General ophthalmic imaging including retinal, corneal, and external imaging; .
Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP). .
Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, . without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.

Device Description

RetCam Ophthalmic Imaging Systems utilize a digital camera in a handpiece with multiple field of view lenses to capture color ophthalmic digital images including retinal, corneal, and external images. An on board computer (RetCam II and RetCam 3) or laptop computer (RetCam Shuttle and RetCam Portable) is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used in all RetCam configurations to provide illumination to the eye through the handpiece. An optional Fluorescein light source is also available with the RetCam II and RetCam 3 configurations. Light intensity, camera focus, and image capture are controlled by the use of a footswitch on all configurations and can also be controlled by a keyboard on the RetCam II and RetCam 3 consoles. Console monitors are provided with the RetCam II and RetCam 3 configurations for viewing images. The laptop monitor is used for viewing images with the RetCam Shuttle and RetCam Portable. Proprietary software is installed on the computers to capture, store, view, retrieve, and export ophthalmic images.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that supports the RetCam Ophthalmic Imaging System, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner as "acceptance criteria" but are implied by the reported performance metrics of the device in screening for ROP. The study establishes the device's accuracy by demonstrating high sensitivity and acceptable specificity for identifying specific stages of ROP.

Acceptance Criteria (Implied)	Reported Device Performance (Sensitivity and Specificity for Type 2 Threshold ROP Or Worse)
Sensitivity for Type 2 pre-threshold or worse ROP in 35-37 week postmenstrual infants.Defined as: - Type 2 pre-threshold ROP (Zone 1, Stage 1 or 2, without plus disease, or Zone 2, Stage 3, without plus disease)- Treatment-requiring ROP (Type 1 ROP: Zone 1, any stage, with plus disease; Zone 1, stage 3 without plus disease; or Zone 2, stage 2 or 3, with plus disease)- Threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)	Grader A: 1.0 (26/26) Grader B: 1.0 (26/26) Grader C: 1.0 (26/26)
Specificity for Type 2 pre-threshold or worse ROP in 35-37 week postmenstrual infants.Same definition as above.	Grader A: 0.883 (83/94) Grader B: 0.851 (80/94) Grader C: 0.851 (80/94)
Image Quality: Technical quality of images captured at 35-37 weeks PMA by trained NICU nurses.	93.3% to 100% of images found to be "adequate" or "possibly adequate"

Study Details

The study referenced is:
Chiang, et. al. (Telemedical Retinopathy of Prematurity Diagnosis Accuracy and, Reliability, and Image Quality: Archives of Ophthalmology; 2007;125(11):1531-1538)

Sample size used for the test set and the data provenance:
- Test set sample size: Images from 67 consecutive infants were used. While the text refers to "eyes," the performance data is given for "26 cases of Type 2 Threshold ROP Or Worse" and "94 cases of no Type 2 Threshold ROP Or Worse," suggesting a total of 120 eyes/instances for the performance evaluation against the reference standard.
- Data provenance: Prospective trial. Country of origin not explicitly stated, but the journal (Archives of Ophthalmology) is a US-based publication, suggesting US data or an internationally recognized standard of practice.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts for image interpretation: Three expert retinal specialist graders interpreted the images. Their specific qualifications (e.g., years of experience) are not detailed beyond "expert retinal specialist graders."
- Number of experts for ground truth (reference standard): "Experienced pediatric ophthalmologists" performed binocular indirect ophthalmoscopy (BIO) to establish the reference standard. The number of these ophthalmologists is not specified.
Adjudication method for the test set:
- The text describes three individual expert retinal specialist graders (Grader A, B, C) interpreting the images, and their findings were compared to a reference standard. It does not indicate an adjudication method (like 2+1 or 3+1 consensus) among these three graders to form a single "AI" diagnosis. Instead, the performance is reported per grader. The reference standard itself was established by experienced pediatric ophthalmologists using BIO.
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, this was not an MRMC comparative effectiveness study involving human readers with vs. without AI assistance. The study evaluates the standalone performance of reading RetCam images by human experts against a clinical gold standard (BIO). The RetCam system itself produces the images, which are then interpreted by human experts; it does not feature an AI component that assists human interpretation in the sense of a diagnostic algorithm providing results.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The study describes human interpretation of images captured by the RetCam device. The RetCam is an imaging system, not an AI algorithm that provides diagnostic output. The "performance" refers to the accuracy of human graders interpreting the images acquired by the device.
The type of ground truth used:
- Clinical Gold Standard: Binocular Indirect Ophthalmoscopy (BIO) performed by experienced pediatric ophthalmologists. This is a direct clinical assessment by experts, considered the gold standard for ROP diagnosis.
The sample size for the training set:
- The text does not mention a training set. This study describes a clinical validation of an imaging device where human experts interpret the images, not an AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as no training set for an AI model is described or implied.

Summary

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K090326

NOV 2 5 2009

510(K) Summary		CLARITY MEDICAL SYSTEMS, INC.
Regulatory Authority:	Safe Medical Devices Act of 1990, 21 CFR 807.92
Device Name:	RetCam II Ophthalmic Imaging SystemRetCam 3 Ophthalmic Imaging SystemRetCam Shuttle Ophthalmic Imaging SystemRetCam Portable Ophthalmic Imaging System
Common Name(s):	Ophthalmic Imaging System
Classification Name(s):	Ophthalmic Camera
Manufacturer:	Clarity Medical Systems, Inc.
Reg. Number:	2952489
Address:	5775 W. Las Positas Blvd.Pleasanton, CA 94588-4084
Telephone:	(925) 463-7984
Classification(s):
Device Class:	Class II
Classification Panel:	Ophthalmology
Product Code(s):	HKI
Equivalent Predicate Devices:	RetCam II Ophthalmic Imaging System, K081858RetCam 3 Ophthalmic Imaging System, K081858RetCam Shuttle Ophthalmic Imaging System, K081858RetCam Portable Ophthalmic Imaging System, K083771

Device Description:

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Indication for Use:

General ophthalmic imaging including retinal, corneal, and external imaging. .
Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP). .
Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, . without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.

*References:

1. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Archives of Ophthalmology 1988: 106(4):471-479.
1. Early Treatment for Retinopathy of Prematurity Cooperative Group. Revised indications for the treatment of retinopathy of prematurity: results of the Early Treatment for Retinopathy of Prematurity Randomized Trial. Archives of Ophthalmology 2003; 121(12):1684-1694.

Clinical Performance Data:

Chiang, et. al. (Telemedical Retinopathy of Prematurity Diagnosis Accuracy and, Reliability, and Image Quality: Archives of Ophthalmology; 2007;125(11):1531-1538) reported the results of a prospective trial to measure the accuracy, reliability, and image quality of RetCam wide-field digital images to screen for ROP. Eyes from 67 consecutive infants underwent RetCam wide-field digital retinal imaging by trained neonatal nurses using a standard protocol of 3 images per eye and the 130 degree lens. The infants were 31 to 33 weeks and/or 35 to 37 weeks postmenstrual age (PMA).

Images were interpreted by three expert retinal specialist graders who provided a diagnosis and evaluation of image quality. Findings were compared with a reference standard of binocular indirect ophthalmoscopy (BIO) by experienced pediatric ophthalmologists. The target condition (referral warranted disease-the presence of Type 2 pre-threshold or worse ROP) in this study that supports the use of RetCam as an ROP screening tool is Type 2 Pre-threshold ROP (Zone 1, Stage 1 or 2, without plus disease, or Zone 2, Stage 3, without plus disease) or treatment requiring ROP (Zone 1, any stage, with Plus disease; Zone 1, stage 3 without plus disease; or Zone 2, stage 2 or 3 with Plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2. with plus disease) at 35-37 weeks PMA.

Performance For Type 2 Threshold ROP Or Worse
Grader	Sensitivity	~95% CI forSensitivity	Specificity	~95% CI forSpecificity
A	1.0 (26/26)	(0.868, 1.0)	0.883 (83/94)	(0.802, 0.933)
B	1.0 (26/26)	(0.868, 1.0)	0.851 (80/94)	(0.765, 0.909)
C	1.0 (26/26)	(0.868, 1.0)	0.851 (80/94)	(0.765, 0.909)

Sensitivity and Specificity Statistics by Grader

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Image Quality

Before providing a diagnosis for each image set, the 3 retinal specialist graders assessed the technical quality of the images for "adequate", "possibly adequate" or "inadequate". Each of them found that images taken at 35-37 weeks PMA by trained NICU nurses were technically "adequate" or "possibly adequate" at a rate of 93.3% to 100%.

Conclusion

The Clinical Performance data note above was gathered using the RetCam II Ophthalmic Imaging System and supports the revised Indication for Use for the RetCam II Ophthalmic Imaging System, the RetCam 3 Ophthalmic Imaging System, the RetCam Shuttle Ophthalmic Imaging System, and the RetCam Portable Ophthalmic Imaging System.

Company Contact:

· Gary A. Seeger Vice President, Quality Assurance and Regulatory Affairs Clarity Medical Systems, Inc.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three overlapping wing-like shapes.

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

NOV 2 5 2009

Clarity Medical Systems, Inc c/o Mr. Gary A. Seeger Vice President, Quality Assurance and Regulatory Affairs 5775 W. Las Positas Blvd. Pleasanton CA 94588

Re: K090326

Trade/Device Name: RetCam II, RetCam 3, RetCam Shuttle, RetCam Portable Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: September 10, 2009 Received: September 14, 2009

Dear Mr. Seeger:

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 or any I 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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Mr. Gary A. Seeger

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/ReportalProblem/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,

Le R. Ramm, in for

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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Indications for Use

510(k) Number:

RetCam II Ophthalmic Imaging System Device Name(s): RetCam 3 Ophthalmic Imaging System RetCam Shuttle Ophthalmic Imaging System RetCam Portable Ophthalmic Imaging System

Indications for Use:

Each and all above listed RetCam Systems are indicated for:

General ophthalmic imaging including retinal, corneal, and external imaging; .
Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP). .
Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, . without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.

*References:

1. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Archives of Ophthalmology 1988: 106(4):471-479.
1. Early Treatment for Retinopathy of Prematurity Cooperative Group. Revised indications for the treatment of retinopathy of prematurity: results of the Early Treatment for Retinopathy of Prematurity Randomized Trial. Archives of Ophthalmology 2003; 121(12):1684-1694.

X Over the Counter Use Or Prescription Use PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Sean.

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

510(k) Number K090326

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.