The RTA Model D Retinal Thickness Analyzer ("RTA Model D") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA Model D 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 Model D 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 Model D is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA Model D 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 Model D 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 mirror, 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

This 510(k) summary for the Talia Technology, Ltd.'s RTA Model D Retinal Thickness Analyzer describes the device's substantial equivalence to a predicate device rather than presenting a full study to meet specific acceptance criteria for performance. The summary explicitly states that it is a modification of a previously cleared device. Therefore, the information typically found in performance studies with explicit acceptance criteria and detailed results is not present. Instead, the justification for clearance relies on demonstrating that the modifications do not raise new questions of safety or effectiveness.

However, based on the provided text, we can infer some details and present them in the requested format, acknowledging the limitations due to the nature of this 510(k) summary.

Inferred Information based on Substantial Equivalence Claim:

Since the RTA Model D is cleared based on substantial equivalence to the predicate RTA Retinal Thickness Analyzer, the implicit acceptance criteria are that the modified device's performance regarding retinal thickness measurement and visualization should be equivalent to or not worse than the predicate device. The study proving this generally involves verification and validation testing to confirm that the changes (laser source, filter, beam optics) haven't negatively impacted the core functionality.

Here's an attempt to structure the information, with significant caveats that explicit details for many fields are not provided in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate)	Reported Device Performance
Accuracy of Retinal Thickness Measurement (Equivalent to predicate RTA)	Not explicitly stated beyond "modifications... do not raise any new questions of safety or effectiveness." Implies performance is maintained or improved, but no specific metrics are given.
Ability to Determine Inner Structure of the Retina (Equivalent to predicate RTA)	Not explicitly stated. Implies maintained functionality.
Ability to Scan Successive Slit Images of the Fundus (Equivalent to predicate RTA)	Not explicitly stated. Implies maintained functionality.
Visualization of Retinal Pathologies (Equivalent to predicate RTA)	Not explicitly stated. Implies maintained functionality.
Safety of Operation (No new safety concerns compared to predicate RTA)	"modifications... do not raise any new questions of safety"
Effectiveness in assessing retinal thickness abnormalities (Equivalent to predicate RTA)	"modifications... do not raise any new questions of... effectiveness."

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

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified. As a 510(k) summary based on modifications, the "study" would be internal verification and validation, likely performed by the manufacturer. It is not specified if any patient data was used for testing, or if the testing was purely engineering/bench testing.
Retrospective or Prospective: Not specified.

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

Not applicable/Not specified. The 510(k) focuses on demonstrating that modifications do not impact substantial equivalence, not on validating a new clinical performance against expert ground truth.

4. Adjudication Method for the Test Set

Not applicable/Not specified. No expert adjudication process is detailed as the testing relates to engineering changes, not a new clinical performance claim requiring such methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this summary. This document is a 510(k) for a modified device, not a de novo clearance requiring extensive clinical performance studies.

6. Standalone (Algorithm Only) Performance Study

A standalone algorithm performance study, in the sense of an AI algorithm, was not performed or reported. The RTA Model D is a hardware and software system for tomography. The "computer analysis of these images" is part of its core functionality, but the 510(k) does not present a standalone clinical performance study of this analysis in isolation. The summary focuses on the device's performance as a whole.

7. Type of Ground Truth Used

Not explicitly stated. Given the context of verifying modifications, the "ground truth" would likely be based on established engineering specifications, benchmarks, and functional testing to ensure the new laser and optics perform equivalently to the previous version and maintain image quality and measurement capabilities. If patient data was used, the ground truth for retinal thickness measurements would typically come from existing gold-standard imaging techniques or expert measurements, but this is not detailed here.

8. Sample Size for the Training Set

Not applicable/Not specified. This document pertains to a 510(k) for a modified hardware device, not a new algorithm requiring a training set in the AI sense.

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

Not applicable/Not specified as no training set for an AI algorithm is mentioned in this context.

Summary

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K041290

MAY 2 4 2004

510(k) SUMMARY

Talia Technology, Ltd's RTA Model D 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 Model D 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 Model D is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA Model D 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 Model D 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 mirror, 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 Model D is a modification to the previously cleared RTA Retinal Thickness Analyzer. The only differences between the previously cleared RTA and the modified RTA Model D are:

The Laser source has been changed from a green He-Ne operating at 1. 543nm to a green Solid State laser operating at 532nm;
The interference filter has been modified accordingly; and 2.
The laser beam optics has been modified to account for a slightly 3. different beam size.

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 Model D is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side, and a stylized symbol on the right. The symbol features a series of three curved lines that resemble a stylized human form or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2004

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

Re: K041290

Trade/Device Name: RTA Model D Retinal Thickness Analyzer Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC-Powered Regulatory Class: Class II Product Code: HLI Dated: May 13, 2004 Received: May 13, 2004

Dear Mr. Kahan:

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 for woo battle in 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 va may a 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 such additional controls. Existing major regulations affecting your device can has 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); 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.

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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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

A Kalgi Rosenthal

A. Ralph Rosenthal, 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 7

Indications For Use Statement

510(K) Number (if known):

Device Name:

RTA Model D 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)

Page 1 of 1

Denis L. McCarthy

510(k) Number_

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.