The DYONICS PLAN Hip Impingement Planning System software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.

Device Description

The Smith & Nephew DYONICS PLAN Hip Impingement Planning System (here in after referred to as DYONICS PLAN software) is a software product that allows orthopedic surgeons and other healthcare professionals to visualize and perform analysis of digital images for assessment of hip preservation treatment options pre-operatively or post-operatively. The software enables the user to import computed tomography (CT) images. display various 2D views of the images, execute image segmentation and 3D rendering of the femur and pelvis. generate anatomic measurements, identify the areas and devree of conflict and simulate the resection of bony lesions, perform a dynamic range of motion analysis of the hip joint, and export the results in an output report. The software automatically generates a default estimate for each step of the analysis based on published literature, and the surgeon should always verify and make adjustments of the parameters based on their clinical judgment. The purpose of the software is to support other clinical findings and patient examination when assessing hip preservation treatment options.

The software is designed to be installed and run locally on a PC-compatible personal computer with a Windows operating system and a graphics card that meets the specified minimum requirements. The software facilitates the importation of CT images in DICOM format and allows the export of the output report in PDF or HTML format which can be referenced pre-operatively, intraoperatively or post-operatively. The user is provided with installation instructions which include the following: a link to a secure website, steps to download the installation file along with a license activation code and password.

AI/ML Overview

The Smith & Nephew DYONICS PLAN Hip Impingement Planning System is a software product designed for orthopedic surgeons and other healthcare professionals to visualize and analyze digital images for assessing hip preservation treatment options.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table outlining quantitative acceptance criteria and reported device performance metrics. Instead, it states that "Software verification and validation testing demonstrates that the DYONICS PLAN does not raise any new questions of safety and efficacy as compared to the predicate device Mimics cleared in K073468." This implies that the device's performance was evaluated to ensure it functions as intended and is comparable to its predicate device, Mimics (K073468), which is a general surgical planning tool.

Given the information, the general acceptance criteria can be inferred as:

Acceptance Criteria Category	Description	Reported Device Performance
Functional Equivalence	The device performs the same core functionalities as the predicate device relevant to hip impingement planning (e.g., image import, segmentation, 3D rendering, measurement tools, surgical simulation/planning).	"Software verification and validation testing demonstrates that the DYONICS PLAN does not raise any new questions of safety and efficacy as compared to the predicate device Mimics cleared in K073468."
Safety and Efficacy	The device does not introduce new safety concerns or demonstrate a lack of efficacy compared to the predicate device.	"Software verification and validation testing demonstrates that the DYONICS PLAN does not raise any new questions of safety and efficacy as compared to the predicate device Mimics cleared in K073468."
Intended Use	The device fulfills its intended use of simulating/evaluating hip preservation surgical treatment options pre-operatively or post-operatively, and historical case review.	The device's intended use is clearly stated and is considered met through its functional capabilities.
Output Generation	The device accurately generates an output report in PDF or HTML format that can be referenced pre-operatively, intra-operatively, or post-operatively.	The software exports the results in an output report.
User Adjustability	The software allows users to verify and adjust automatically generated estimates based on their clinical judgment.	"The software automatically generates a default estimate for each step of the analysis based on published literature, and the surgeon should always verify and make adjustments of the parameters based on their clinical judgment."

2. Sample Size Used for the Test Set and the Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The statement "Software verification and validation testing" is a general declaration without specific details about the clinical data used for this testing.

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 used to establish ground truth for a test set, nor their specific qualifications.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with or without AI assistance. The submission focuses on substantial equivalence to a predicate device rather than a comprehensive clinical effectiveness study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is described as "software product that allows orthopedic surgeons and other healthcare professionals to visualize and perform analysis." It also states, "The software automatically generates a default estimate... and the surgeon should always verify and make adjustments... based on their clinical judgment." This indicates that the device is intended to be used with a human-in-the-loop, allowing for surgeon oversight and adjustment. There is no information suggesting a standalone (algorithm-only) performance evaluation.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any testing. However, given the nature of a surgical planning system, it's plausible that ground truth would involve:

Expert Consensus: For verifying the accuracy of measurements, segmentations, and simulated resections against clinical best practices.
Radiological Interpretation: Expert review of images and software outputs.
Published Literature: The software generates default estimates "based on published literature," which effectively serves as a form of established ground truth for these estimates.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set sample size. This type of detail is often associated with machine learning models, and while the device uses "image segmentation and 3D rendering," the specific details of its underlying algorithms and whether they involve a distinct training phase with a labeled dataset are not disclosed.

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

Since no information about a training set or its sample size is provided, there is no description of how ground truth for a training set was established.

Summary

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K132636

Endoscopy Smith & Nephew, Inc. 150 Minuteinan Road Andover MA 01810 USA

000-049-1000 F 978-749-1443 www.smilh-nephew.com

We are smith&nephew

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

DYONICS PLAN Hip Impingement Planning System

Date Prepared: August 21, 2013

OCT 17 2013

A. Submitter's Name:

Smith & Nephew. Inc., Endoscopy Division 150 Minuteman Road, Andover MA. 01810

B. Company Contact

Kathleen Solomon Sr. Regulatory Affairs Specialist T 978-749-1605 F 978-749-1443

C. Device Name

Trade Name:	DYONICS PLAN Hip Impingement Planning System
Common Name:	Hip Impingement Planning System
Classification Name:	Picture archiving and communications system per CFR882.2050

D. Predicate Devices

The Smith & Nephew DYONICS PLAN is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Mimics cleared in K073468.

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Description of Device E.

F. Intended Use

The DYONICS PLAN is intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review. respectively.

G. Comparison of Technological Characteristics

The proposed DYONICS PLAN has the following similarities as the predicate device Mimics cleared in K073468. In that:

The proposed and predicate devices both have the same intended use: . surgical planning tool
. The proposed and predicate devices both utilize the same principle of operation: stand-alone software for computer assisted surgical planning
The proposed and predicate devices both import CT scans in DICOM . format
The proposed and predicate devices both provide image processing tools, . including image segmentation and 3D rendering tools
� The proposed and predicate devices both provide measurement tools

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Endosconv Smith & Hephew, Inc. 150 Minuteman Road Andover, MA 01810 1150

078-749-1000 F 978-740-1443 www.smith-nephew.com

> We are smith&nephew

The proposed and predicate devices both have tools for surgical simulation . and planning
The major differences between the proposed DYONICS PLAN and the predicate device Mimics are:
The DYONICS PLAN is only indicated for surgical planning for hip . preservation treatment options whereas Mimics is for general surgical planning
. The DYONICS PLAN provides output report which can be referenced pre-operatively, intra-operatively or post-operatively.
Mimics uses additional image formats such as JPEG. TIFF. BMP, or Raw . image data
In addition to CT scans, Mimics can also import MRI scans. .

The differences between the proposed and predicate device does not introduce new types of safety or effectiveness questions. The DYONICS PLAN is only a pre-planning surgical tool that provides surgeons an additional method for planning hip preservation surgeries.

H. Summary Performance Data

Software verification and validation testing demonstrates that the DYONICS PLAN does not raise any new questions of safety and efficacy as compared to the predicate device Mimics cleared in K073468.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

October 17, 2013

KATHLEEN SOLOMON SMITH & NEPHEW, INC. SR. RA SPECIALIST 150 MINUTEMAN RD, ANDOVER MA 01810

Re: K132636

Trade/Device Name: DYONICS PLAN Hip Impingement Planning System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 21, 2013 Received: August 22. 2013

Dear Ms. Solomon:

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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Page 2-Ms. Solomon

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

FDA

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications for Use Statement

K132636 510(k) Number (if known):

Device Name: DYONICS PLAN Hip Impingement Planning System

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

Image /page/5/Picture/10 description: The image shows a stylized logo with the letters FDA. The letters are formed by a series of parallel lines that create a three-dimensional effect. The letters are interconnected, with the F and D sharing a common vertical line. The A is depicted as a triangle with a horizontal line through the middle.

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).