PhantomMSK Hip is an image-processing software indicated to assist in the positioning of Total Hip Replacement and Hip Preservation components. It is intended to assist in precisely positioning Total Hip Replacement and Hip Preservation 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. The device is not for primary image interpretation. The software is not for use on mobile phones.

Device Description

The PhantomMSK Hip is a non-invasive software system that provides image analysis tools for Total Hip Replacement and Hip Preservation procedures that use fluoroscopic imaging to assist with implant and anatomic alignment. PhantomMSK Hip provides templating, measurement, and distortion adaptation (correction) tools for intraoperative fluoroscopic image assessment. PhantomMSK Hip 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 Hip operates on image principles that are not vendor specific. To operate PhantomMSK Hip, 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 Hip uses software features in conjunction with its radiopaque calibration array, which attaches to the C-arm image intensifier, to calculate and adapt for fluoroscopic distortion.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria with quantitative results, sample sizes, expert qualifications, or ground truth establishment methods typical for AI performance testing.

Instead, the document is an FDA 510(k) clearance letter and a 510(k) summary for the OrthoGrid Systems, Inc. PhantomMSK Hip. It focuses on demonstrating substantial equivalence to a predicate device (PhantomMSK K182332) rather than providing a performance study report against specific acceptance metrics for AI functionality.

The key points regarding testing are:

Verification and validation testing: Performed at code and system level according to written test protocols.
Purpose of testing: To ensure that all templating overlay, measurement, and distortion correction tools performed as expected.
Specific equipment used: Philips Zenition 50 Digital Video Signal.
Calibration array compatibility: Designed for C-arms with specific image intensifier outer diameters (34.5 to 38.5 cm and 28.6 to 33 cm).
Review of results: Reviewed by "designated technical professionals" to ensure "acceptability criteria were satisfied."
Conclusion of testing: "Verification strategies and test procedures used are appropriate," "System test procedures trace to requirements," "All requirements are tested or otherwise verified," and "Test results meet the required pass/fail criteria."

Below is a table showing the lack of specific acceptance criteria and performance data in the provided document, along with explanations.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Metric)	Target Performance	Reported Device Performance	Comments/Evidence from Text
Accuracy of Templating Overlay	Not specified quantitatively	"performed as expected"	The document states "all templating overlay... tools performed as expected" and "Test results meet the required pass/fail criteria." No specific numerical accuracy or error margin is provided.
Accuracy of Measurement Tools	Not specified quantitatively	"performed as expected"	Same as above. No specific numerical accuracy or error margin is provided for angle, relative, or calibrated measurements.
Effectiveness of Distortion Correction	Not specified quantitatively	"performed as expected"	The document notes the device "calculate and adapt for fluoroscopic distortion" and "distortion correction tools performed as expected." No specific quantification of distortion reduction or resulting image quality improvement is given.
System Functionality	Meets all requirements	All requirements tested and verified	"All requirements are tested or otherwise verified" and "System test procedures trace to requirements." This is a high-level statement without specific functional or non-functional criteria detailed.

Study Details (Based on provided text)

The document does not provide a detailed study report with the specific information requested. Here's what can be inferred or explicitly stated:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "testing was conducted" and "test results were reviewed." It does not provide the number of images, cases, or patients used in the validation.
- Data Provenance: Not specified. There is no mention of the country of origin of the data, nor whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document states "The test results were reviewed by designated technical professionals." It does not specify the number of professionals or whether they were medical experts (e.g., radiologists, surgeons) or engineering professionals.
- Qualifications of Experts: Only "designated technical professionals" are mentioned. Their specific qualifications (e.g., medical degrees, years of experience, board certification) are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. The document only states results were "reviewed by designated technical professionals." There's no mention of consensus methods or conflict resolution for ground truth establishment.
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:
- MRMC Study: No. This type of study is not mentioned or described. The device is indicated to "assist in the positioning" and "is intended to assist in precisely positioning," implying an assistive role, but no human-in-the-loop performance study is reported. The document explicitly states, "The device is not for primary image interpretation."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: While the software has automated functions (e.g., distortion correction, templating, measurement), the document does not detail specific standalone performance metrics (e.g., sensitivity, specificity, F1-score for automated detections/measurements) against a ground truth. The testing described is more about functional verification ("performed as expected").
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not explicitly stated. Given the nature of the device (image processing for surgical assistance and measurements), the "ground truth" for the tests would likely involve known geometric properties, simulated distortions, or measurements from calibrated phantoms or expert-annotated images. However, the document does not specify how the ground truth was established for the "test results" that "meet the required pass/fail criteria."
The sample size for the training set:
- Training Set Sample Size: Not applicable/Not specified. The document does not describe the PhantomMSK Hip as an AI/ML device that requires a distinct "training set" in the context of deep learning or similar algorithms. It is described as "image-processing software" with "software features" to perform templating, measurement, and distortion adaptation. While some algorithms might be used, the typical AI/ML paradigm with training and test sets is not detailed. The focus is on substantial equivalence and functional testing.
How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable/Not specified, for the same reasons as #7.

Summary

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

February 18, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & 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. % Mr. Trevor Hafer Product Development Engineer 3865 Wasatch Boulevard, Suite 301 SALT LAKE CITY UT 84109

Re: K210136

Trade/Device Name: PhantomMSK Hip Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 15, 2021 Received: January 19, 2021

Dear Mr. Hafer:

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 and Part 809); 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)

K210136

Device Name PhantomMSK Hip

Indications for Use (Describe)

PhantomMSK Hip is an image-processing software indicated to assist in the positioning of Total Hip Replacement and Hip Preservation components. It is intended to assist in precisely positioning Total Hip Preservation 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. The device is not for primary image interpretation. The software is not for use on mobile phones.

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}------------------------------------------------

510(k) SUMMARY

OrthoGrid Systems, Inc.'s PhantomMSK Hip

Date Prepared:	1/15/2021
Submitter:	OrthoGrid Systems Inc.3865 Wasatch Blvd. Suite 301Salt Lake City, UT 84109Phone: +1 (801) 330 3113 or +1 (801) 703 5866 Ext 107Facsimile: +1 (801) 801 206 2756
Contact Person:	Trevor HaferProduct Development EngineerThafer@orthogrid.comM: +1 (801) 793 7015
Name of Device:	PhantomMSK Hip
Classification Name:	Picture Archiving and Communications System (21 CFR 892.2050)
Regulatory Class:	Class II
Product Code:	LLZ
Predicate Devices:	PhantomMSK (K182332)

Device Description:

Indications for Use:

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

radiology images. Clinical judgement and experience are required to properly use the device. 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 Hip	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 image-processing 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, anglemeasurements, relative &calibrated measurements,drawing, compare, andoverlay tool, picture in picture,PACS export, tutorial mode.	Templating, distortion correction,angle measurements, relativemeasurements

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 Philips Zenition 50 Digital Video Signal. The calibration array is intended for Carms having an outer diameter of the image intensifier ranging between 34.5 to 38.5 cm and 28.6 to 33 cm.

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

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:

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

Conclusions

The PhantomMSK Hip is shown to be substantially equivalent to its predicate, PhantomMSK. The PhantomMSK Hip 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 Hip does not raise different questions of safety or effectiveness. Thus, the PhantomMSK Hip 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).