The TraumaCAD program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.

Device Description

TraumaCAD is a software application to be used by licensed physicians for preoperative planning of orthopedic surgical procedures. The application can be used in a workstation or in a PC as standalone software. The system allows the physician to import medical images, and to overlay them with templates of medical prosthesis and to perform measurements to facilitate surgical planning. The surgical plan is available on the hospital network, and can be sent to the Operating Room prior to surgery. The TarumaCAD does not have any image acquisition or image storage functionality, this is the responsibility of the systems alongside which TraumaCAD. In addition the system does not specify the requirements for the prosthetic template - this is the responsibility of the prosthetic manufacturer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the TraumaCAD device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Total Hip Replacement (Stem Size): A similar or improved level of accuracy in templating stem sizes compared to standard acetate overlays. This implies that the percentage of implanted stems being the same size, within one size, or within two sizes of the templated size should be comparable to or better than the acetate overlay method.	Total Hip Replacement (Stem Size): - Standard Templating (Acetate Overlays): - 60% same size - 30% within 1 size - 10% within 2 sizes - Digital Templating (TraumaCAD): - 65% same size - 23% within 1 size - 11% within 2 sizes (The device produced slightly better or comparable results: 5% more cases matched exactly, and the overall deviation within two sizes was similar (98% vs 99%).)
Total Hip Replacement (Acetabular Component Size): A similar or improved level of accuracy in templating acetabular components compared to standard acetate overlays. The percentage of implanted cups being the same size, within 2 mm, or within 4 mm of the templated size should be comparable to or better than the acetate overlay method.	Total Hip Replacement (Acetabular Component Size): - Standard Templating (Acetate Overlays): - 40% same size - 30% within 2 mm - 30% within 4 mm - Digital Templating (TraumaCAD): - 47% identical size - 47% within 2 mm - 6% within 4 mm (The device produced significantly better results: 7% more cases matched exactly, and 94% were within 2mm compared to 70% for acetate overlays, indicating higher precision.)
Clinical Outcomes: No intraoperative or postoperative fractures related to the templating method.	Clinical Outcomes: All postoperative films show good fit of the components and there were no intraoperative or postoperative fractures.
Overall Equivalence: TraumaCAD's performance in preoperative planning should be comparable to or better than planning using acetate overlays, while offering additional advantages of digital planning (ease of use, improved documentation, wider tools, greater accessibility).	Overall Equivalence: The non-clinical testing of pre-operative planning using TraumaCAD produces results comparable to planning using acetate overlays, with additional advantages.

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: 20 cases for standard templating (acetate overlays) and 20 cases for digital templating (TraumaCAD).
- Data Provenance: Not explicitly stated, but the study compares pre-operative planning methods. It doesn't specify if the cases were retrospective or prospective, nor does it specify the country of origin.
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 summary. The study compares two planning methods, but doesn't detail the process of establishing a "ground truth" for each case in terms of expert consensus before the planning, other than the implication that the outcome (implanted size) serves as a form of reference.
Adjudication method for the test set:
- This information is not provided. The comparison is based on the final implanted size versus the templated size. It's unclear if there was an adjudication panel for discrepancies in templating or outcomes.
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, an MRMC comparative effectiveness study, in the typical sense of evaluating human readers' diagnostic performance with and without AI, was not conducted. This study compares two methods of planning (manual acetate vs. digital software) and the accuracy of the templated size relative to the implanted size. The device (TraumaCAD) is presented as an assistance tool for "healthcare professionals," implying a human-in-the-loop, but the study doesn't quantify improvement in human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not explicitly stated. The device is described as "assisting healthcare professionals" and requiring "clinical judgments and experience." The study explicitly compares "pre-operative planning methods," which inherently involve human input.
The type of ground truth used:
- The "ground truth" used in this study appears to be the actual implanted prosthesis size and the fit of components on postoperative films. This is an outcome-based ground truth, where the accuracy of the prediction (templated size) is compared against the real-world outcome (implanted size).
The sample size for the training set:
- The summary does not mention a training set nor any machine learning component of the TraumaCAD device that would typically require a training set. The device is described as a software application for pre-operative planning, providing tools for measurements and prosthesis overlay, rather than an AI/ML algorithm that requires training data in the modern sense. The "Performance Data" section states "The subject device is developed according to IS0 9001:2000," which relates to quality management systems, not algorithm training.
How the ground truth for the training set was established:
- Since a training set is not mentioned and the device doesn't appear to be an AI/ML device requiring such, this information is not applicable/provided.

Summary

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K042816

NOV 1 0 2004

510(k) Summary of Safety and Effectiveness

The Following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).

807.92(a)(1) - Submitter Details:

Submitter name	OrthoCrat Ltd
Address:	Bar Kochva 34/3
	Tel Aviv
	Israel
	Phone:
Fax:	+972 3 7255731
E-mail:	zeev@orthocrat.com
Contact Person:	Adi Ickowicz
	MedicSense Ltd
	P.O.B 367
	Ramat Hasharon
	Israel
	Phone: +972 3 9233666Fax: + 972 3 923 1274E mail: adi@medicsense.com
Date:	August 18, 2004

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807.92(a)(2) - Device Details:

Trade Name	TraumaCAD Release 1.00
Common Name	Picture Archiving and Communication
	(PACS) System
Classification	892.2050 Image Processing System
Class	II
Product Code	LLZ

807.92(a){3) - Predicate Devices:

Medical DeviceName	Applicant Name	510(k)Number	Classification
Orthoview	Meridian Technique Ltd	K032401	Class II, Productcode LLZ
Sectra OrthopedicPackage	Sectra Imtec AB	KO31590	Class II, Productcode LLZ

Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.

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SEP 28 2004

807.92(a)(4) - Device Description:

Device Functions:

The system allows the physician to import medical images, and to overlay them with templates of medical prosthesis and to perform measurements to facilitate surgical planning. The surgical plan is available on the hospital network, and can be sent to the Operating Room prior to surgery.

The TarumaCAD does not have any image acquisition or image storage functionality, this is the responsibility of the systems alongside which TraumaCAD. In addition the system does not specify the requirements for the prosthetic template - this is the responsibility of the prosthetic manufacturer.

807.92(a)(5) — Device Intended Use:

Non-Clinical Testing

A study entitled "The Accuracy of Digital (filmless) Templating in Total Hip Replacement" was performed comparing pre-operative planning methods for total hip procedures. 20 cases planned using standard acetate overlays and radiographs were compared with 20 cases using TraumaCAD to perform digital preoperative planning.

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It was found that using standard templating, sixty percent of implanted stems were the same size as templated, 30 percent were within one size, and 10 percent were within 2 sizes. With digital templating 65 percent were the same size, 23 percent were within 1 size and 11 percent were within two sizes. For acetabular components using acetate overlays, 40 percent of implanted cups were the same size as templated, 30 percent were within 2 mm, and 30 percent within 4 mm. Digitally, 47 percent were the identical size, 47 percent were within 2 mm, and 6 percent within 4mm. All postoperative films show good fit of the components and there were no intraoperative or postoperative fractures.

Thus the non-clinical testing of the pre-operative planning using TraumaCAD produces results comparable to planning using acetate overlays with the additional advantages of digital planning including ease of use, improved case documentation, access to a wider arrange of tools, and greater accessibility.

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Parameter	OrthoView	Sectra OrthopedicPackage	TraumaCAD
Computer	PC Compatible	Part of workstationand PC compatible	PC Compatible
Operating System	Windows	Same	Same
Image input	Can receive digitalimages fromvarious sources	Same	Same
Number ofimages that canbe simultaneouslyviewed on thescreen	Four	One	One
Runs on server	Yes	Yes	Yes
Trauma module	No	No	Yes
Osteotomymodule	No	No	Yes
Digital Prosthetictemplates	Template overlaycapabilityInteractivetemplatepositioningAutomatic ScalingTemplate supportfrommanufacturersPermits templaterotation	Same	Same
Pre-operativeplanning	Allowed	Same	Same
Patient contact	None	Same	Same
Control of life-saving devices	None	Same	Same
Humanintervention forinterpretation andmanipulation ofimages	Required	Same	Same
Ability to addadditionalmodules whenavailable	Yes	Yes	Yes

807.92(a)(6) – Substantial Equivalence Comparison Table:

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Technological Characteristics

TraumaCAD will run on Windows 2000 or Windows XP.

Performance Data

The subject device is developed according to IS0 9001 :2000.

Conclusion

Similar to the predicate devices the TraumaCAD does not control life-sustaining equipment or contact the patient and does not alter the source data and original image. In addition all three require intervention of trained medical for process and interpretation of the images.

Based on the information supplied in this 510(k), we conclude that this device is safe, effective, and substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes extending from its body, representing health, human services, and well-being. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2004

Orthocrat, Ltd. 1% Mr. Robert Mosenkis President Citech Medical Device Testing and Consulting 5200 Butler Pike Plymouth Meeting PA 19462-1298 Re: K042816 Trade/Device Name: TraumaCAD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and

communications system

Regulatory Class: II Product Code: 90 LLZ Dated: October 28, 2004 Received: October 29, 2004

· Dear Mr. Mosenkis:

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 do not require approvial or wisions 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 n Jour av 100 ho 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.

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 statues 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 / 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)
10 a legal This letter will allow you to begin marketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA finding of substantial of 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 device on our laboring regulation (
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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to prematic notification" (21 CFR Also, please note the regulation entitled, "Whisonation on your responsibilities under the Act from the 180 807.97). You may obtain other general manon on Juner Assistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumers of Manufacturers, Division of Small Manufacturers, International and Consulter Particle.
638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmadsmamain.html

Sincerely yours,

Nancy C. brogdon

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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2. STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

TraumaCAD Device Name:

Indication For Use:

Prescription Use X (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological 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).