PhantomMSK Trauma is an image-processing software indicated to assist in the positioning of Orthopedic Trauma components. It is intended to assist in precisely positioning Orthopedic Trauma components intraoperatively by measuring their positions relative to the bone structures of interest, provided that the points of interest can be identified from radiology images. Clinical judgement and experience are required to properly use the device is not for primary image interpretation. The software is not for use on mobile phones.

Device Description

The PhantomMSK Trauma is a non-invasive software system that provides image analysis tools for Orthopedic Trauma procedures that use fluoroscopic imaging to assist with implant, instrument and anatomic alignment. PhantomMSK Trauma provides templating, measurement, and distortion correction tools for intraoperative fluoroscopic image assessment. PhantomMSK Trauma does not include any custom computer hardware and is a software-based device that can be run on a "commercial off-the-shelf" system (i.e. PC, keyboard, mouse, touchscreen monitor etc.) that meet minimum performance requirements. Furthermore, PhantomMSK Trauma operates on image principles that are not vendor specific. To operate PhantomMSK Trauma, a fluoroscopic image is acquired from a C-arm and displayed outside the sterile field, where the image analysis tools can be used at the surgeon's discretion.

Fluoroscopic distortion is attributed to external electromagnetic interference and the mapping of the planar image on a curved input phosphor. The PhantomMSK Trauma uses software features in conjunction with its radiopaque calibration array, which attaches to the C-arm image intensifier, to calculate and correct for fluoroscopic distortion.

AI/ML Overview

This document, K192279, is an FDA 510(k) Premarket Notification for the device "PhantomMSK Trauma." Based on the provided text, the device itself is an image-processing software intended to assist in the positioning of Orthopedic Trauma components. It offers templating, measurement, and distortion correction tools for intraoperative fluoroscopic image assessment.

However, the provided text does not contain specific acceptance criteria, reported device performance metrics (e.g., accuracy, sensitivity, specificity), details about test set sample sizes and provenance, the number and qualifications of experts for ground truth establishment, adjudication methods, details of any multi-reader multi-case (MRMC) studies, or information about the training set (size, ground truth establishment).

The document states that "Verification and validation testing were done at the code and system level according to written test protocols established before testing was conducted to ensure that all templating overlay, measurement, and distortion correction tools performed as expected." It also mentions that "The test results were reviewed by designated technical professionals to ensure acceptability criteria were satisfied prior to the release of the software," and that "Test results meet the required pass/fail criteria."

While these statements confirm that testing was performed against pre-defined criteria, the specific details of those criteria and the quantitative results are not included in this FDA 510(k) summary. The summary focuses on demonstrating substantial equivalence to a predicate device, PhantomMSK (K182332), rather than providing a detailed performance study report.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance metrics, or specific details about sample sizes, expert qualifications, adjudication methods, or MRMC studies for a performance study based solely on the provided text. The document indicates that such testing was performed internally by the manufacturer, but the results and methodologies are not publicly detailed here beyond general statements.

In summary, based on the provided document, I can report the following:

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

Acceptance Criteria: Not explicitly stated in quantitative terms. The document vaguely refers to "written test protocols established before testing was conducted to ensure that all templating overlay, measurement, and distortion correction tools performed as expected" and "acceptable criteria were satisfied."
Reported Device Performance: Not explicitly stated in quantitative metrics (e.g., accuracy, precision). The conclusion broadly states, "performance data demonstrate that the PhantomMSK Trauma does not raise different questions of safety or effectiveness."

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

Sample Size: Not specified.
Data Provenance: Not specified (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:

Not specified. The document only mentions that "The test results were reviewed by designated technical professionals."

4. Adjudication method for the test set:

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

Not indicated or described in the provided text. The document focuses on demonstrating substantial equivalence based on technical characteristics and intended use.

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

The document implies that testing was done on the software's functionality, but does not provide details on whether this was a standalone algorithmic performance study or part of a human-in-the-loop workflow. The device itself is described as "image-processing software indicated to assist in the positioning...Clinical judgement and experience are required to properly use the device."

7. The type of ground truth used:

Not explicitly defined. The testing mentioned refers to ensuring "templating overlay, measurement, and distortion correction tools performed as expected," implying comparisons against expected or reference values for these functions.

8. The sample size for the training set:

No information about a training set is provided in this 510(k) summary, as it is primarily focused on post-development verification and validation.

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

No information about a training set is provided.

Summary

{0}------------------------------------------------

December 7, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

OrthoGrid Systems Inc. % Sebastian Edin Regulatory Affairs Consultant 3216 South Highland, Suite 202 SALT LAKE CITY UT 84106

Re: K192279

Trade/Device Name: PhantomMSK Trauma Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 4, 2019 Received: November 13, 2019

Dear Sebastian Edin:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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

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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K192279

Device Name PhantomMSK Trauma

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

{3}------------------------------------------------

K192279 510(k) SUMMARY

OrthoGrid Systems, Inc.'s PhantomMSK Trauma

Date Prepared:	08/19/2019
Submitter:	OrthoGrid Systems Inc.3216 Highland Drive Suite 202Salt Lake City, UT 84106Phone: +1 (801) 703 5866Facsimile: +1 (385) 415 2110
Contact Person:	Sebastian EdinRegulatory Affairs ConsultantM: +1 (801) 330 3113
Name of Device:	PhantomMSK Trauma
Classification Name:	Picture Archiving and Communications System (21 CFR 892.2050)
Regulatory Class:	Class II
Product Code:	LLZ
Predicate Devices:	PhantomMSK (K182332)

Device Description:

Intended Use / Indications for Use:

PhantomMSK Trauma is an image-processing software indicated to assist in the positioning of Orthopedic Trauma components. It is intended to assist in precisely positioning Orthopedic Trauma components intraoperatively by measuring their positions relative to the bone structures of interest. provided that the points of interest can be identified from radiology images. Clinical judgement and

{4}------------------------------------------------

experience are required to properly use the device is not for primary image interpretation. The software is not for use on mobile phones.

Substantial Equivalence:

Company	OrthoGrid Systems, Inc.	OrthoGrid Systems, Inc.
Product Name	PhantomMSK Trauma	PhantomMSK
FDA 510(k) #	-	K182332
Product Code	LLZ	LLZ
Principles ofOperation	The subject device is animage processing software. Afluoroscopic image is acquiredfrom a C-arm by the softwareand displayed outside thesterile field, where the imageanalysis tools can be used atthe surgeon's discretion.	The predicate device is an imageprocessing software. Afluoroscopic image is acquiredfrom a C-arm by the software anddisplayed outside the sterile field,where the image analysis toolscan be used at the surgeon'sdiscretion.
Image Data	C-arm, X-ray	C-arm, X-ray
Features	Templating, distortioncorrection, measurements,PACS and Networkcompatibility.	Templating, distortion correction,measurements.

Testing:

Verification and validation testing were done at the code and system level according to written test protocols established before testing was conducted to ensure that all templating overlay, measurement, and distortion correction tools performed as expected. Specifically, testing was performed with the GE OEC 9900 and 9800 Composite Video Signal and for C-arms having an outer diameter of the image intensifier ranging between 34.5 to 38.5 cm and 28.6 to 33 cm.

The test results were reviewed by designated technical professionals to ensure acceptability criteria were satisfied prior to the release of the software.

The results are summarized in test summary reports. The conclusion states that:

{5}------------------------------------------------

Verification strategies and test procedures used are appropriate ●
System test procedures trace to requirements
All requirements are tested or otherwise verified
. Test results meet the required pass/fail criteria

Conclusion:

The PhantomMSK Trauma is shown to be substantially equivalent to its predicate, PhantomMSK. The PhantomMSK Trauma has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended surgical use of the device and do not raise new question of safety or effectiveness when used as labeled. In addition, performance data demonstrate that the PhantomMSK Trauma does not raise different questions of safety or effectiveness. Thus, the PhantomMSK Trauma is substantially equivalent.

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).