(182 days)
Not Found
No
The summary describes image processing and measurement tools, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for model development. The description of performance studies focuses on validation against clinical and cadaver data, not on evaluating an AI/ML model's performance metrics.
No
The device is an image-processing software intended to assist in surgical planning and intra-operative guidance for hip and knee replacement; it does not directly treat or diagnose a disease or condition.
No.
JointPoint is an image-processing software intended to assist healthcare professionals in surgical planning and intraoperative positioning of components, rather than to diagnose medical conditions or diseases.
Yes
The device description explicitly states "The JointPoint software is a client/server based software product wherein a primary server software component and database store user, patient and case information and a client software package is installed on user devices such as laptops or tablets." It also mentions that the medical aspects can function on the laptop or tablet alone, indicating the core functionality is software-based and runs on general-purpose computing devices. There is no mention of dedicated hardware components being part of the device itself.
Based on the provided text, JointPoint is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- JointPoint's Intended Use: JointPoint's intended use is focused on assisting in the positioning of total hip replacement components and preoperative analysis of orthopedic surgery using radiology images. It works with images of the body, not with specimens taken from the body.
- Device Description: The device description confirms it's a software system that processes images and data related to orthopedic procedures. There is no mention of handling biological specimens.
Therefore, JointPoint falls under the category of medical devices that assist in surgical planning and execution based on imaging data, rather than IVDs which analyze biological samples.
N/A
Intended Use / Indications for Use
Joint is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
JointPoint is also indicated for assisting healthcare professionals in preoperative analysis of orthopedic surgery in Total Hip Replacement, Total Knee Replacement, and Intertrochanteric Fracture Reduction. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, HAW
Device Description
JointPoint is a non-invasive software system intended to provide preoperative templating for orthopaedic procedures and intraoperative data for total hip arthroplasties (THA). The JointPoint software is a client/server based software product wherein a primary server software component and database store user, patient and case information and a client software package is installed on user devices such as laptops or tablets. The two software components communicate with each other over the internet in a fully HIPAA compliant manner. The medical aspects of the software can function on the laptop or tablet alone, without the user of the internet, so that the system will still function in an OR that does not have internet connectivity.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiology images
Anatomical Site
Hip, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals, OR
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Performance testing of the JointPoint system included the FDA recommended verification and validation testing. Software verification testing was performed in the laboratory to evaluate setup, accuracy and functionality of the system in supporting orthopedic procedures. Further testing was performed using clinical data to compare the templated versus actual size of the implants in order to validate the system's pre-operative intended use, as well as, cadaver data to validate the system's intra-operative intended uses.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification testing was performed in the laboratory to evaluate setup, accuracy and functionality of the system in supporting orthopedic procedures. Further testing was performed using clinical data to compare the templated versus actual size of the implants in order to validate the system's pre-operative intended use, as well as, cadaver data to validate the system's intra-operative intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K022364, K142923, K073714, K042816
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2016
JointPoint, Inc. % Ms. Michelle McDonough Senior Associate, Regulatory & Clinical Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street, NW, 12th Floor WASHINGTON DC 20005
Re: K160284
Trade/Device Name: JointPoint Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, HAW Dated: June 30, 2016 Received: July 5, 2016
Dear Ms. McDonough:
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-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.
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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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours.
Michael 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) K160284
Device Name JointPoint
Indications for Use (Describe)
Joint is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
JointPoint is also indicated for assisting healthcare professionals in preoperative analysis of orthopedic surgery in Total Hip Replacement, Total Knee Replacement, and Intertrochanteric Fracture Reduction. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software 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) |
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510(k) Summary
| Manufacturer: | JointPoint, Inc. |
|---|---|
| 402 Buttonwood Lane | |
| Largo, FL 33770 | |
| Contact: | Michelle McDonough, MS |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street, NW, 12th Floor | |
| Washington, DC 20005 | |
| 202.552.5800 (phone) | |
| 202.552.5798 (fax) | |
| Date Prepared: | August 2, 2016 |
| Device Trade Name: | JointPoint |
| Common Name: | Picture archiving and communications system (PACS) |
| Classification: | 21 CFR 892.2050 |
| Class: | II |
| Product Code: | LLZ: HAW |
Indications For Use:
JointPoint is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
JointPoint is also indicated for assisting healthcare professionals in preoperative planning and postoperative analysis of orthopedic surgery in Total Hip Replacement, Total Knee Replacement, and Intertrochanteric Fracture Reduction. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
Device Description:
JointPoint is a non-invasive software system intended to provide preoperative templating for orthopaedic procedures and intraoperative data for total hip arthroplasties (THA). The JointPoint software is a client/server based software product wherein a primary server software component and database store user, patient and case information and a client software package is installed on
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user devices such as laptops or tablets. The two software components communicate with each other over the internet in a fully HIPAA compliant manner. The medical aspects of the software can function on the laptop or tablet alone, without the user of the internet, so that the system will still function in an OR that does not have internet connectivity.
Predicate Devices:
JointPoint is substantially equivalent to ORTHOsoft, Inc. Navitrack™ System (K022364) and TraumaCad (K142923, K073714, K042816).
Substantial Equivalence:
Testing performed on this device demonstrates that JointPoint is substantially equivalent to the predicate devices. Performance testing of the JointPoint system included the FDA recommended verification and validation testing. Software verification testing was performed in the laboratory to evaluate setup, accuracy and functionality of the system in supporting orthopedic procedures. Further testing was performed using clinical data to compare the templated versus actual size of the implants in order to validate the system's pre-operative intended use, as well as, cadaver data to validate the system's intra-operative intended uses.
Conclusion
JointPoint is shown to be substantially equivalent to previously cleared devices with respect to its intended use, indications for use, technological characteristics, and performance characteristics.