(350 days)
Not Found
No
The description explicitly states the planning report is generated through "a validated internal Medacta Manufacturing software and with a highly specialized engineering manual landmark selection." There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on manual landmark selection and validated software, not automated learning or inference.
No.
The device is a surgical planning report that provides pre-operative information and post-operative estimations for acetabular realignment, which aids in planning but does not directly treat or diagnose a disease.
No
Explanation: The device is described as a surgical planning report that provides pre-operative information and estimates post-operative parameters for surgical procedures. It does not identify or diagnose a disease, condition, or state of being. Instead, it supports surgical planning based on existing patient anatomical data.
Yes
The device is described as a software that processes CT scan data to generate a surgical planning report in PDF format. The performance studies focus on software verification and validation, and measurement repeatability, indicating a software-centric device. While it supports a surgical procedure, the device itself is the software generating the report, not a physical instrument or implant.
Based on the provided information, the Medacta MyPAO surgical planning report is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality. The MyPAO device, on the other hand, uses CT scan images of the patient's anatomy to create a surgical planning report. It does not analyze biological specimens.
- The intended use is for pre-operative surgical planning based on anatomical data from imaging. This is a different purpose than the diagnostic information provided by IVD devices.
- The device description focuses on bone segmentation and parameter calculation from imaging data. This aligns with surgical planning tools, not IVD testing.
The device falls under the category of medical image processing software used for surgical planning. Its function is to assist surgeons in visualizing and planning a surgical procedure based on the patient's specific anatomy, not to diagnose a condition through the analysis of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
Hip, pelvis, acetabulum
Indicated Patient Age Range
Skeletally mature population
Intended User / Care Setting
Surgeon, Clinicians, Medacta operators
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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°.
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.
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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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
1
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)
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.
| 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 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.
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.
4
V. Indications for Use
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 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 Simulation
Service (K162559)
[Predicate device] |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Input images | CT images | CT or MRI images |
| Design | Image processing software providing a
report with parameters of interest
calculated on the pre-operative images
of the patient | Same |
| Report
generation
workflow | 1) Surgeon uploading of the patient's
CT images
2) Images quality control check | Same |
| Parameters | MyPAO Planning Report
[Subject device] | Move Forward 3D Motion Simulation
Service (K162559)
[Predicate device] |
| | 3) Segmentation and 3D bone model
reconstruction
4) Anatomic landmark selection
5) Surgery plan upload
6) Surgery plan validation by the surgeon
7) Report provision | |
| Image quality
control,
segmentation
and landmark
acquisition | Performed manually by Medacta
operators who have been specifically
trained for this purpose | Performed by Zimmer Biomet operators
who have been specifically trained for
this purpose |
| User
interactions | Clinicians do not interact with the image
analysis software directly. The image
analysis software is only operated by
Medacta operators who have been
specifically trained for this purpose.
The user is only required to upload the
patients' images and validate the plan | Same |
| Report content | Parameters of interest calculated on
• the pre-operative anatomical
situation of the patient's pelvis
• Proposed correction of the
pathological situation (Hip
dysplasia).
• Calculation of the same parameters
referred to the proposed post-op
position. | Parameters of interest calculated on
• the pre-operative anatomical situation
of the patient's pelvis
• Proposed correction of the
pathological FAI situation. |
| Parameters and
evaluation
provided in the
report | • 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 along
defined 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
6
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.