(151 days)
Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants).
NAVIPLAN - CT Planning Software for Total Hip Replacement, or "Naviplan", is a software which assists in the pre-operative planning of total hip replacement surgery based on three dimensional CT-images (computed tomography). The Naviplan allows the user to process CT DICOM images which are automatically segmented. The user gets an automatic identification of anatomical landmarks as an output, which is normally used in hip surgery. The Naviplan automatically computes an initial planning (implant type and size selection as well as positioning) which can be inspected and edited by the user until the optimal configuration is established. The user can export the plan as a pdf report and as a navigation archive to be used with the Naviswiss Hip Navigation System. The export steps are optional, whereas the report serves a documentation purpose.
Here's a breakdown of the acceptance criteria and study information for the NAVIPLAN - CT Planning Software for Total Hip Replacement, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" with numerical targets and then directly provide "reported device performance" in a separate section. Instead, it describes a software verification and validation testing approach. The "reported device performance" is summarized by the statement: "Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning." And the overall conclusion: "the applicant concludes, that substantial equivalence between the new and the predicate device has been demonstrated and that the new device, NAV-IPLAN - CT Planning Software for Total Hip Replacement, is at least as safe and as effective as the legally marketed predicate device, Zedview (K133022)."
Based on the information, the acceptance criteria are implicitly tied to the performance of manual segmentation and landmark positioning. The device is expected to perform at a level comparable to, or as accurate as, manual methods.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Automated segmentation and landmark positioning performance comparable to manual methods. | "Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning." This implies the automated segmentation and planning results were found to be acceptable when compared to manual methods, leading to the overall conclusion of substantial equivalence. |
| Device is at least as safe and effective as the legally marketed predicate device (Zedview, K133022). | The study concludes that substantial equivalence has been demonstrated, indicating the device meets this criterion. |
2. Sample Size for Test Set and Data Provenance
The document states: "Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning." However, it does not specify the sample size used for this testing. It also does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). It only implies the use of "manual segmentation and landmark positioning" as a reference for comparison.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. The study described focuses on comparing the automated software's performance to manual methods, not on human reader performance with or without the software.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, a standalone performance assessment was done. The software verification testing "compare[d] manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning." This implies the algorithm's performance in segmentation and planning was evaluated independently against manual ground truth without a human in the loop of the algorithm's output. The device itself is described as primarily standalone for planning, though its output can be used with a navigation system.
7. Type of Ground Truth Used
The ground truth used was based on manual segmentation and landmark positioning. This can be interpreted as a form of expert consensus or expert-derived ground truth, as manual methods in such a clinical context would typically be performed by trained medical professionals or experts.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set.
9. How Ground Truth for the Training Set was Established
The document does not provide information on how the ground truth for the training set was established.
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Naviswiss AG % Stefano Adami Senior Consultant confinis AG Allee 1b Sursee. 6210 SWITZERLAND
October 5, 2021
Re: K211429
Trade/Device Name: NAVIPLAN - CT Planning Software for Total Hip Replacement Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 26, 2021 Received: August 30, 2021
Dear Stefano Adami:
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
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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 (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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211429
Device Name
NAVIPLAN - CT Planning Software for Total Hip Replacement
Indications for Use (Describe)
Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants)
| 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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ള NAVISWISS
K211429
5. 510(k) Summary
ln accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Applicant: Naviswiss AG
Submitter name: Jan Stifter Responsible person: Jan Stifter Phone: +41 78 806 12 60 E-mail: jan.stifter@naviswiss.eu
Official Correspondent:
| Contact person: | Stefano Adami |
|---|---|
| Phone: | +41 79 515 4426 |
| Mailto: | stefano.adami@confinis.com |
| Date prepared: | 26 August 2021 |
Device Name: NAVIPLAN - CT Planning Software for Total Hip Replacement
| Proprietary name: | NAVIPLAN - CT Planning Software for Total Hip Replacement |
|---|---|
| 510(k) number: | To be assigned |
| Common name: | System, image processing, radiological |
| Classificationname: | System, image processing, radiological |
| Product code: | LLZ |
Predicate Device:
Substantial equivalence is claimed with the device, K1303022 "ZedView", manufactured by Lexi Co., Ltd. on the basis of equivalent intended use / indications for use, technological characteristics, and principle of operation.
This predicate has not been subject to a design-related recall.
Device Description:
NAVIPLAN - CT Planning Software for Total Hip Replacement, or "Naviplan", is a software which assists in the pre-operative planning of total hip replacement surgery based on three dimensional CT-images (computed tomography).
The Naviplan allows the user to process CT DICOM images which are automatically segmented. The user gets an automatic identification of anatomical landmarks as an output, which is normally used in hip surgery. The Naviplan automatically computes an initial planning (implant type and size selection as well as positioning) which can be inspected and edited by the user until the optimal configuration is established. The user can export
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the plan as a pdf report and as a navigation archive to be used with the Naviswiss Hip Navigation System. The export steps are optional, whereas the report serves a documentation purpose.
Indications for Use:
Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants).
Comparison of Technological Characteristics:
Table 05-1 provides a comparison of the predominant technical characteristics of the subject device and the legally marketed predicate device. A more detailed comparison of the devices is presented in Section 12.
| Description | Subject Device | Predicate Device |
|---|---|---|
| Device Name | Naviplan | ZedView (ZedHip) |
| 510(k) Number | To be assigned | K133022 |
| Manufacturer | Naviswiss AG | Lexi Co., Ltd. |
| Prescription device | Yes | Yes |
| Intended Use | Naviplan is intended to be usedby a suitably licensed and quali-fied healthcare professional to ac-cess medical images with the in-tention of using such images, inconjunction with templates forprosthetic devices, for the pur-poses to assist qualifiedhealthcare professional in choos-ing the nature and characteristicsof the prosthetic device to beused when planning a potentialsurgical hip procedure.The software is basically intendedto be standalone, however theplanning data can be importedinto the "Naviswiss System" (navi-gation system) for intra-operativeuse. | ZedView is intended to be used toassist qualified medical profession-als to perform fast and effective pre-operative planning for various surgi-cal procedures related to hip andknee by using 2D image data. Thesoftware is basically intended to bestandalone, however some part ofthe software provides features forcommunicating with PACS serversto acquire the CT data of various pa-tients or to upload planned projects,images orreports to the servers.ZedHip is the specific 3-DimensionalPre-Op. Planning software for TotalHip Arthroplasty with CT images. |
| Indications for use | Naviplan is indicated for pre-oper-ative planning for surgical proce-dures related to hip, such as artifi-cial joint replacement (3D tem-plating of implants). | Zed View is indicated for pre-opera-tive planning for various surgical pro-cedures related to hip and knee,such as artificial joint replacement(3D templating of implants) and os-teotomy. |
| Principles of Oper-ations | The user can manage a databaseof patients data and perform apre-operative planning per pa-tient. For each patient a hip DI-COM series of a CT scan can be | The software primarily provides im-port and storage of CT images ofvarious patients in DICOM or otherformats which are automatically seg-mented by the software. ZedView |
| Description | Subject Device | Predicate Device |
| loaded and automatically seg-mented. When the segmentation,which is done on the local com-puter, is completed, the user canedit the initialized case.While planning the user can trydifferent configurations of im-plant types, sizes, positions, orien-tations and more. The planningview shows the user useful met-rics such as resulting leg length,lateral offset, acetabular orienta-tion, CCD-angle, femoral offsetand femur antetorsion. The pre-operative planning can be ex-ported in PDF format for printingor in the Naviswiss Hip Naviga-tion System as a binary format forintra-operative use. | provides a means of 3D templatingof implants and positioning of fixa-tion devices by calculating surgicalparameters in simulated environ-ments and performing 3D measure-ments on each pre-operative patientdata using 2D image viewing andmanipulations, 3D visualizations andvarious MPR (Multi-Planar Recon-struction) functions.ZedHip is the software that supportspre-operative planning of hip arthro-plasty from 2D digital X-ray imagesobtained with the EOS imaging andCT images. | |
| Operating system | Windows or OS X | Windows |
| Availability of de-vice | Can be configured to be launchedfrom within a workstation environ-ment or as a standalone PC appli-cation for planning orthopedicprocedures. | Can be configured to be launchedfrom within a workstation environ-ment or as a standalone PC applica-tion for planning orthopedic proce-dures. |
| Source of images | Receive digital images from thecomputer or via USB stick | Receive digital images from varioussources (including PACS system) |
| Processing of im-ages | The software processes data inorder to provide an overlap and di-mensioning of digital representa-tions of the prosthetic material | Scaling of image facility |
| Superimposingdigital ProstheticTemplates | Allows the overlap of models andthe intersection of the models | Permits overlay of templates |
| Interactive posi-tioning of template | Yes | Yes |
| Interactive sizingof template | Yes | Yes |
| Permits templaterotation | Yes | Yes |
| Provides templat-ing support fromprosthetic manu-facturers. | Yes | Yes |
| Permits automaticscaling | Yes | Semi-automatic measurements |
| Pre-operative plan-ning | Yes | Yes |
| Description | Subject Device | Predicate Device |
| Patient contact | None | None |
| Control of life sus-taining devices | None | None |
| Human interven-tion for interpreta-tion of images | Required | Required |
| Ability to add addi-tional moduleswhen available | Yes | Yes |
| Operating system | Windows or OS X | Windows |
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Image /page/6/Picture/0 description: The image shows the logo for NAVISWISS. The logo consists of a square with a design inside of it, followed by the word "NAVISWISS". The "NAVI" portion of the word is in black, while the "SWISS" portion is in red.
The technological principle for both the subject and predicate devices is to use DICOM image standards that are automatically segmented, and the software provides anatomical landmarks and an initial proposed planning that can be edited by the surgeon to find the best implant configuration and positioning. Both software can be configured to be launched from within a workstation environment or as a standalone PC application for planning orthopedic procedures related to the hip joint.
Both software can manaqe a database of patient's data and perform a pre-operative planning per patient based on DICOM series of a CT scan and allow different configurations of implant types, sizes, positions, orientations and more and show the user useful metrics such as resulting leg length, lateral offset, acetabular orientation, CCD-angle, femoral offset and femur antetorsion.
Naviplan has an additional feature that allows export of planning data to be used in the Naviswiss Hip Navigation system (K193034). This difference does not represent a substantial difference since it is just an export feature to allow visualization of the planned positioning of the orthopedic implant to the intraoperative navigation.
Summary of Testing:
The relevant requirements set forth in standards listed in Section 9 by the manufacturer are sufficient to assure a safe and effective functioning of the NAVIPLAN - CT Planning Software for Total Hip Replacement. The device has fulfilled the requirements detailed above. The results of the bench and performance testing are summarized in the verification and validation plan and report enclosed.
The following performance data were provided in support of the substantial equivalence determination.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This
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ള NAVISWISS
software is considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning.
Conclusion:
Based on equivalence of intended use / indications for use, technological characteristics and operational principle the applicant concludes, that substantial equivalence between the new and the predicate device has been demonstrated and that the new device, NAV-IPLAN - CT Planning Software for Total Hip Replacement, is at least as safe and as effective as the legally marketed predicate device, Zedview (K133022).
§ 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).