Aibolit 3D+ 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 imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, training, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ 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

Aibolit 3D+ is a web-based stand-alone application that can be presented on a computer connected to the internet. Once the enhanced images are created, they can be used by the physician for case review, patient education, professional training and intraoperative reference.

Aibolit 3D+ is a software only device, which processes CT images from a patient to create 3-dimensional images that may be manipulated to view the anatomy from virtually any perspective. The software also allows for transparent viewing of anatomical structures artifacts inside organs such as ducts, vessels, lesions and entrapped calcifications (stones). Anatomical structures are identified by name and differential coloration to highlight them within the region of interest.

The software may help to facilitate the surgeon's decision-making during planning, review and conduct of surgical procedures and, hence, may potentially help them to decrease or prevent possible errors caused by the misidentification of anatomical structures and their positional relationship.

AI/ML Overview

Here's an analysis of the provided text to fulfill your request, noting that the document is a 510(k) summary focused on substantial equivalence rather than a detailed performance study report. Therefore, some information requested (e.g., specific performance metrics against acceptance criteria, detailed ground truth establishment for a test set, MRMC study results) is not explicitly present.

Device Name: Aibolit 3D+
Manufacturer: Albolit Technologies, LLC
K Number: K211443
Predicate Device: Ceevra Reveal 2.0 Image Processing System [510(k) K173274]

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study against specific, quantitative acceptance criteria. Therefore, there isn't a direct "table of acceptance criteria and reported device performance" in the traditional sense of metrics like sensitivity, specificity, accuracy, or volume measurement error for a standalone deep learning algorithm.

Instead, the "acceptance criteria" for a 510(k) are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by comparing their Indications for Use, technological characteristics, and performance. The document implies that the device "meets" its "criteria" by being substantially equivalent to the Ceevra Reveal 2.0 system.

The "Performance Testing" section lists various documentation submitted (Hardware Requirements, Software Description, etc.), but does not specify quantitative performance metrics or the results of comparative studies with the predicate for individual features. The "Conclusion" explicitly states: "AIBOLIT 3D+ is substantially equivalent to the previously cleared Ceevra Reveal 2.0 Image Processing System with respect to intended use, principle of operation, general technological characteristics and performance."

Therefore, for the requested table, we can infer the implicit acceptance criteria based on the comparison to the predicate. The "reported device performance" is essentially the claim of "substantial equivalence" across these aspects.

Acceptance Criterion (Implicitly based on Predicate Comparison)	Reported Device Performance (Claimed)
Intended Use: Processing, review, analysis, communication, media interchange of multi-dimensional digital images from CT devices; preoperative surgical planning, training, patient information, intraoperative display.	Substantially Equivalent (Same Indications for Use)
Principle of Operation: Software-based capture and enhancement of DICOM images, conversion to 2D/3D anatomical structure images manipulation.	Substantially Equivalent (Same Mechanism of Action)
Technological Characteristics:
- Input: DICOM images from CT	Substantially Equivalent (DICOM from CT)
- Functions: Generation of 2D/3D images, organ segmentation/identification, dimensional/volume references, multi-axis rotation, organ transparency.	Substantially Equivalent (Includes all predicate functions, plus "organ retraction animation")
- Image output: High-definition digital images	Substantially Equivalent (Up to 4K, vs predicate's "High-definition")
- Security: Data coded and HIPAA compliant	Substantially Equivalent (Data coded and HIPAA compliant)
Performance (General): Safe and effective for intended use	Substantially Equivalent (Claimed based on the full submission)

Study Details (Based on available information)

Given this is a 510(k) for substantial equivalence, the "study" described is a comparison to a predicate, not necessarily a de novo clinical trial with a traditional test set and ground truth.

Sample Size used for the Test Set and Data Provenance:
- The document does not explicitly state a quantitative "test set" sample size in terms of number of cases or scans used for validation testing of the algorithm's performance (e.g., for segmentation accuracy or other quantitative metrics).
- It mentions "Performance Testing" by listing documentation submitted, such as "Software Validation Report" and "Usability Evaluation." These documents would contain details about the types and number of cases used, but this information is not directly provided in the summary.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).
Number of Experts used to establish the Ground Truth for the Test Set and Qualifications of those Experts:
- The document states, for the AIBOLIT 3D+ workflow, under "Image Segmentation": "By Radiologist (MD) – Manual annotation is done for all CT slices with optional use of AI/ML algorithms as determined by Radiologist and with Radiologist's approval."
- Under "Organ identification": "By Radiologist."
- This indicates that Radiologists are involved in the segmentation and identification process for the device's operation, and implicitly for any internal validation or ground truth generation.
- The number of radiologists/experts and their specific qualifications (e.g., years of experience) used for establishing a test set ground truth are not explicitly stated in this 510(k) summary. It only indicates that "Radiologist (MD)" performs these tasks.
Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- The document describes a user interface and system workflow where a "Radiologist reviews images generated by imaging technician and returns output file to requesting physician."
- However, a specific "adjudication method" involving multiple experts resolving discrepancies for a test set ground truth is not described in the provided text. The workflow suggests a single Radiologist's approval of the imaging technician's work, but not a consensus process for validation per se.
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 comparative effectiveness study is described in this 510(k) summary. The device's substantial equivalence is based on its similarity to the predicate device in functionality and intended use. The device is intended to "assist the clinician who is responsible for making all final patient management decisions," but no data on human reader improvement with the AI assistance is provided.
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device workflow clearly involves a human-in-the-loop (Radiologist) for "Manual annotation" and "approval" even with the optional use of AI/ML algorithms. The AI/ML is stated to "facilitate annotation," suggesting it is a tool for the radiologist, not a fully standalone diagnostic or analytical algorithm.
- The summary does not explicitly describe a standalone performance study of the algorithm component without human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the operation of the device itself (i.e., for segmentation and organ identification within the Aibolit 3D+ workflow) is stated to be established "By Radiologist (MD) – Manual annotation." This implies expert (Radiologist) annotation/consensus is the basis for the data processed by the system.
- For any underlying software validation/training data:
  - For segmentation, it's explicitly stated to be "By Radiologist (MD) – Manual annotation."
  - For organ identification, "By Radiologist."
- It is not stated if this "ground truth" was verified by pathology or outcomes data.
The Sample Size for the Training Set:
- The document does not specify the sample size for any training set. It mentions the "optional use of AI/ML algorithms" to "facilitate annotation," suggesting that AI/ML components exist, which would imply a training phase. However, no details on the training data size are provided.
How the Ground Truth for the Training Set was Established:
- While a specific "training set" is not detailed, the general method for annotation and identification within the Aibolit 3D+ workflow is described as being performed "By Radiologist (MD) – Manual annotation" and "By Radiologist" for organ identification. This suggests that any ground truth used for training would also be based on manual annotations by medical professionals (Radiologists).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

Albolit Technologies, LLC Howard Schrayer Official Correspondent 9616 Moritz Way Delray Beach, Florida 33446

Re: K211443

January 7, 2022

Trade/Device Name: Aibolit 3D+ Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: November 30, 2021 Received: December 2, 2021

Dear Howard Schrayer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)	TBD K21143
Device Name	AIBOLIT 3D+

Indications for Use (Describe)

Aibolit 3D+ 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 imaging devices. Aibolit 3D+ is intended as
software for preoperative surgical planning, training, patient information and as software for the intraoperative display of
the multidimensional digital images. Aibolit 3D+ 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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PSC Publishing Sarvices (301) 443-6740

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K211443

Exhibit E - 510(k) Summary (Per 21 CFR 807.92)

Contact:	Howard SchrayerAlbolit Technologies, LLC9616 Moritz WayDelray Beach, FL 33446Telephone: 609-273-7350hs.ss@lucidmedical.net
Date Prepared:	January 7, 2022
Device Trade Name:	AIBOLIT 3D+
Manufacturer:	Albolit Technologies, LLC9616 Moritz WayDelray Beach, FL 33446
Common Name:	Automated Radiological Image Processing SoftwareMedical image management and processing system
Classification:	Class II
Product Code:	QIH - LLZ
Regulation:	21 CFR 892.2050
Predicate Devices:
Primary Predicate

Ceevra, Inc. Ceevra Reveal 2.0 Image Processing System [510(k) K173274]

Reference Predicate

Intuitive Surgical, Inc. IRIS 1.0 System [510(k) K182643]

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Indications for Use:

Device Description:

Substantial Equivalence and Predicate Devices:

The device was shown to be substantially equivalent to a previously cleared video image processing system, the Ceevra Reveal 2.0 Image Processing System [510(k) K173274].

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Manufacturer	Albolit Technologies, LLC	Ceevra
Trade Name	AIBOLIT 3D+Image Processing System	Ceevra Reveal 2.0Image Processing System
510(k) Number	Subject Device - TBD	K173274
Type of Device/Product Code /	Radiological ImageProcessing System / QIH -LLZ	Radiological Image ProcessingSystem / LLZ
Regulation / Class	21 CFR 892.2050 - Class II	21 CFR 893.2050 - Class II
Indications for Use	Aibolit 3D+ is intended as amedical imaging system thatallows the processing, review,analysis, communication andmedia interchange of multi-dimensional digital imagesacquired from CT imagingdevices. It is also intended assoftware for preoperativesurgical planning, training,patient information and assoftware for the intraoperativedisplay of the multidimensionaldigital images. Aibolit 3D+ isdesigned for use by healthcare professionals and isintended to assist the clinicianwho is responsible for makingall final patient managementdecisions.	Ceevra Reveal 2.0 is intended asa medical imaging system thatallows the processing, review,analysis, communicationand media interchange of multi-dimensional digital imagesacquired from CT or MR imagingdevices. It is also intended assoftware for preoperative surgicalplanning, and as software for theintraoperative display of theaforementioned multidimensionaldigital images. Ceevra Reveal 2.0is designed for use by health careprofessionals and is intended toassist the clinician who isresponsible for making all finalpatient management decisions.
Mechanism ofAction	Capture and enhancement of(DICOM) digital video imagesvia software-based conversionto 2-D and 3-D anatomicalstructure images that can bemanipulated for viewing	Capture and enhancement of(DICOM) digital video images viasoftware-based conversion to 2-Dand 3-D anatomical structureimages that can be manipulatedfor viewing
Intended Users	Health care professionals	Health care professionals
Intended UseEnvironment	Healthcare facilities such ashospitals and clinics	Healthcare facilities such ashospitals and clinics
Format of CapturedImages	DICOM	DICOM
Intended Use	AIBOLIT 3D+ is intended foruse as a medical imagingsystem that allows theprocessing, review, analysis,communication and mediainterchange of multi-dimensional digital imagesacquired from CT imagingdevices. It is also intended assoftware for preoperativesurgical planning, and assoftware for the intraoperativedisplay of multi- dimensionaldigital images. AIBOLIT 3D+is designed for use by healthcare professionals and isintended to assist the clinicianwho is responsible for makingpatient managementdecisions.	Intended as a medical imagingsystem that allows theprocessing, review, analysis,communication and mediainterchange of multi- dimensionaldigital images acquired from CTor MR imaging devices. It is alsointended as software forpreoperative surgical planning,and as software for theintraoperative display of theaforementioned multi-dimensional digital images.Ceevra Reveal 2.0 is designed foruse by health care professionalsand is intended to assist theclinician who is responsible formaking all final patientmanagement decisions.
Security	Data coded and HIPAAcompliant	Data coded and HIPAA compliant
Form of Device	AIBOLIT 3D+ is a softwareonly device that permitselectronic image uploads,provides image conversionand allows viewing on amobile device or standardcomputer monitor.	The Ceevra Reveal 2.0 VideoProcessor is a software onlydevice that permits electronicimage uploads, provides imageconversion and allows viewing on amobile device or standardcomputer monitor.
Image processing	High-definition digital imagesup to 4K	High-definition digital images
Functions	Generation of 2D and 3Dimages from DICOM dataOrgan segmentation andstructure identificationDimensional and volumereferencesMulti-axis image rotationOrgan transparencyOrgan retraction animation	Generation of 2D and 3D imagesfrom DICOM dataOrgan segmentation and structureidentificationDimensional and volumereferencesMulti-axis image rotation
Body contact	None	None
User Interface andSystem Work-Flow	Physician uploads DICOMimages and specifies desiredanatomical segments ofinterestRadiologist annotates sample(segments) imagesAI software facilitatesannotation of available imagesunder guidance and control bythe RadiologistImaging technician generatesmulti-axis rotatable image andretraction modelRadiologist reviews imagesgenerated by imagingtechnician and returns outputfile to requesting physician	Physician uploads DICOM imagesand specifies desired anatomicalsegments of interestImaging technician annotatessample (segments) imagesImaging technician generatesmulti-axis rotatable image andreturns output file to requestingphysician
External / InternetConnections	Web-based software	Web-based software
CT ImageUploading	By requesting physician	By requesting physician
Other User Inputs	List of organ structures to beannotated and displayed,patient ID and demographics	List of organ structures to beannotated and displayed, patientID and demographics
ImageSegmentation	By Radiologist (MD) – Manualannotation is done for all CTslices with optional use ofAI/ML algorithms asdetermined by Radiologist andwith Radiologist's approval	By Imaging Technician – Manualannotation done for all CT slices –No software used for annotation
Organidentification	By Radiologist	Unknown proprietary methodused to identify organ structures
3D Imagegeneration	3D image file generated by 3rdparty software (3D Slicer)following Radiologist reviewand approval of annotation	3D image file generated by 3rdparty software
Organ structureidentification	Proprietary software assignscolor coding to each structureidentified by Radiologist anddisplays color-coded imagewith labeled key tocolor/structure identity	Proprietary software assigns colorcoding to each structure identifiedby imaging technician anddisplays color-coded image withkey to color/structure identity
Image editingpermission	Only the radiologist can alteror edit images following review- User physicians cannot editimages - Physicians haveoption to show or hide organson display	Imaging technician can editimages generated by the systemsoftware – User physicianscannot edit images - Physicianshave option to show or hideorgans on display
Device OutputDevices	3D image can be displayed onstandard monitor	3D image can be displayed onstandard monitor, smart phone(with separate software) or VirtualImaging 3D headset
Supplementaloutputs	Organ structure dimensions,volume, organ labels, patientID, CT date and demographics	Organ structure dimensions,volume, organ labels, patient IDand demographics
Output imagemanipulation byuser	Physician user can show orhide individual organstructures, zoom capability,rotational capability andtransparency capability	Physician user can show or hideindividual organ structures, zoomcapability, rotational capability,transparency capability (currentversion)

Predicate Comparison Table

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Performance Testing:

The following documentation was submitted in the 510(k).

Hardware Requirements Level of Concern Statement Software Description Architecture Design User Manual and Instructions for Use Software Design Specification Risk Analysis Traceability Analysis Software Validation Report Usability Evaluation Software Development Lifecycle Unresolved Anomalies Cybersecurity

Conclusion

AIBOLIT 3D+ is substantially equivalent to the previously cleared Ceevra Reveal 2.0 Image Processing System with respect to intended use, principle of operation, general technological characteristics and performance.

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).