Ceevra Reveal 2.0 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. Ceevra Reveal 2.0 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Device Description

Ceevra Reveal 2.0 is a software-only device that allows clinicians to review CT and MR image data in three-dimensional (3D) format and/or stereoscopic 3D format (commonly known as virtual reality, or VR). The 3D and VR images are accessible through the Ceevra Reveal 2.0 mobile application which is used by clinicians for preoperative surgical planning and for the intraoperative display of the aforementioned 3D and VR images.

Ceevra Reveal 2.0 includes two main software-based user interface components, the Processing Interface and Viewer Interface. The Processing Interface is hosted on a cloud-based, virtual workstation and only accessed by authorized personnel, such as an imaging technician. The Processing Interface contains a graphical user interface where an imaging technician can select DICOM-compatible medical images, segment such imitiate processing into a 3D format. The Viewer Interface is a mobile application that is accessible via a compatible, touchscreen enabled, off-the-shelf mobile device to allow for clinicians to review the medical images in 3D and/or VR formats. Only when the compatible mobile device is used in conjunction with a compatible off-the-shelf VR headset can the surgeon view medical images in the VR format.

The product is intended to be used by trained medical professionals, including imaging technicians and clinicians/surgeons, and is used to assist in clinical decision making.

The 3D images generated using Ceevra Reveal 2.0 are intended to be used in connection with surgical operations in which CT or MR images are used for preoperative planning and/or reviewed intraoperatively.

The manner in which the 3D images are viewed and used does not vary between surgery types. The 3D images are viewed solely from the clinicians' compatible mobile devices, and are not viewed through or otherwise integrated with surgical navigation systems.

AI/ML Overview

The provided document, a 510(k) premarket notification for Ceevra Reveal 2.0, does not contain the detailed information necessary to fully address all aspects of the request regarding acceptance criteria and the study that proves the device meets them. The document focuses on establishing substantial equivalence to a predicate device (Clarity Reveal 1.0, K171356), rather than presenting a performance study with detailed acceptance criteria and validation results against ground truth.

Here's an attempt to extract and infer information based on the provided text, and to explain why certain sections cannot be fully completed:

Missing Information: It's important to note that this 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device. For devices seeking substantial equivalence as a "picture archiving and communication system" (PACS) with features like 3D visualization, the FDA often emphasizes software verification and validation, and occasionally clinical validation to demonstrate that the device performs as intended and is as safe and effective as the predicate. However, detailed studies with specific performance metrics against a defined ground truth, like those required for diagnostic AI algorithms, are typically not a mandatory part of a 510(k) for such a device unless it introduces a new intended use or technology that raises new questions of safety or effectiveness.

The document indicates: "Safety and performance of Ceevra Reveal 2.0 has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing." And it refers to IEC 62304 and FDA Guidance documents for software. This suggests that the "study" proving the device meets acceptance criteria was primarily software V&V, not a clinical performance study with human readers or standalone AI performance metrics against a specific ground truth.

1. A table of acceptance criteria and the reported device performance

Based on the provided document, there are no explicit quantitative acceptance criteria or reported device performance metrics in the format of a clinical study or diagnostic accuracy study. The primary "performance" is implicitly tied to its function as a medical imaging system for processing, review, analysis, communication, and media interchange, as well as for surgical planning and intraoperative display. The acceptance is based on demonstrating that it performs these functions adequately and is substantially equivalent to the predicate.

Acceptance Criteria (Inferred from functionality and SE claims)	Reported Device Performance (Inferred from documentation)
Functional Equivalence: Ability to process, review, analyze, communicate, and interchange multi-dimensional digital images from CT/MR.	Stated to perform these functions, comparable to the predicate device.
Image Quality / Fidelity: Produce 3D and VR images suitable for preoperative surgical planning and intraoperative display.	Images are accessible through the mobile application, and viewable in 3D/VR, suggesting visual fidelity is acceptable for intended use.
Software Reliability & Safety: Software operates without critical errors and adheres to medical device software standards (IEC 62304).	"Safety and performance of Ceevra Reveal 2.0 has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing." Compliance with IEC 62304 and FDA guidance on software and cybersecurity noted.
User Interface & Experience: Intuitive and effective interfaces for imaging technicians (Processing Interface) and clinicians/surgeons (Viewer Interface).	Implied through description of interfaces and intended use by medical professionals.
Intraoperative Use Capability (Delta from Predicate): Ability to display images intraoperatively.	Explicitly stated as a new feature for Ceevra Reveal 2.0 and compared against the predicate (which does not have this feature), indicating it was tested for this capability.

2. Sample sized used for the test set and the data provenance

The document does not detail a "test set" in the context of a clinical performance study with patient data and ground truth labels. The "testing" referred to is primarily software verification and validation. Therefore, there is no information on:

Sample size for a test set (e.g., number of cases or patients).
Data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Again, given that the document does not describe a clinical performance study against a specific ground truth for diagnostic accuracy, this information is not available. The ground truth for this type of device, which is a display and processing system, typically relates to the accuracy of the image reconstruction, segmentation, and visualization, rather than a diagnostic outcome. These are validated through engineering and software testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no external clinical test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study is mentioned. This device is described as a "medical imaging system" for processing and display, and "software for preoperative surgical planning" and "intraoperative display." It is not described as an AI/CAD (Computer-Aided Detection/Diagnosis) device, and therefore comparative effectiveness studies demonstrating human improvement with AI assistance are not applicable or described in this document.

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

The device's function is described as providing 3D/VR visualizations for human clinicians. It is explicitly stated that it "is intended to assist the clinician who is responsible for making all final patient management decisions." As such, standalone diagnostic performance in the sense of an algorithm making a decision is not the device's intended function or claimed capability. The "standalone" performance would be related to the accuracy of its 3D reconstruction and segmentation algorithms, which would be validated through internal software testing, not typically reported in detail in the 510(k) summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a device primarily focused on image processing and visualization (like a PACS), the "ground truth" for validation typically refers to the accuracy and fidelity of the 3D reconstructions to the original DICOM data and the anatomical structures within them. This would be established through:

Reference standard imaging (DICOM): The input CT/MR scans are the "ground truth" regarding the anatomy captured.
Known segmentation accuracy: If segmentation is performed, its accuracy against manually segmented or expert-reviewed ground truth models.
Visual inspection and clinical utility assessment: Review by qualified clinicians to ensure the 3D/VR representations are accurate, useful, and do not introduce artifacts or distortions that could mislead.

The document does not specify the exact methods for establishing this ground truth for the "software verification and validation testing."

8. The sample size for the training set

The document does not mention "training sets" as would be relevant for a machine learning or AI-based device. Since it seems to be a rules-based or traditional image processing software, a "training set" in the AI sense is unlikely to have been used or described.

9. How the ground truth for the training set was established

Not applicable, as no training set is indicated.

Summary

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July 10th, 2018

Ceevra, Inc. % Rory Carrillo Quality/Regulatory RAC Medical LLC 368 San Carlos St. SAN FRANCISCO, CA 94104

Re: K173274

Trade/Device Name: Ceevra Reveal 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 9, 2017 Received: October 12, 2017

Dear Rory Carrillo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jeff Ryges

for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173274

Device Name Ceevra Reveal 2.0

Indications for Use (Describe)

Ceevra Reveal 2.0 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multidimensional digital images. Ceevra Reveal 2.0 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

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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Image /page/3/Picture/0 description: The image shows the logo for CEEVRA. The logo consists of a stylized letter 'C' formed by a series of blue curved lines that resemble waves or a digital signal. Below the symbol, the word "CEEVRA" is written in a sans-serif font, also in blue, matching the color of the symbol above.

Section 5. 510(k) Summary

1. General Information

510(k) Sponsor	Ceevra, Inc.
Address	180 Sansome St., 2nd Floor
	San Francisco CA 94104
Correspondence Person	Rory A. Carrillo
	Quality and Regulatory
	Ceevra, Inc.
Contact Information	Email: rcarrillo@gmail.com
	Phone: 562-533-7010
Date Prepared	June 8, 2018

2. Proposed Device

Proprietary Name	Ceevra Reveal 2.0
Common Name	Reveal 2.0
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Regulation Name	Picture archiving and communication system
Product Code	LLZ
Regulatory Class	II

3. Predicate Device

Proprietary Name	Clarity Reveal 1.0
Premarket Notification	K171356
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Regulation Name	Picture archiving and communications system
Product Code	LLZ
Regulatory Class	II

4. Device Description

Ceevra, Inc., Traditional 510(k)

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Image /page/4/Picture/0 description: The image shows the logo for CEEVRA. The logo consists of a stylized crescent shape made up of blue lines that get progressively lighter in color. Below the crescent shape, the word "CEEVRA" is written in a sans-serif font, with the letters also transitioning from dark blue to light blue.

The product is intended to be used by trained medical professionals, including imaging technicians and clinicians/surgeons, and is used to assist in clinical decision making.

5. Intended Use

Ceevra Reveal 2.0 is intended as a medical imaging system that allows the processing, review, analysis. communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. Ceevra Reveal 2.0 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

6. Substantial Equivalence

Feature/Function	Proposed Device:Ceevra Reveal 2.0	Predicate Device:Clarity Reveal 1.0 (K171356)
Intended Use	Intended as a medical imagingsystem that allows the processing,review, analysis, communication	Intended as a medical imagingsystem that allows the processing,review, analysis, communication and

Ceevra, Inc., Traditional 510(k)

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	and media interchange of multi-dimensional digital images acquiredfrom CT or MR imaging devices. Itis also intended as software forpreoperative surgical planning, andas software for the intraoperativedisplay of the aforementioned multi-dimensional digital images. CeevraReveal 2.0 is designed for use byhealth care professionals and isintended to assist the clinician whois responsible for making all finalpatient management decisions.	media interchange of multi-dimensional digital images acquiredfrom CT or MR imaging devices. Itis also intended as software forpreoperative surgical planning.Clarity Reveal is designed for use byhealth care professionals and isintended to assist the clinician who isresponsible for making all finalpatient management decisions.
Intended Users	Health care Professionals	Health care Professionals
IntendedEnvironment	Healthcare facilities such ashospitals and clinics	Healthcare facilities such as hospitalsand clinics
Device Class	Class II	Class II
ImageAnalysisFeatures	Interactivemanipulation andsegment	Interactivemanipulation and segment
PreoperativeUse	Yes	Yes
IntraoperativeUse	Yes	No
Pan image	Pan image in any direction	No

7. Performance Data

Safety and performance of Ceevra Reveal 2.0 has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2008- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices. "

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Image /page/6/Picture/0 description: The image shows the logo for CEEVRA. The logo consists of a stylized letter C formed by a series of blue arcs that gradually decrease in size, creating a sense of motion or flow. Below the graphic is the word "CEEVRA" in a sans-serif font, with the letters in a teal or blue color.

8. Conclusion

Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Ceevra Reveal 2.0 raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy, and performance.

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Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).