(92 days)
The MatchedFlicker® device is a software program that is intended for use by health care professionals to collect, store, and spatially calibrate (i.e. register and align) images of the posterior segment of the human eye.
The MatchedFlicker® device is a software program that is intended for use by health care professionals to collect, store, and spatially calibrate (i.e. register and align) images of the posterior segment of the human eye.
EyeIC's MatchedFlicker® Device: Acceptance Criteria and Study Details
The provided 510(k) summary for K090266 describes the MatchedFlicker® device as digital imaging software intended for healthcare professionals to collect, store, and spatially calibrate images of the posterior segment of the human eye for monitoring disease progression. As a Class II device (21 CFR 892.2050. NFJ), it is regulated as a Picture Archiving & Communication System.
Based on the provided document, the device did not undergo performance testing with specific acceptance criteria that would typically involve numerical metrics (e.g., sensitivity, specificity, accuracy). Instead, its substantial equivalence was established by comparing its technological characteristics and intended use to legally marketed predicate devices.
The document does not describe a study that proves the device meets specific acceptance criteria in terms of clinical performance metrics. The regulatory approval appears to rely on demonstrating that the device is substantially equivalent to existingpredicate devices for its stated intended use.
Here's an analysis of the provided information in the context of the requested details:
1. Table of Acceptance Criteria and Reported Device Performance
As discussed, the document does not lay out explicit acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, alignment accuracy thresholds) for the MatchedFlicker® device itself that were then measured and reported.
Instead, the "performance" described is the device's functionality and its technological characteristics being similar to predicate devices. The implicit "acceptance criterion" from the FDA's perspective for a 510(k) submission based on substantial equivalence is that the new device is as safe and effective as a legally marketed predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Ability to collect images | MatchedFlicker® is designed to collect images. |
| Ability to store images | MatchedFlicker® is designed to store images. |
| Ability to spatially calibrate (register and align) images of the posterior segment of the human eye | MatchedFlicker® is designed to spatially calibrate (register and align) images of the posterior segment of the human eye. The core feature is comparing time-series images through spatial calibration ("MatchedFlicker" implies visual comparison of aligned images). |
| Aids professionals to more easily compare and annotate time-series images | The device's technological characteristic section states it "is software to aid professionals to more easily compare and annotate time-series images." |
| Substantially equivalent to predicate devices (NAVIS (K013694), Retasure (K071299), IMAGEnet (K082364)) | The submission asserts and the FDA confirms (via 510(k) clearance) that MatchedFlicker® is substantially equivalent to these predicate devices based on its intended use and technological characteristics. |
Note: The document does not provide details on specific studies where numerical performance metrics were collected for these functionalities. The term "acceptance criteria" in the context of this 510(k) submission refers more to demonstrating functional equivalence and safety/effectiveness comparable to predicates, rather than meeting quantitative performance thresholds.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The document does not describe a performance study with a dedicated "test set" of patient data for evaluating new performance metrics. The clearance is based on substantial equivalence, implying the device's functionality is inherently similar to existing predicate devices, and therefore, does not necessitate a novel clinical performance study with a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No test set requiring expert ground truth establishment for performance evaluation is described.
4. Adjudication method for the test set
Not applicable/Not provided. No test set or adjudication process for performance evaluation 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
No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study or any study evaluating the improvement of human readers with or without AI assistance. The device is purely a digital imaging software for image management and spatial calibration, not an AI-assisted diagnostic tool in the sense of generating interpretations or aiding in detection beyond improved visualization.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The device is described as "software to aid professionals," explicitly designed for human-in-the-loop use. There is no mention of a standalone algorithm performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. No novel performance study requiring ground truth for clinical outcomes or diagnostic accuracy is described. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable/Not provided. As a substantial equivalence submission for image management and calibration software, the document does not indicate the use of AI/machine learning models that would require a "training set" in the context of predictive or diagnostic performance. If any algorithms are involved (e.g., for image registration), their development would fall under standard software engineering practices rather than a "training set" as understood in machine learning.
9. How the ground truth for the training set was established
Not applicable/Not provided. No training set requiring ground truth establishment is described.
{0}------------------------------------------------
510(k): k 090266
510(k) SUMMARY EyeIC's MatchedFlicker® Device
MAY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Morris Waxler, Ph.D. | Tel: 608-219-7547 |
|---|---|
| President | No FAX number |
| Waxler Regulatory Consultancy, LLC | mwaxler@charter.net |
| 1920 Arlington Place | |
| Madison, WI 53726-4002 |
Contact Person: Morris Waxler, Ph.D Date Prepared: January 29, 2009
Name of Device and Name/Address of Sponsor
| Ira Wallace, MD, MBACEOEyeIC Corporation231 Tower LaneSuite 200Narbeth, PA 19072-1127 | Phone 610-617-8957Cell 610-331-5759Fax 610-617-8883iwallace@eyeic.com |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------- |
MatchedFlicker®
Common or Usual Name: Digital Imaging Software
Classification Name: Picture Archiving & Communication System (21 CFR 892.2050. NFJ)
Predicate Devices
-
- NAVIS by Nidek, Inc. (K013694)
-
- Retasure by Digital Healthcare, Inc. (K071299),
-
- IMAGEnet by Topcon Corp (K082364)
Intended Use:
The MatchedFlicker® device is a software program that is intended for use by health care professionals to collect, store, and spatially calibrate (i.e. register and align) images of the posterior segment of the human eye.
{1}------------------------------------------------
Technological Characteristics and Substantial Equivalence:
The MatchedFlicker® device is software to aid professionals to more easily compare and annotate time-series images of the posterior segment of the human eye for monitoring the progression of glaucoma and other diseases. Currently these analyses are performed by a side-by-side comparison of serial mono or stereo-photographs. For example, in glaucoma there are two challenges to assessing the structure of the optic nerve. The first is distinguishing between a normal and a glaucomatous optic nerve. Changes in retinal structure, which signal the advent and progression of retinal disease, can be seen in photographs much earlier than in visual field tests. The more important challenge is detecting glaucoma progression over time prior to visual field loss. The MatchedFlicker® device is an aid to photo-documentation of stereo evidence of glaucomatous (or other diseases') changes in the retina and other structures of the posterior segment over time.
MatchedFlicker® is digital imaging software regulated by FDA as a type of Picture Archiving and Communications System (21CFR 892.2050) under product code NFJ. It is substantially equivalent to other legally marketed digital imaging software. Specifically, EyeIC's MatchedFlicker® software is substantially equivalent to NAVIS manufactured by Nidek, Inc. (K013694), to Retasure manufactured by Digital Healthcare, Inc. (K071299), and to IMAGEnet manufactured by Topcon Corp (K082364).
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle.
MAY - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EyeIC, Corporation c/o Morris Waxler, Ph.D. Waxler Regulatory Consultancy, LLC 1920 Arlington Place Madison, Wisconsin 53726
Re: K090266
Trade/Device Name: MatchedFlicker™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: April 6, 2009 Received: April 7, 2009
Dear Dr. Waxler:
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 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 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.
{3}------------------------------------------------
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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. Eglekus, 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
{4}------------------------------------------------
Indications for Use Statement
K090266 510(k) Number (if known):
Device Name: MatchedFlicker®
Indications for Use:
The MatchedFlicker" device is a software program that is indicated for use by health care professionals to collect, store, and spatially calibrate (i.e. register and align) images of the posterior segment of the human eye.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER LINE IF NECESSARY0
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Diysion Sign-Off) Division of Ophthalmic & ENT Devices
510(k) Number
Prescription Use_X or Over-The-Counter Use (Optional Format 1-2-96)
EyeIC
Additional Information for K
April 13, 2009 Page 1 of 1
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).