iPACS ORTHO™is intended for the manipulation, displaying, and distribution of medical images. It can show images from different modalities and interfaces to medical images. It one and printing devices using DICOM or similar interface standards.

The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.

Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.

Device Description

iPACS ORTHO™ handles and displays various objects in a Picture Archive and Communication System (PACS) environment and is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The device is used to overlaying prosthesis templates on radiological images, tools for repositioning the templates, and tools for measurements in the images.

AI/ML Overview

This 510(k) submission (K041366) does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical performance study for an AI/ML device. This submission is for a Picture Archiving Communications System (PACS) software, specifically iPACS ORTHO™, intended for image manipulation, display, and distribution, and to assist orthopedic surgeons with pre-operative planning and post-operative follow-up.

The primary demonstration of "acceptance" in this document is the claim of substantial equivalence to an existing predicate device (Sectra orthopedic package, K031590). The acceptance criteria for such a device are typically related to its functional performance, safety, and effectiveness compared to the predicate, rather than statistical performance metrics like sensitivity or specificity.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth for training set) are not applicable or documented in this type of 510(k) submission for a PACS system from 2004. This submission pre-dates the rigorous clinical validation standards often applied to AI/ML devices today.

Here's an attempt to answer the questions based on the provided document, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device:
- Ability to handle and display various PACS objects	iPACS ORTHO™ handles and displays various objects in a PACS environment.
- Assistance in pre-operative planning	The device assists orthopedic surgeons when doing preoperative planning.
- Assistance in post-operative follow-up	The device assists orthopedic surgeons when doing post-operative follow-up.
- Overlaying prosthesis templates on radiological images	Provides tools for overlaying prosthesis templates.
- Tools for repositioning templates	Provides tools for repositioning templates.
- Tools for measurements in images	Provides tools for measurements in images.
- Manipulation, displaying, and distribution of medical images	Intended for manipulation, displaying, and distribution of medical images.
- Show images from different modalities and interfaces	Can show images from different modalities and interfaces using DICOM or similar standards.
Safety:
- No operating of life-sustaining devices	The device does not operate any life-sustaining devices.
- Ample opportunity for competent human intervention	A physician interprets images and information, providing human intervention.
Voluntary Standards, Hazard Analysis:	The device has been and will be manufactured in accordance with listed voluntary standards. Hazard analysis classified potential hazards as "minor."
Substantial Equivalence to Predicate (K031590):	The FDA determined the device is substantially equivalent to the predicate device.

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

Not applicable/Not provided in the document. This type of 510(k) submission for a PACS system primarily relies on demonstrating functional equivalence and safety rather than a quantitative performance evaluation with a specific test set. There is no mention of a test set with patient data.

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

Not applicable/Not provided in the document. No specific test set or ground truth establishment process is described as part of the submission for substantial equivalence. The "experts" are the "trained professionals" (orthopedic surgeons, physicians, radiologists) who use the system in practice.

4. Adjudication method for the test set

Not applicable/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

Not applicable/Not provided in the document. This is a PACS software, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.

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

Not applicable/Not provided in the document. The device is explicitly stated to require human intervention: "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."

7. The type of ground truth used

Not applicable/Not provided in the document. The device isn't making a diagnosis; it's a tool for manipulating and displaying images for manual planning and follow-up by a human expert. The "ground truth" implicitly relies on the physician's expertise and the accuracy of the underlying medical images.

8. The sample size for the training set

Not applicable/Not provided in the document. This document describes a software system, not a machine learning algorithm that requires a training set.

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

Not applicable/Not provided in the document.

Summary

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K04 1366

JUN - 8 2004

Image /page/0/Picture/2 description: The image shows the words "RealTime Image" stacked on top of each other. The word "RealTime" is on the top line, and the word "Image" is on the bottom line. There is a black square in the upper left corner of the image. The text is written in a simple, sans-serif font.

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

April 2, 2004

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Zvi Eintracht Real Time Image Inc. 1111 Bayhill Dr, San Bruno, CA94066, suite 290 Tel: 650.616.4671 Fax: 650.616.4680

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name: Common Name: Device Classification: Name:

iPACS ORTHO™ Picture Archiving Communications System 892.2050 System, Image Processing

Predicate Device: 21 CFR 807. 92(a)(3)

Device Classification Name	system, image processing, radiological
510(k) Number	K031590
Regulation Number	892.2050 Class II
Device Name	Sectra orthopedic package
Applicant	sectra-imtec ab
Product Code	LLZ
Decision Date	10/02/2003
Decision	Substantially equivalent (SE)
Classification Advisory Committee	Radiology
Review Advisory Committee	Radiology
Type	Traditional

Device Description: 21 CFR 807 92(a)(4)

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Image /page/1/Picture/0 description: The image shows a logo with a black square in the upper left corner. Below the square, the words "RealTime Image" are written in a simple, sans-serif font. The word "RealTime" is on the first line, and the word "Image" is on the second line.

Indications for Use: 21 CFR 807 92(a)(5)

The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.

Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.

Technological Characteristics: 21 CFR 807 92(a)(6)

iPACS ORTHO™ runs together with iPACS Prism on Windows 2000 or Windows If AOO ORTTTO - Fans togetherling upon system configuration).The device does Ar operating of any of any life sustaining devices. A nbysician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for iPACS ORTHO™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

iPACS ORTHO™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards have been classified as "minor".

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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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The symbol is black, and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2004

Real Time Image, Inc. % Mr. Ned Devine Official Correspondent Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49571 Re: K041366 Trade/Device Name: iPACS ORTHOTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: April 2, 2004 Received: May 24, 2004

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becemined the device is substantially equivalent (for the indications felerenced above and nave action legally marketed predicate devices marketed in interstate 101 use stated in the enclosers's 10 vegany the Medical Device Amendments, or to conninered phor to may 20, 1970, in accordance with the provisions of the Federal Food, Drug, devices may nave occh resulted in equire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, thanks of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 be subject to such additional controls. Existing major regulations affect may be subject to save additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouv cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I DA 3 lossants of our device complies with other requirements of the Act that ITDA has made a decermination administered by other Federal agencies. You must comply of ally it call the Act's requirements, including, but not limited to: registration and listing (21 CFR Part with an the Ace 3 roquirements, more and manufacturing practice requirements as set forth in the 807), labornig (21 OFR Part 820); and if applicable, the electronic product quality Systems (QD) regular(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 letter will anow you to obgin hanteting of substantial equivalence of your device to a legally premarket notification. The PDF mailing sittems 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 If you desire specific advice for your de to 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 Additionally, for questions on the presses and e the regulation entitled, "Misbranding Other or of or premarket notification" (21CFR Part 807.97) you may obtain. Other general by receice to premarket neathed. Er the Act may be obtained from the Division of Small information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 1410146101613, 11:01:01:01:01:01 am its Internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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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41266

Image /page/4/Picture/1 description: The image shows a logo with a black square in the upper left corner. Below the square, the words "RealTime Image" are written in a simple, sans-serif font. The text is arranged in two lines, with "RealTime" on the first line and "Image" on the second line.

Indications for Use

510(k) Number (if known): Коч 1366

Device Name: iPACS ORTHO™

Indications For Use:

iPACS ORTHO™is intended for the manipulation, displaying, and distribution of if AOO ONYTIO fo Thenaba interent modalities and interfaces to medical intages. It can and printing devices using DICOM or similar interface standards.

The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.

Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.

Prescription Use __
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

and Redintogical 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).