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 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 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.

AI/ML Overview

The provided text describes the JointPoint device, an image-processing software intended to assist in the positioning of total hip replacement components and for preoperative analysis of orthopedic surgery. The document confirms that the device has undergone performance testing to establish substantial equivalence to predicate devices, but it does not explicitly provide a table of acceptance criteria or detailed results of a specific study proving the device meets those criteria.

However, by carefully extracting information, we can infer some details about the testing performed.

Here's a breakdown of the available information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

A specific table of acceptance criteria with corresponding performance metrics is not explicitly provided in the document. The document generally states that "Testing performed on this device demonstrates that JointPoint is substantially equivalent to the predicate devices" and mentions "Performance testing of the JointPoint system included the FDA recommended verification and validation testing."

It vaguely describes two types of testing:

Software verification testing: "performed in the laboratory to evaluate setup, accuracy and functionality of the system in supporting orthopedic procedures."
Validation testing: "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."

Without specific numerical targets or results, a formal table cannot be constructed from the given text.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated. The document refers to "clinical data" and "cadaver data" for validation testing but does not provide the number of cases or images.
Data Provenance:
- Clinical Data: Used for pre-operative intended use validation. The country of origin is not specified. It is implied to be retrospective as it compares "templated versus actual size of the implants," suggesting outcomes were known.
- Cadaver Data: Used for intra-operative intended use validation. The country of origin is not specified. It is implied to be prospective in nature, as it simulates intra-operative use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

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

The document does not provide information on the adjudication method used for the test set.

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

The document does not mention an MRMC comparative effectiveness study or any effect size related to human reader improvement with AI assistance. The device's indications for use emphasize "assisting" healthcare professionals, but no study details are provided to quantify this assistance.

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

The document implies standalone testing was done as part of "software verification testing ... to evaluate setup, accuracy and functionality of the system." Also, the validation testing comparing "templated versus actual size of the implants" and using "cadaver data" suggests evaluating the algorithm's performance in predicting or measuring. However, it's not explicitly labeled as a "standalone" study in the detailed sense of comparing its performance to a ground truth in isolation from human input. The device is not for primary image interpretation and requires clinical judgment, suggesting it's designed as a human-in-the-loop system.

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

For the pre-operative intended use validation, the ground truth was "actual size of the implants," which likely corresponds to outcomes data (i.e., surgical records or measurements of the implants used).
For the intra-operative intended use validation using cadaver data, the exact type of ground truth is not specified but would likely involve direct measurements on the cadaver or from high-precision imaging, serving as a reference.

8. The sample size for the training set

The document does not provide information on the sample size used for the training set.

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

The document does not provide information on how the ground truth for the training set was established.

Summary

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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.

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, MSMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, 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 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:

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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.

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).