The DRSplus is a scanning ophthalmoscope which uses infrared and white light to obtain confocal images of the retina, without pharmacological dilation. The DRSplus operates as a standalone unit, running a dedicated software application, is intended for prescription use only, and includes: 1. an optical head; 2. a patient forehead rest; 3. a display; 4. a base; 5. a stand. The CenterVue DRSplus operates based on the following principles: a) An illumination system consisting of infrared (IR) LEDs, white LEDs and a green LED illuminates the patient eye with the following functions: · the IR LED allows the capture of IR photos, which are used for alignment and focusing purposes. The patient's retina is uniformly illuminated by a line in the horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina. · Two IR LEDs are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine's optical axis. The LEDS are switched on during all exams in order to enable pupil tracking. · The white LEDs allow the capture of color photos. The retina is uniformly illuminated by a line in the horizontal direction. Along the optical path an oscillating mirror scans the line in order to illuminate the retina. · The green LED is used as fixation target. b) An imaging system collects back-reflected light from the retina and creates a high-resolution image. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera. c) An anterior segment alignment system is included, using two cameras and the two IR LEDs. The LEDs illuminate the anterior segment by diffusion, whereas the cameras allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument's frontlens. The DRSplus interacts with the patient by directing infrared, white (for imaging) and green (for fixation) illumination into the patient's eye. The only part of the only part of the device that contacts the patient.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CenterVue DRSplus, a confocal scanning ophthalmoscope. The majority of the document focuses on regulatory information, device description, technical specifications, and comparison to predicate devices, demonstrating substantial equivalence based on engineering and safety standards.

However, the provided text does not contain the details required to directly answer all parts of your request regarding acceptance criteria and a specific study proving device performance against those criteria as would typically be found in an AI/ML medical device submission.

The document mentions "Performance data - Clinical" but this section is very brief and describes a qualitative comparison ("similar to those of the mentioned predicate device") rather than a quantitative study with defined acceptance criteria and performance metrics. It also does not describe an AI/ML algorithm within the device that would necessitate ground truth establishment, expert adjudication, or MRMC studies.

Given the information, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Based on provided text)

The document implicitly defines acceptance criteria through compliance with various industry standards and demonstrating substantial equivalence to predicate devices, particularly in terms of image quality for a fundus camera. No specific quantitative performance metrics for a disease detection algorithm are provided.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied/Directly Stated)	Reported Device Performance
Electrical Safety: Compliance with EN 60601-1:2006	Device complies with EN 60601-1:2006.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2015	Device complies with IEC 60601-1-2:2015.
Software Verification & Validation: Adherence to FDA Guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") and IEC 62304 standard for software life cycle. Software classified as "moderate" level of concern.	Software verification and validation testing conducted; documentation provided as recommended by FDA Guidance. Software compiles with IEC 62304 standard. No issues mentioned regarding the "moderate" level of concern.
Fundus Camera Standards: Compliance with ISO 10940:2009	Device complies with ISO 10940:2009.
Light Hazard Protection: Compliance with ISO 15004-1:2006 and ANSI Z80.36-2016	Device complies with ISO 15004-1:2006 and ANSI Z80.36-2016.
Image Quality (Qualitative Clinical Comparison): Images similar to predicate device (EIDON)	"The comparison showed that the DRSplus provides images that are similar to those of the mentioned predicate device." (This is a qualitative statement, not a quantitative performance metric against specific acceptance criteria for image quality, such as sharpness, contrast, or resolution in a measurable way beyond the technical specifications listed elsewhere).
Safety and Effectiveness: Differences from predicate devices must have no effect on safety and effectiveness.	Differences (IR reflectance imaging for alignment/focusing, smaller field of view, slightly larger minimum pupil diameter, smaller dimensions/lighter weight, different scanning technology) are believed to have no effect on safety and effectiveness.

Regarding the study proving the device meets acceptance criteria (Clinical Performance Data):

The document describes a very limited qualitative clinical performance assessment, not a robust AI/ML algorithm validation study. Therefore, most of the requested information regarding AI/ML-specific study design is not present in the provided text.

Sample size used for the test set and the data provenance:
- Test Set Size: "Images from randomly selected normal subjects and subjects with retinal pathologies were acquired." No specific number of subjects or images is provided.
- Data Provenance: "acquired at two different sites" and "patients were imaged without pharmacological pupil dilation." No country of origin is explicitly stated, but the manufacturer is Italian. The study appears to be "prospective" in the sense that images were acquired specifically for this comparison using both devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Mentioned. The "clinical performance data" section describes a qualitative comparison of images between two devices, not a study evaluating an AI/ML algorithm's diagnostic performance against a clinical ground truth. Hence, there's no mention of experts establishing a ground truth for diagnostic purposes.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Mentioned. As no ground truth for diagnostic performance was established, no adjudication method is described.
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. The provided text does not describe an AI-assisted reading study or an MRMC study. The device is described as an imaging device, not an AI diagnostic algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device, as described, is an ophthalmoscope that captures images. It's not presented as a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for diagnostic ground truth. The "ground truth" implicitly used for the clinical comparison was that the DRSplus should produce images similar to the predicate device (EIDON) for both normal and pathological retinas. There's no mention of a ground truth for disease diagnosis itself in this section.
The sample size for the training set:
- Not applicable. This device is an imaging instrument, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above.

Summary of what's missing and why:

The provided document (K192113) is a 510(k) clearance letter and summary for an ophthalmoscope. This type of device is an imaging hardware device. It is not an Artificial Intelligence/Machine Learning (AI/ML) diagnostic or assistive device. Therefore, the detailed criteria typically required for AI/ML performance validation (e.g., expert reads, ground truth establishment for disease, MRMC studies, training/testing sets for algorithms) are not present and not relevant to this specific submission as described. The performance data presented focuses on demonstrating imaging quality and electrical/software safety compliance in comparison to a predicate device, which is typical for hardware clearances.

Summary

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November 15, 2019

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

CenterVue SpA Roberto Gabriotti Quality and Regulatory Manager Via S. Marco 9H Padova, 35129 It

Re: K192113

Trade/Device Name: DRSplus Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: October 7, 2019 Received: October 10, 2019

Dear Roberto 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. 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/cdrh/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

for Tieuvi Nguyen, Ph.D., Acting Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/202 See PRA Statement below.

K192113 510(k) Number (if known)

Device Name

DRSplus

Indications for Use (Describe)

The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent.

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

▽ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(K) SUMMARY

Regulatory information

Device Name:	DRSplus
Type of 510(k) submission:	Traditional
Date summary prepared:	November 8th, 2019
Manufacturer:	CenterVue S.p.A.via San Marco 9h35129 Padova Italy
510(k) Submitter and Contact:	Mr. Roberto GabriottiCentervue S.p.A.Manager of Quality and Regulatory AffairsVia San Marco 9H35129 Padova ItalyPhone: +39 049 501 8399Fax: +39 049 501 8398E-mail: roberto.gabriotti@centervue.com
Product Code:	MYC
Regulation Number: Classification	886.1570
Name:	Ophthalmoscope, Laser, Scanning
Panel:	Ophthalmic
FDA Classification:	Class II
Indications for use:	The CenterVue DRSplus is a confocal scanningophthalmoscope indicated for color imaging of a humanretina without the use of a mydriatic agent.

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Device description

The DRSplus is a scanning ophthalmoscope which uses infrared and white light to obtain confocal images of the retina, without pharmacological dilation.

The DRSplus operates as a standalone unit, running a dedicated software application, is intended for prescription use only, and includes:

1. an optical head;
a patient forehead rest; 2.
a displav: 3.
1. a base;
1. a stand.

The CenterVue DRSplus operates based on the following principles:

An illumination system consisting of infrared (IR) LEDs, white LEDs and a green LED a) illuminates the patient eye with the following functions:
- · the IR LED allows the capture of IR photos, which are used for alignment and focusing purposes. The patient's retina is uniformly illuminated by a line in the horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina.
- · Two IR LEDs are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine's optical axis. The LEDS are switched on during all exams in order to enable pupil tracking.
- The white LEDs allow the capture of color photos. The retina is uniformly illuminated by a line in the horizontal direction. Along the optical path an oscillating mirror scans the line in order to illuminate the retina.
- · The green LED is used as fixation target.
An imaging system collects back-reflected light from the retina and creates a highb) resolution image. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera.
An anterior seqment alignment system is included, using two cameras and the two IR c) LEDs. The LEDs illuminate the anterior segment by diffusion, whereas the cameras allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument's frontlens.

The DRSplus interacts with the patient by directing infrared, white (for imaging) and green (for fixation) illumination into the patient's eye. The only part of the only part of the device that contacts the patient.

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Technical Specifications

Class and type of applied part

Class I, Type B (according to IEC 60601-1).

IP classification:

IP20 (according to the degree of protection provided by the enclosure with respect to harmful penetration of particulate matter or water).

lmage acquisition:

|--|

Field of individual image: 45° (H) x 40° (V) captured in a single exposure
lmage size: 3600 x 2910 pixels (10 MP)
Light sources: infrared LED (825-870 nm), white LED (420-675 nm) ●
lmaging modalities: ●
color, red-free Working distance: 25 mm ●
Pixel pitch: 3.7 microns ●

Other features:

Automatic operation: auto-alignment, auto-focus, auto-exposure, auto-capture
Focus adjustment range:
Internal fixation target:
Display: • Hard disk:
10 positions 10.1" multi-touch, color SSD, 512 GB
-15 D to +15 D

Dimensions:

· Weight: 11 Kg (24 lbs)
Size (W x H x D): W 300mm x H 450mm x D 650mm

Power supply:

. Voltage: 12 V DC; Power consumption: 60 W

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Predicate devices

The predicate device selected for comparison with the CenterVue DRSplus is identified as follows:

Predicate Device:
Device Name:	EIDON
Manufacturer:	CenterVue S.p.A.
510(k) Number:	K142047
Product Code:	MYC
Classification Name:	Ophthalmoscope, Laser, Scanning
Regulation No:	886.1570
Reference Device:
Device Name:	DRS
Manufacturer:	CenterVue S.p.A.
510(k) Number:	K101935
Product Code:	HKI
Classification Name:	Camera, ophthalmic
Regulation No:	886.1120

Comparison of technological characteristics with the predicate device(s)

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

Difference	Equivalence discussion
Infrared reflectance imaging is availablewith the DRSplus only for the purpose ofalignment and focusing	No additional concerns for safety and effectivenessas this is a
Field of view is smaller	No additional concerns for safety and effectivenessas the subject device is equivalent to the referencedevice in terms of field
Minimum pupil diameter is slightly larger	No additional concerns for safety and effectivenessas the subject device is equivalent to the referencedevice in terms of minimum pupil size
Significantly smaller dimensions andlighter weight	No additional concerns for safety and effectiveness
Different technology is used to scan theillumination light onto the retina	No additional concerns for safety and effectiveness

Such differences are believed to have no effect on the safety and effectiveness of the device.

1 Neither the EIDON nor the DRSplus contain lasers but rather use LEDs for confocal imaging

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Performance data - Bench

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

Electrical safety and electromagnetic compatibility (EMC) The device complies with the EN 60601-1:2006 and IEC 60601-1-2:2015 standards.

Software Verification and Validation Testing

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.

Fundus cameras testing

The device complies with the ISO 10940:2009 standard for fundus cameras.

Light hazard testing

The device complies with the ISO 15004-1:2006 standard for ophthalmic instruments and with the ANSI Z80.36-2016 standard for light hazard protection.

Performance data - Clinical

The imaging properties of the DRSplus were checked by comparing color images captured using the DRSplus and the predicate device EIDON. Images from randomly selected normal subjects and subjects with retinal pathologies were acquired at two different sites and included in the comparison. The two devices were alternated and patients were imaged without pharmacological pupil dilation. The comparison showed that the DRSplus provides images that are similar to those of the mentioned predicate device.

Conclusions

Based on the information contained within this submission, it is concluded that the CenterVue DRSplus is substantially equivalent to the identified predicate devices already in interstate commerce within the USA, and that any differences that do exist have no effect on the safety and effectiveness of the device.

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.