The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. The HOLOSCOPE-i is intended to be used as a reference display for consultation to assist the clinician who is responsible for making all final patient management decisions.

Device Description

The HOLOSCOPE-i is a software-controlled optical system that displays 3D holographic medical images. The system generates color 3D holograms from 3D volumetric imaging datasets acquired from standard imaging modalities such as CT and 3D ultrasound. The HOLOSCOPE-i is comprised of an Optical Unit that creates the optical path for the generation of the holographic image; a system computer and electronics supporting the Human Machine Interactions (HMI) and a graphical user interface (GUI) display; a cart and boom mechanical fixture that mechanically connects the Optical Unit and the system computer; and a 3D Control Device for interfacing with the hologram.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: HOLOSCOPE-i (Medical display workstation for 3D image visualization and interaction)

Intended Use: The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the healthcare professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. The HOLOSCOPE-i is intended to be used as a reference display for consultation to assist the clinician who is responsible for making all final patient management decisions.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes two main clinical studies: an "Expert Evaluation study" primarily focusing on visualization and ease of identification, and a "comparative clinical study" establishing substantial equivalence through measurement agreement. While explicit "acceptance criteria" values are not presented in a table format with pass/fail thresholds, the outcomes of these studies serve as the "reported device performance" against implied clinical acceptance.

Acceptance Criteria (Implied from Study Goals)	Reported Device Performance
I. Visualization & Spatial Understanding
A. Ease of Landmark Identification	For 10 adult 3DTEE and 10 adult CT images, all 5 pre-identified anatomical landmarks were identified for all images. Ease of identification scored at least 3 (Scale not defined, but context implies 'easy'), with 99% scoring 5 (very easily).
B. Performance under varied lighting	No difference in ability or ease of identification under dim vs. bright ambient lighting conditions.
C. Perception of Spatial Relationships/3D Depth	Evaluators indicated an excellent, intuitive ability to perceive the spatial relationships of anatomical structures, similar to "real-life" 3D depth perception.
II. Measurement Accuracy & Agreement (Comparative Study)
A. Agreement in Annular Diameter Measurements	Overall: ICC 0.895 (95% CI 0.810-0.943) and ICC 0.906 (95% CI 0.830-0.949) with reference device. Normal Valves: Very good agreement. Pathological Valves: Very good agreement (0.934, 0.943).
B. Agreement in Scallop Measurements	Low agreement for both normal and pathological groups.
C. Similarity to Predicate Device's Performance	Similarity in correlation for Mitral Valve diameters and similarly low correlation for leaflet (scallop) measurements when comparing HOLOSCOPE-i to reference vs. Predicate to reference.
III. Image Quality for Intended Use	Image quality of the hologram is sufficient for its intended use by enabling visualization of measured structures and spatial understanding.

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

Expert Evaluation Study:
- Sample Size: 10 adult 3DTEE images and 10 adult CT images.
- Data Provenance: Not explicitly stated, but clinical studies are generally conducted with patient data. No indication of specific country or retrospective/prospective nature is provided.
Comparative Clinical Study:
- Sample Size: 41 adult Mitral Valve images (19 normal, 22 pathological).
- Data Provenance: Not explicitly stated. Assumed to be retrospective clinical images for such a comparative measurement study. Nothing about country of origin is mentioned.

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

The document refers to "expert evaluators" in the "Expert Evaluation study" but does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience"). For the comparative study, it refers to a "validated reference device" for ground truth comparison, implying an established, accurate measurement method rather than a panel of human experts directly establishing ground truth for the measurements themselves.

4. Adjudication Method for the Test Set

Expert Evaluation Study: The document states that "All landmarks were identified for all images and ease of identification, as expected, was scored at least 3, with 99% of identifications scoring 5 (very easily)." This phrasing suggests consensus or high agreement, but an explicit adjudication method (e.g., 2+1, 3+1, majority vote) is not described.
Comparative Clinical Study: For the measurement comparison, the "validated reference device" serves as the standard, so human adjudication of measurements is not the primary method for ground truth establishment. Agreement was measured against this reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

An MRMC study per se comparing human readers with and without AI assistance was not explicitly described.
The "Expert Evaluation study" involved expert evaluators assessing the device's visualization capabilities, which is a form of human interaction with the device.
The "Comparative clinical study" focused on the device's measurement agreement with a reference device, rather than human reader performance improvement.

Effect Size: Not applicable, as a direct MRMC comparative effectiveness study for human reader improvement with AI assistance was not detailed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device, HOLOSCOPE-i, is a display workstation for human users. Its intended use inherently involves human interaction ("visual information to be used by the health care professional," "assist the clinician"). Therefore, standalone algorithm-only performance metrics separate from human interaction are not directly relevant to its function and were not a focus of the described clinical evaluations. Performance tests cover resolution, sharpness, luminance, contrast, color, 3D fidelity, orientation, and measurement accuracy, which are technical standalone performance aspects, but these are assessed for the purpose of supporting the human user's visual perception and interaction.

7. The Type of Ground Truth Used

Expert Evaluation Study: The ground truth for this study was the pre-identified anatomical landmarks. The experts' role was to identify these landmarks using the device and assess the ease of identification and spatial perception. The existence and location of these landmarks implicitly serve as the ground truth. This combines aspects of expert consensus (likely used to pre-identify the landmarks) and defined anatomical structures.
Comparative Clinical Study: The ground truth for the measurements was established by a "validated reference device" (K132165 - Philips QLAB Quantification (MVN) Software). This is a previously cleared or established measurement tool, implying its measurements are considered accurate and reliable.

8. The Sample Size for the Training Set

The document focuses solely on the validation/test sets for demonstrating performance and substantial equivalence. It does not provide any information regarding the training set size for the algorithms that generate the holographic display or process the 3D data.

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

As no information is provided about the training set, there is no information on how its ground truth was established.

Summary

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May 14, 2021

Real View Imaging Ltd. % Yehudit Kraizer, Ph.D. VP Quality and Regulatory Affairs 4 Hatnufa St. Yokneam, 2069202 ISRAEL

Re: K210072

Trade/Device Name: HOLOSCOPE-i Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 20, 2021 Received: April 20, 2021

Dear Dr. Kraizer:

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,

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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Indications for Use

510(k) Number (if known)

K210072

Device Name HOLOSCOPE-i

Indications for Use (Describe)

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

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510(k) SUMMARY of K210072

Applicant		Real View Imaging Ltd.HaTnufa 4 Yokneam 2069202 Israel
Contact		Yehudit KraizerVP Quality and Regulatory+972-54-9599172yehudit@RealViewimaging.com
Date Prepared		January 11, 2021
Trade Name:		HOLOSCOPE-i
Classification Name:		System, image processing, radiological
Product Code:		LLZ
Device Class:		II
Regulation Number:		892.2050
Panel:		Radiology
Predicate Device:		K193149 - EchoPixel True 3D Viewer Software
Reference Device:		K132165 - Philips QLAB Quantification (MVN) Software

Intended Use/ Indications for Use:

Device Description

The HOLOSCOPE-i is comprised of an Optical Unit that creates the optical path for the generation of the holographic image; a system computer and electronics supporting the

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Human Machine Interactions (HMI) and a graphical user interface (GUI) display; a cart and boom mechanical fixture that mechanically connects the Optical Unit and the system computer; and a 3D Control Device for interfacing with the hologram.

Technological Characteristics / Principles of Operation

The HOLOSCOPE-i receives 3D volumetric medical imaging data from standard imaging modalities such as CT or US and generates a holographic display. The hologram, floating in air, provides a three dimensional image of the data and enables the health care professional to visualize the image at hands reach and directly interact with the image.

The digital data required to create the hologram is imported to the HOLOSCOPE-i from a PACS, USB or directly from a connected compatible 3D Ultrasound acquisition modality. This data is the input to the Real View algorithms that run on the system computer. The output of this process is a digital interference pattern that is subsequently digitally addressed on a Spatial Light Modulator (SLM). Once coherent light is projected on the SLM optical panel, the hologram is created and guided to the desired projection area via the optical system adjacent to the SLM.

The optical system consists of two separate optical channels, one per each eye. Each optical channel consists of an SLM. a Red-Green-Blue (RGB) coherent light source, a set of lenses and mirrors to direct the light propagation ending with the see-through evepieces that enable the viewer to see the hologram at arms-reach.

Performance Data

The following non-clinical testing was conducted to evaluate the device:

. Bench testing performance tests demonstrated the system meets its performance requirements by verifying the following elements: Resolution, sharpness, luminance response, low contrast response, contrast ratio, color representation and uniformity, 3D fidelity, object orientation and measurement accuracy.
. Electrical safety was tested in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 - Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
. Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
. System cleaning and disinfection validation was performed according to AAMI TIR 30:2011/(R)2016, AAMI TIR 12:2010, and FDA guidance:" Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" (March 17, 2015).
. The biocompatibility of all user contact materials was evaluated according to ISO 10993- 1:2018 and FDA guidance on the use of ISO 10993-1.
. Software verification and validation testing was conducted as required by JEC 62304 and FDA guidance on general principles of software validation, January 11, 2002.

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. Usability evaluation - the system was validated with intended users in simulated use conditions to ensure the user needs and intended use requirements were met. All tasks, including a critical task, were met and no new issues of safety or effectiveness were raised.
The following clinical testing was conducted to evaluate the device:
The HOLOSCOPE-i was validated in an Expert Evaluation study. Ten adult 3DTEE . and ten adult CT images each with 5 pre-identified anatomical landmarks were reviewed by expert evaluators. All landmarks were identified for all images and ease of identification, as expected, was scored at least 3, with 99% of identifications scoring 5 (very easily). There was no difference in ability to identify the structures, or the ease of identification, under both dim ambient lighting and bright ambient lighting conditions. Overall the evaluators indicated an excellent, intuitive ability to perceive the spatial relationships of the anatomical structures directly from the image, similar to "real-life" 3D depth perception supporting the intended use of the system.
. Substantial Equivalence was demonstrated in a comparative clinical study that measured features within 41 adult Mitral Valve images (19 normal, 22 pathological). The study demonstrated a high agreement in measurements, as compared to the validated reference device, similarly to comparative results previously published by the predicate. Measurements for annular diameters demonstrated very good agreement in terms of Intra-Class Correlation (ICC) between HOLOSCOPE-i and reference device (ICC 0.895; 95% Cl 0.810- 0.943 and ICC 0.906; 95% Cl 0.830-0.949). Very good agreement was shown for annular diameters in normal valves, as well as for pathological valves, with slightly higher agreement for pathological valves (0.864, 0.840 and 0.934. 0.943. respectively). Agreements in scallop measurements were low for both groups. Comparing the results of the True 3D Viewer to the reference device and the HOLOSCOPE-i to the reference device demonstrated similarity in the correlation for the Mitral Valve diameters and similarly low correlation for leaflet measurements. The study confirmed that that measurements of the Mitral Valve can be performed directly and accurately, within the 3D volumetric image and that the image quality of the hologram is sufficient for its intended use by enabling visualization of the measured structures and spatial understanding of the image and therefore support the substantial equivalence of the HOLOSCOPE-i to the True 3D Viewer software.

All performance testing demonstrates that the HOLOSCOPE-i performs according to specifications, as intended.

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Substantial Equivalence

	Subject Device:HOLOSCOPE-i	Predicate Device:EchoPixel True 3D ViewerSoftware - K193149
Indications forUse	The HOLOSCOPE-i is a medicaldisplay workstation intended for 3Dimage visualization and imageinteraction. The holograms aregenerated from 3D volumetric dataacquired from CT and Ultrasoundsources. The device is intended toprovide visual information to beused by the health careprofessional for analysis of surgicaloptions, and the intraoperativedisplay of the images. TheHOLOSCOPE-i is intended to beused as a reference display as anadjunct to the interpretation ofimages performed using diagnosticimaging systems and is notintended for primary diagnosis.The HOLOSCOPE-i is intended tobe used for consultation to assistthe clinician who is responsible formaking all final patientmanagement decisions.	The True 3D Viewer Software isintended for processing, review,analysis, communication andmedia interchange of digitalimages acquired from CT, MRI, XAand Ultrasound sources.It is also intended as softwarewhich provides visual informationto be used by the health careprofessional for analysis of surgicaloptions, and the intraoperativedisplay of the mentioned images.The True 3D Viewer software isdesigned for use by health careprofessionals and is intended toassist the clinician who isresponsible for making all finalpatient management decisions.
Intended users	Health care professional who isresponsible for making all finalpatient management decisions.	Health care professional who isresponsible for making all finalpatient management decisions.
Product Code	CFR 892.2050 LLZ, RadiologicalImage Processing Device	CFR 892.2050 LLZ, RadiologicalImage Processing Device
Product Class	Class II	Class II
Image type	3D stereoscopic medical hologram	3D stereoscopic medical image
Image analysisfeatures	Interactive manipulation, zoom,rotate, move, slice, mark, measure	Interactive manipulation, tag,annotate, measure, segment
SW controlled	Yes	Yes
Gui	Yes, for users to interact with thesystem, select tools and driveworkflow.	Yes, for users to interact with thesoftware, select tools and driveworkflow.
Device includesHW and opticalelements	Optical System	3D glasses; Performance testedhardware is provided by user
Computer	PC supporting user interface SWand PC supporting system	PC; Performance tested hardwareis provided by user
	Subject Device:HOLOSCOPE-i	Predicate Device:EchoPixel True 3D ViewerSoftware - K193149
	computations and processes, bothembedded in the system.
Display	Stereoscopic Holographic display	Stereoscopic display;Performance tested hardware isprovided by user
Input imagesources	CT and Ultrasound sources	CT, MRI, XA and Ultrasoundsources
DICOMCompatible	Yes	Yes
Directinteraction withthe image byoptical motioncontrol system	Yes	Yes.Performance tested hardware isprovided by user
Visual Tracking	Yes	Yes
Original 2D/3Dimage remainsvisible(acquisition datasource)	Yes	Yes

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Based on the above comparison, the HOLOSCOPE-i has a similar intended use and similar technological/functional features as the predicate device in providing tools and workflow designed to support users with 3D visualization and image interaction with medical images. Similar to the cited predicate device, the HOLOSCOPE-i is used for image viewing and interaction both prior to and during procedures.

The HOLOSCOPE-i is substantially equivalent to the predicate device with regard to intended use and technological characteristics and any differences between the HOLOSCOPE-i and the predicate do not introduce different questions of safety and effectiveness. Performance testing demonstrates that the device performs as intended.

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).