ZedView is intended to be used to assist qualified medical professionals to perform fast and effective pre-operative planning for various surgical procedures related to hip and knee by using 2D image data. The software is basically intended to be standalone, however some part of the software provides features for communicating with PACS servers to acquire the CT data of various patients or to upload planned projects, images or reports to the servers.

ZedView is indicated for pre-operative planning for various surgical procedures related to hip and knee, such as artificial joint replacement (3D templating of implants) and osteotomy.

Device Description

ZedView is a software package that provides computer-assisted 3D planning and evaluations using 2D image data in DICOM or other formats, for various pre-operative hip and knee surgical procedures. The software is composed of various modules as shown in Figure 1, below.

The software primarily provides import and storage of CT images of various patients in DICOM or other formats. Also, it provides a means of 3D templating of implants and positioning of fixation devices by calculating surgical parameters in simulated environments and performing 3D measurements on each pre-operative patient data, using 2D image viewing and manipulations, 3D visualizations and various MPR (Multi-Planar Reconstruction) functions.

The software also provides separate modules that support pre-operative planning of hip and knee arthroplasty for 2D digital X-rav images obtained with the EOS imaging system by providing quasi-3D templating, 3D measurement, etc. Besides the functional modules for artificial joint replacement surgeries, the software also provides a module that incorporates planning and evaluations for osteotomy (Curved Periacetabular Osteotomy etc.).

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. Instead, it describes a 510(k) summary for a medical image management software called ZedView, focusing on its substantial equivalence to predicate devices (Meridian Technique Ltd. Orthoview™).

However, I can extract the information available from the document regarding the device's performance claims and the nature of the evaluation.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria, nor does it provide quantitative performance metrics for ZedView. The performance section broadly claims that the software "meets its requirements for intended use and its performance requirements" and is "as safe, as effective, and performs as well as or better than the predicates."

Acceptance Criteria (Implied)	Reported Device Performance
Meet requirements for intended use	Verification and validation results confirm ZedView meets its requirements for intended use.
Meet performance requirements	Verification and validation results confirm ZedView meets its performance requirements.
As safe as predicates	Non-clinical tests confirm ZedView is as safe as the predicates.
As effective as predicates	Non-clinical tests confirm ZedView is as effective as the predicates.
Performs as well as or better than predicates	Non-clinical tests confirm ZedView performs as well as or better than the predicates.

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

The text states: "The Lexi ZedView Software was fully tested, verified and validated by Lexi as part of its own internal design control requirements using the test image data or real-life patient data."

Test Set Sample Size: Not specified.
Data Provenance: The text mentions "test image data or real-life patient data," but does not specify the country of origin or whether it was retrospective or prospective.

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

This information is not provided in the document. The text does not elaborate on how ground truth was established for any test data used.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the document. The evaluation described is internal verification and validation against predicate devices, not a study of human reader improvement with AI assistance.

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

Yes, the device is explicitly described as "basically intended to be standalone." The performance evaluation mentioned (internal design control requirements, verification, and validation) would inherently assess its standalone functionality, comparing it to its requirements and predicates, rather than its impact on human performance in a clinical setting.

7. The Type of Ground Truth Used

The type of ground truth used is not explicitly stated. The document mentions "test image data or real-life patient data" but does not detail how the definitive truth for these cases was established (e.g., pathology, clinical outcomes, expert consensus). Given the device's function as a pre-operative planning tool, the ground truth would likely relate to the accuracy of 3D reconstructions, measurements, and implant templating against known anatomical or surgical parameters, potentially derived from expert consensus or cadaveric studies, but none of this is detailed.

8. The Sample Size for the Training Set

This information is not provided. The document describes a traditional software verification and validation process, not a machine learning model that typically involves distinct training and test sets. While the software uses "real-life patient data" for testing, it's not clear if there's a "training set" in the context of an AI/ML algorithm.

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

Since a "training set" (in the context of AI/ML) is not mentioned, and the process of establishing ground truth for any data used is not detailed, this information is not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the word LEXI in bold, black letters. To the left of the word is a blue square design with several squares inside of each other. There is a blue line on either side of the word and design.

''510(k) SUMMARY'' AS REQUIRED BY SECTION 807.92(c)

510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared.

Lexi Co., Ltd. Kyodo-Keikaku Bldg. 9F 3-36-6 Sugamo, Toshima-ku, Tokyo 170-0002, JAPAN Phone: +81 (0)3 5394 4833 Fax: + 81 (0)3 5394 4834 E-mail: admin@lexi.co.jp Website: http://www.lexi.co.jp/

Contact Person:

Edward A. Kroll President, Spectre Solutions, Inc. and Representative Consultant for Lexi Co., Ltd. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9801 Fax: (440) 546-9124

Date Prepared: September 8, 2013

Name of Device

Trade Name: ZedView ●
Common Name: Image Management Software
Classification Name: Medical Image Management System, Product Code LLZ

Predicate Device

ZedView is substantially equivalent to the Meridian Technique Ltd. Orthoview™ (510(k) Accession Numbers: K032401 and K063327).

Volume Number
8

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Device Description:

Image /page/1/Figure/4 description: The image is a flowchart that shows the architecture of the ZedView software. The top-level component is ZedView, which is composed of ZedViewDB, ZedView3D, and ZedReport. ZedViewDB is responsible for 2D slice image data management, ZedView3D is responsible for 3D visualization, measurement, and simulations, and ZedReport is responsible for screenshot report generation, editing, and transmission. The ZedViewDB and ZedReport components are connected to ZedEdit, ZedHip, ZedKnee/JIGEN, ZedHip-EOS, ZedKnee-EOS, and ZedOsteotomy.

Image /page/1/Figure/5 description: The image shows the text "FIGURE 1" in a bold, sans-serif font. The text is underlined. The words are stacked on a single line.

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Intended Use

Predicate Device Comparison

The ZedView software is substantially equivalent to the Meridian Technique Ltd. Orthoview™ Software (K032401 and K063327). (See Page 11-1 for the comparative analysis).

Performance Data: (Non-clinical Testing)

The Lexi ZedView Software was fully tested, verified and validated by Lexi as part of its own internal design control requirements using the test image data or real-life patient data. Verification and validation results confirm that the ZedView Software meets its requirements for intended use and its performance requirements.

Conclusions of non-clinical tests

The results of the non-clinical tests confirm that ZedView is as safe, as effective, and performs as well as or better than the predicates.

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ZedView/OrthoView Comparative Analysis

Characteristic	Meridian TechniqueOrthoView (K032401)	Meridian TechniqueOrthoView (K063327)	Lexi ZedView
Computer	PC Workstation	Personal computer orWorkstation/Server	Personal computer orWorkstation
OperatingSystem	Windows	Windows	Same
Availability ofDevice	Can be configured to belaunched from within aworkstation environment oras a standalone PCapplication for planningorthopedic procedures.	Same	Same
Source ofimages	Receive digital imagesfrom various sources(including PACS system)	Same	Same
Processing ofdata	Scaling of image facility	Same	Same
SuperimposingdigitalProstheticTemplates	Permits overlay oftemplates	Same	Same
Interactivepositioning oftemplate	Yes	Same	Same
Interactivesizing oftemplate	Yes	Same	Same
Permits templaterotation	Yes	Same	Same
Providestemplatingsupport fromprostheticmanufacturers.	Yes	Same	Same
Permitsautomaticscaling	Yes	Same	Semi-automaticmeasurements
Pre-operativeplanning	Allowed	Same	Same
Osteotomymodule	No	Yes	Yes
Patient contact	None	Same	Same
Control of life-sustainingdevices	None	Same	Same
Humanintervention forinterpretation of	Required	Same	Same

Volume Number
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Characteristic	Meridian TechniqueOrthoView (K032401)	Meridian TechniqueOrthoView (K063327)	Lexi ZedView
images
Ability to addadditionalmodules whenavailable	Yes	Same	Same
Intended use	The OrthoviewTM systemis designed with theintention that licensedmedical professionals canaccess digitised medical X-Ray images in DICOM orother formats obtainedfrom a variety ofmodalities such as PACSsystems, X-Ray digitisersetc.This permits the review ofsuch images and allows theoverlay of digitised imagesof templates for prostheticdevices thereby providingan alternative to traditionalmeans of optically viewingprocessed X-Ray filmsoverlaid with the acetatetemplates of suchprostheses supplied by theprosthetic manufacturer.OrthoviewTM provides themeans of recording, storingand retrieving thetemplating process stepsperformed by the licensedmedical professional whenassessing theoptimum prosthetic devicefor a particular patient.The OrthoviewTM systemdoes not have any functionsuch as image acquisition,image storage etc, this isthe responsibility of thesystems alongside whichOrthoviewTM operates.The OrthoviewTM systemdoes not specify therequirements for theprosthetic template - this isthe responsibility of theprosthetic manufacturer.	OrthoviewTM intended use is toenable a suitably licensed andqualified healthcareprofessional access to medicalimages with the intention ofusing such images, in conjunctionwith templates for prosthetic andfixation devices, for the purposesof choosing the nature andcharacteristics of theprosthetic/fixation device to beused whenplanning a potential surgicalprocedure. In addition, Traumaand Osteotomy modules andTrauma Templates are includedto extend the range offunctionality available to thehealthcare professional.	ZedView is intended to beused to assist qualifiedmedical professionals toperform fast and effective pre-operative planning for varioussurgical procedures related tohip and knee by using 2Dimage data. The software isbasically intended to bestandalone, however somepart of the software providesfeatures for communicatingwith PACS servers to acquirethe CT data of variouspatients or to upload plannedprojects, images or reports tothe servers.The software primarilyprovides import and storageof CT images of variouspatients in DICOM or otherformats and provides a meansof 3D templating of implantsand positioning of fixationdevices by calculatingsurgical parameters insimulated environments andperforming 3D measurementson each pre-operative patientdata using 2D image viewingand manipulations, 3Dvisualizations and variousMPR (Multi-PlanarReconstruction) functions.The software also providesseparate modules that supportpre-operative planning of hipand knee arthroplasty for 2Ddigital X-ray images obtainedwith the EOS imaging systemby providing quasi-3Dtemplating, 3D measurement,etc.Besides the functionalmodules for artificial jointreplacement surgeries, thesoftware also provides a

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Characteristic	Meridian TechniqueOrthoView (K032401)	Meridian TechniqueOrthoView (K063327)	Lexi ZedView
			module that incorporatesplanning and evaluations forosteotomy (CurvedPeriacetabular Osteotomyetc.).
Indications foruse	OrthoviewTM is indicatedfor use when a suitablylicensed and qualifiedhealthcare professionalrequires access to medicalimages with the intentionof using such images, inconjunction with templatesfor prosthetic devices, forthe purposes of choosingthe nature andcharacteristics of theprosthetic device to be usedwhen planning a potentialsurgical procedure.	OrthoviewTM is indicated for usewhen a suitably licensed andqualified healthcare professionalrequires access to medical imageswith the intention of using suchimages, in conjunction withtemplates for prosthetic andfixation devices, for the purposesof choosing the nature andcharacteristics of theprosthetic/fixation device to beused when planning a potentialsurgical procedure. In addition,Trauma and Osteotomy modulesand Trauma Templates areprovided to extend the range offunctionality available tohealthcare professionals.	Pre-operative planning forvarious surgical proceduresrelated to hip and knee likeartificial joint replacement(3D templating of implants),osteotomy.

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Discussion of Differences

Important Differences

1. Image format

OrthoView uses digital X-ray image data, ZedView provides pre-operative planning from CT sliced image data.

Discussion:

The CT image data provides more relevant information than the X-ray images, thus offers a better and precise pre-operative planning, while the intended use and the indications for use remain the same. Besides, ZedView also contains separate operational modules (ZedHip-EOS, ZedKnee-EOS) for providing pre-operative planning for hip and knee using the digital X-ray (DX modality) images from the EOS imaging systems.

2. Templating system

In contrast to the conventional 2D templating of OrthoView. ZedView provides CTbased 3D templating system. In addition to the template overlays in 2D cross-sectional images, the software allows user to place and register the 3D imported models of implants or fixation devices over the 3D reconstructed bone models and also provides 3D movement (translation, rotation) of the implants. In addition. ZedView offers visualization of bone models in various simulated post-operative positions and calculation of surgical parameters with respect to various coordinate systems.

Discussion:

The 3D templating system provides flexibility and extension of functionality by providing additional information (surgical parameters, range of motion analysis, etc.) for pre-operative planning than the 2D templating systems. Moreover, the 3D visualizations of bone and implant models help visualize elements that cannot be visualized in 2D, thus allowing for intuitive, effective and more accurate and precise planning.

3. Osteotomy operational module

In addition to the joint replacement modules, the Osteotomy module in ZedView also offers simulations, measurements, surgical parameters calculations, etc. in 3D.

Discussion:

Similar to the discussion in section 2 above, the extra information and the 3D visualization of simulated bone models allow for intuitive, effective and more accurate and precise planning.

Conclusion

While there are some differences between ZedView and its predicates, these differences are minor and do not affect device substantial equivalence. It has the same basic operational principles and technical characteristics as its predicates and it functions in the same manner. Additionally, it has the indications for use and intended function and

Volume Number	Page Number
8	8-7

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use and performs as well as or better than its predicates. Therefore, Lexi believes that ZedView is substantially equivalent to the predicate devices cited within this submission.

Volume Number	Page Number
8	8-8

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

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

March 6, 2014

LEXI Co., Ltd. % Mr. Edward Kroll President Spectre Solutions, Inc. 5905 Fawn Lane CLEVELAND OH 44141

Re: K133022

Trade/Device Name: ZedView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 20, 2014 Received: February 21, 2014

Dear Mr. Kroll:

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 11 (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-Mr. Kroll

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.7)

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133022

Device Name

ZedView

Indications for Use (Describe)

ZedView is indicated for pre-operative planning for various surgical procedures related to hip and knee, such as artificial joint replacement (3D templating of implants) and osteotomy.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm.h.7)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the f the to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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).