The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye.

Device Description

The CA device uses the same Optical Coherence Tomography (OCT) technology that was previously reviewed by FDA in its clearance of premarket notification K062552 for RTVue. The CA adapter gives the user an option to use the RTUve device as previously approved for retina scans, or to use it for cornea and anterior eye scans. Aside from the CA auxiliary attachment, the RTVue is virtually unchanged for the CA use except the CA software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina. The system scans a beam into patient's eye and uses a low coherence interferometer to measure the reflectivity of the ocular tissue. The cross-sectional ocular tissue structure is composed of sequence of A-scans. RTVue has a traditional patient and instrument interface like most ophthalmic devices. The device is mounted on a motorized patient table. The patient will rest their head on the forehead and chin rest. The operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring, analyzing and displaying the acquired image. The RTVue image acquisition speed and image resolution remain the same when used in conjunction with CA.

AI/ML Overview

The provided document describes the Optovue CA (CAM model) device, an auxiliary lens adapter for the RTVue Optical Coherence Tomography (OCT) system, intended for imaging and measurement of the cornea and other anterior segment ocular structures. The document includes a 510(k) summary and related FDA correspondence.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance characteristics and compares them to predicate devices or establishes correlation with other measurement methods.

Metric / Objective	Acceptance Criteria (Implicit from Study)	Reported Device Performance (RTVue/CA)
Image Resolution	Comparable to or better than predicate devices. Resolution suitable for anterior segment imaging.	5.1 ± 0.4 um (axial resolution). Noted as "about 3 times better than the predicate device Visante OCT."
Image Quality (Corneal Imaging)	Capable of providing images comparable to or better than predicate devices, with visible anatomic features.	Capable of providing images that "compare well with the Visante OCT." "Anatomic features of the anterior segment of the eye were visible to the physicians that assessed the RTVue/CA images; the same physicians could not identify these features in the Visante OCT images." (Suggests superiority in feature visibility).
Cornea Thickness Measurement Correlation	High correlation with established commercial pachymeters.	- Highly correlated with ultrasound pachymetry system (Pearson r = 0.9889) - Highly correlated with Orbscan II (Pearson r = 0.9995) - Highly correlated with Visante OCT (Pearson r = 0.9924 at vertex, r = 0.9939 over central zone).
Cornea Thickness Measurement Reproducibility	Low root-mean-square difference for repeat measurements.	1.2 um root-mean-square for the difference between repeat pachymetry maps.
Safety	No change in safety profile compared to the RTVue base device.	The energy level and all safety-related design of the RTVue remain the same. The addition of the CA does not change safety.

2. Sample Size and Data Provenance

Non-Clinical (Image Resolution Test): No sample size is specified for the number of devices or scans. The data provenance is not mentioned, but it's likely an in-house lab test given the "Optovue, Inc." signature at the bottom of the page.
Clinical (Corneal Imaging Comparison & Cornea Thickness Measurement Comparison): No specific sample sizes for patients or images are provided in the document. The studies are described in a factual manner, implying they are retrospective or prospective clinical evaluations, but no details on study design or data provenance (e.g., country of origin) are given.

3. Number and Qualifications of Experts for Ground Truth

Clinical (Corneal Imaging Comparison): "Physicians that assessed the RTVue/CA images." The number and specific qualifications (e.g., years of experience, specialty beyond "physicians") of these experts are not specified.
Clinical (Cornea Thickness Measurement Comparison): The "ground truth" for correlation was established using other commercial pachymeters (ultrasound pachymetry, Orbscan II, Visante OCT), which themselves are considered established measurement tools. No explicit "experts" were used to establish the ground truth beyond the inherent calibration and validation of these established devices.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the image assessment or measurement comparisons. It only states that physicians assessed the images and that measurements were compared.

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

No MRMC comparative effectiveness study is mentioned. The document describes a comparison of image quality and measurement correlation, but it does not evaluate human reader performance with or without AI assistance, nor does it provide an effect size for human reader improvement.

6. Standalone Performance Study

Yes, the performance tests described (Image Resolution Test, Corneal Imaging Comparison, Cornea Thickness Measurement Comparison) are all evaluating the standalone performance of the RTVue/CA device. There is no mention of a human-in-the-loop component for these specific performance assessments. The device is purely an imaging and measurement tool.

7. Type of Ground Truth Used

Image Resolution Test: Likely a physical phantom or standardized target with known dimensions.
Corneal Imaging Comparison: Subjective assessment by physicians comparing images from RTVue/CA against Visante OCT. The "ground truth" here is the visibility of anatomic features as perceived by the physicians.
Cornea Thickness Measurement Comparison: The "ground truth" was established by comparison with measurements obtained from other commercially available, established pachymeters (ultrasound pachymetry, Orbscan II, Visante OCT). This relies on the established validity of these predicate measurement devices.

8. Sample Size for the Training Set

The document does not mention any training set or machine learning components. The device as described is an imaging and measurement instrument, not an AI/ML-driven diagnostic tool. Therefore, the concept of a "training set" is not applicable based on the provided information.

9. How Ground Truth for Training Set Was Established

As no training set is mentioned or relevant to the device as described, this information is not applicable.

Summary

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Optovue RTVue/CA 510(K) Premarket Notification

Ko 71250

510(k) Summary

Optovue, Incorporated CA Model: CAM

SEP 2 8 2007

This 510(k) summary for the CA is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

General Information

Manufacturer:	Optovue, Inc.41752 Christy Street,Fremont, CA 94538Phone: (510) 623-8868Fax: (510) 623-8668Registration No.:
Contact Person:	Jay WeiCEO/PresidentOptovue, Inc.Phone: (510)623-8868 x102e-mail: jay_wei@optovue.com

Device Information

Classification: Trade Name:

Common Name: Classification Name: Class II CA Model: CAM Optical Coherence Tomography (OCT) Ophthalmoscope, a-c powered (21 CFR§ 886.1570)

Predicate Devices

RTVue (K062552) – Optovue Visante OCT (K051789) - Carl Zeiss Meditec Bioptigen (K063343) - Bioptigen Inc.

Intended Use

The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye.

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Device Description

Safety

The energy level and all safety related design of the RTVue remains the same when used in conjunction with CA. The only difference is that the CA allows RTVue system to image the cornea instead of the retina. The addition of the CA does not change the safety.

Effectiveness

The image resolution of RTVue when used in conjunction with CA is 5um which is about 3 times better than the predicate device Visante OCT. The scan speed of RTVue when used in conjunction with CA is also 13 times faster than Visante OCT.

Substantial Equivalence

The RTVue/CA is substantially equivalent to the predicate devices presented within this premarket notification with regard to intended use, operating principle, function, material, and energy source, all of which are similar. The RTVue/CA can perform imaging on cornea and anterior segment by simply adding a lens in front the existing RTVue ocular lens. The indication of use on the cornea and anterior segment of the eye are equivalent to another predicate device, Visante OCT marketed by Carl Zeiss Meditec and to that of Bioptigen Inc. All these devices are based on the same Optical Coherence Tomography technology.

Performance Test Data

Non-Clinical:

Image Resolution Test:

Objective: To measure the axial resolution of RTVue/CA

Result: The axial resolution of the tested RTVue/CA system is 5.1± 0.4um

Optovue, Inc.

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Clinical:

1. Corneal Imaging Comparison:

Objective: To compare images of cornea obtained with the RTVue/CA and with the Visante OCT.

Result: The RTVue/CA is capable of providing images that compare well with the Visante OCT. Anatomic features of the anterior segment of the eye were visible to the physicians that assessed the RTVue/CA images; the same physicians could not identify these features in the Visante OCT images.

2. Cornea Thickness Measurement Comparison:

Objective: To compare the cornea thickness measurement with other commercial available pachymeters.

Result: The cornea thickness measurement made by RTVue/CA is highly correlated with the ultrasound pachymetry system (Pearson correlation r = 0.9889), Orbscan II (Pearson correlation r = 0.9995), and Visante OCT (Pearson correlation r = 0.9924 at the vertex, r == 0.9939 over the central zone). The reproducibility of the RTVue/CA corneal measurement was 1.2 um root-mean-square for the difference between repeat pachymetry maps.

Conclusion

As described in this 510(k) Summary, all testing and analysis were conducted on the RTVue/CA to ensure that the device is safe and effective for its intended use when used in accordance with its instructions for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Optovue, Inc. c/o Jay Wei 41752 Christy Street Freemont, CA 94538

SEP 2 8 2007

Re: K071250

Trade/Device Name: CA Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: August 22, 2007 Received: August 23, 2007

Dear Mr. Wei:

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 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 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

M.B. Egerlton, mD

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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Indications for Use

510(k) Number (if known):

Device Name: CA Model:CAM

Indications for Use:

The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clay R. Buttem

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

510(k) Number K071250

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.