The MyHip Planner software is intended for image processing and preoperative planning of acetabular cup and femoral stem positioning for Total Hip Arthroplasty (THA). The user is assisted in producing a preoperative plan, making decisions based on the leg offsets, the patient's potential impingement and, optionally, the spino-pelvic interaction. Through the software, the user can request 3D Printed Patient Specific Bone Models not intended for dragnostic use, but only intended for a physical representation of the 3D anatomical models visualized in the software. The 3D Printed Patient Specific Bone Models are provided non-sterile.

Device Description

The MyHip Planner is a software whose output is a patient-specific preoperative plan based on CT scans and aimed at evaluating the effects of different device choices and positioning options on the patient's hip joint biomechanics in terms of leg length and offset. It is intended to be used in Primary Hip Arthroplasty and it is compatible with Windows and Mac OS operating system. The subject Advanced version of the MyHip Planner additionally allows to evaluate patient's spinopelvic deformities and pelvic tilt starting from preoperative X-ray images, to help the surgeon to understand the implications of spinopelvic mobility on THA stability and optimize implant components orientation. Through the software, the user can request non-sterile 3D Printed Patient Specific Bone Models intended to be used as an additional visual reference of the patients' specific anatomy.

AI/ML Overview

The Medacta International S.A. Advanced MyHip Planner (K221725) is a software intended for image processing and preoperative planning of acetabular cup and femoral stem positioning for Total Hip Arthroplasty (THA). The software assists users in producing a preoperative plan, making decisions based on leg offsets, potential impingement, and optionally, spino-pelvic interaction. It also allows users to request 3D Printed Patient Specific Bone Models (non-sterile, not for diagnostic use, but for physical representation of 3D anatomical models).

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, precision) of the Advanced MyHip Planner software. However, it states that "Software verification and validation including segmentation validation" was conducted, and "[n]o statistical divergence between the algorithm and the manual segmentation has been revealed by an analysis of the automatic segmentation and landmark picking performance on a two-sided students t-distribution."

Based on this, an inferred table might look like this, with the understanding that specific numerical acceptance criteria (e.g., within X mm or degrees of ground truth) are not explicitly detailed:

Acceptance Criteria (Inferred)	Reported Device Performance
Segmentation Accuracy: Robust and accurate automatic segmentation of anatomical structures relevant for THA planning, spino-pelvic evaluation, and 3D bone model generation.	"No statistical divergence between the algorithm and the manual segmentation has been revealed by an analysis of the automatic segmentation and landmark picking performance on a two-sided students t-distribution." This suggests that the automated segmentation and landmark identification are statistically comparable to manual methods.
Landmark Picking Accuracy: Accurate automatic identification of anatomical landmarks crucial for preoperative planning measurements (cup/stem positioning, ROM, spino-pelvic evaluation).	"No statistical divergence between the algorithm and the manual segmentation has been revealed by an analysis of the automatic segmentation and landmark picking performance on a two-sided students t-distribution." This indicates the automated landmark picking is statistically comparable to manual methods.
Functionality: Correct operation of all software features, including image upload, segmentation, planning tools, spino-pelvic evaluation, and 3D bone model request.	"Based on the risk analysis, verification activities were conducted to written protocols." This typically implies testing of all functional requirements.

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

The document does not explicitly state the sample size used for the test set. It mentions "an analysis of the automatic segmentation and landmark picking performance," but the number of cases or images included in this analysis is not provided.

The data provenance (e.g., country of origin, retrospective or prospective) for the test set is also not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document refers to "manual segmentation" as a comparison point for the algorithm's performance. However, it does not specify the number of experts who performed this manual segmentation or landmark picking, nor does it explicitly detail their qualifications (e.g., radiologist with X years of experience, orthopedic surgeon).

4. Adjudication Method for the Test Set

The document refers to a "two-sided students t-distribution" analysis to compare algorithm performance with manual segmentation. This implies a statistical comparison rather than a formal adjudication process involving multiple human readers to resolve discrepancies. Therefore, an explicit adjudication method like 2+1 or 3+1 is not mentioned. The "manual segmentation" serves as the reference, suggesting a single ground truth from a human expert or a pre-established "gold standard" of manual interaction.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

The document explicitly states: "No clinical studies were conducted." Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to evaluate human reader improvement with AI assistance was not performed.

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

The performance data section mentions "Software verification and validation including segmentation validation" and "an analysis of the automatic segmentation and landmark picking performance." This indicates that standalone performance evaluation (algorithm only) of the segmentation and landmark picking functionalities was performed. The comparison was against "manual segmentation" which serves as the independent reference for the algorithm's output.

7. The Type of Ground Truth Used

The ground truth for the verification and validation activities, specifically for segmentation and landmark picking, appears to be expert consensus through "manual segmentation" and "manual landmark picking." The document uses these manual methods as the reference against which the algorithm's performance was compared. There is no mention of pathology or outcomes data being used for ground truth for these specific performance evaluations.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set for the Advanced MyHip Planner software.

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

The document does not describe how the ground truth for the training set was established. While it mentions comparison to manual segmentation for validation, it does not elaborate on the process or sources of ground truth used during the development and training phases of the algorithm.

Summary

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Medacta International S.A. % Chris Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street MEMPHIS, TENNESSEE 38118

Re: K221725

Trade/Device Name: Advanced MyHip Planner Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 22, 2022 Received: December 23, 2022

January 20, 2023

Dear Chris Lussier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K221725

Device Name Advanced MyHip 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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K221725 510(k) Summary

I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Sr. Director of Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: June 13, 2022 Date Revised: January 19, 2023

II. Device

Device Proprietary Name:	Advanced MyHip Planner
Common or Usual Name:	Advanced MyHip Planner
Classification Name:	Medical image management and processing system
Primary Product Code:	LLZ
Regulation Number:	21 CFR 892.2050
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following primary predicate device:

A MyHip Planner, K200350, Medacta Interational SA
In addition, the following reference device is cited within the submission:
A My Knee Cutting Blocks, K093806, Medacta International SA

IV. Device Description

It is intended to be used in Primary Hip Arthroplasty and it is compatible with Windows and Mac OS operating system.

The subject Advanced version of the MyHip Planner additionally allows to evaluate patient's spinopelvic deformities and pelvic tilt starting from preoperative X-ray images, to help the surgeon to

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understand the implications of spinopelvic mobility on THA stability and optimize implant components orientation.

Through the software, the user can request non-sterile 3D Printed Patient Specific Bone Models intended to be used as an additional visual reference of the patients' specific anatomy.

V. Indications for Use

Through the software, the user can request 3D Printed Patient Specific Bone Models not intended for diagnostic use, but only intended for a physical representation of the 3D anatomical models visualized in the software. The 3D Printed Patient Specific Bone Models are provided non-sterile.

Parameters	Advanced MyHip Planner(Subject device)	MyHip Planner(Predicate device K200350)
Indication foruse	The MyHip Planner software isintended for image processing andpreoperative planning of acetabularcup and femoral stem positioningfor Total Hip Arthroplasty (THA).The user is assisted in producing apreoperative plan, making decisionsbased on the leg offsets, thepatient's potential impingementand, optionally, the spino-pelvicinteraction.Through the software, the user canrequest 3D Printed Patient SpecificBone Models not intended fordiagnostic use, but only intended fora physical representation of the 3Danatomical models visualized in thesoftware. The 3D Printed PatientSpecific Bone Models are providednon-sterile.	The MyHip Planner software isintended for image processing and pre-operative planning of acetabular cupand femoral stem positioning for TotalHip Arthroplasty (THA). The deviceassists the user in assessing potentialleg length and offset differences aswell as potential range of motionimpingement.
Operativesystem	Windows or Mac OS	Same
Hardware	Laptop and/or PC	Same
Input images	• CT scan images	CT scan images

VI. Comparison of Technological Characteristics

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Parameters	Advanced MyHip Planner(Subject device)	MyHip Planner(Predicate device K200350)
Input imagesacquisitionmethod	X-rays Through hard disk (CD/USB) or wireless through MySolution website	Same
User interface	GUI	Same
Workflow	CT images upload Segmentation Planning including spino-pelvic evaluation Bone models production and shipping (optional)	CT images upload Segmentation Planning
Segmentation	Automatic but the user has to check, eventually modify, and confirm it	Same
Availableimplants	Medacta hip implants cleared to FDA by Medacta	Same
Measurementsoutput	Cup positioning Stem positioning ROM evaluation Spino-pelvic evaluation	Cup positioning Stem positioning ROM evaluation

The subject Advanced MyHip Planner and the predicate device are substantially equivalent with regards to the following characteristics:

operative system compatibility;
design concept/principle of operation;
. user interface;
images importation method;
segmentation and landmark acquisition method; and
. available implants.

The subject Advanced MyHip Planner differs from the predicate device with respect to:

input images;
workflow; and
measurements output.

Discussion

The slightly different input images and workflow of the subject device with respect to the predicate does not affect the safety and effectiveness of the Advanced MyHip Planner since it is only related to the addition of new input images (x-rays) and workflow steps strictly related to the newly developed feature allowing spino-pelvic evaluation and the manufacturing of bone models, both optional steps. Identically to the bone models included in the reference device clearance (K093806), the subject bone models are manufactured through the software starting from the patient's CT as an additional visual reference of the patients' specific anatomy, thus no new issue of safety and effectiveness arise.

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Also measurements output differences are strictly related to the new spino-pelvic evaluation feature and does not raise any new issue of safety and effectiveness since the other output measurements are identical to the ones of the predicate device (K200350).

The comparison of technological characteristics and validation provided within this submission, supports the substantial equivalence of the subject devices respect to the predicate devices.

VII. Performance Data

Based on the risk analysis, verification activities were conducted to written protocols. The following software verification and validation are provided in support of the substantial equivalence determination:

Non-Clinical Studies

. Software verification and validation including segmentation validation. No statistical divergence between the algorithm and the manual segmentation has been revealed by an analysis of the automatic segmentation and landmark picking performance on a two-sided students t-distribution.

Clinical Studies:

No clinical studies were conducted. ●

Conclusion VIII.

The information provided above supports that the Advanced MyHip Planner is substantially equivalent to the predicate devices.

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).