Medacta MyPAO surgical planning report is intended to provide users with patient's pre-operative information and an estimation of the post-operative parameters after the realignment of the acetabulum following the osteotomy. It is intended to be used for the pre-operative planning phase of Peri-Acetabular Osteotomy surgeries and it consists of a report in .pdf format elaborated on the basis of Patient's Anatomical Data derived from the CT scan of the patient. The planning report is generated through a validated internal Medacta Manufacturing software and with a highly specialized engineering manual landmark selection.

The Medical Device, in accordance with a written prescription of the Surgeon, is intended for the specific patient for which the case is created. Medacta MyPAO surgical planning is intended to be used on a skeletally mature population for which a PAO surgery is required.

Device Description

MyPAO uses the patients' CT scan to segment the patient's bones in order to provide the surgeons with a report (MyPAO Surgical Planning Report) with some parameters of interest that can be used to properly plan the peri-acetabular osteotomy (PAO) and the manual repositioning of the acetabulum during standard PAO procedures. Specifically, the MyPAO Planning Report includes all the relevant preoperative anatomic data of the patient's hip, a proposal of the repositioning of the acetabulum, following the manual osteotomy, and a calculation of the expected postoperative results in relation to the anatomical reference data.

AI/ML Overview

The MyPAO Planning Report device provides pre-operative information and estimated post-operative parameters for acetabular realignment following osteotomy in Peri-Acetabular Osteotomy (PAO) surgeries. The device itself is a PDF report generated from a patient's CT scan using Medacta Manufacturing software and manual landmark selection by specialized engineers.

Here's an analysis of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intra-observer variability for chosen Hip Dysplasia parameters	Intraclass Correlation Coefficients (ICC) analysis revealed excellent intra-observer agreement (> 0.9 for both parameters, with 95% CI > 0.9). All differences between paired measurements were less than ±5°.
Inter-observer variability for chosen Hip Dysplasia parameters	Intraclass Correlation Coefficients (ICC) analysis revealed excellent inter-observer agreement (> 0.9 for both parameters, with 95% CI > 0.9). All differences between paired measurements were less than ±5°.
All test results met established acceptance criteria.	All stated performance measures met the criteria.

2. Sample Size for Test Set and Data Provenance

Sample Size: The document states "different PAO cases" were used for the measurements repeatability test but does not specify the exact number of cases.
Data Provenance: Not explicitly stated. However, given it's for pre-operative planning, it would imply patient CT scans. The document does not mention the country of origin or if it was retrospective or prospective data.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: The study did not use "experts" to establish ground truth in the traditional sense of independent clinical review. Instead, human operators performed the measurements. The study evaluated the repeatability of these measurements done by Medacta operators.
Qualifications of Experts: The measurements were performed by "Medacta operators who have been specifically trained for this purpose." No further details on their specific qualifications (e.g., years of experience, professional certifications) are provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in the context of this study. The study focused on the intra- and inter-observer agreement of measurements made by operators, rather than an adjudication of a device output against a reference standard established by multiple experts. The "ground truth" was effectively the measurements themselves, and the variability was assessed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study evaluated the consistency of measurements made by operators using the MyPAO software, not the effectiveness of the AI or assistance for human readers in a diagnostic capacity.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Standalone Performance Study: The MyPAO Planning Report is not a standalone AI algorithm in the traditional sense. The report generation involves "a highly specialized engineering manual landmark selection" by trained Medacta operators. Therefore, the performance described (repeatability of measurements) inherently includes human-in-the-loop interaction. There's no mention of an algorithm-only performance evaluation separate from human input.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the repeatability study was not an independent clinical gold standard like pathology or outcome data. Instead, it was the measurements of two specific parameters relevant to Hip Dysplasia, as performed by trained Medacta operators using the MyPAO software. The study aimed to show the consistency (repeatability) of these measurements.

8. Sample Size for the Training Set

Sample Size: The document does not provide any information regarding the sample size used for the training set of the validated internal Medacta Manufacturing software.

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

Ground Truth for Training Set: The document does not describe how the ground truth for the training set (if any, for the "validated internal Medacta Manufacturing software") was established. It only mentions that the report is "elaborated on the basis of Patient's Anatomical Data derived from the CT scan of the patient" and generated through "a validated internal Medacta Manufacturing software and with a highly specialized engineering manual landmark selection." This implies that the 'validation' might refer to internal company processes rather than external ground-truth establishment.

Summary

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February 19, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.

Medacta International SA % Mr. Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street MEMPHIS TN 38118

Re: K200589

Trade/Device Name: MyPAO Planning Report Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 11, 2021 Received: January 12, 2021

Dear Mr. 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 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

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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 (QS) 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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)

Device Name MyPAO Planning Report

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary 2.0

K200589

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 Affairs Manager, Medacta International SA Applicant Correspondent: Christopher Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: March 4, 2020 Date Revised: January 11, 2021

II. Device

Device Proprietary Name:	MyPAO Planning Report
Common or Usual Name:	Picture archiving and communications system (PACS)
Classification Name:	System, Image Processing, Radiological
Primary Product Code:	LLZ
Regulation Number:	21 CFR 892.2050
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

Move Forward 3D Motion Simulation Service, K162559, Biomet Inc. ●

Device Description IV.

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V. Indications for Use

It is intended to be used for the pre-operative planning phase of Peri-Acetabular Osteotomy surgeries and it consists of a report in .pdf format elaborated on the basis of Patient's Anatomical Data derived from the CT scan of the patient. The planning report is generated through a validated internal Medacta Manufacturing software and with a highly specialized engineering manual landmark selection.

The Medical Device, in accordance with a written prescription of the Surgeon, is intended for the sole use of the specific patient for which the case is created. Medacta MyPAO surgical planning is intended to be used on a skeletally mature population for which a PAO surgery is required.

Comparison of Technological Characteristics VI.

The MyPAO Planning Report and the predicate device, Move Forward 3D Motion Simulation Service (K162559), share the following characteristics:

design concept/principle of operation; ●
workflow;
image processing method; ●
user interactions. ●

The subject MyPAO Planning Report and the predicate device, Move Forward 3D Motion Simulation Service (K162559), are technologically different with respect to the specific contents of the report and the provided parameters.

A comparison of key technological features between the subject and predicate device is provided in the table below.

Parameters	MyPAO Planning Report[Subject device]	Move Forward 3D Motion SimulationService (K162559)[Predicate device]
Input images	CT images	CT or MRI images
Design	Image processing software providing areport with parameters of interestcalculated on the pre-operative imagesof the patient	Same
Reportgenerationworkflow	1) Surgeon uploading of the patient'sCT images2) Images quality control check	Same
Parameters	MyPAO Planning Report[Subject device]	Move Forward 3D Motion SimulationService (K162559)[Predicate device]
	3) Segmentation and 3D bone modelreconstruction4) Anatomic landmark selection5) Surgery plan upload6) Surgery plan validation by the surgeon7) Report provision
Image qualitycontrol,segmentationand landmarkacquisition	Performed manually by Medactaoperators who have been specificallytrained for this purpose	Performed by Zimmer Biomet operatorswho have been specifically trained forthis purpose
Userinteractions	Clinicians do not interact with the imageanalysis software directly. The imageanalysis software is only operated byMedacta operators who have beenspecifically trained for this purpose.The user is only required to upload thepatients' images and validate the plan	Same
Report content	Parameters of interest calculated on• the pre-operative anatomicalsituation of the patient's pelvis• Proposed correction of thepathological situation (Hipdysplasia).• Calculation of the same parametersreferred to the proposed post-opposition.	Parameters of interest calculated on• the pre-operative anatomical situationof the patient's pelvis• Proposed correction of thepathological FAI situation.
Parameters andevaluationprovided in thereport	• Center Edges Angle (LCE-MCE)• Tonnis angle• Femoral Head coverage• Range of Motion analysis• Femoral neck anteversion• PAO correction proposal	• Femoral Head and neck diameters• Alpha angles• Center Edge Angle (LCE)• Femoral Head coverage• Acetabular orientation analysis(inclination and version)• Range of Motion analysis alongdefined path• FAI treatment proposal

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Discussion

The subject and predicate devices are substantially equivalent with reference to the intended use, design concept, workflow, image processing method and user interactions. The differences in the report contents and provided parameters do not raise new questions of safety or effectiveness as

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demonstrated by design validation testing. The comparison of technological characteristics and performance data provided within this submission, shows that there are no new risks associated with the subject device design, and supports the substantial equivalence of the MyPAO Planning Report to the identified predicate device.

VII. Performance Data

Based on the risk analysis, verification and validation activities were conducted according to written protocols with defined acceptance criteria. The following tests are being provided in support of a substantial equivalence determination:

Non-Clinical Studies

software verification and validation;
measurements repeatability test based on an analysis intra and inter-observer of two different parameters, chosen for their relevance to detect Hip Dysplasia, on different PAO cases planned with MyPAO software. Intraclass correlation coefficients (ICC) analysis revealed excellent intra-observer and intra-observer agreement for both the relevant parameters measurements, with the whole 95% confidence interval lying above 0.9. All differences between paired measurements were less than ±5°. Therefore, test results have been met the established acceptance criteria.

Clinical Studies

No clinical studies were conducted.

VIII. Conclusion

The information provided above supports that the MyPAO Planning Report is as safe and effective as the identified predicate devices.

Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations provided within this submission. Therefore, it is concluded that the MyPAO Planning Report can be considered substantially equivalent to the identified predicate device.

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).