JointVue's 3D Echo is a software application for the display and 3D visualization of ultrasound volume data derived from the Sonix Ultrasound Scanner. It is designed to allow the user to observe images and perform analyses of musculoskeletal structures using the ultrasound volume data acquired with the Sonix Ultrasound Scamer. Typical users of this system are trained medical professionals including physicians, nurses, and technicians.

Device Description

JointVue's 3D Echo is a software application that uses the raw ultrasound signals generated from an imaging ultrasound machine to visualize musculoskeletal structures in three dimensions. The 3D Echo software is pre-loaded on one of the following two ultrasound systems: 1) SonixOne, a tablet-based system; or 2) SonixTouch Q+ with linear transducer (BK Ultrasound model L14-5/38 GPS) and driveBAY™ tracking unit (Ascension Technology Corporation). There are also two electromagnetic (EM) sensors (Ascension 6DOF sensors, model 800, part #600786) included with the JointVue 3D echo software to identify the relative location of the ultrasound probe. Finally, there is a foot switch (stuete model MKF-2-MED GP25) included as an input device. The major software functions of the JointVue 3D Echo system include the following: 1) the ability to display axial, sagittal, coronal and oblique 2D images; 2) the ability to display the 3D surface of musculoskeletal structures; 3) the ability to display axial images with 3D visualization; and 4) the ability to provide contouring and US image visualization. The device is intended to be used in a clinical or hospital environment. JointVue's 3D Echo ultrasound system utilizes raw ultrasound signals to detect tissue interfaces and visualize joint anatomy in three dimensions. The system provides clinicians with three-dimensional models of the joint anatomy.

AI/ML Overview

The provided document is a 510(k) premarket notification for the 3D Echo device by JointVue, LLC. It outlines the FDA's determination of substantial equivalence to a predicate device, but it does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.

The document states that "Performance Testing" demonstrated equivalent precision and accuracy based on benchtop testing using a phantom. However, it does not provide the specific acceptance criteria, the detailed results of this testing, or the methodology for evaluating accuracy and precision.

Here's an attempt to answer your questions based only on the information provided, highlighting what is missing:

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

Acceptance Criteria	Reported Device Performance
Precision and Accuracy (implied from predicate equivalence statement)	Equivalent precision and accuracy to the predicate device, "5D Viewer" (K161955), based upon benchtop testing using a phantom.
Software Verification and Validation	Demonstrated safety and efficacy. Potential hazards classified as a moderate level of concern (LOC). Specific performance metrics are not provided.
Mechanical and Acoustic Performance	Demonstrated safety and effectiveness with the same accuracy and precision as the predicate device (based on benchtop testing using a phantom). Specific performance metrics are not provided.

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

Sample Size for Test Set: Not specified. The document only mentions "benchtop testing using a phantom."
Data Provenance: Not specified. The testing was described as "benchtop," implying laboratory testing, not human data.

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)

Not applicable. The ground truth for benchtop phantom testing would likely be based on the known physical properties or measurements of the phantom itself, not expert interpretation.

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

Not applicable. This typically refers to medical image interpretation by multiple experts, which was not the nature of the described performance testing.

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

No. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the 3D Echo software." Therefore, no MRMC study was performed.

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

Yes, in a sense. The described "benchtop testing using a phantom" and "Software verification and validation testing" would fall under standalone performance assessment. However, the exact metrics and how "accuracy and precision" were quantified are not detailed. The device itself is described as a "software application for the display and 3D visualization," implying its performance as an algorithm is what was assessed.

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

For the benchtop testing using a phantom, the ground truth would likely be the known physical dimensions, geometries, or simulated conditions of the phantom. No human-derived ground truth (like expert consensus, pathology, or outcomes) was used.

8. The sample size for the training set

Not specified. The document does not describe the development or training of any machine learning model, nor does it specify a training set size.

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

Not specified, as no training set or machine learning development is detailed in the provided text.

Summary of what's missing:

The document focuses on the regulatory clearance process and establishing substantial equivalence rather than providing a detailed technical report of performance studies. Key details like specific numerical acceptance criteria, the methodology of phantom testing, and quantitative results of accuracy and precision are absent from this regulatory summary.

Summary

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Public Health Service

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

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

Re: K172513

Trade/Device Name: 3D Echo Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 18, 2017 Received: August 21, 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 (reporting of medical device-

Image /page/0/Picture/10 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird or a human figure. The logo is black and white.

September 14, 2017

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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.

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/MedicalDevices/ResourcesforYou/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) K172513

Device Name 3D Echo

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 Tel: (877) 725-6920 x101

Contact Person:	Mohamed R. Mahfouz,
Title:	President/CEO
Date Prepared:	August 4, 2017

II. DEVICE
Name of Device:	3D Echo
Classification Name:	Picture Archiving and Communications System
Regulation:	21 CFR 892.2050
Regulatory Class:	Class II
Product Classification Code:	LLZ

III. PREDICATE DEVICE

Predicate Manufacturer:	Samsung Medison CO., LTD
Predicate Trade Name:	5D Viewer
Predicate 510(k):	K161955

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

JointVue's 3D Echo is a software application that uses the raw ultrasound signals generated from an imaging ultrasound machine to visualize musculoskeletal structures in three dimensions.

The 3D Echo software is pre-loaded on one of the following two ultrasound systems: 1) SonixOne, a tablet-based system; or 2) SonixTouch Q+ with linear transducer (BK Ultrasound model L14-5/38 GPS) and driveBAY™ tracking unit (Ascension Technology Corporation). There are also two electromagnetic (EM) sensors (Ascension 6DOF sensors, model 800, part #600786) included with the JointVue 3D echo software to identify the relative location of the ultrasound probe. Finally, there is a foot switch (stuete model MKF-2-MED GP25) included as an input device.

The major software functions of the JointVue 3D Echo system include the following: 1) the ability to display axial, sagittal, coronal and oblique 2D images; 2) the ability to display the 3D surface of musculoskeletal structures; 3) the ability to display axial

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images with 3D visualization; and 4) the ability to provide contouring and US image visualization.

The device is intended to be used in a clinical or hospital environment.

JointVue's 3D Echo ultrasound system utilizes raw ultrasound signals to detect tissue interfaces and visualize joint anatomy in three dimensions. The system provides clinicians with three-dimensional models of the joint anatomy. Figure 5-1 outlines the overall system flowchart for 3D joint visualization.

Image /page/4/Figure/5 description: The image shows a flowchart with 10 steps. The first step is "Hardware Initialization (1)", followed by "Input Patient Information (2)", "Intialize Session (3)", "Femur Scan (4)", and "Tibia Scan (5)". From "Tibia Scan (5)", the process goes to "Femur and Tibia Registration (6)", then "Femur and Tibia Morphing (7)", "Inspection (8)", "Create Case File and Complete (9)", and finally "Export Case Data (10)".

Figure 5-1. Overall system flow chart

> INDICATIONS FOR USE

JointVue 3D Echo is a software application for the display and 3D visualization of ultrasound volume data derived from the Sonix Ultrasound Scanner. It is designed to allow the user to observe images and perform analysis of musculoskeletal structures using the ultrasound volume data acquired with the Sonix Ultrasound Scanner. Typical users of this system are trained professionals, including physicians, nurses, and technicians.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE

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

Intended Use / Indications for Use The predicate and subject device have . equivalent intended use.
. 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.
. Enerav Source - Subject device is operated on SonixOne or SonixTouch Q+ that can operate via battery or mains power, while the predicate is loaded on a computer that can operate via battery or mains power.
. Performance Testing - The predicate and subject device have equivalent precision and accuracy based upon benchtop testing using a phantom.

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Table 5-1

Feature	Subject Device (3D Echo)	Predicate Device (5D Viewer)
Computer Operating System	Windows 7	Windows 7
2D Image Display
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 Image with3D visualization)	Yes (Display Axial image with3D image)
Contouring	Yes	Yes
US Image Visualization	Yes	Yes

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 software. Accessory that has patient contact is already used for another 510(k) cleared device that has equivalent duration of contact and type of contact.

Electrical safety and electromagnetic compatibility (EMC)

Not applicable to the subject device, because the device is software. Accessory that runs the software is already 510(k) cleared device that has been evaluated for electrical safety and EMC.

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), because the software is an accessory to a Class 2 ultrasound system.

Mechanical and acoustic Testing

Benchtop testing using a phantom was presented to demonstrate safety and effectiveness of the device with the same accuracy and precision as the predicate device.

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 3D Echo software.

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VIII. CONCLUSIONS

The subject device is equivalent to the predicate device with regard 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).