The TraumaCad Mobile Release 1.0 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 judgment and experience are required to properly use the software is not for primary image interpretation. The software is not for use on mobile phones.

Device Description

TraumaCad Mobile Release 1.0 allows surqeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitate the film-less orthopedic practice. The program features full PACS integration and an extensive reqularly updated library of digital templates from leading manufacturers. TraumaCad Mobile Release 1.0 supports DICOM and enables the importing and exporting of image files from a central PACS system, or Quentry (Class I device reqistered by Brainlab AG in the FDA).

TraumaCad Mobile Release 1.0 is the web based version of the predicate device TraumaCad 2.0 (cleared by the FDA on March 19, 2008). The TraumaCad Mobile Release 1.0 has the same basic functionality and intended use as the predicate device, but is now available as a web based version on additional platforms. The differences between the device and the predicate device do not impact on substantial equivalence.

TraumaCad Mobile Release 1.0 is a web based device that can be used on PCs, Mac, or iPad 3, 4 or 5 (Air) and interacts with a PACS system or Quentry. No installation is required. TraumaCad Mobile Release 1.0 provides web based access and should only be used on computers and iPads that are already qualified for wireless use in a clinical setting. TraumaCad Mobile is not intended for use on mobile phones. Use of TraumaCad Mobile for planning on a tablet is not to replace planning on a workstation. Use on a tablet is only for situations when a workstation is not available.

In order to access TraumaCad Mobile, the user needs to browse to a specific URL and enter the system via username and password. A Web Application will be available in the iTunes store that will automatically open the browser with the correct URL. The application can be downloaded from iTunes for free but cannot be used without receiving a license to ensure the use by appropriate healthcare professionals.

The program features full PACS integration and an extensive reqularly updated library of digital templates from leading manufacturers. TraumaCad Mobile supports DICOM and enables the importing and exporting image files from a central PACS system or from Quentry.

AI/ML Overview

The provided document describes the 510(k) premarket notification for TraumaCad Mobile Release 1.0. This device is a web-based version of the previously cleared TraumaCad 2.0 and is intended for assisting healthcare professionals in preoperative planning of orthopedic surgery.

The document does not explicitly state "acceptance criteria" and "reported device performance" in a formal table format as requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device (TraumaCad 2.0) through functional testing, comparison of technological characteristics, and usability testing. The "acceptance criteria" can be inferred from the successful outcome of these tests, implying that the new device performs "as well as or better than the legally marketed predicate device."

Here's an analysis of the study and information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of quantitative acceptance criteria with numerical performance targets and reported values. Instead, it asserts that the TraumaCad Mobile Release 1.0 performs comparably to its predicate device, TraumaCad 2.0, across its shared functionalities.

Acceptance Criteria (Inferred from testing)	Reported Device Performance (TraumaCad Mobile Release 1.0)
Functional Equivalence to Predicate Device:
- Marker detection accuracy	Same expected results as TraumaCad 2.0
- Calibration result accuracy	Same expected results as TraumaCad 2.0
- Template positioning accuracy	Same expected results as TraumaCad 2.0
- Image selection from Quentry/PACS	Successfully performed
- Image calibration	Successfully performed
- Implant selection	Successfully performed
- Evaluation of LLD and offset changes	Successfully performed
- Changing implant properties	Successfully performed
- Use of measurement tools	Successfully performed
- Saving results to Quentry/PACS	Successfully performed
Safety and Effectiveness:	Successfully demonstrated through non-clinical testing
Risk Mitigation:	New risk control measures implemented and deemed effective for the mobile environment
System Stability/Reliability:	Passed unit, system/integration, and acceptance tests including security, negative testing, error handling, stress testing, platform testing, workflow testing, functional testing, multi-user/external access testing, data integrity testing, compatibility testing, load testing, regression testing, and hazard mitigation testing.
Usability: (Inferred from Usability Testing)	Successfully performed preoperative planning on various Hip X-rays, with familiar workflow for users of the predicate device.

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

Test Set Sample Size: The document does not specify a numerical sample size for the test set (number of cases or images). It mentions "various medical images from a range of cases" and "various Hip X-rays" for usability testing.
Data Provenance: The document implies the use of existing digital images from PACS systems or Quentry. The country of origin is not explicitly stated. The nature of the study appears to be retrospective as it uses pre-obtained digital images for testing the software's functionality and comparison.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience).
It states that "Clinical judgment and experience are required to properly use the software" as part of its indications for use, implying that healthcare professionals with relevant expertise would interpret the results.
The testing compared the results of TraumaCad Mobile with TraumaCad 2.0, suggesting the "ground truth" for the comparison was based on the performance of the predicate device, which would have been validated by experts previously.

4. Adjudication Method for the Test Set:

The document does not describe a formal adjudication method (e.g., 2+1, 3+1).
The comparison involved running tests in parallel on TraumaCad Mobile and the predicate device TraumaCad 2.0 and observing if they yielded "the same expected results." This implies a direct comparison rather than an expert consensus adjudication on individual cases.

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

No, an MRMC comparative effectiveness study was not explicitly described. The study focused on demonstrating substantial equivalence between TraumaCad Mobile and its predicate device, TraumaCad 2.0.
While usability testing involved test participants (who may be healthcare professionals and potentially users of the predicate device), the document does not present data on how much human readers improve with AI (TraumaCad Mobile) vs. without AI assistance (presumably manual planning or planning with the predicate device) in a formal MRMC study design to determine an effect size.

6. Standalone Performance:

Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation was effectively performed for the core algorithms. The document states: "The algorithms contained on TraumaCad Mobile are the same as those that are in the predicate device TraumaCad 2.0 that have been extensively tested." And "Testing included the main functions such as: Marker detection, Calibration result and Templates positioning. The test shows that the predicate device TraumaCad and TraumaCad Mobile have the same expected results in all of the tests." This suggests that the inherent algorithmic performance for these functions was compared in a standalone manner.
However, the device is explicitly indicated for "assisting healthcare professionals," meaning human-in-the-loop is part of its intended use. The usability testing further underscores the interaction with humans.

7. Type of Ground Truth Used:

The ground truth for the functional comparison testing was primarily based on the expected results from the predicate device (TraumaCad 2.0). The document states that the new device and the predicate device "have the same expected results in all of the tests."
For the initial validation of the predicate device (TraumaCad 2.0) and the underlying algorithms, it is highly probable that expert consensus (e.g., orthopedic surgeons, radiologists) and potentially comparison against surgical outcomes data or pathology (if applicable for certain measurements) would have been used. However, for this specific 510(k), the ground truth is anchored to the performance of the already-cleared predicate device.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is because TraumaCad Mobile Release 1.0 is largely a porting of existing, already-trained algorithms from TraumaCad 2.0 to new platforms (web-based, iPad, Mac). It's not a new machine learning algorithm that requires a separate training phase with new data. The document explicitly states: "The algorithms contained on TraumaCad Mobile are the same as those that are in the predicate device TraumaCad 2.0 that have been extensively tested."

9. How the Ground Truth for the Training Set Was Established:

As there's no mention of a new training set for TraumaCad Mobile 1.0, there's no information on how its ground truth would have been established.
For the original TraumaCad 2.0 and its algorithms (from which TraumaCad Mobile's algorithms are derived), the ground truth for training (if machine learning was involved, which is not explicitly stated in this document but is common for such systems) would typically be established through expert consensus by orthopedic surgeons or radiologists, potentially using manually annotated anatomical landmarks, measurements, or templating results validated against surgical outcomes or physical measurements.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and three human figures in profile facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

October 08, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Voyant Health Ltd. % Mrs. Yael Guttentag QM&RA Manager 35 Efal Street Petach-Tikva 4951132 ISRAEL

Re: K142923

Trade/Device Name: TraumaCad Mobile Release 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 26, 2015 Received: January 28, 2015

Dear Mrs. Guttentag:

This letter corrects our substantially equivalent letter of March 5, 2015.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

ery yours,

Jeff B. Myers

For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142923

Device Name TraumaCad Mobile Release 1.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower-like graphic on the left, with three petals in green, gray, and orange. To the right of the graphic is the text "Voyant HEALTH" in blue and green, with a trademark symbol after the word "HEALTH".

vant Health Ltd ch-Tikva, 4951132

ww.vovanthealth.com

Phone: +972-3-929-0929 +972-3-923-6413 Fax:

510(k) Summary

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

1. Submitter's Yael Guttentag (a) Address: Voyant Health, Ltd. 35 Efal Street Petach-Tikva Israel, 4951132
1. Manufacturer Voyant Health, Ltd. (b) Address: 35 Efal Street Petach-Tikva Israel, 4951132
- Mfq. Phone: 972-3-929-0929
- Mfg. Fax: 972-3-923-6413
- Contact Yael Guttentag, QM&RA Manager Person:
- Date: March 4, 2015
1. Device & Imaging Processing System (Class 2), Product Code LLZ, 21 CFR 892,2050 Classification Name: Trade name of device: TraumaCad Mobile Release 1.0
1. Predicate TraumaCad Release 2.0 (K073714) Device:
1. Description: TraumaCad Mobile Release 1.0 allows surqeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitate the film-less orthopedic practice. The program features full PACS integration and an extensive reqularly updated library of digital templates from leading manufacturers. TraumaCad Mobile Release 1.0 supports DICOM and enables the importing and exporting of image files from a central PACS system, or Quentry (Class I device

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Image /page/4/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower with three petals in green, gray, and orange, followed by the word "Voyant" in blue. To the right of "Voyant" is the word "HEALTH" in green, with a trademark symbol next to it.

vant Health Ltd ch-Tikva, 4951132

www.vovanthealth.com

Phone: +972-3-929-0929 +972-3-923-6413 Fax:

reqistered by Brainlab AG in the FDA).

Intended Use: The TraumaCad Mobile Release 1.0 program is indicated for 5. 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 judgment and experience are required to properly use the software. The software is not for primary

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Image /page/5/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower-like graphic on the left, with the text "Voyant HEALTH" to the right. The word "Voyant" is in blue, while "HEALTH" is in green. There is a trademark symbol after the word HEALTH.

vant Health Ltd ch-Tikva, 4951132

ww.vovanthealth.com

Phone: +972-3-929-0929 +972-3-923-6413 Fax:

image interpretation. The software is not for use on mobile phones.

Conclusion The successful non-clinical testing demonstrates the safety and 6. effectiveness of the TraumaCad Mobile Release 1.0 when used for the defined indications for use and demonstrates that these devices for which this 510(k) is submitted perform as well as or better than the legally marketed predicate device.
TraumaCad Mobile contains a subset of the features from TraumaCad 2.0. The algorithms contained on TraumaCad Mobile are the same as those that are in the predicate device TraumaCad 2.0 that have been extensively tested.

The testing for each release consisted of Unit, System/Integration and Acceptance test levels. Testing included security, negative testing, error message handling, stress testing, platform testing, workflow testing, functional testing, multi-user/external access testing, data integrity testing, compatibility testing, load testing, regression testing, and hazard mitigation testing.

In case a test was failed any necessary corrections were made, the relevant test was executed and repeated again until all passed.

1. Comparison of TraumaCad Mobile 1.0 has the same intended use and risk Technological control measures as the predicate device TraumaCad 2.0. Characteristics: TraumaCad Mobile contains a limited feature set in comparison to the predicate device TraumaCad. The features in TraumaCad Mobile already exist in the predicate device TraumaCad but have been modified to run on new platforms. Thus we revisited our risk analysis to consider any new potential failure modes and causes for hazards intrinsic to the new mobile environment and implemented new risk control measures as necessary.
  Testing was done to compare TraumaCad Mobile with the predicate device TraumaCad using various medical images from a range of cases in parallel and comparing TraumaCad on a PC device and TraumaCad Mobile on an iPad device. Testing included the main functions such as: Marker detection, Calibration result and Templates positioning. The test shows that the predicate device TraumaCad and TraumaCad Mobile

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Image /page/6/Picture/0 description: The image shows the logo for "Voyant HEALTH™". The word "Voyant" is in blue, and the word "HEALTH" is in green. To the left of the word "Voyant" is a graphic of three leaves in the colors orange, gray, and green.

vant Health Ltd ch-Tikva, 4951132

www.vovanthealth.com

Phone: +972-3-929-0929 +972-3-923-6413 Fax:

have the same expected results in all of the tests.

In addition, usability testing was performed using mobile devices and PC environments. The Usability testing simulated a clinical environment and required the test participant to perform preoperative planning on various Hip X-rays in a manner that is almost identical to the planning done on the predicate device. Most of the test participants had used the predicate device TraumaCad in the past and were familiar with the workflow in the predicate device.

The primary operating functions (which exist in the predicate device as well) were tested in a clinical environment and include:

Select an x-ray image from Quentry/PACS ●
Calibrate the image
Select implants
. Evaluate LLD and offset changes
Change the implant properties accordingly
Use measurement tools
Save the results back to Quentry/PACS ●

Based on the above testing and updated risk analysis, the differences between the device and the predicate device do not impact on substantial equivalence.

Parameter/Character	Subject DeviceTraumaCad Mobile1.0	Predicate DeviceTraumaCad 2.0
Operating System	MS Windows 7iOS 6.1 or 7.xMac OS X	Windows/PCMS Windows 2000 orlater
Devices supported	PC/MACiPad 3, 4 and 5 (Air)	PC
Parameter/Character	Subject DeviceTraumaCad Mobile1.0	Predicate DeviceTraumaCad 2.0
Browsers supported	Minimum requirements:iOS based browsers:- Safari 7- Chrome 30Mac based browsers:- Firefox 26- Safari 5Windows basedbrowsers:- Chrome 30- Firefox 26- Safari 5- IE 11	NA
Image Input	Can receive digitalimages from varioussources	Can receive digitalimages from varioussources
Means of CollectingData	Obtained from pre-obtained digital imagesvia PACS system or viaQuentry	Obtained from pre-obtained digital imagesvia PACS system
Number of Images thatcan simultaneouslyviewed on screen	One	Up to 4
Runs on Server	Yes	Yes
Hip Module	Yes	Yes
Trauma Module	No	Yes
Knee Module	No	Yes
Spinal Module	No	Yes
Pediatric Module	No	Yes
Foot & Ankle Module	No	Yes
Upper Limb Module	No	Yes
Input 3D Images	No	Yes
Digital ProstheticTemplates	Yes	Yes
Interactive templatepositioning	Yes	Yes
Parameter/Character	Subject DeviceTraumaCad Mobile1.0	Predicate DeviceTraumaCad 2.0
Automatic Scaling	Yes	Yes
Template support frommanufacturers	Yes	Yes
Permits templaterotation	Yes	Yes
Pre-operative Planning	Yes	Yes
Patient Contacting	No	No
Control of Life-SavingDevices	No	No
Healthcare professionalsintervention forinterpretation andmanipulation of images	Yes	Yes
510(k) #	K142923 (Pending)	K073714

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Image /page/7/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower-like symbol on the left, with three petals in orange, gray, and green. To the right of the symbol is the text "Voyant HEALTH" in blue and green, with a trademark symbol next to the word "HEALTH".

Voyant Health Ltd. 35 Efal Street Petach-Tikva, 4951132 ISRAEL

www.voyanthealth.com

Phone: +972-3-929-0929
Fax: +972-3-923-6413

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Voyant Health Ltd. 35 Efal Street Petach-Tikva, 4951132 ISRAEL

www.voyanthealth.com

Phone: +972-3-929-0929
Fax: +972-3-923-6413

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).