source:
Imaging modalities:

Otherfeatures:

Non-mydriatic operation:
Auto-focus range:

minimum pupil size 3 mm -12D to +15D

color, infrared, red-free

infrared (825-870 nm) and white LED (440-650 nm)

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Image /page/6/Picture/0 description: The image contains the logo for Centervue. The logo features a stylized eye made up of yellow squares and a black pupil. Below the eye is the word "centervue" in lowercase letters, with the "vue" portion of the word in yellow.

PREDICATE DEVICES The predicate devices selected for comparison with the CenterVue COMPASS are:

Predicate Device 1 (primary):	MAIA
510(k) Owner:	CenterVue
510(k) Number:	K133758
Clearance Date:	2014-04-23
FDA Product Code 1:	HPT
Classification Name 1:	Perimeter, Automatic, Ac-powered
Regulation Number 1:	886.1605
Product Code 2:	HLI
Classification Name 2:	Ophthalmoscope, Ac-powered
Regulation Number 2:	886.1570
Predicate Device 2:	EIDON
510(k) Owner:	CenterVue
510(k) Number:	K142047
Clearance Date:	2014-11-12
FDA Product Code:	MYC
Classification Name:	Ophthalmoscope, Laser, Scanning
Regulation Number:	886.1570
Predicate Device 3:	Humphrey Field Analyzer (HFA-II), model 720
510(k) Owner:	Carl Zeiss, Inc.
510(k) Number:	K954167
Clearance Date:	1995-11-24
FDA Product Code:	HPT
Classification Name:	Perimeter, Automatic, Ac-powered
Regulation Number:	886.1605

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Image /page/7/Picture/0 description: The image shows a stylized logo. The logo is a semi-circular shape with a black circle in the center. The semi-circular shape is made up of small, yellow squares that are arranged in a grid-like pattern. The squares are set against a gray background, giving the logo a three-dimensional appearance.

centervue

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE(S)

Fundus Perimetry is the technological principle for both the subject and primary predicate device. It is based on continuous imaging of the retina using infrared illumination, to enable compensation of eye movements during perimetry. At a high level, the subject and primary predicate device are based on the same technological elements.

Difference	Equivalence discussion
Capabilities for color and red-freeimaging	No additional concern in terms of safety and effectiveness as thedevice is equivalent to EIDON in this respect
Modified optics for wider imagingfield	No additional concern in terms of safety and effectiveness as thedevice is equivalent to EIDON in this respect
Use of visible light source for colorand red-free imaging	No additional concern in terms of safety and effectiveness as thedevice is equivalent to EIDON in this respect
Use of additional infrared lightsource for alignment	No additional concern in terms of safety and effectiveness as thedevice is equivalent to EIDON in this respect
Modified optics for widerperimetry measurement field	No new concerns for safety and effectiveness vs. the primarypredicate device as differences represent a performanceimprovement
Luminance parameters andmeasurement range	Differences are due to the adoption of Humphrey perimetricstandards for luminance. No new concerns for safety andeffectiveness as the device is equivalent to the Humphrey HFA-II inthis respect
Presence of anterior eye imagingsystem used for patient alignment	No additional concern in terms of safety and effectiveness as thedevice is equivalent to EIDON in this respect
Use of green fixation target(instead of red)	No additional concern in terms of safety and effectiveness as thedevice is equivalent to EIDON in this respect

The following technological differences exist between the subject and primary predicate device:

PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Electricalsafetyandelectromagneticcompatibility(EMC)

The device complies with the IEC 60601-1:2005 standard for safety and with the IEC 60601-1-2:2007 standard for EMC.

SoftwareVerificationandValidationTesting

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury. The software also complies with the IEC 62304 standard for software life cycle processes.

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Image /page/8/Picture/0 description: The image shows a stylized logo or graphic. It features a semi-circular arrangement of small, yellow squares that appear to be arranged in a spherical pattern. At the center of this arrangement is a black circle, giving the impression of an eye or a globe with a dark center. The overall design is abstract and modern.

centervue Perimetersstandardtesting The device complies with the ISO 12866:1999 standard for perimeters.

Lighthazardtesting

The device complies with the ISO 15004-1:2006 standard for ophthalmic instruments and with the ISO 15004-2:2007 standard for light hazard protection.

Clinicaltesting

Measurements have been obtained with the CenterVue COMPASS and with the Humphrey HFA-II on 200 normal subjects and on 120 subjects with pathology affecting the visual field (in particular glaucoma) to support equivalence. Subjects' age ranged from 20 to 86 years (58.5 ± 16.7).

Perimetric settings used for the measurements with both devices were:

. stimuli locations: 24-2 grid;
. threshold strategy: 4-2 (or full threshold) for COMPASS and SITA standard for HFA-II;
stimulus size: Goldmann III;
. stimulus color: white;
. stimulus duration: 200 msec.;
background luminance: 31.4 asb;
maximum luminance: 10,000 asb.

Mean differences in thresholds between the Centervue COMPASS and the Humphrey HFA-II in both subjects groups were found to be equivalent to those reported for the Humphrey HFA between SITA Standard and full threshold. No adverse event was reported during the study. This demonstrates equivalence of the subject device to the predicate in terms of effectiveness.

REFERENCE DATABASE

The COMPASS reference database was developed by obtaining threshold sensitivity data from 200 eyes of 200 normal subjects. Age range of the measured population was 20 - 86 (50.6 ± 15.2).

The perimetric settings used for the measurements were:

stimuli locations: 24-2 grid
threshold strategy: 4-2
stimulus size: Goldmann III
. stimulus color: white
. stimulus duration: 200 msec.
background luminance: 31.4 asb
maximum luminance: 10,000 asb

The reference database is only available for the 24-2 test grid.

CONCLUSIONS

Based on the information contained within this submission, it is concluded that the CenterVue COMPASS is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.

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.