MEDIP PRO is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning.

The 3D printed models generated from the output file are meant for non-diagnostic use. MEDIP PRO should be used in conjunction with other diagnostic tools and expert clinical judgement.

Device Description

MEDIP PRO is medial image processing software that provides 3D reconstruction and visualization of ROI, advanced image quality improvement, auto segmentation for specific target, texture analysis and etc. through loading DICOM file imaged from CT or MRI by user(doctors). Also, it supports exporting STL data for 3D printing.

AI/ML Overview

The provided text describes the MEDIP PRO device, but it lacks detailed information regarding specific acceptance criteria and the comprehensive study results to explicitly prove the device meets these criteria. The document focuses on regulatory approval (510(k)) by demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study with quantifiable acceptance criteria.

However, based on the available information, we can extract some relevant details and acknowledge the missing ones:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study to Prove Performance
Segmentation Performance: Similarity of auto-segmentation results to ground truth.	"Segmentation Performance" was evaluated. Specific metrics (e.g., Dice score, Jaccard index, accuracy, precision, recall) and their target values are not specified in the provided document.	Comparative Performance Test with a predicate device. Details on specific metrics and results are not provided.
Measurement Accuracy: Accuracy of distance measurements within the software.	"Measurement of Distance Phantom study" was conducted. Specific accuracy limits (e.g., ±X mm) are not specified.	Comparative Performance Test with a predicate device. Details on specific metrics and results are not provided.
Usability: User experience and ease of use of the software.	"Usability test System measurements & segmentation" was conducted. Specific acceptance criteria for usability (e.g., task completion rate, time on task, satisfaction scores) are not specified.	Comparative Performance Test with a predicate device. Details on specific metrics and results are not provided.
Software Validation: Adherence to software development processes and functional requirements.	"The MEDIP PRO... was designed and developed according to a software development process and was verified and validated."	Verified each independent software subsystem against defined requirements, interfaces between subsystems, and validated the integrated system against overall system requirements.

Study Details Based on Provided Information:

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

The document does not specify the sample size (number of cases or images) used for the "Comparative Performance Test" which included segmentation and measurement evaluation.
The data provenance (e.g., country of origin, retrospective or prospective) for the test set is not mentioned.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. It only mentions that the device "should be used in conjunction with other diagnostic tools and expert clinical judgement."

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

The document does not specify any adjudication method used for the test set.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

An MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned or performed. The study mentioned is a "Comparative Performance Test" between MEDIP PRO and a predicate device, focusing on the device's inherent performance.

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

Yes, a standalone performance assessment was done. The "Comparative Performance Test" and "Performance Test" sections describe evaluating the device's (MEDIP PRO application) functionalities and performance (segmentation, measurement) against a predicate device. This implies evaluating the algorithm's performance without direct human-in-the-loop interaction for performance improvement measurement within the study.

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

The document does not explicitly state the type of ground truth used for the segmentation and measurement performance evaluations. It refers to a "Distance Phantom study" for measurements, implying physical phantoms as ground truth for that aspect. For segmentation, it's likely expert-derived segmentations, but this is not confirmed.

8. The sample size for the training set:

The document does not provide any information regarding the sample size used for the training set for the MEDIP PRO software (if it uses machine learning/AI for features like auto-segmentation, which is implied by "auto segmentation for specific target").

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

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

Summary

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Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

November 7, 2019

MEDICALIP Co., Ltd % GeumHyeon Kim Lead Consultant DT&S Co., Ltd. #202, Mario Tower, 28, Digital-ro 30-gil Guro-gu, 08389 SEOUL KR

Re: K191026

Trade/Device Name: Medip Pro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 5, 2019 Received: September 16, 2019

Dear GeumHyeon Kim:

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.

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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 and Part 809); 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 (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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191026

Device Name MEDIP PRO

Indications for Use (Describe)

The 3D printed models generated from the output file are meant for non-diagnostic use. MEDIP PRO should be used in conjunction with other diagnostic tools and expert clinical judgement.

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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Image /page/3/Picture/0 description: The image is a logo for a company called MEDICAL IP. The logo features a blue semicircle above a blue line graph, which is likely meant to represent a heartbeat. Below the semicircle and line graph, the words "MEDICAL IP" are written in a sans-serif font. Underneath the company name is the tagline "Empowering Medicine through Lifesaving Technologies" in a smaller font.

K191026

510(k) Summary

[As Required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

November 7, 2019

2. Submitter's Information [21 CFR 807.92(a)(1)]

- Name of Manufacturer:	MEDICAL IP Co., Ltd.
- Address:	7F, Changkyung Building,174, Yulgok-ro, Jongno-gu, Seoul, Republic ofKorea, 03127
- Telephone No.:	+82-2-2135-9148

3. Submission Correspondent

- Name of company:	DT&S Co., Ltd.
- Address:	#202, Mario Tower, 28, Digital-ro 30-gil, Guro-gu, Seoul, 08389,Republic of Korea
- Contact Name:	GeumHyeon Kim
- Contact Title	Lead Consultant
- E-mail Address	ghkim@dtncro.co.kr
- Telephone No.:	+82-2-357-8401
- Fax No.:	+82-2-357-8027

4. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]

Trade Name	MEDIP PRO
Regulation Number	21 CFR 892.2050
Regulation Name	Picture archiving and communications system
Regulation Class	II
Product Code	LLZ
Product Code Name	System, Image Processing, Radiological

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Image /page/4/Picture/0 description: The image shows the logo for Medical IP. The logo is blue and features a stylized heart rate line with a curved line above it. Below the graphic, the text "MEDICAL IP" is written in a sans-serif font, with the tagline "Empowering Medicine through Lifesaving Technologies" written in a smaller font below it.

5. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[

The identified predicate devices within this submission are shown as follow:

Predicate device
- 510(k) Number:	K173619
- Applicant:	Materialise N.V.
- Classification Name:	System, Image processing, Radiological
- Trade Name:	Mimics inPrint
Reference device
- 510(k) Number:	K161841
- Applicant:	3D Systems, Inc.
- Classification Name:	System, Image processing, Radiological
- Trade Name:	D2P

6. Description of the Device [21 CFR 807.92(a)(4)]

7. Indications for Use [21 CFR 807.92(a)(5)]

The 3D printed models generated from the output file are meant for non-diagnostic use. MEDIP PRO should be used in conjunction with other diagnostic tools and expert clinical judgement.

8. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]

There are no significant differences in the technological characteristics of this device compared to the predicate devices which adversely affect safety or effectiveness. The below table is summarized and compared with the technological characteristics between the MEDIP PRO and the predicate device:

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Image /page/5/Picture/0 description: The image shows the logo for Medical IP. The logo features a blue semicircle above a blue line that resembles a heart rate monitor. Below the graphic is the text "MEDICAL IP" in a sans-serif font, with the tagline "Empowering Medicine through Lifesaving Technologies" in a smaller font underneath.

	Table 1. Technological Characteristics Comparison

	Proposed Device	Predicate Device	Reference Device
K Number	K191026	K173619	K161841
Manufacturer	MEDICALIP.CO.,LTD	Materialise N.V.	3D Systems, Inc.
Model	MEDIP PRO	Mimics inPrint	D2P
Product Code	LLZ	LLZ	LLZ
Indicationsfor Use	MEDIP PRO is intended foruse as a software interfaceand image segmentationsystem for the transfer ofDICOM imaginginformation from a medicalscanner to an output file. Itis also used as pre-operativesoftware for treatmentplanning.The 3D printed modelsgenerated from the outputfile are meant for non-diagnostic use. MEDIP PROshould be used inconjunction with otherdiagnostic tools and expertclinical judgement.	Mimics inPrint is intendedfor use as a softwareinterface and imagesegmentation system for thetransfer of DICOM imaginginformation from a medicalscanner to an output file. Itis also used as pre-operativesoftware for treatmentplanning. For this purpose,the Mimics inPrint outputfile can be used for thefabrication of physicalreplicas of the output fileusing traditional or additivemanufacturing methods.The physical replica can beused for diagnostic purposesin the field of orthopedic,maxillofacial andcardiovascular applications.Mimics inPrint should beused in conjunction withother diagnostic tools andexpert clinical judgement.	The D2P software isintended for use as asoftware interface andimage segmentation systemfor the transfer of imaginginformation from a medicalscanner such as a CTscanner to an output file. Itis also intended as pre-operative software forsurgical planning.3D printed modelsgenerated from the outputfile are meant for visual,non-diagnostic use.
Type of Use	Prescription Use	Prescription Use	Prescription Use
Component	Stand-alone software	Stand-alone software	Stand-alone software
ImageSupport Type	DICOM imaginginformation from CT, MRI	DICOM imaginginformation from CT, MRI	DICOM imaginginformation from CT, MRI
Feature/Functionality	Analysis & MeasurementImage Enhancement2D/3D visualizationSegmentation3D RenderingExporting STL data for 3DPrinting	Analysis & MeasurementImage Enhancement2D/3D visualizationSegmentation3D RenderingExporting STL data for 3DPrinting	Analysis & MeasurementImage Enhancement2D/3D visualizationSegmentation3D RenderingExporting STL data for 3DPrinting

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Image /page/6/Picture/0 description: The image shows a logo for a company called "MEDICAL IP". The logo features a blue graphic of a heartbeat line underneath a curved line. Below the graphic, the words "MEDICAL IP" are written in a bold, sans-serif font. Underneath the company name is the tagline "Empowering Medicine through Lifesaving Technologies" in a smaller, lighter font.

A detailed comparison shows the subject device is substantially equivalent in intended use, software type, modality support operating system, image communication standard and functionality to the predicate device. The subject device only intends to be a software for treatment planning and does not include the simulation of treatment options. The 3D printed models generated from the output file are meant for nondiagnostic use.

Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

1. Software Validation
  The MEDIP PRO contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.

The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.

· Verification of each independent software subsystem against defined requirements
· Verification of interfaces between software subsystems against defined interface requirements
· Validation of fully integrated system including all subsystems against overall system requirements.
1. Performance Test

The MEDIP PRO application has been validated for its intended use to determine substantial equivalence to the predicate device. The device functionalities were performed, verified and validated to be within specification.

Comparative Performance Test

The MEDIP PRO engineers conducted a Comparative Performance Test for segmentation and measurement functionalities in the software with predicate device.

· Measurement of Distance Phantom study
· Segmentation Performance
· Usability test System measurements & segmentation

Clinical Test Summary [21 CFR 807.92(b)(2)]

No clinical studies were considered necessary and performed.

9. Conclusion [21 CFR 807.92(b)(3)]

Based on a comparison of the intended use and technological characteristics, the MEDIP PRO software is substantially equivalent to the identified predicate device and reference device. Minor differences in technological and performance characteristics did not raise new or different questions of safety and effectiveness. Additionally, the non-clinical testing supports that the system performs in accordance with its intended use and is as safe, as effective, and performs as well as the predicate device and reference 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).