The RTA 5 & RTA Model E Retinal Thickness Analyzer ("RTA 5 & RTA Model E") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA 5 & RTA Model E scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.

Device Description

The RTA 5 & RTA Model E is a computerized electro-optical system comprised of two primary components, namely the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and a digital camera. The RTA 5 & RTA Model E is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA 5 & RTA Model E scans successive slit images of the fundus to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. The RTA 5 & RTA Model E uses a solid-state laser source that emits green light at a wavelength of 532 nm. The beam is focused into a thin slit and, by means of a beam-splitter, is directed toward the eye. The scanner and optics then detect the image of the illuminated portion of the retina and transmit the image to the digital camera. The digital camera then captures the image, where it can then be stored and analyzed by the computer system.

AI/ML Overview

The provided 510(k) summary for the Talia Technology, Ltd.'s RTA 5 & RTA Model E Retinal Thickness Analyzer does not contain specific acceptance criteria or a dedicated study section detailing how the device meets such criteria in the way a modern medical device submission typically would.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Talia Technology Ltd.'s RTA Retinal Thickness Analyzer, Model D) by highlighting modifications and stating that these changes do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is absent:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The document doesn't outline specific numerical acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) or present a formal study comparing the RTA 5 & RTA Model E's performance against these criteria. Instead, the "acceptance" is based on demonstrating that the modifications made do not negatively impact the device's original performance or safety, thereby maintaining substantial equivalence to its predicate.

Therefore, the "reported device performance" implicitly refers to the performance of the predicate device, which is assumed to be safe and effective.

Acceptance Criteria (Implicit from Substantial Equivalence)	Reported Device Performance (Implicit from Substantial Equivalence)
Maintain the safety profile of the predicate device.	No new safety concerns identified through verification and validation testing of modifications.
Maintain the effectiveness of the predicate device for its intended use (manual and computerized tomography of the retina, assessing retinal thickness abnormalities, visualizing other pathologies).	Modifications (e.g., additional scanning procedure, changes in stereo angle, light intensity, target mechanism, materials, software) were subject to design control assessment, including verification and validation testing, demonstrating that they do not raise new questions of effectiveness.

Study Details Based on Provided Information:

Given the nature of this 510(k) submission (substantial equivalence for modifications), a formal "study" with a distinct test set, ground truth experts, etc., as one might find for a de novo device, is not explicitly described. Instead, the submission relies on design control assessment, verification, and validation testing of the modifications to ensure they do not alter the substantial equivalence.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated. The document mentions "verification and validation testing" for the modifications. However, it does not specify the number of cases or patients used in these tests, nor their provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not explicitly stated. Since a formal clinical study or performance study with expert-established ground truth is not detailed, this information is not provided. The device's output (retinal thickness measurements and images) is intended for interpretation by a healthcare professional.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not explicitly stated. No information is provided regarding an adjudication method for a test set, as a formal performance assessment against a clinical ground truth is not detailed.
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 evidence of an MRMC study. The RTA 5 & RTA Model E is described as a diagnostic imaging device that provides data for human interpretation and computer analysis, not an AI-assisted diagnostic tool that augments human readers in the way an MRMC study would typically evaluate. The "computer analysis" mentioned is for determining thickness and structure from the images, not for providing an AI-driven diagnosis or improving human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No evidence of a standalone algorithm performance study. The device's operation inherently involves "manual and computerized tomography," with output for "observation of the slit images and by computer analysis of these images," implying human involvement in interpretation. It's not presented as a fully automated diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated. For the "verification and validation testing" of the modifications, the ground truth would likely refer to engineering specifications, previous RTA Model D performance standards, or internal benchmarks rather than clinical outcomes or pathology. For the predicate device (RTA Model D), the implicit ground truth for its original clearance would have been its ability to accurately measure retinal thickness and image retinal structures, presumably validated against established clinical methods or other reference instruments, but this is not detailed in this document.
The sample size for the training set
- Not applicable / not stated. This submission is for a device with a "computer analysis" component, not necessarily a machine learning or AI algorithm that requires a "training set" in the modern sense. The "software change" is mentioned as a modification, but no details on training data for an AI component are provided.
How the ground truth for the training set was established
- Not applicable / not stated. (See point 7).

In summary, the provided 510(k) summary is for a device seeking clearance based on substantial equivalence. It outlines the device's intended use, technological characteristics, and focuses on demonstrating that modifications from a predicate device do not introduce new safety or effectiveness concerns. It does not contain the detailed, formal performance study data typically found in submissions for novel devices or AI/ML-driven diagnostics, which would include specific acceptance criteria, test set details, ground truth establishment, and clinical performance metrics.

Summary

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K061674

AUG 2 3 2006

510(k) SUMMARY

Talia Technology, Ltd.'s RTA 5 & RTA Model E Retinal Thickness Analyzer

Contact Information:

Submitter:	Talia Technology, Ltd.2 Yodfat Lod, IsraelPhone: 011-972-892-090-40Facsimile: 011-972-891-510-09Email: eamoyal@talia.com
Contact Person:	Mr. Efi Amoyal, QA Manager
Name of The Device:	RTA 5 & RTA Model E Retinal Thickness Analyzer
Common or Usual Name:	Retinal Thickness Analyzer
Classification Name:	Ophtalmoscope, AC-Powered (Product Code HLI)
Predicate Devices:	Talia Technology Ltd.'s RTA Retinal Thickness Analyzer

Intended Use:

Device Description, Principles of Operation, and Technological Characteristics:

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The RTA 5 & RTA Model E is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA 5 & RTA Model E scans successive slit images of the fundus to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. The RTA 5 & RTA Model E uses a solid-state laser source that emits green light at a wavelength of 532 nm. The beam is focused into a thin slit and, by means of a beam-splitter, is directed toward the eye. The scanner and optics then detect the image of the illuminated portion of the retina and transmit the image to the digital camera. The digital camera then captures the image, where it can then be stored and analyzed by the computer system.

Substantial Equivalence:

The RTA 5 & RTA Model E is a modification to the previously cleared RTA Model D Retinal Thickness Analyzer. The only differences between the previously cleared RTA and the modified RTA 5 & RTA Model E are:

1. An additional scanning procedure was added with the capability to scan 24 sequential positions with overall coverage of 6x3 mm (HxV) on the retina. The basic scan of 16 sequential positions with overall coverage of 3x3 mm (HxV) on the retina was preserved and has not been changed.
1. Stereo Angle can be set at 9.8° or 5.4°, compared to 12.2° and 7.4°, respectively. in Model D.
1. Filament Light Illumination the light illumination intensity on the retina was reduced for patient convenience to allow better penetration through a small pupil and an undilated pupil.
1. Target Mechanism new target mechanism allows grabbing of fundus image without dark pattern artifact on the fundus image.
1. Human Engineering and External Product Design
1. Material change for patient contacting materials from C-Flex R70-091 to C-Flex Opaque, both of which are primarily composed of thermoplastic elastomer (TPE).
1. Software Change

Through design control assessment, including verification and validation testing, Talia has demonstrated that the modifications to the cleared RTA do not raise any new questions of safety or effectiveness. Accordingly, the RTA 5 & RTA Model E is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread. The eagle is facing to the right and has three lines representing its feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2006

Talia Technology, Ltd. c/o Jonathan S. Kahan Hohan & Hartson L.L.P. 555 Thirteenth St. N.W. Washington, DC 20004-1109

K061674 Re:

Trade/Device Name: RTA 5 & RTA Model E Retinal Thickness Analyzer Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC-Powered Regulatory Class: II Product Code: HLI Dated: August 14, 2006 Received: August 14, 2006

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave roviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based of 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 I ou may, dicrerer, mains 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 such 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 r toase of actived that I Drimination that your device complies with other requirements of the Act that i Drederal 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); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quarty by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Jonathan S. Kahan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eychler SimMD

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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ATTACHMENT 8

Indications For Use Statement

510(K) Number (if known):

Device Name:

RTA 5 & RTA Model E Retinal Thickness Analyzer

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Denis L. Mc Carthy

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

510(k) Number K061674

Page 1 of 1

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.