The DRS is an ophthalmic camera used to take colored digital images of a human retina without use of a mydriatic agent. The instrument body includes: optical head, head-rest, chin rest and a base. The device integrates a dedicated computer and a touch-screen display and operates as a standalone unit, running a dedicated software application. The device is provided with a front lens cap, a power cord and spare fuses.

AI/ML Overview

The provided document describes the CenterVue Digital Retinography System (DRS), an ophthalmic camera. The performance testing section outlines its acceptance criteria and the results of a study demonstrating its performance.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Item	Acceptance Criteria	Reported Device Performance
Sensor resolution	48 pixels / degree	48.15 pixels / degree
Resolution on retina	≥ 60 line pairs/mm at the center of the field≥ 40 line pairs/mm at the mid field (r/2)≥ 25 line pairs/mm at the periphery of the field (r)	YesYesYes
Field of view	45° horizontal x 40° vertical	42.95° horizontal x40.3° vertical
Pixel pitch	6 μm	6.39 μm
Range of focus	-15 D to + 15 D	-15 D to + 15 D
Minimum pupil size	4.0 mm	4.0 mm
Position of internalfixation targets forcentral and peripheralfields	CENTRAL: field centered on the foveal pitNASAL: field centered 17° nasally to the foveaTEMPORAL: field centered 17° temporally to the foveaSUPERO-TEMPORAL: field centered 12° superiorly and 12°temporally to the foveaPERI-CENTRAL: field centered 5° nasally to the foveaSUPERIOR: field centered 17° superiorly to the foveaINFERIOR: field centered 17° inferiorly to the fovea	Actual position (fornormally fixatingsubjects) within ±1°from expectedposition
OD/OS detection	Device captures OD or OS or both based on operator'sselection	Yes (tested onmultiple subjects)
Auto-alignment	Device automatically aligns to the center of the pupil priorto auto-focusing and capture	Yes (tested onmultiple subjects)

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

The document does not specify a precise sample size for the test set in terms of number of patients or images. For several performance items ("OD/OS detection" and "Auto-alignment"), it states "tested on multiple subjects" without providing a specific count.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective.

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

The document does not describe the use of human experts or ground truth establishment by experts for the performance testing cited. The performance items are technical specifications of the device.

4. Adjudication Method for the Test Set

Not applicable, as the performance testing focuses on technical specifications of the device rather than diagnostic or interpretative outcomes that would require adjudication.

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

An MRMC comparative effectiveness study is not mentioned in the document. The DRS is an imaging device, not an AI-assisted diagnostic tool.

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

The performance tests described are for the standalone device's technical specifications and functionality, as it is an imaging system. It assesses the device's ability to capture images with specific technical characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing appears to be based on physical measurements, calibrations, and functional checks against engineering specifications, rather than clinical outcomes, pathology, or expert consensus on medical conditions. For example, resolution is measured in line pairs/mm or pixels/degree, and angles in degrees.

8. The Sample Size for the Training Set

A training set is not mentioned, as this document describes performance testing for a medical imaging device's technical specifications, not a machine learning or AI model.

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

Not applicable, as there is no mention of a training set or ground truth in the context of machine learning.

Summary

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Image /page/0/Picture/0 description: The image is a logo for "centerview at the center of vision". The logo features the word "centerview" in a sans-serif font, with the tagline "at the center of vision" in a smaller font below it. Above the text is a stylized eye symbol, which is composed of a circle and a series of curved lines that create a sense of depth and dimension.

APPENDIX B

OCT 2 7 2010

510(k) Summary of safety and effectiveness

510(k) OWNER INFORMATION

A. Company name:	CenterVue SpA
B. Company address:	via Tommaseo 77, 35131, Padova, ITALY
C. Company phone:	+39 049 781 1828
C. Company fax:	+39 049 781 1899
D. Contact person:	Giuliano Barbaro, Managing Director
E. Revised summary date:	September 21st 2010

SUBMITTER INFORMATION

	A. Company name:	Donawa Lifescience Consulting Srl
	B. Company address:	Piazza Albania, 10, 00153 Rome, ITALY
	C. Company phone:	+39 06 578 2665
	D. Company fax:	+39 06 574 3786
	E. Contact person:	Roger Gray, VP Quality and Regulatory

DEVICE IDENTIFICATION

Camera, ophthalmic, ac-powered Generic Device name: A.
B. Trade/proprietary name: Digital Retinography System DRS
Classification: ll C.
HKI Product code: D.

DEVICE DESCRIPTION

tel. +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com

REA: 378243 CCIAA PD C.F./P. IVA: 04296580287

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Image /page/1/Picture/0 description: The image shows a logo for "centerview at the center of vision". The logo features a stylized eye design above the word "centerview", with the tagline "at the center of vision" written in a smaller font below. The eye design is abstract and appears to be made up of several geometric shapes.

INTENDED USE

The CenterVue Digital Retinography System DRS is intended for taking digital images of a human retina without the use of a mydriatic agent.

SUBSTANTIAL EQUIVALENCE

The DRS device is substantially equivalent to the following predicate devices with regard to intended use, operating principle, and function:

Predicate Device	510(k) Holder	510(k) No.	Date cleared
EyeScan	Ophthalmic Imaging Systems	K092374	17 November 2009
Orion	Nidek Technologies Srl	K070231	24 April 2007

TEST DATA

The DRS has undergone extensive performance testing before release to ensure that the device and its software meet the functional requirements and to demonstrate equivalence to the predicate devices.

A summary of the results of performance testing vs. the device requirements follows:

Performance item	Requirements	Test results
Sensor resolution	48 pixels / degree	48.15 pixels / degree
Resolution on retina	≥ 60 line pairs/mm at the center of the field≥ 40 line pairs/mm at the mid field (r/2)≥ 25line pairs/mm at the periphery of the field (r)	YesYesYes
Field of view	45° horizontal x 40° vertical	42.95° horizontal x40.3° vertical
Pixel pitch	6 μm	6.39 μm
Range of focus	-15 D to + 15 D	-15 D to + 15 D
Minimum pupil size	4.0 mm	4.0 mm
Position of internalfixation targets forcentral and peripheralfields	CENTRAL: field centered on the foveal pitNASAL: field centered 17° nasally to the foveaTEMPORAL: field centered 17° temporally to the foveaSUPERO-TEMPORAL: field centered 12° superiorly and 12°temporally to the foveaPERI-CENTRAL: field centered 5° nasally to the foveaSUPERIOR: field centered 17° superiorly to the foveaINFERIOR: field centered 17° inferiorly to the fovea	Actual position (fornormally fixatingsubjects) within ±1°from expectedposition
OD/OS detection	Device captures OD or OS or both based on operator'sselection	Yes (tested onmultiple subjects)
Auto-alignment	Device automatically aligns to the center of the pupil priorto auto-focusing and capture	Yes (tested onmultiple subjects)

via Tommaseo, 77 35131 Padova, Italy www.centervue.com tel. +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com

REA: 378243 CCIAA PD C.F./P. IVA: 04296580287

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Image /page/2/Picture/0 description: The image shows a logo for "centerview at the center of vision". The logo features a stylized eye design above the text. The eye is composed of geometric shapes, with a dark circle representing the pupil. The text is in a sans-serif font and is stacked, with "centerview" on top and "at the center of vision" below.

PERFORMANCE STANDARDS

The DRS complies with the following standards: IEC 60601-1:2005; IEC 60601-1-2:2007; ISO 10940-2:2009; ISO 15004-2 2007.

CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the DRS to ensure that the device is safe and effective for its intended use, when used in accordance with its Instructions for Use, and equivalence with the identified predicate devices has been demonstrated.

tel. +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com REA: 378243 CCIAA PD C.F./P. IVA: 04296580287

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

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

CENTERVUE SpA c/o Mr. Roger Gray Vice President, Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 00153 Rome, Italy

Re: K101935

Trade/Device Name: Digital Retinography System (DRS) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI Dated: September 29, 2010 Received: October 4, 2010

OCT 2 7 2010

Dear Mr. Gray:

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.

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. 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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Debra Falls

Malvina B. Eydelman, M.D. Director

Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix A

Indications for Use Statement

510(k) Number (if known): K101935

Device Name: CenterVue Digital Retinography System DRS .

Indications for Use: The CenterVue Digital Retinography System DRS is intended for taking digital images of a human retina without the use of a mydriatic agent.

Prescription Use (Part 21 CFR 801 Subpart D)

ਨੇ

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sigh-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

Page 1 of 1 Rev.2 Apr 4, 2008

510(k) Number_k101935

Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.