TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.

Device Description

TraumaCad Neo allows surgeons 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 facilitates the film-less orthopedic practice. TraumaCad Neo allows post-operative review of images obtained after the surgical procedure. The program features an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Neo supports DICOM and is integrated to communicate with Quentry®, a proprietary web-based cloud service from Brainlab. It is through Quentry®, where the medical staff can upload images to plan their expected results prior to the procedure to create a smooth surgical workflow from start to finish.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, TraumaCad Neo, and compares it to a predicate device, TraumaCad Mobile 2.0. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets acceptance criteria.

Instead, the document highlights that:

The performance evaluation was based on "well-established test methods which demonstrated conformity to the intended use."
These methods were the "same which were used to demonstrate the substantial equivalence of the predicate device TraumaCad Mobile 2.0."
"The performance tests have been completed and successfully confirm the performance of the device."

Without an actual study described, I cannot populate the table or answer most of the requested questions. The document focuses on regulatory equivalence rather than a detailed performance study with specific metrics.

Here's how I can address the request based on the absence of the detailed information you are looking for in the provided text:

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

Acceptance Criteria (Example - Not provided in the text)	Reported Device Performance (Example - Not provided in the text)
[Specific metric 1, e.g., Measurement accuracy within X mm]	[Actual performance, e.g., 0.5 mm deviation]
[Specific metric 2, e.g., Template overlap accuracy]	[Actual performance, e.g., 95% overlap within tolerance]
[Specific metric 3, e.g., Processing time]	[Actual performance, e.g., < 2 seconds per image]

Note: The provided document states that "Performance Evaluation... was based upon well-established test methods which demonstrated conformity to the intended use" and "confirm the performance of the device." However, specific quantitative acceptance criteria and corresponding reported device performance metrics are not included in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the text. The document refers to "performance tests" that "successfully confirm the performance" but does not detail the sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the text. The document does not describe how ground truth was established for any test set.

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

This information is not provided in the text. There is no mention of an adjudication method for a test set.

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

There is no indication of a multi-reader, multi-case (MRMC) comparative effectiveness study being performed or reported in this document. The device "assists healthcare professionals" but no study comparing human performance with and without the device is detailed.

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

While the device's performance was evaluated, the document does not explicitly state whether a standalone (algorithm only) performance study was conducted. It emphasizes that "Clinical judgment and experience are required to properly use the software."

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

This information is not provided in the text. The document does not specify how ground truth was established for any performance evaluation.

8. The sample size for the training set

This information is not provided in the text. The document focuses on performance evaluation for regulatory purposes rather than the development and training of an AI algorithm.

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

This information is not provided in the text. As there is no mention of a training set, the method for establishing its ground truth is also absent.

Summary of what is stated about performance evaluation:

The document indicates that TraumaCad Neo's performance evaluation was conducted using "well-established test methods" that were consistent with those used for its predicate device, TraumaCad Mobile 2.0. These tests "demonstrated conformity to the intended use" and "successfully confirm the performance of the device," leading to the conclusion that the device is substantially equivalent to the predicate. However, detailed results, specific metrics, study design, and sample information are not included in this regulatory summary.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Brainlab Ltd. % Yael Guttentag QM & RA Senior Manager 35 Efal Street Petach-Tikva, 4951132 Israel

Re: K231498

November 20, 2023

Trade/Device Name: TraumaCad Neo Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 18, 2023 Received: October 18, 2023

Dear Yael Guttentag:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231498

Device Name TraumaCad Neo

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Æ BRAINLAB 510(k) Summary

K231498

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

1. (a)	SubmitterAddress:	Brainlab Ltd35 Efal StreetPetach-Tikva, Israel 4951132
1. (b)	ManufacturerAddress:	Brainlab Ltd35 Efal StreetPetach-Tikva, Israel 4951132
	Mfg. Phone:	Tel.: +972-3-929-0929
	Contact Person:	Mrs. Yael Guttentag
	Date:	May 22, 2023
2.	Device &ClassificationName:	Radiological Image Processing System -classified as Class 2 LLZ, Regulation Number 21 CFR 892.2050TraumaCad Neo
3.	Predicate Device:	TraumaCad Mobile 2.0 (K160001)
4.	Description:	TraumaCad Neo allows surgeons to evaluate digital images whileperforming various pre-operative surgical planning and evaluation ofimages. This software application enables surgeons to plan operations onscreen, execute measurements, and facilitates the film-less orthopedicpractice. TraumaCad Neo allows post-operative review of imagesobtained after the surgical procedure. The program features an extensiveregularly updated library of digital templates from leading manufacturers.TraumaCad Neo supports DICOM and is integrated to communicate withQuentry®, a proprietary web-based cloud service from Brainlab. It is throughQuentry®, where the medical staff can upload images to plan their expectedresults prior to the procedure to create a smooth surgical workflow from startto finish.
5.	Indications forUse:	TraumaCad Neo is indicated for assisting healthcare professionals toanalyze orthopedic conditions and to plan orthopedic procedures byoverlaying on relevant radiological images visual information such asmeasurements and prosthesis templates. Clinical judgment and experienceare required to properly use the software. The software is not intended forprimary radiological image interpretation or radiological appraisal. Device isnot intended for use on mobile phones.

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1. Comparison of With respect to technology and intended use, TraumaCad Neo is Technological substantially equivalent to its predicate device. Based upon the outcomes Characteristics: from the Risk Analysis and Performance Testing Evaluation, Brainlab Ltd believes that the modification of TraumaCad Mobile 2.0 (predicate device) which allows it to become TraumaCad Neo does not raise additional safety or efficacy concerns. The following comparison table depicts the changes.

	Submitted Device	Predicate Device
Features/ Characteristics	TraumaCad Neo	TraumaCad MobileRelease 2.0
Product Code	LLZ	LLZ
Indication for Use	TraumaCad Neo is indicatedfor assisting healthcareprofessionals to analyzeorthopedic conditions and toplan orthopedic proceduresby overlaying on relevantradiological images visualinformation such asmeasurements andprosthesis templates. Clinicaljudgment and experienceare required to properly usethe software. The software isnot intended for primaryradiological imageinterpretation or radiologicalappraisal. Device is notintended for use on mobilephones.	The TraumaCad MobileRelease 2.0 program isindicated for assistinghealthcare professionals inpreoperative planning oforthopedic surgery. Thedevice allows foroverlaying of prosthesistemplates on radiologicalimages, and includes toolsfor performingmeasurements on theimage and for positioningthe template. Clinicaljudgment and experienceare required to properlyuse the software. Thesoftware is not for primaryimage interpretation. Thesoftware is not for use onmobile phones.
Operating System	Microsoft Windows 10 andaboveiOS 16.x and aboveMAC OS 11 and aboveAndroid 11 and above	MS Windows 7,8 or 10iOS 7.x, 8.x or9.x MAC OS X
Devices Supported	PCMACiPadsAndroid tablets	PC/MACiPad 3, 4 and 5 (Air)
Browsers Supported	Microsoft EdgeFirefoxChromeSafari (MAC/iOS)	Minimumrequirements:iOS basedbrowsers:- Safari 7- Chrome 30Mac basedbrowsers:- Firefox 26- Safari 5Windows basedbrowsers:- Chrome 30- Firefox 26- Safari 5- IE 11
Image Input	Can receive digital imagesfrom Quentry®	Can receive digital imagesfrom various sources
Means of Collecting Data	Obtained from pre-obtaineddigital images via Quentry®	Obtained from pre-obtained digital images viaPACS or via Quentry®
Number of Images that cansimultaneously viewed onthe screen	Up to 3	Up to 2
Runs on Server	yes	yes
Hip Module	yes	yes
Knee Module	yes	yes
Foot and Ankle Module	yes	yes
Upper Limb Module	yes	yes
Digital ProstheticTemplates	yes	yes
Interactive templatepositioning	yes	yes
Automatic Scaling	yes	yes
Template support frommanufacturers	yes	yes
Permits TemplateRotation	yes	yes
Pre-Operative Planning	yes	yes
Post Operative Review	yes	no
Patient Contacting	no	no
Control of Life SustainingDevices	no	no
Healthcare professionalintervention forinterpretation of images	yes	yes
510(k) #	Pending	K160001

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510k Notification: TraumaCad Neo

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The Performance Evaluation of TraumaCad Neo was based upon well-7. Performance Evaluation: established test methods which demonstrated conformity to the intended use. These test methods were the same which were used to demonstrate the substantial equivalence of the predicate device TraumaCad Mobile 2.0.
1. Conclusion: The intended use and the fundamental technological characteristics of TraumaCad Neo are the same as those in the TraumaCad Mobile 2.0, which is the predicate device. Any additions or differences do not affect the safety and effectiveness of the device. The performance tests have been completed and successfully confirm the performance of the device. Based upon this data, Brainlab Ltd believes that TraumaCad Neo is substantially equivalent to the predicate device.

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).