SeeMor™ 5.0 software program should be used for the transfer, display and image manipulation of multimodality diagnostic medical images and for the image than backprojection reconstruction reconstruction of SPECT & PET gated and ungated myocardial perfusion data.

Device Description

The SeeMor™ 5.0 medical viewing application is used for transfer and viewing diagnostic medical images. The program provides the capabilities of manipulating the images being displayed with the command options including: 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. The ReconTool™ processing application within Seemor™ 5.0 can be used to reorient and apply tomographic reconstruction to SPECT & PET gated and ungated myocardial perfusion image data sets.

AI/ML Overview

Acceptance Criteria and Study for SeeMor™ 5.0 (K041132)

Based on the provided text, the SeeMor™ 5.0 device is a medical imaging display and processing program. The study described focuses on proving its "safety and effectiveness" for its intended use, which primarily involves the display, manipulation, reorientation, and tomographic reconstruction of SPECT & PET gated and ungated myocardial perfusion image data sets. It's explicitly stated that the device "does not provide any interpretive output other than the display of the images."

Due to the nature of the device (a display and reconstruction tool rather than an AI diagnostic aid), the typical metrics for AI performance (e.g., sensitivity, specificity, AUC) and an MRMC comparative effectiveness study are not explicitly mentioned in the provided text. The study primarily validates the functionality and accuracy of the image processing aspect.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or precise performance metrics in the format of "X% accuracy" or "Y level of error." Instead, it relies on the successful completion of "initial design, coding, debugging, testing, and in-house validation" to demonstrate safety and effectiveness. The effectiveness is judged by the ability to correctly reorient and reconstruct images, as observed in the trial.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: No direct adverse effects on health.	"This program serves merely as a display program... It poses no direct adverse effect on health since it is only providing a means of displaying the medical images for the physician."
Effectiveness: Program functions as intended (transfer, display, manipulation, reorientation, and reconstruction of SPECT & PET myocardial perfusion images).	"The effectiveness of the program has been established in an in-house trial validation which included an evaluation of 20 patients." "We contend that the method employed for the development and the final in-house trial validation results of the SeeMor™ medical software program (with ReconTool™) have proven its safety and effectiveness."
Equivalence to Predicate: Substantial equivalence to AutoSPECT Plus.	Stated as substantially equivalent to AutoSPECT Plus (K992317).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 20 patients.
Data Provenance: Not explicitly stated, but implied to be retrospective as it refers to an "evaluation of 20 patients" in an "in-house trial validation." The country of origin is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document states that "The final responsibility for interpretation of the study lies with the physician," implying that physician judgment would be the ultimate arbiter, but doesn't detail their specific role in establishing ground truth for the technical effectiveness of the reconstruction.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of the device (a display and reconstruction tool), the "ground truth" for its effectiveness would likely be the visual correctness of the reconstructed images compared to expected outputs, rather than a diagnostic consensus among clinicians for a specific diagnosis.

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

MRMC Study Done? No. The document does not describe an MRMC study comparing human readers with and without AI assistance. This is consistent with the device's function as a display and processing tool, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance

Standalone Study Done? Yes, in a sense. The "in-house trial validation" assessed the functionality and output of the SeeMor™ 5.0 program (including ReconTool™) on its own, without human intervention in the image processing itself, although human review was necessary to verify its effectiveness. The device's "effectiveness" was based on its ability to produce accurate reconstructed images.

7. Type of Ground Truth Used

Type of Ground Truth: Implied to be technical correctness/visual fidelity of the reconstructed images. The effectiveness was assessed on whether the program successfully performed the requested reorientation and tomographic reconstruction of SPECT & PET data, likely validated by visual inspection and comparison to expected outputs or existing proven methods. It is not pathology, expert consensus on diagnosis, or outcomes data, as the device does not provide diagnostic interpretations.

8. Sample Size for the Training Set

Sample Size: Not applicable/not specified. The device is a software application for image display and reconstruction, not an AI model that undergoes a "training set" in the machine learning sense. Its development involved "initial design, coding, debugging, testing, and in-house validation," which are typical software development stages, not AI model training.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable. As discussed above, there is no "training set" in the AI sense for this device. Its functionalities are based on established image processing algorithms.

Summary

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K041132

AUG 1 6 2004

ITEM I

510(k) SUMMARY

Safety and Effectiveness

1. Medical Device Establishment:

Areeda Associates Ltd Registration No. 2030898 Owner Operator I.D. 9029223 Device Regulation Number: 892.1200 Product Code: 90 LLZ Classification Panel: Radiology Voice: (323) 653-5515, FAX: (323) 653-5514 Contact Person: Joseph Areeda or Kenneth Van Train Areeda Associates, Ltd. Address: 516 N. Curson Avenue Los Angeles, CA 90036 Date Summary Prepared: May 17, 2004

2. Medical Device:

SeeMor™ 5.0 - Medical Imaging Display & Processing program executing on personal computer systems with ReconTool™ .

3. Medical Device Equivalence:

AutoSPECT Plus developed by ADAC Laboratories Ref. 510(k) #: K992317.

4. Device Description:

Intended Use and Potential Adverse Effect on Health:

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The intended use of this program was to provide the physician with a display program which would allow for the transfer, remote viewing and interpretation of medical images. In whilen would and optional feature has been added to allow for the reorientation and addition, "of "Optional" T& PET gated and ungated myocardial perfusion image data sets. This program serves merely as a display program to aid in the diagnostic interpretation of a This program sorves morory as a display provide reconstruction capability of SPECT & PET patients Study and to provide roomantic interpretive output other than the display of the images. It does not provide any magins no direct adverse effect on health since it is only wroviding 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 programs marketed in the past which perform similar functions to those performed by SeeMor™ with the ReconTool™ . These programs are all used for the purpose of reorienting and reconstruction of SPECT & PET myocardial perfusion image data sets. The SeeMor™ 5.0 program with ReconTool™ provides a program which executes on non-propriety hardware (such as Windows PC or Macintosh) and we believe is substantially equivalent to the (outoration) Plus developed by ADAC Laboratories K992317. To our knowledge there have been no safety problems with the AutoSPECT Plus medical display program which has been in the marketplace for over four 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 20 patients. We contend that the method employed for the development and the final in-house trial validation results of the SeeMor™ medical software program (with ReconTool™) have proven its safety and effectiveness.

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings or feathers. The symbol is black, and the text is also in black.

Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2004

Re: K041782

Mr. Joseph Areeda President Areeda Associates Ltd. 516 N. Curson Ave. LOS ANGELES CA 90036-1814

Trade/Device Name: SeeMor™ Image Display Program Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ and KPS Dated: June 15, 2004 Received: July 1, 2004

Dear Mr. Arceda:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beceible of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) vo vogo J
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to ooniner of the 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). and Cosmetic (110) that be nevice, subject to the general controls provisions of the Act. The r ou may, therefere, misions 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 may or subject to satin additions, 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 I toase be determination that your device complies with other requirements of the Act that I DT has made a vegulations administered by other Federal agencies. You must comply or uny I occareer and managements, 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) I ms lotter with and in you to substantial equivalence of your device of your device to a legally promative notification: "The 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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510(k) NUMBER (IF KNOWN): K041782

DEVICE NAME: SeeMor™ 5.0 Image Display Program

INDICATION FOR USE:

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR Over-the-Counter Use

(Optional Format 1-2-96)

Nancy broglon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041782

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).