ARTICOR planner

K252195 · Artiness S.R.L · LLZ · Mar 27, 2026 · Radiology

Device Facts

• Record ID: K252195
• Device Name: ARTICOR planner
• Applicant: Artiness S.R.L
• Product Code: LLZ · Radiology
• Decision Date: Mar 27, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

ARTICOR planner is intended for use as a software interface and image segmentation system to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, ARTICOR planner provides additional visualization and measurement tools to enable the user to screen and plan the procedure. ARTICOR planner should be used in conjunction with other diagnostic tools and expert clinical judgement.

Device Story

Software interface and image segmentation system; enables structural heart and vascular procedure planning. Inputs: DICOM-compliant medical images. Processing: manual and semi-automatic segmentation to create 3D anatomical reconstructions; desktop software communicates with augmented reality (AR) head-mounted display (HMD) via cloud services. Outputs: 3D models, measurements, fluoroscopic projection angles. Used in clinical settings by physicians (surgeons, cardiologists, radiologists). Healthcare providers use AR environment to visualize anatomy, evaluate device sizing/positioning, and prepare fluoroscopy angles. Benefits: improved pre-operative planning and procedure preparation. Does not produce physical replicas.

Clinical Evidence

No clinical data. Bench testing only. Software verification/validation per IEC 62304. AR measurement accuracy/reproducibility validated against OsiriX MD (K101342) on CT datasets (bias <5%, correlation ≥0.9, p>0.05). Fluoroscopic angle accuracy validated against OsiriX MD (bias <5°, correlation ≥0.9, p>0.05). Usability testing per IEC 62366 (94% success rate). HMD display quality characterized per IEC 63145/IDMS.

Technological Characteristics

Software interface; desktop and AR HMD (Microsoft HoloLens 2) components; cloud-hosted communication. Imaging modality: CT. Segmentation: manual and semi-automatic. Standards: IEC 62304 (software lifecycle), IEC 63145/IDMS (display quality), IEC 62366 (usability).

Indications for Use

Indicated for use by qualified healthcare professionals (surgeons, cardiologists, radiologists) to aid in reading and interpreting DICOM-compliant medical images for structural heart and vascular treatment planning.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Materialise Mimics Enlight (K190874)

Reference Devices

• Elucis (K220649)
• OsiriX MD (K101342)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

March 27, 2026

Artiness s.r.l.
% Monica R. Montanez
Principal Strategy Consultant
NAMSA
6750 Wales Road
Toledo, OH 43619

Re: K252195
Trade/Device Name: ARTICOR planner
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: March 2, 2026
Received: March 3, 2026

Dear Monica R. Montanez:

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 (the 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 available 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.

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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

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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Lamb, PhD
Assistant Director
Imaging Software Team
DHT8B: Division of Radiological Imaging Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K252195 | ? |
| Please provide the device trade name(s). | | ? |
| ARTICOR planner | | |
| Please provide your Indications for Use below. | | ? |
| ARTICOR planner is intended for use as a software interface and image segmentation system to aid in
reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For
this purpose, ARTICOR planner provides additional visualization and measurement tools to enable the user
to screen and plan the procedure.

ARTICOR planner should be used in conjunction with other diagnostic tools and expert clinical judgement. | | |
| Please select the types of uses (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
ARTICOR planner
K252195

1. Submission Sponsor
Artiness s.r.l.
Viale Cassala, 57
Milan
20143
Italy
Contact Dr. Omar Antonio PAPPALARDO
Title: Chief Technical Officer
Office number: [phone]

2. Submission Correspondent
NAMSA
6750 Wales Road
Toledo, OH 43619
USA
Contact: Monica R. MONTANEZ
Title: Principal Strategy Consultant
Mobile Phone: [phone]

3. Date Prepared
06-Feb-2026

4. Device Identification
Trade/Proprietary Name: ARTICOR® planner
Common/Usual Name: Medical image management and processing system
Classification Name: System, Image Processing, Radiological

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Regulation Number: 892.2050
Product Code: LLZ, System, Image Processing, Radiological
Device Class: Class II
Classification Panel: Radiology

## 5. Legally Marketed Predicate Device

K190874, Device: Materialise Mimics Enlight, Manufacturer: Materialise N.V.

## 6. Indications for Use Statement

ARTICOR planner is intended for use as a software interface and image segmentation system to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, ARTICOR planner provides additional visualization and measurement tools to enable the user to screen and plan the procedure.

ARTICOR planner should be used in conjunction with other diagnostic tools and expert clinical judgement.

## 7. Device Description

ARTICOR planner is a software interface that enables the user to plan structural heart and vascular procedures through the following phases:

1. Analyze anatomy
2. Plan device
3. Plan delivery
4. Output

The user can create and optimize 3D reconstruction of the patient's anatomy based on DICOM-compliant medical images using a variety of manual and semi-automatic segmentation tools available in a desktop software. These models, and the images from which they are created, can then be used, in an Augmented Reality (AR) environment that communicates with the desktop software through cloud services, to conduct measurements and plan the treatment. In particular, the user can evaluate the sizing and positioning of structural heart and vascular devices and prepare the fluoroscopy angles for the procedure.

## 8. Predicate Device Comparison

The following table compares the ARTICOR planner to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

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# Table: Comparison of Characteristics

| Manufacturer | Artiness s.r.l. | Materialise N.V. | Device Comparison |
| --- | --- | --- | --- |
| Trade Name | ARTICOR® planner | Materialise Mimics Enlight | |
| 510(k) Number | K252195 | K190874 | Not applicable |
| Product Code | LLZ | LLZ | Same |
| Regulation Number | 892.2050 | 892.2050 | Same |
| Regulation Name | Medical image management and processing system | Medical image management and processing system | Same |
| Indications for Use | ARTICOR planner is intended for use as a software interface and image segmentation system to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, ARTICOR planner provides additional visualization and measurement tools to enable the user to screen and plan the procedure. ARTICOR planner should be used in conjunction with other diagnostic tools and expert clinical judgement. | Materialise Mimics Enlight 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 intended as a software to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, Materialise Mimics Enlight provides additional visualization and measurement tools to enable the user to screen and plan the procedure. The Materialise Mimics Enlight output file can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of cardiovascular applications. Materialise Mimics Enlight should be used in conjunction with other diagnostic tools and expert clinical judgement. | Similar; the indications for use comparing ARTICOR planner and Materialise Mimics Enlight are similar. The predicate device can also produce output files whereas physical replicas of the planned device can be made through additive manufacturing. This does not raise any additional questions of safety or efficacy. |
| Intended User Profile | Qualified healthcare professionals like surgeons, cardiologists, radiologists, physicians. | The user is a medical professional, like cardiologists, radiologists or clinical specialists. | Same |
| Intended Patient Population | The device is a software intended to be used on DICOM compliant medical images acquired on patients | The device is a software intended to be used on DICOM compliant medical images acquired on patients | Same |

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| Manufacturer | Artiness s.r.l. | Materialise N.V. | Device Comparison |
| --- | --- | --- | --- |
| Trade Name | ARTICOR® planner | Materialise Mimics Enlight | |
| | referred to structural heart and vascular procedures. | referred to structural heart and vascular procedures. | |
| Device Description | ARTICOR planner is a software interface that enables the user to plan structural heart and vascular procedures through the following phases:
1. Analyze anatomy
2. Plan device
3. Plan delivery
4. Output
The user can create and optimize 3D reconstruction of the patient’s anatomy based on DICOM-compliant medical images using a variety of manual and semi-automatic segmentation tools available in a desktop software. These models, and the images from which they are created, can then be used, in an augmented reality software that communicates with the desktop software through cloud services, to conduct measurements and plan the treatment. In particular, the user can evaluate the sizing and positioning of structural heart and vascular devices and prepare the fluoroscopy angles for the procedure. | Materialise Mimics Enlight for structural heart and vascular planning is a software interface that is organized in a workflow approach. High level, each workflow in the field of structural heart and vascular will follow the same kind of structure of 4 steps which will enable the user to plan the procedure:
1. Analyse anatomy
2. Plan device
3. Plan delivery
4. Output
To perform these steps the software provides different methods and tools to visualize and measure based on the medical images. The user is a medical professional, like cardiologists, radiologists or clinical specialists. To start the workflow DICOM compliant medical images will need to be imported. The software will read the images and convert them into a project file. The user can now start the workflow and follow the steps visualized in the software. The base of the workflow is to create a 3D reconstruction of the anatomy based on the medical images to use this further together with the 2D medical images in the workflow to plan the procedure. | Similar; the predicate device Materialise Mimics Enlight functionality is organized as a guided workflow with different steps where the relevant information to plan the procedure is produced and assessed by the user at each step, while in the subject device the workflow is not guided. There are no additional questions of safety or efficacy as the product requirements are met. |
| Prescription or OTC | Prescription | Prescription | Same |

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| Manufacturer | Artiness s.r.l. | Materialise N.V. | Device Comparison |
| --- | --- | --- | --- |
| Trade Name | ARTICOR® planner | Materialise Mimics Enlight | |
| Hardware | PC and head-mounted display: ARTICOR planner comprises a desktop software running on a PC and an augmented reality software running on a HMD; the two communicates through cloud-hosted services. | PC: Materialise Mimics Enlight consists of a desktop software running on a PC. | Different; the subject device includes option to run on a commercial head mounted display and allows to plan patient's treatment in an augmented reality environment. Usability of the head mounted display software and performances of the measurement function implemented in it have been evaluated through usability tests and performance bench tests respectively, showing that the technological difference between predicate and subject device does not hinder safety and effectiveness. In addition, display quality tests have been executed as per IEC 63145 on the head mounted display with satisfactory results for the intended use of the subject device. Finally, there are other cleared devices with head mounted display options (including the reference device Elucis K220649), so this does not raise any additional questions of safety or efficacy. |
| Imaging Modality | CT | CT | Same |
| Input Data Type Supported | DICOM compliant medical images OBJ/STL | DICOM compliant medical images STL that needs to be checked by Materialise team so to validate the algorithms for the device | Same |
| Software Organization | Functionality is not organized as a guided workflow. | Functionality is organized as a guided workflow. | Different; the subject device shares the same functionalities of the predicate device without a guided workflow. There are no additional questions of safety or efficacy as the product requirements are met. |
| Image Viewing | View medical images in a variety of planar and volumetric reformations | View medical images in a variety of planar and volumetric reformations | Same |

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| Manufacturer | Artiness s.r.l. | Materialise N.V. | Device Comparison |
| --- | --- | --- | --- |
| Trade Name | ARTICOR® planner | Materialise Mimics Enlight | |
| 3D patient-specific models creation | Create 3D models from medical images using a variety of common modeling tools. Review and edit existing 3D models. | Either automatic or semi-automatic segmentation. Semi-automatic segmentation is done through placing two points on each structure of interest. | Similar; the ability to complete semi-automatic segmentation does not have an impact on the operation or function of the device raising no additional questions of safety or efficacy. |
| Multi-phases images | Advanced modeling algorithms enable dynamic segmentation of multi-phase (4D) images | Possibility to tag and switch between cardiac phases to gain more 4D insight from being able to work with multi-phase data | Similar; the end result is the same for both the subject device and predicate device, though the process is slightly different. There are no additional questions of safety or efficacy raised. |
| Planning | ARTICOR planner is an augmented reality software, which allows the clinician to prepare a plan for a structural heart or vascular procedures based on:
- DICOM images
- 3D models of anatomy and devices
- landmarks
- measurements performed on the aforementioned objects. | Mimics Enlight is intended as a software to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, Materialise Mimics Enlight provides visualization and measurement tools to enable the user to screen and plan the procedure. | Same |
| Measurements | Perform measurements on images and models on an head-mounted display in augmented reality environment | The software provides different methods and tools to visualize and measure based on the medical images. Measurement tools are either automated or manual. Measurements are performed on PC monitors. | Similar, the same type of measurements can be performed. The only difference is that the subject device offers the possibility to perform measurements only on augmented reality head-mounted displays, while the predicate device is a software to be executed on a PC. Usability of the head mounted display software and performances of the measurement function implemented in it have been evaluated through usability tests and performance bench tests respectively, showing that the technological difference between predicate and subject device does not hinder safety and |

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| Manufacturer | Artiness s.r.l. | Materialise N.V. | Device Comparison |
| --- | --- | --- | --- |
| Trade Name | ARTICOR® planner | Materialise Mimics Enlight | |
| | | | effectiveness. In particular, measurements accuracy and reproducibility results were obtained by executing tests on the headset using as reference the measurements obtained with an FDA-cleared DICOM viewer on a conventional PC monitor. Moreover, the identified reference device is cleared for market which also includes ability to perform measurements on images and models in virtual reality. |
| Device Planning | Plan treatments using 3D models (both anatomical models derived from medical images and models derived from files describing the geometry of planning objects) and medical images. | Device delivery simulation provides an understanding of device feasibility and implant fit. | Similar; the planning process is similar allowing the same function and operation for the healthcare professional to formulate treatment plans and assist in surgical planning. Validation of the software application is done for the planning activities, therefore no additional questions are raised for safety or efficacy. |
| Landmarks | Possibility to place or compute landmarks on models in the augmented reality (AR) environment | Possibility to place or compute landmarks on the CT or directly on the interactive 3D model | Similar; the operation of placing landmarks only differs also being able to conduct this in an AR environment which is not available with the predicate device. There are no additional questions of safety or efficacy. |
| Delivery pathway assessment | Possibility to define a delivery pathway (spline) by selecting reference points in the augmented reality environment. | For TMVR plan for transseptal or transapical delivery viewing surrounding anatomy and visualization of potential fossa ovalis puncture locations. | Similar; the operation of determining delivery pathway differs in the process for how this is done by each application and being able to conduct this in an AR environment. There are no additional questions of safety or efficacy. |
| Fluoroscopic angles for procedure | Fluoroscopic simulation with possibility for the user to look for optimal projection angles | Fluoroscopic simulation with possibility for the user to look for optimal projection angles | Same. Accuracy results were obtained by executing tests on the headset using as reference the fluoroscopic projection angles obtained with an FDA-cleared DICOM |

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| Manufacturer | Artiness s.r.l. | Materialise N.V. | Device Comparison |
| --- | --- | --- | --- |
| Trade Name | ARTICOR® planner | Materialise Mimics Enlight | |
| | | | viewer on a conventional PC monitor. |
| Save of surgical planning | Save images, measurements, 3D models, and other treatment planning information for later review | Save images, measurements, 3D models, and other treatment planning information in a PowerPoint report for later review | Same |
| Processing to output file | Not available | The device generates an output file that can be used for the fabrication of physical replicas | Different; the predicate device generates an output file that can be used for the fabrication of physical replicas, the subject device does not have such a functionality. There is no impact to safety or efficacy offering this feature by the predicate device. |
| Remote collaboration | Support for collaboration between multiple remote users in the accompanying augmented reality (AR) environment | Not available | Different; remote collaboration is enabled on the subject device offering support for collaboration between multiple remote users in the augmented reality environment. Collaborative sessions are available on other cleared devices and does not raise any additional questions or safety or efficacy. |

## 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of ARTICOR planner and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, Artiness s.r.l. completed a number of non-clinical performance tests. Testing addressed software functionality, image segmentation, visualization, interoperability with head-mounted displays (HMD), optical quality testing of HMD, augmented reality (AR) measurement accuracy and reproducibility, fluoroscopic planning accuracy, and usability. All testing was performed according to internal verification and validation procedures compliant with IEC 62304, international standards and/or applicable FDA guidance documents:

- Software verification and validation conducted across the full software life cycle in accordance with internal procedures aligned with IEC 62304 and FDA guidance "Content of Premarket Submissions for Device Software Functions" confirmed that the finished product meets its predefined requirements. Verification confirmed correct implementation of core

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functions, including DICOM import, segmentation, 3D model generation, visualization, measurement tools, and AR rendering.

- Interoperability between ARTICOR planner and the HMD Microsoft HoloLens 2 was confirmed through operational use testing, software verification testing of the AR application, accuracy and reproducibility testing of measurements and fluoroscopic projection angles in the augmented reality environment and usability tests performed by multiple intended users with the HMD.

- Display quality of the HMD: since ARTICOR planner supports visualization on a commercial HMD in addition to conventional monitors, the display quality of the HMD was characterized by an ISO/IEC 17025-accredited laboratory according to IEC 63145 and IDMS standards. Testing included luminance and luminance uniformity, gamma behavior, Michelson contrast, spectral transmittance, field of view, distortion, and qualitative visual assessment using TG270-sQC patterns. The HMD display performance was found suitable for the intended use of ARTICOR planner, which is a non-diagnostic, pre-operative planning use.

- Augmented reality environment use for acquisition of measurements: bench performance testing was conducted based on FDA guidance "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions" to evaluate the accuracy and reproducibility of manual measurements performed in the AR environment of ARTICOR planner. Accuracy was assessed by comparing measurements obtained using ARTICOR planner on the HMD with measurements obtained using the FDA-cleared DICOM viewer OsiriX MD (K101342) on a conventional PC monitor. Reproducibility was assessed by comparing measurements performed by different operators using ARTICOR planner. Multiple cardiovascular anatomic structures were evaluated using representative CT datasets. Statistical analyses compared ARTICOR planner results to the reference system and between operators. Results showed all measurement biases well below the 5% predefined acceptance criteria, correlation coefficients ≥0.9 between operators, and no statistically significant differences (p &gt; 0.05). These results demonstrate that ARTICOR planner provides accurate and reproducible measurements in the AR environment.

- Augmented reality environment for planning of fluoroscopic projection angles: bench performance testing was conducted based on FDA guidance "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions" to evaluate the accuracy of fluoroscopic projection angles planned in the AR environment of ARTICOR planner. Projection angles obtained with ARTICOR planner on the HMD were compared with angles obtained using the FDA-cleared device OsiriX MD (K101342) on a conventional PC monitor. Multiple fluoroscopic views were evaluated on a representative synthetic dataset. Results showed that all projection angle biases were well below the 5° predefined acceptance criteria, correlation coefficients ≥0.9, and no statistically significant differences (p &gt; 0.05). These results demonstrate that ARTICOR planner enables accurate fluoroscopic projection planning in the AR environment.

- Usability testing was conducted according to a human factors engineering protocol aligned with IEC 62366 principles and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices". Representative intended users (e.g., clinicians) performed predefined planning and measurement tasks in simulated use environments using

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ARTICOR planner. Participants received training consistent with intended use. Tasks included loading datasets, interacting with 3D models, performing measurements, and planning views in the AR environment. Across participants, 94% of tasks were completed successfully, 5% resulted in close calls, and 1% were classified as failures. All failures were analyzed and determined not to impact safety or device effectiveness. Risk analysis confirmed that identified usability risks were adequately controlled and no residual usability risks remain that would affect safe and effective use of ARTICOR planner.

## 10. Clinical Performance Data

There was no human clinical testing required to support the substantial equivalence of the subject device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

## 11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Based on the comparison and analysis above, the ARTICOR planner is determined to be substantially equivalent to the referenced predicate device.

## 12. Revision History

| Rev. | Description |
| --- | --- |
| 00 | First emission |
| 01 | Updated date the summary was prepared.
Clarified that measurements can be performed only on AR HMD in the subject device, while on PC in the predicate device and that measurements accuracy and reproducibility results were obtained by executing tests on the headset using as reference the measurements obtained with an FDA-cleared DICOM viewer on a conventional PC monitor.
Added information that fluoroscopic projection angles accuracy results were obtained by executing tests on the headset using as reference the projection angles obtained with an FDA-cleared DICOM viewer on a conventional PC monitor.
Added reference to display quality tests performed on the headset.
Added details and reorganized content of section 9 “Non-Clinical Performance Data” |