This medical device (SeeMor™) is a display program for viewing diagnostic medical images. The program provides the capabilities of manipulating the images being displayed with the following command options: clipping, window/level adjustment, magnification, pan, relate, add, delete, next, cine, lock, select, view, flip vertical/horizontal, set color table, orthogonal view reconstruction, cascade, tile, and reset.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SeeMor™ device:

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

Acceptance Criteria	Reported Device Performance
Safety	Determined through stages of software development: initial design, coding, debugging, testing, and in-house validation.
Effectiveness	Established in an in-house trial validation.
Intended Use	Display and image manipulation of multi-modality diagnostic medical images.
Equivalence	Substantially equivalent to MedVision™ Imaging Software (K924178).

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

Sample Size: 25 patients
Data Provenance: The document states "an in-house trial validation," which suggests the data was collected internally by Areeda Associates Ltd. No specific country of origin is mentioned, nor is it explicitly stated whether the study was retrospective or prospective. Given the small sample size and "in-house trial validation," it's likely a relatively short-term, possibly retrospective or small prospective study.

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)

The document does not specify the number of experts used or their qualifications for establishing ground truth for the 25-patient test set. It only mentions that the program "serves merely as a display program to aid in the diagnostic interpretation of a patients' study" and "The final responsibility for interpretation of the study lies with the physician." This implies that physicians would be using the display program for their interpretation, but it doesn't detail how a "ground truth" was formally established for the purpose of validating the software's effectiveness, especially since the software itself doesn't provide diagnostic output.

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

No adjudication method is described or mentioned for the test set.

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 MRMC comparative effectiveness study was done. The device is a display program and does not incorporate AI or provide diagnostic interpretive output; therefore, it would not be applicable for measuring human reader improvement with AI assistance.

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

A standalone performance study, as typically understood for an AI algorithm (measuring its diagnostic accuracy independently), was not done. The device is a display program, not a diagnostic algorithm. Its "effectiveness" as stated is in its ability to display and manipulate images reliably for a physician.

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

The document does not explicitly state the type of ground truth used. Given that the device is a display program and does not generate diagnostic output, the "effectiveness" validation likely focused on the software's functionality (e.g., correct display of images, proper application of manipulation commands like window/level, zoom, etc.) as perceived by users or through technical checks, rather than establishing a true medical diagnosis ground truth for each case. The responsibility for interpretation rests with the physician using the display.

8. The sample size for the training set

The document does not mention a training set. This is consistent with the device being a display and manipulation program, which typically does not involve machine learning or training on medical data in the way an AI diagnostic algorithm would. Its development is based on software engineering principles rather than data-driven model training.

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

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

Summary

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ITEM I

K973653 ×973653

510(k) SUMMARY

DEC 1 2 1997

Safety and Effectiveness

1. Medical Device Establishment

Areeda Associates Ltd 516 N. Curson Avenue Los Angeles, CA 90036 Voice: (213) 653-5515 (213) 653-5514 FAX: e-mail: joe@areeda.com Contact person: Joseph Areeda or Kenneth Van Train Date Summary Prepared: September 24, 1997

2. Medical Device:

SeeMor™ - Medical Imaging Display & Processing program executing on personal computer systems.

3. Medical Device Equivalence:

MedVision™ Imaging Software developed by Evergreen Technologies, Inc., Ref. 510(k) #: K924178.

4. Device Description:

5. Intended Use and Potential Adverse Effect on Health:

The intended use of this program was to provide the physician with a display program which would allow for the remote viewing and interpretation of

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medical images. This program serves merely as a display program to aid in the diagnostic interpretation of a patients' study. It does not provide any diagnostic interpretive output other than the display of the images. Therefore, this program has no direct adverse effect on health since it is only providing a means of displaying the medical images for the physician. The final responsibility for interpretation of the study lies with the physician.

6. Marketing History:

There have been multiple medical device display programs marketed in the past which perform similar functions to those performed by SeeMor™. These programs are all used for the sole purpose of displaying medical images for the diagnostic interpretation by a physician. The SeeMor™ program provides a program which executes on non-propriety hardware (IBM PC or Macintosh) and we believe is substantially equivalent to the MedVision Viewer developed by Evergreen Medical Technologies K924178. To our knowledge there have been no safety problems with the MedVision Viewer medical display program which has been in the marketplace for over four years. In addition, we are not aware of any problems on any of the proprietary medical display programs which have been in the marketplace for over 20 years.

7. Conclusions:

The safety of this program has been determined through the various stages of software development which included the initial design, coding, debugging, testing, and in-house validation. The effectiveness of the program has been established in an in-house trial validation which included an evaluation of 25 patients. We contend that the method employed for the development and the final in-house trial validation results of this medical display software program (SeeMor™) have proven its safety and effectiveness.

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Image /page/2/Picture/0 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 a stylized symbol that resembles three human figures in profile, with flowing lines suggesting movement or connection.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

DEC | 2 |997

Joseph Areeda President Areeda Associates, Ltd. 516 N. Curson Ave. Los Angeles, CA 90036-1814 Re:

K973653 SeeMor™ (Image Processing System) Dated: September 24, 1997 Received: September 25, 1997 Regulatory class: Unclassified Procode: 90 LLZ

Dear Mr. Areeda:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 misbranion.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Liau Yu
Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): ___K973653

Device Name: _________________________________________________________________________________________________________________________________________________________________ Personal Computers

Indications For Use:

The SeeMor™ software program should be used for the display and image manipulation of multimodality diagnostic medical images.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ 1 (Per 21 CER 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Willian Y

(Division Sign-Off) (Division Sign-Off)
Division of Denductive, Abdominal, ENT, and Rachelogical Devices

510(k) Number _

Regulation Number and Section

§ 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).