The RTVue with Software 5.0 is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.

Device Description

The RTVue is a computer controlled ophthalmic imaging and measurement system that employs optical coherence tomography to image and measure the posterior segment of the eye. The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K062552). Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disk structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL, GCC, the outer retinal thickness and total retinal thickness are thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE. The current submission, RTVue with Software 5.0, is for minor software modifications, such as such as scan name changes, scan length limits, marking and labeling conventions, and improved data acquisition/archiving speeds.

AI/ML Overview

The provided document (K100861) is a 510(k) summary for a software modification (RTVue with Software 5.0) to an existing device (RTVue). The submission is a Special 510(k), which indicates that it's for minor changes that don't raise new questions of safety or effectiveness. As such, it relies on substantial equivalence to the predicate device and does not typically contain acceptance criteria or detailed study results for device performance validation in the way a traditional 510(k) for a novel device would.

Therefore, much of the requested information cannot be extracted from this specific document. The document explicitly states: "The RTVue with Software 5.0 is a modification to RTVue. ... The minor differences in the RTVue with Software 5.0 do not raise any new questions of safety or effectiveness. Thus, the RTVue with Software 5.0 is substantially equivalent to its predicate devices." This implies that the performance characteristics and acceptance criteria were established and met by the predicate device (RTVue).

Here's a breakdown based on the provided text, highlighting what is available and what is not:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided special 510(k) summary. For a special 510(k), the focus is on demonstrating that the modification does not alter the fundamental safety and effectiveness profile already established for the predicate device. Therefore, new acceptance criteria or performance studies are generally not required to be submitted in the summary.

2. Sample size used for the test set and the data provenance

This information is not present in the provided special 510(k) summary. Given that it's a special 510(k) for minor software modifications, new clinical or performance studies with test sets are not typically conducted or summarized if the change is non-impactful to clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not present in the provided special 510(k) summary.

4. Adjudication method for the test set

This information is not present in the provided special 510(k) summary.

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

This information is not present in the provided special 510(k) summary. The device description does not indicate AI functionality or reader assistance, focusing on imaging and measurement.

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

This information is not present in the provided special 510(k) summary. The device is described as an "optical coherence tomography system" involving "in vivo imaging and measurement," implying it's a diagnostic tool where a human interprets the output. There is no mention of an algorithm acting as a standalone diagnostic.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not present in the provided special 510(k) summary.

8. The sample size for the training set

This information is not present in the provided special 510(k) summary. The document does not describe the use of machine learning or algorithms that would require a "training set" in the conventional sense of AI.

9. How the ground truth for the training set was established

This information is not present in the provided special 510(k) summary.

Conclusion regarding the Special 510(k) (K100861):

This document describes a Special 510(k) submission for minor software modifications to an existing device. Such submissions typically don't include new performance data or acceptance criteria because the changes are considered not to affect the fundamental safety and effectiveness already established by the predicate device. Therefore, a detailed study proving the device meets acceptance criteria, with specific metrics, sample sizes, expert qualifications, and ground truth methodologies, is not part of this type of submission summary. To find such information, one would need to consult the 510(k) summaries for the predicate devices (K062552 and K071250) which established the initial performance and safety characteristics.

Summary

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K 100861

JUN 1 7 2010

510(k) SUMMARY

Optovue's RTVue with Software 5.0

General Information

Manufacturer: Optovue, Inc. 45531 Northport Loop West, Fremont, CA 94538 Phone: (510) 623-8868 (510) 623-8668 Fax: Registration No.: 3005950902

Azimun Jamal Contact Person: Regulatory Manager Optovue, Inc. Phone: (510)623-8868 x188 e-mail: azimun_jamal@optovue.com

Device Information

Classification:	Class II
Trade Name:	RTVue with Software 5.0
Common Name:	Optical Coherence Tomography (OCT)
Classification Name:	Ophthalmoscope, a-c powered (21 CFR§ 886.1570)

Predicate Device

RTVue (K062552) Manufactured by Optovue, Inc (1)
CA (K071250) Manufactured by Optovue, Inc (2)

Purpose of the Special 510(k) notice.

The RTVue with Software 5.0 is a modification to RTVue.

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Intended Use

Device Description

Substantial Equivalence

RTVue with Software 5.0 has the same intended use and indications, principles of operation, and technological characteristics as RTVue. The minor differences in the RTVue with Software 5.0 do not raise any new questions of safety or effectiveness. Thus, the RTVue with Software 5.0 is substantially equivalent to its predicate devices.

K100861

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.

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

JUN 1 7 2010

Optovue, Inc c/o Ms. Azimun Jamal Manager of Quality/Regulatory 45531 Northport Loop W. Fremont, CA 94538

Re: K100861

Trade/Device Name: RTVue with Software 5.0 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI Dated: May 19, 2010 Received: May 20, 2010

Dear Ms. Jamal:

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. 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 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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Page 2 - Ms. Azimun Jamal

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,

Kesia Alexander

A _ 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 Statement

510(k) Number (if known):

K100861

Device Name: RTVue with Software 5.0

Indications for Use:

Prescription Use (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deshn.

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

510(k) Number K100861

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.