CarnaLife® Holo is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, annotations, and 3D visualization.

Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.

Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.

CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians.

When accessing CarnaLife® Holo software from a wireless stereoscopic head-mounted display (HMD), images viewed are for informational purposes only and not intended for diagnostic use.

Device Description

CarnaLife® Holo is a Software as a Medical Device (SaMD) to be used by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians for the visualization of medical images in 3D to allow for surgical planning activities. The device makes it possible to visualize 3D Digital Imaging and Communications in Medicine (DICOM) files using volume and surface rendering in 3D to be viewed on a classic display or on a stereoscopic, holographic display. CarnaLife® Holo is intended to be used in operating rooms; office environments within hospitals or at any other location with a computer; and for informational purposes only at any location using the head-mounted display (HMD). The images can be viewed on desktop PCs with a monitor allowing the interaction with CarnaLife® Holo to be performed with a mouse and/or keyboard; and on an HMD, where the interaction with CarnaLife® Holo is performed using hand gestures, voice commands and virtual menus.

CarnaLife® Holo is used to:

Load patient DICOM data; ●
. Image review, image manipulation, basic measurements, annotations, and 3D visualization; and
. View DICOM data using a traditional computer monitor, display monitors used for reading medical images for diagnostic purposes, or in mixed reality (MR) using a head-mounted display (HMD).

AI/ML Overview

The provided document is a 510(k) summary for the CarnaLife® Holo device. It outlines the device description, indications for use, comparison to a predicate device (SurgicalAR K190764), and performance data. However, it does not provide detailed acceptance criteria or extensive study information typically found in a clinical study report for proving performance.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving de novo clinical effectiveness. The "Performance Data" section describes design verification and validation activities, but these are primarily focused on software functionality and accuracy rather than clinical performance based on a substantial patient cohort.

Here's an attempt to extract and infer the requested information based on the provided text, heavily noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a formal, quantifiable table with corresponding performance metrics like sensitivity, specificity, or reader agreement for diagnostic tasks. Instead, it describes functional accuracy tests.

Acceptance Criteria (Inferred from testing description)	Reported Device Performance
Accuracy of Measuring Function:	"Measurement accuracy met specified requirements" for:
* X - distance of P1-P2 and P3-P4	* X - distance of P1-P2 and P3-P4
* Y - distance of P1-P3 and P2-P4	* Y - distance of P1-P3 and P2-P4
* Angles defined by points P1-P2-P3	* Angles defined by points P1-P2-P3
* Diagonals defined by P1-P4 and P3-P2	* Diagonals defined by P1-P4 and P3-P2
Accuracy of Volume Rendering:	"The accuracy of Volume Rendering meeting specified requirements was demonstrated by comparing the size and dimensions of resulting displayed holograms to the known size and dimensions of the two geometric objects." (Implicitly, it met the requirements)
* Comparison of displayed hologram size/dimensions to known object size	"Design validation was successfully completed, and testing met all predetermined acceptance criteria based on user needs and intended use."
General Design Validation:	"The design verification was successful in that the design output specifications satisfactorily met the design input requirements."
* Design output specifications met design input requirements

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

Sample Size for Testing: The document mentions "two data sets characterized by different voxel sizes (isotropic and anisotropic data)" for the measuring function test, and "CT scans of two different geometric objects of known size and dimensions" for the volume rendering test. This implies a very small, controlled, and synthetic/phantom-based test set, not a clinical patient image dataset.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of the tests (geometric objects, voxel sizes), it's highly likely to be controlled lab data, possibly simulated or phantom studies. It is not indicated as a clinical patient dataset.

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

The document describes functional accuracy testing against known geometric properties or defined points, implying a ground truth established by engineering specifications or measurement tools, not human expert consensus from medical professionals.
Therefore, the number of experts and their qualifications are not applicable in the context of the described performance tests.

4. Adjudication Method for the Test Set

Given that the ground truth establishment involves direct measurement or comparison to known geometric properties, and not human expert interpretation, an adjudication method like 2+1 or 3+1 is not applicable and is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done or reported. The document focuses on the device's functional accuracy (measurements, rendering) and its substantial equivalence to a predicate, not on a direct comparison of human reader performance with and without AI assistance using this specific device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The described "Performance Data" section details tests of the software's accuracy in performing measurements and rendering. This can be considered a form of standalone performance assessment of these specific functionalities. However, it's not a standalone diagnostic accuracy study in the traditional sense (e.g., classifying disease vs. no disease). The device itself is described as an image display and manipulation tool, not an AI diagnostic algorithm.

7. Type of Ground Truth Used

The ground truth used was based on known geometric properties/dimensions of objects or precise definitions for measurements (e.g., P1, P2, P3, P4 points for distance and angle calculations). It was not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI model training. The described tests are for the accuracy of features like measurement and 3D rendering, which are typically based on deterministic algorithms, not learned models. Therefore, the concept of a training set is not applicable to the performance data presented.

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

Since no training set is mentioned or implied for the performance data provided, this information is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

MedApp S.A. % Albert Pacheco Alliance Network Independent Consultant PAREXEL International 8 Federal Street BILLERICA, MASSACHUSETTS 01821

May 1, 2023

Re: K221870

Trade/Device Name: CarnaLife® Holo Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: March 21, 2023 Received: March 22, 2023

Dear Albert Pacheco:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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,

Jessica Lamb

Jessica Lamb, 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

510(k) Number (if known) K221870

Device Name CarnaLife® Holo

Indications for Use (Describe)

Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.

CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians.

When accessing CarnaLife® Holo software from a wireless stereoscopic head-mounted display (HMD), images viewed are for informational purposes only and not intended for diagnostic use.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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510(k) Summary as Required by 21 CFR 807.92(c)

For CarnaLife® Holo

Date Prepared:	April 26, 2023
Submitter:	MedApp,S.A.Armii Krajowej 2530-150 Kraków, Poland
Official Contact:	Al PachecoIndependent ConsultantParexel International2520 Meridian Parkway, Suite 200Durham, NC 27713, USAPhone: +1 760 421 2919Email: albert.pacheco@parexel.com
Proprietary Name:	CarnaLife® Holo
Classification:	Class IIMedical Image Management and Processing System21 CFR 892.2050Product Code: LLZ
Predicate Device:	SurgicalAR (K190764)
Reason for Submission:	New Device

Device Description

CarnaLife® Holo is used to:

Load patient DICOM data; ●
. Image review, image manipulation, basic measurements, annotations, and 3D visualization; and
. View DICOM data using a traditional computer monitor, display monitors used for reading medical images for diagnostic purposes, or in mixed reality (MR) using a head-mounted display (HMD).

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Indications for Use

Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.

CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians.

When accessing CarnaLife® Holo software from a wireless stereoscopic head-mounted display (HMD), images viewed are for informational purposes only and not intended for diagnostic use.

Substantial Equivalence Discussion

CarnaLife® Holo is substantially equivalent to the predicate device, SurgicalAR (K190764), as both devices have the same intended use and similar technological characteristics. While both devices do not have the same software features, the differences do not raise different questions of safety and effectiveness.

DeviceCharacteristic	Subject Device:CarnaLife® Holo (K221870)	Predicate Device:SurgicalAR (K190764)	Comparison
Classification	Class II	Class II	Same
Product Code	LLZ	LLZ	Same
Indications forUse	CarnaLife® Holo is a softwaredevice for display of medicalimages and other healthcaredata. It includes functions forimage review imagemanipulation, basicmeasurements, and 3Dvisualization.Lossy compressedmammography images anddigitized film screen imagesmust not be reviewed forprimary image interpretations.Mammographic images mayonly be interpreted using anFDA- cleared display that meetstechnical specificationsreviewed and accepted by FDAor displays accepted by theappropriate regulatory agency	SurgicalAR is a software device fordisplay of medical images andother healthcare data. It includesfunctions for image review imagemanipulation, basicmeasurements, and 3Dvisualization (MPR reconstructionsand 3D volume rendering).Lossy compressed mammographyimages and digitized film screenimages must not be reviewed forprimary image interpretations.Mammographic images may onlybe interpreted using an FDA-cleared display that meetstechnical specifications reviewedand accepted by FDA or displaysaccepted by the appropriateregulatory agency for the countryin which it is used.	Same
DeviceCharacteristic	Subject Device:CarnaLife® Holo (K221870)	Predicate Device:SurgicalAR (K190764)	Comparison
	for the country in which it is used.Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians.When accessing CarnaLife® Holo software from a wireless stereoscopic head-mounted display (HMD), images viewed are for informational purposes only and not intended for diagnostic use.	Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.SurgicalAR software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technologists.When accessing SurgicalAR software from a wireless stereoscopic head-mounted display (HMD) or mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
PrescriptionUse or OTCUse	Prescription use	Prescription use	Same
Annotation andMeasurementTools	Line Angle Ruler Arrow	Line Angle Ruler Arrow	Same
Data TypeSupported	DICOM Non-DICOM	DICOM Non-DICOM	Same
Image InputTypesSupported	CT/angio CT MR/4D MR 3DRA ECHO PET USG	CT MR	Different:Thedifferencedoes not alterintended useand issupported bysoftwareverificationandvalidation.
Image View/Manipulation	Image Zoom/Zoom Pan Window Level AutoWindow/Presets	Image Zoom Pan Window Level AutoWindow	Different:Thepredicatedevice does
DeviceCharacteristic	Subject Device:CarnaLife® Holo (K221870)	Predicate Device:SurgicalAR (K190764)	Comparison
	Level Reset Scout Lines/Intersection Lines Image Rotate Image Flipor Intersection Image Invert Magnify	Level Reset Scout Lines Image Rotate Image Flip Magnify	not have the"ImageInvert"functionality.
Data Encryption	HTTPS SSL	HTTPS SSL	Same
PatientDemographicDisplay	Capable of displaying patientdemographic information	Capable of displaying patientdemographic information	Same
Data Security	Stored locally on the workstation(PC)	Stored on server	Same
Audit Trail	Audit trail logged	Audit trail logged	Same
File Type Used	JPEG for lossy data PNG for lossless data	JPEG for lossy data PNG for lossless data	Same
MPR Viewing	This viewing feature enables thedisplay of reformatted CT andMR images into axial, coronal,and sagittal orientations.	This viewing feature enables thedisplay of reformatted CT and MRimages into axial, coronal, andsagittal orientations.	Same
3D VolumeRenderedViewing	This viewing feature enables thedisplay of 3D perspective viewsof CT and MR image sets thathave been transformed intovolumes. It also provides presetsto enable users to alter thevisualization parameters of the3D views to highlight features.	This viewing feature enables thedisplay of 3D perspective views ofCT and MR image sets that havebeen transformed into volumes. Italso provides presets to enableusers to alter the visualizationparameters of the 3D views tohighlight features.	Same
CrosshairNavigation andSynchronization	This viewing feature provides afacility to synchronize and scrollthrough multiple views at thesame time.	This viewing feature provides afacility to synchronize and scrollthrough multiple views at the sametime.	Same
Ability to closean image byclicking an "X"in the upper-leftportion of theview port	Ability to close an image byclicking an "X" in the examinationtab.	Ability to close an image by clickingan "X" in the upper-left portion ofthe viewport.	Same
Support for TIFFiles	Yes	Yes	Same
Support forBMP Files	Yes	No	Different:Thedifferencedoes not alterintended useand issupported bysoftwareverification
DeviceCharacteristic	Subject Device:CarnaLife® Holo (K221870)	Predicate Device:SurgicalAR (K190764)	Comparison
			andvalidation.
Support ofStored ECHOData	Yes	No	Different:Thedifferencedoes not alterintended useand issupported bysoftwareverificationandvalidation.
HMD supportforinformationalpurposes only(not fordiagnostic use)	This viewing feature providesaccess of CarnaLife® Holosoftware on consumer, off-the-shelf wireless, Wi-Fi enabled,stereoscopic head-mounteddisplay with minimum of 2GBRAM.	This viewing feature providesaccess of SurgicalAR software onconsumer, off-the-shelf wireless,Wi-Fi enabled, stereoscopic head-mounted display with minimum of2GB RAM.	Same
Diagnosticquality medicalimage review	Ability to provide diagnosticquality medical image review formulti-dimensional digital imagesacquired from a variety ofimaging devices.	Ability to provide diagnostic qualitymedical image review for multi-dimensional digital images acquiredfrom a variety of imaging devices.	Same

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Performance Data

Design validation and verification activities were performed for CarnaLife® Holo as a result of the risk analysis assessment and product requirements. The purpose of software design verification activities was to ensure that the design output specifications met the design input requirements. It is concluded that the design verification was successful in that the design output specifications satisfactorily met the design input requirements.

Design validation was successfully completed, and testing met all predetermined acceptance criteria based on user needs and intended use. Human factors activities were completed per ANSI/AAMI/IEC 62366.

Performance testing included:

. Accuracy of the Measuring function: This testing was conducted using two data sets characterized by different voxel sizes (isotropic and anisotropic data). For each set, points P1, P2, P3 and P4 were defined for both Axial and Coronal projections. Measurement accuracy met specified requirements for the below measurements of distance:
- o X - distance of P1-P2 and P3-P4
- o Y - distance of P1-P3 and P2-P4
- Angles defined by points P1-P2-P3 o
- Diagonals defined by P1-P4 and P3-P2. o

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Accuracy of Volume Rendering: This testing was conducted by performing Volume Rendering on . CT scans of two different geometric objects of known size and dimensions. The accuracy of Volume Rendering meeting specified requirements was demonstrated by comparing the size and dimensions of resulting displayed holograms to the known size and dimensions of the two geometric objects.

Conclusion

The performance data demonstrate the CarnaLife® Holo is as safe, as effective, and performs as well as or better than the predicate device, SurgicalAR (K190764). In conclusion, the subject device, CarnaLife® Holo, is substantially equivalent to the predicate device, SurgicalAR (K190764).

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).