The IKOEngelo™ System is intended for use in tumor and normal tissue contour delineation to support the radiotherapy treatment planning process.
The IKOEngelo™ System is indicated for use by radiation oncologists, medical physicists, and medical dosimetrists for tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.

Device Description

The IKOEngelo device is a software system that will assist radiation oncologists, with the assistance of physicists and dosimetrists, to more efficiently perform contour delineation of the tumor target and normal tissue on patient's CT images.
The sequence of events is illustrated in the following bullet items and diagram:

Import patient's CT images. .
Select the proper Expert Case (including the CT image data set and . contours) to match patient's CT.
Automatically fuse the images to align patient's CT image data sets . with those of the Expert Case.
Run deformable segmentation to auto-contour on the patient's CT . images.
Review patient's contours and modify them if necessary. .
Approval by qualified radiation oncologist. .
Export patient's CT with its contours to the treatment planning system . used by the facility.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets such criteria. It primarily focuses on the device's description, intended use, and a comparison to a predicate device for 510(k) submission. Therefore, much of the requested information is not available in the provided document.

However, based on the information that is present, here's what can be extracted and inferred:

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

The document does not explicitly state acceptance criteria or provide a table of reported device performance against those criteria. It offers a "Predicate Comparison Table" which outlines functional equivalence to the QwikSIM Virtual Simulation System (K013531). This comparison serves as the basis for demonstrating substantial equivalence for regulatory purposes, rather than a direct performance study against defined acceptance criteria.

Predicate Comparison Table (Indicating Functional Equivalence, not specific performance metrics against acceptance criteria):

#	Feature	IMPAC Medical Systems, Inc. QwikSIM (K013531)	IKOEtech IKOEngelo ™
1	Intended Use	QwikSIM is a radiation therapy virtual simulation system for patient image review, target and critical structure delineation, and geometric treatment planning.	The IKOEngelo ™ System is intended for use in tumor and normal tissue contour delineation to support the radiotherapy treatment planning process.
2	Image Study Import	Dicom3	Dicom3
3	Treatment Planning Connectivity	DICOM CT SCP and DICOM RT Structure Set SCP/SCU interface modalities.	DICOM CT SCP and DICOM RT Structure Set SCP/SCU interface modalities.
4	Flexible Image Display	Multiple-image views and allows side-by-side views for comparison, displaying the following perspectives: Slice View, Orthogonal Multi-Planar Reconstructed View, and Digital Scout View.	Multiple-image views and allows side-by-side views for comparison, displaying the following perspectives: Slice View, Orthogonal Multi-Planar Reconstructed View.
5	Image Viewing Tools	Tools for image review include zoom and pan tools for reviewing MPR/Slice planes, and tape measure and protractor controls.	Tools for image review include zoom and pan tools for reviewing MPR/Slice planes, slice indicators, tape measure, CT number displayer, and isocenter lines.
6	Contour Source	Anatomy Templates	Expert Case Library
7	Automatic Contouring	Based on pre-defined CT thresholds	Deformable registration and segmentation.
8	Contour Expansion	2D inflation of anatomical objects with specified margins.	N/A
9	Image Fusion	N/A	Auto and manual fusion
10	Contours Review	Side-by-side only	Side-by-side with image linking to scroll through simultaneously.
11	Contour Modification Tools	Point-click draw contour tool.	Nudge contour, cut contour, draw contour and create new contour tools.

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The document describes a general comparison to a predicate device but does not detail a specific test set, its size, or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document.

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

This information is not provided in the document.

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:

This information is not provided in the document. The document describes the device as a software system to assist radiation oncologists, physicists, and dosimetrists, implying a human-in-the-loop scenario. However, no MRMC study or its results are mentioned.

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

The document states the device will assist radiation oncologists, with assistance of physicists and dosimetrists, to perform contour delineation. It also mentions "Review patient's contours and modify them if necessary" and "Approval by qualified radiation oncologist." This suggests the device is intended for use with human oversight and modification, not as a standalone, fully automated system without human-in-the-loop. Therefore, it is highly likely that a standalone performance study as an algorithm without human interaction was not the primary focus or reported.

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

This information is not provided in the document. The "Expert Case Library" is mentioned as a "Contour Source," which implies pre-existing contours were used, likely established by experts, but the method for their establishment as "ground truth" for validation is not described.

8. The sample size for the training set:

This information is not provided in the document. The document mentions "Select the proper Expert Case (including the CT image data set and contours) to match patient's CT" and "Run deformable segmentation to auto-contour on the patient's CT images." This implies an underlying model that would have been trained, but no details of the training set size are given.

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

This information is not provided in the document. While "Expert Case Library" is identified as a contour source, the method of how those "Expert Cases" (and their contours) were established as ground truth for training (or for the general functioning of the system) is not detailed.

Summary

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Experts at your Fingertips

3000 Richmond Suite 200 Houston, TX 77908

TEL: (713) 600-2410 Fax: (713) 600-2411 E-MAIL: INFORMATION@IKOETECH.COM WEB SITE: HTTP://www.iKOETECH.COM

JUN - 5 2006

Premarket Notification [510(k)] Summary

K06/006

March 31, 2006

Trade Name:	IKOEngelo™
Common Name:	Radiation Therapy Simulation accessory
Classification Name:	Radiation Therapy Simulation System,Product Code: KPQ (per 21 CFR 892.5840)
Manufacturer's Name:	IKOEtech, LLC.
Address:	3000 Richmond, Suite 200Houston, TX 77098
Corresponding Official:	Ms. Huimin Chao, LLM
Title:	President
Telephone:	(713) 600-2410
Fax:	(713) 600-2411
Predicate:	IMPAC Medical Systems, Inc.QwikSIM Virtual Simulation System, 510(k) #: K01353

The IKOEngelo device is a software system that will assist radiation Device Description: oncologists, with the assistance of physicists and dosimetrists, to more efficiently perform contour delineation of the tumor target and normal tissue on patient's CT images.

The sequence of events is illustrated in the following bullet items and diagram:

Import patient's CT images. .
Select the proper Expert Case (including the CT image data set and . contours) to match patient's CT.

{1}------------------------------------------------

Experts at your Fingertips

3000 Richmond Suite 200 Houston, TX 77908

Tel.: (713) 600-2410 Fax: (713) 600-2411

E-MAIL: INFORMATION@IKOETECH.COM WEB SITE: HTTP://www.ikoetech.com

061006

Automatically fuse the images to align patient's CT image data sets . with those of the Expert Case.
Run deformable segmentation to auto-contour on the patient's CT . images.
Review patient's contours and modify them if necessary. .
Approval by qualified radiation oncologist. .
Export patient's CT with its contours to the treatment planning system . used by the facility.

The IKOEngelo™ System is intended for use in tumor and normal tissue Intended Use: contour delineation to support the radiotherapy treatment planning process See the attached "Predicate Comparison Table". Technological Characteristics:

Predicate Comparison Table

#	Feature	IMPAC Medical Systems, Inc.QwikSIM (K013531)	IKOEtechIKOEngelo ™
1	Intended Use	QwikSIM is a radiation therapyvirtual simulation system for patientimage review, target and criticalstructure delineation, and geometrictreatment planning.	The IKOEngelo ™ System is intendedfor use in tumor and normal tissuecontour delineation to support theradiotherapy treatment planningprocess.
2	Image StudyImport	Dicom3	Dicom3
3	TreatmentPlanningConnectivity	DICOM CT SCP and DICOM RTStructure Set SCP/SCU interfacemodalities.	DICOM CT SCP and DICOM RTStructure Set SCP/SCU interfacemodalities.

{2}------------------------------------------------

Experts at your Fingertips

3000 Richmond Suite 200 Houston, TX 77908

Tel: (713) 600-2410 Fax: (713) 600-2411

E-Mail: Information@ikoetech.com Web Site: http://www.ikoetech.com

K061006

4	Flexible ImageDisplay	Multiple-image views and allowsside-by-side views for comparison,displaying the following perspectives:Slice View, Orthogonal Multi-PlanarReconstructed View, and DigitalScout View.	Multiple-image views and allowsside-by-side views for comparison,displaying the following perspectives:Slice View, Orthogonal Multi-PlanarReconstructed View.
5	Image ViewingTools	Tools for image review include zoomand pan tools for reviewingMPR/Slice planes, and tape measureand protractor controls.	Tools for image review include zoomand pan tools for reviewingMPR/Slice planes, slice indicators,tape measure, CT number displayer,and isocenter lines.
6	Contour Source	Anatomy Templates	Expert Case Library
7	AutomaticContouring	Based on pre-defined CT thresholds	Deformable registration andsegmentation.
8	ContourExpansion	2D inflation of anatomical objectswith specified margins.	N/A
9	Image Fusion	N/A	Auto and manual fusion
10	Contours Review	Side-by-side only	Side-by-side with image linking toscroll through simultaneously.
11	ContourModificationTools	Point-click draw contour tool.	Nudge contour, cut contour, drawcontour and create new contour tools.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Huimin Chao President IKOTech, LLC 3000 Richmond, Suite 200 HOUSTON TX 77098

JUN - 5 2006

Re: K061006

Trade/Device Name: IKOEngelo TM Regulation Number: 21 CFR §892.5840 Regulation Name: Radiation therapy simulation system Product Code: KPQ Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Product Code: MUJ and IYE Regulatory Class: II Dated: April 1, 2006 Received: April 11, 2006

Dear Ms. Chao:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image shows a circular logo with the text "1906 - 2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a stylized font. The logo is surrounded by text that follows the circular shape.

Protecting and Promoting Public Health

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Page 2 -

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.

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 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 yours,

Nancy Chrogdon

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

Enclosure

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Indications For Use

Kollool 510(k) Number (if known): Rending IKOEngelo™ Device Name:

Indications for Use:

The IKOEngelo™ System is indicated for use by radiation oncologists, medical physicists, and medical dosimetrists for tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.

David A. Ayres

(Division Si of Reproductive A

Prescription Use
(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)

Regulation Number and Section

§ 892.5840 Radiation therapy simulation system.

(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.