JointVue's ¡Fit Surgical Planner is a software device intended to assist medical professionals in preoperative planning of orthopedic surgery. The device allows for overlaying templates of prostheses on 3D bone models generated from radiological images. The software includes tools for performing measurements on the images and for positioning the prosthetic template. Clinical judgment and experience are required to properly use the software.

Device Description

JointVue's ¡Fit Surgical Planner is an orthopedic preoperative planning software. It allows for overlaying templates of prostheses on patient 3D bone models generated from radiological images using JointVue's 3D echo software (K172513) for overlaying templates of prostheses for surgical preplanning of joint replacement surgery. jFit Surgical Planner is intended to run on a PC and requires the Microsoft Windows™ operating system, version 7, windows 8 or windows 10 (32-bit/64-bit). A PDF Reader such as Adobe Acrobat or Foxit is recommended in order to access the instructions for use. ¡Fit Surgical Planner software requires the following minimum requirements for computer hardware listed in the following table: Processor Intel Core i5-5300 @ 2.3 GHz or higher, Memory 8 GB RAM or more, Graphics Intel HD Graphics 5500 or higher, Resolution Minimum 1920*1080, HD Space 1 GB or more. The major functions and features of jFit Surgical Planner include: 1. Patient Case Loading, 2. Loading X-Ray Images, 3. Editing and Verifying Femur Landmarks, 4. Editing and Verifying Tibia Landmarks, 5. Conducting Femur Planning, 6. Conducting Tibia Planning, 7. Validating Surgical Planning, 8. Generation of a Surgical Planning Summary Report. iFit Surgical Planner is for installation on a secure computer workstation to protect patient data. Typical environment of use is an office environment. jFit Surgical Planner utilizes 3D bone models for preoperative planning of joint replacement surgery. Surgical preplanning starts by importing patient 3D bone models along with anterior-posterior and lateral X-Ray images, if available. ¡Fit Surgical Planner calculates relevant surgical landmarks which can then be verified and edited. ¡Fit Surgical Planner will suggest an initial implant selection and placement based on anatomical landmarks selected and verified by the clinician is responsible to adjust the implant selection and placement parameters to validate patient-specific surgical plan. Upon completion of surgical planning, a summary report is generated that must be signed by a physician to approve the surgical plan.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the jFit Surgical Planner, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the equivalence of the subject device (jFit Surgical Planner) to the predicate device (TraumaCAD 2.0) based on their ability to identify the same size implants.

Acceptance Criteria	Reported Device Performance (jFit Surgical Planner)
Identify same size implants as predicate	100% agreement with predicate
Precision and accuracy equivalent to predicate	Equivalent demonstrated by benchtop testing

Study Details

2. Sample Size and Data Provenance for Test Set

Sample Size: 39 simulated cases.
Data Provenance: The cases were "simulated," implying they were not from real patients but rather constructed scenarios for testing. The country of origin is not specified. The study was retrospective in nature as it involved pre-defined simulated cases.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with 10 years of experience) used to establish the ground truth for the test set in the benchtop study. However, the study involved "two independent users" who performed the implant sizing tasks for both devices. While these "users" are implicitly qualified to perform surgical planning, their specific expert credentials for establishing ground truth are not detailed.

4. Adjudication Method for Test Set

The adjudication method for the test set is implied to be a direct comparison of the output from two independent users operating both the subject and predicate devices. No formal "adjudication method" in the sense of resolving discrepancies among multiple experts (like 2+1 or 3+1) is mentioned, as the focus was on the agreement between the devices' outputs by individual users. The case IDs were blinded for both operators, suggesting an attempt to reduce bias.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was explicitly mentioned or conducted as described in the provided text. The study focused on side-by-side performance of the two devices by two independent users, rather than a comparative effectiveness study involving human readers with and without AI assistance to measure improvement effect size.

6. Standalone (Algorithm Only) Performance

The benchtop testing implicitly demonstrates standalone performance of the algorithm within the software, as it evaluated the device's output (implant sizing) based on simulated cases. The "two independent users" were operating the software to achieve these results. The device itself is a "software device."

7. Type of Ground Truth Used

The ground truth for the benchtop testing was established by the "predicate device" (TraumaCAD 2.0) as the reference, which the subject device was compared against. The study aimed to demonstrate that the subject device identified "the same size implants" as the predicate. This implies the ground truth was essentially the output of a previously cleared device, rather than pathology, expert consensus on imaging, or outcomes data.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. The description focuses on validation testing and equivalence to a predicate device. If the device uses machine learning, the training data used to develop the underlying models is not disclosed in this regulatory submission.

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

As no training set is mentioned, the method for establishing its ground truth is also not provided.

Summary

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November 15, 2017

JointVue LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K173329

Trade/Device Name: jFit Surgical Planner Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 19, 2017 Received: October 23, 2017

Dear Mr. Job:

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 of medical device-related adverse events) (21 CFR 803); 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

Michael D. O'Hara 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) K173329

Device Name jFit Surgical Planner

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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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

1. SUBMITTER JointVue LLC 2099 Thunderhead Rd., Suite 104 Knoxville, TN, 37922 USA Tel: (877) 725-6920 x101 Fax: (865) 539-8136

Contact Person:	Mohamed R. Mahfouz
Title:	President/CEO
Date Prepared:	November 1, 2017

II. DEVICE
Name of Device:	jFit Surgical Planner
Classification Name:	Picture Archiving and Communications System
Regulation:	21 CFR §892.2050
Regulatory Class:	Class II
Product Classification Code:	LLZ

. PREDICATE DEVICE

Predicate Manufacturer:	Orthocrat, Ltd.
Predicate Trade Name:	TraumaCAD 2.0
Predicate 510(k):	K073714

No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

jFit Surgical Planner is intended to run on a PC and requires the Microsoft Windows™ operating system, version 7, windows 8 or windows 10 (32-bit/64-bit). A PDF Reader such as Adobe Acrobat or Foxit is recommended in order to access the instructions for use. ¡Fit Surgical Planner software requires the following minimum requirements for computer hardware listed in the following table:

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Hardware Requirements for jFit Surgical Planner
Processor	Intel Core i5-5300 @ 2.3 GHz or higher
Memory	8 GB RAM or more
Graphics	Intel HD Graphics 5500 or higher
Resolution	Minimum 1920*1080
HD Space	1 GB or more

The major functions and features of jFit Surgical Planner include:

1. Patient Case Loading
1. Loading X-Ray Images
1. Editing and Verifying Femur Landmarks
1. Editing and Verifying Tibia Landmarks
1. Conducting Femur Planning
1. Conducting Tibia Planning
1. Validating Surgical Planning
1. Generation of a Surgical Planning Summary Report

iFit Surgical Planner is for installation on a secure computer workstation to protect patient data. Typical environment of use is an office environment.

jFit Surgical Planner utilizes 3D bone models for preoperative planning of joint replacement surgery. Surgical preplanning starts by importing patient 3D bone models along with anterior-posterior and lateral X-Ray images, if available. ¡Fit Surgical Planner calculates relevant surgical landmarks which can then be verified and edited. ¡Fit Surgical Planner will suggest an initial implant selection and placement based on anatomical landmarks selected and verified by the clinician is responsible to adjust the implant selection and placement parameters to validate patient-specific surgical plan. Upon completion of surgical planning, a summary report is generated that must be signed by a physician to approve the surgical plan.

V. INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

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Intended Use / Indications for Use – The predicate device and the subject device have identical intended use and the only difference in the indications for use is that the iFit Surgical Planner uses patient 3D bone models generated from radiological images (K172513) rather than overlaying templates of prostheses directly on native radiological images for surgical preplanning of joint replacement surgery.
Materials Not applicable, because both are software devices and do not have ● patient contact.
Design Features The predicate and subject device design features are . summarized in comparison Table 5-1.
Energy Source The predicate and subject device are both operated on a PC . computer via battery or mains power.
Performance Testing The predicate and subject device have equivalent ● precision and accuracy based on benchtop testing.

Feature	Subject Device(jFit Surgical Planner)	Predicate Device(TraumaCAD 2.0)
Computer Operating System	Windows 7, 8 or 10	Windows 7
Axial	Yes	Yes
Sagittal	Yes	Yes
Coronal	Yes	Yes
Oblique	Yes	Yes
3D Visualization	Yes (Surface Visualization)	Yes (Volumetric Visualization)
View Mode Render	Yes (Display Axial imagewith 3D visualization)	Yes (Display Axial image with3D image)
Contouring	Yes	Yes

Table 5-1

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

Not Applicable to the subject device, because the device is stand-alone software.

Electrical safety and electromagnetic compatibility (EMC)

Not Applicable to the subject device, because the device is stand-alone software.

Software Verification and Validation Testing

Software verification and validation testing was provided to demonstrate safety and efficacy of the subject device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC). Software validation documentation provided to demonstrate that the software design specification (SDS) meets the software requirements specification (SRS) includes:

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Software description
. Hazard Analysis
Software requirements specification (SRS) ●
Software Architecture Description
Traceability Matrix ●
. Software Development Environment Description
. Software Verification Test Description
. Revision Level History
Unresolved Anomalies
Procedure for Software Development Lifecycle
Software Verification Test Protocol ●
Software Verification Test Report
Cybersecurity Risk Analysis ●

Mechanical and Acoustic Testing

Not Applicable to the subject device, because the device is stand-alone software.

Bench Top Testing

Side by side testing was performed between the predicate and subject device to confirm equivalent safety and efficacy. Testing consisted of performing femoral and tibial implant sizing with the predicate device and the subject device on 39 simulated cases. Testing was completed by two independent users, and the case ID was blinded for both operators. Both the predicate and the subject device identified the same size implants in 100% of the simulated cases.

Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of the ¡Fit Surgical Planner. This conclusion is based upon a comparison of intended use, technological characteristics and benchtop testing.

VIII. CONCLUSIONS

The subject device is equivalent to the predicate device with reqard to safety and efficacy. This conclusion is based upon a comparison of intended use, technological characteristics and benchtop testing.

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).