The OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.

Device Description

OIS EyeScan is a portable, modular imaging device, which is designed to perform retinal imaging (including color, FA, FAF, Red-free) and corneal imaging (including tear film analysis, corneal fluorescences, slit). OIS EyeScan Portable Modular Imaging System, consistent with the predicate imaging devices previously listed, uses light photography to obtain clinical information. OIS EyeScan captures images using light sources (LEDs of different colors), functionally optimized lenses and filters, and digital camera sensors. OIS EyeScan uses OIS WinStation software for image capture, review and analysis. The device comprises a base unit, and interchangeable imaging modules and optional chin rest. Images may be stored on industry standard storage media.

AI/ML Overview

The provided text describes the OIS EyeScan Portable Modular Imaging System, a portable monocular camera intended for imaging both the posterior and anterior segments of the eye. It is suitable for documenting findings in a clinical setting.

However, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than proving a new device's efficacy through specific clinical performance studies with acceptance criteria, sample sizes, and ground truth methodologies.

Therefore, the requested information cannot be fully extracted as such studies are not present in this 510(k) submission.

Here's an breakdown of what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for disease detection or diagnostic accuracy. The acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This means the device should have similar technological characteristics, intended use, and be as safe and effective as existing legally marketed devices.
Reported Device Performance: The document only states that the device was subjected to "extensive performance testing and validation" and that "EMC and safety tests currently underway will ensure the device complies with industry and safety standards." No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for clinical tasks.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This submission focuses on demonstrating substantial equivalence, not on a clinical performance study with a test set of patient data to assess diagnostic accuracy. Therefore, sample sizes and data provenance for such a test set are not mentioned.

3. 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 applicable. As there is no clinical performance study with a "test set" of patient data to establish ground truth on, this information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical performance study requiring adjudication is described.

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:

Not applicable. This document describes a new imaging system, not an AI-powered diagnostic aide designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or reported.

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

Not applicable. This device is an imaging system, not a standalone diagnostic algorithm.

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

Not applicable. As a clinical performance study for diagnostic accuracy is not outlined, the concept of "ground truth" for disease states is not relevant in this 510(k) summary. The "ground truth" for this submission would be adherence to functional specifications, safety standards, and equivalence to predicate devices.

8. The sample size for the training set:

Not applicable. This device is an imaging system, not a machine learning algorithm that requires a training set of data.

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

Not applicable. As there is no training set mentioned, this information is irrelevant.

Summary of Device Evaluation in the 510(k) Submission:

The OIS EyeScan Portable Modular Imaging System demonstrated substantial equivalence by:

Comparative Analysis to Predicate Devices: The submission extensively compares the OIS EyeScan to several predicate devices (Topcon TRC-50EX and TRC-50IX, WinStation Digital Imaging System, IRI Integrated Retinal Imager, BX900, Tearscope Plus).
Similarities Highlighted: The document emphasizes that the OIS EyeScan employs similar principles (light photography), light sources (LEDs instead of halogen/xenon lamps), optical specifications, image processing, and storage capabilities as the predicate devices.
Performance Testing: While specific results are not provided, the document states the device underwent "extensive performance testing and validation" and "software validation tests" to ensure it met "all its functional specifications." This functional specification fulfillment is the closest equivalent to "acceptance criteria" in this context.
Safety and EMC Compliance: The submission notes that EMC and safety tests were underway or completed to ensure compliance with industry and safety standards, another critical aspect of demonstrating equivalence.

Conclusion Drawn:

The conclusion drawn from the performance testing (functional and safety) and the comparison to predicate devices is that the OIS EyeScan Portable Modular Imaging System is substantially equivalent in safety and effectiveness to the listed predicate devices. This substantial equivalence is the primary "proof" provided in a 510(k) process for devices of this nature, rather than a clinical trial demonstrating specific diagnostic performance metrics against a defined ground truth.

Summary

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NOV 1 7 2009

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510(k) Summary

(Revision 10/14/2009)

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510(K) SUMMARY

OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM

510(k) Number __K092374

Applicant's Name:	Ophthalmic Imaging Systems221 Lathrop WaySuite ISacramento, CA 95864USATel: (916) 646-2020Fax: (916) 646-0207e-mail:aambrose@oisi.com
Contact Person:	Andrea Ambrose / Gil Allon221 Lathrop WaySuite ISacramento, CA 95864USATel: (916) 646-2020Fax: (916) 646-0207e-mail:aambrose@oisi.com or gallon@oisi.com
Date Prepared:	August 3, 2009 (Revised 10/14/2009)
Trade Name:	OIS EyeScan Portable Modular Imaging System
Classification Name:	CFR Classification section 886.1120 (Product code HKI)CFR Classification section 886.1850 (Product code HJO)CFR Classification section 892.2020 (Product code NFG)
Classification:	Class II Medical Device
Predicate Device:	The OIS EyeScan Portable Modular Imaging System issubstantially equivalent to a combination of the following predicatedevices:

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Topcon TRC-50EX and TRC-50IX (K041367), manufactured by TOPCON Corp. Topcon TRC devices are ophthalmic camera systems intended to photograph the eye's fundus, similar to the OIS EyeScan device with the Retina Module or Fluorescein Angiography Module. To the best of our understanding, the TRC-50EX received market clearance as an addition or a modification to the 510(k) clearance of the TRC-NW200 device, K041367.

WinStation Digital Imaging System (K913929) manufactured by Ophthalmic Imaging Systems is used in conjunction with ophthalmic fundus cameras to take images of the eye, similar to the OIS EyeScan device using the Retina Module or Fluorescein Angiography Module.

IRI Integrated Retinal Imager (K062295) manufactured by Medivision Medical Imaging is intended to photograph the eye's fundus similar to the OIS EyeScan device using the Retina Module or Fluorescein Angiography Module.

BX900 manufactured by Haag Streit is a slit-lamp biomicroscope with viewing and illumination optical systems, similar to the OIS EyeScan device with the Slit Module, Red Reflex Module or Topical Fluorescein Module. To the best of our understanding, the BX900 received market clearance as an addition or a modification to the 510(k) clearance of the BC900 device K982057.

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Tearscope Plus (K973064) manufactured by Keeler is a device for specular observation of the tear film, similar to the OIS EyeScan device with the Tear Film Module.

OIS EyeScan is a portable, modular imaging device, which is Device Description: designed to perform retinal imaging (including color, FA, FAF, Red-free) and corneal imaging (including tear film analysis, corneal fluorescences, slit).

OIS EyeScan Portable Modular Imaging System, consistent with the predicate imaging devices previously listed, uses light photography to obtain clinical information. OIS EyeScan captures images using light sources (LEDs of different colors), functionally optimized lenses and filters, and digital camera sensors. OIS EyeScan uses OIS WinStation software for image capture, review The device comprises a base unit, and and analysis. interchangeable imaging modules and optional chin rest. Images may be stored on industry standard storage media.

Intended Use / Indication for Use: The OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.

Performance Standards: None. There are no mandatory performance standards for this type of device.

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The OIS EyeScan Portable Modular Imaging System has been Test Data: subjected to extensive performance testing and validation before release. Final testing of the OIS EyeScan included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. EMC and safety tests currently underway will ensure the device complies with industry and safety standards. The device does now or will comply . with these industry and safety standards prior to commencing marketing of the device. See Section 9 for statement and declaration of conformity.

The OIS EyeScan Portable Modular Imaging System is Substantial Equivalence: similar to currently legally marketed ophthalmic imaging systems intended for posterior segment and anterior segment imaging applications. Similar to other predicate devices, the operating modes of the device include color, FA, FAF, red-free, ICG angiography, autofluorescence, tear film analysis, corneal fluorescences, slit. The device uses LEDs, similar to other predicate devices, as a safe low voltage light source instead of halogen and xenon lamps. Optical specifications are similar to those of predicate devices. Image processing and storage capabilities are similar to those of predicate devices. All of the above features are similar to these features in the predicate devices.

The conclusions drawn from the above Performance Testing and Conclusions: comparison to predicate devices is that OIS EyeScan Portable i Modular Imaging System is substantially equivalent in safety and effectiveness to the predicate devices listed above.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Ophthalmic Imaging Systems (OIS) c/o Ms. Andrea Ambrose Quality Manager 221 Lathrop Way, Suite I Sacramento, CA 95815

NOV 1 7 2009

Re: K092374

Trade Name: OIS EyeScan Portable Modular Imaging System Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI, HJO, NFG Dated: October 14, 2009 Received: October 15, 2009

Dear Ms. Ambrose:

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 includions for use stated in the enclosure) to legally marketed predicate devices marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical In microa in microatic 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, into receive 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, PDA 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 aft 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 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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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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Kessia Alexander for

Malvina B. Eydelman, M 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

K092374 510(k) Number (if known):

OIS EyeScan Portable Modular Imaging System Device Name:

Indications for Use:

Prescription Use V (Per 21 C.F.R. 801 Subpart D) C)

Over-The-Counter Use (Optional Format Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deare 11/09/09

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

510(k) Number K092374

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.