MediLab is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediLab displays and manages diagnostic quality DICOM images. MediLab is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediLab is not intended for diagnostic use on mobile devices.

Contraindications: MediLab is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.

Device Description

The MediLab is a DICOM medical image viewer that allows downloading, reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. MediLab is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. MediLab enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software.

AI/ML Overview

The provided text describes the MediLab device, its intended use, and compares it to predicate devices. However, it does not explicitly state acceptance criteria in a quantitative manner or detail a specific study proving the device meets said criteria for diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (ZeeroMED View, IMPLANTER DENTAL PLANNING SOFTWARE, and aPROMISE X) based on intended use, technical characteristics, and functionalities as a medical image management and processing system.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide specific quantitative acceptance criteria or diagnostic performance metrics for the MediLab device. The comparison focuses on feature similarity with predicate devices. The closest to "performance" mentioned is "Performance Testing (Measurement Accuracy) was conducted on the MediLab system to determine measurement accuracy when performing the various distance and area measurements." However, the results of this testing, or any specific acceptance criteria for these measurements, are not provided.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of diagnostic performance metrics.	"Performance Testing (Measurement Accuracy) was conducted on the MediLab system to determine measurement accuracy when performing the various distance and area measurements."
Functionality (e.g., DICOM image loading, display operations, user authentication, report generation)	"Subject device has similar features and functionality as the predicate and reference devices."
Safety and Effectiveness	"The non-clinical performance test data and software verification and validation demonstrate that the MediLab system performs comparably to and it is as safe and effective as the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the text. The document mentions "Non-clinical product evaluation to demonstrate safety and effectiveness was conducted" and "Performance Testing (Measurement Accuracy) was conducted," but it does not specify the details of the test data (sample size, origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the text. The document does not mention any expert review or ground truth establishment process for diagnostic performance validation.

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

This information is not provided in the text, as no details of a diagnostic performance study are given.

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

There is no indication in the text that an MRMC comparative effectiveness study was conducted. The MediLab device is described as a medical image management and processing system and a diagnostic/analysis tool, not specifically an AI-assisted diagnostic tool.

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

There is no indication in the text that a standalone algorithm performance study was conducted. The device is presented as a medical image viewer and management system for use by qualified medical personnel.

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

This information is not provided in the text, as no diagnostic performance study details are given.

8. The sample size for the training set

The document describes "Software Verification and Validation" and mentions "software requirements and specifications, design architecture, risk analysis and software validation and verification." However, it does not mention a "training set" or "training data" in the context of an AI/ML device. The MediLab is described as a DICOM image viewer and processor, not as a device utilizing machine learning for diagnostic interpretations.

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

As there is no mention of a training set in the context of an AI/ML algorithm, this information is not applicable and therefore not provided in the text.

Summary

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Sigma Scientific Services LLC Jorge Millan Biomedical Director 7737 N University Drive, Suite 101 Tamarac, Florida 33321

Re: K221065

June 10, 2022

Trade/Device Name: MediLab Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 5, 2022 Received: April 12, 2022

Dear Jorge Millan:

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

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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 and Part 809); 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 medical devices and radiation-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. Ph.D. 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) K221065

Device Name MediLab

Indications for Use (Describe)

Contraindications: MediLab is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Submitter Information

Submitter	SIGMA SCIENTIFIC SERVICES LLC7737 N UNIVERSITY DRIVE, SUITE 101TAMARAC, FL 33321
Contact:	Jorge Millan, PhDBiomedical Director
Telephone number	(786) 416-5587
E-mail	sigmabiomedical@gmail.com
Date prepared:	June 6, 2022

Subject Device Name

Trade/Proprietary Name:	MediLab
Regulation Number:	892.2050
Regulation Name:	Medical image management and image processing System
Product Code:	LLZ
Class	II
Panel	Radiology

Predicate Device

Predicate Device:	ZeeroMED View
Sponsor	O3 ENTERPRISE SRL
510(K)	K200546
Regulation Number:	892.2050
Regulation Name:	Medical image management and image processing System
Product Code:	LLZ
Class	II
Panel	Radiology

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Reference Predicates

Reference Devices:	IMPLANTER DENTAL PLANNING SOFTWARE, K173083aPROMISE X, K220590
Regulation Number:	892.2050
Regulation Name:	Medical image management and image processing System
Product Code:	LLZ
Class	II
Panel	Radiology

Device Description:

Indications for Use:

MediLab is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediLab displays and manages diagnostic quality DICOM images. MediLab is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. MediLab is not intended for diagnostic use on mobile devices.

Contraindications: MediLab is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.

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Image /page/5/Picture/0 description: The image shows the logo for Sigma Scientific. The word "Sigma" is in a large, gray, sans-serif font. Below "Sigma" is the word "Scientific" in a smaller, blue, sans-serif font. The logo is simple and modern.

Non-Clinical Data:

Non-clinical product evaluation to demonstrate safety and effectiveness was conducted. Non-clinical testing includes:

Software Verification and Validation

Software verification and validation testing were conducted on the MediLab system and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would lead to a delayed delivery of appropriate medical care. Documentation includes level of concern, software requirements and specifications, design architecture, risk analysis and software validation and verification.

Performance Testing (Measurement Accuracy) was conducted on the MediLab system to determine measurement accuracy when performing the various distance and area measurements.

Predicate Devices

Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]: MediLab is comparable with and substantially equivalent to ZeeroMED View by 03 ENTERPRISE cleared under K200546. Medilab is also comparable to the reference devices cleared under K173083 and K220590.

Technical Characteristics Comparison:

The basic and main technical features of the subject device are the same as the predicated device.

Feature Comparison:

Subject device has similar features and functionality as the predicate and reference devices:

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Image /page/6/Picture/0 description: The image shows the logo for Sigma Scientific. The word "Sigma" is written in a large, gray, sans-serif font. Below "Sigma" is the word "Scientific" in a smaller, blue, sans-serif font. The logo is simple and modern.

Product comparison to primary predicate

Feature	ZeeroMED View	MEDILAB	Comparisonto Predicate
K#	K200546	K221065	N/A
Intended Use	ZeeroMED View software isintended for use as a diagnosticand analysis tool for diagnosticimages for hospitals, imagingcenters, radiologists, readingpractices and any user whorequires and is granted accessto patient image, demographicandreportinformation.ZeeroMEDView displays and managesdiagnostic qualityDICOMimages. ZeeroMED View isnot intended for diagnostic usemammographywithimages. Usage formammography is for referenceand referral only. ZeeroMEDView is not intended fordiagnosticusemobiledevices.Contraindications:TheZeeroMEDViewisnotintended for the acquisition ofmammographic image dataand is meant to be used byqualified medical personnel.	The MediLab software isintended foruseasadiagnostic and analysis toolfor diagnostic images forhospitals, imaging centers,radiologists,readingpractices and any user whorequires and is grantedaccess to patient image,demographic andreportinformation.MediLabdisplaysand amanagesdiagnostic quality DICOMimages. MediLab is notintended for diagnostic usemammographywithimages. Usage formammographyisforreference and referral only.MediLab is not intended fordiagnostic use on mobiledevices.Contraindications: MediLabis not intended for theacquisitionofmammographic image dataand is meant to be used byqualified medical personnel.	Similar
Mammographic use	No	No	No difference
DICOM image loading andvisualization	Yes	Yes	No difference
Patient study search data	Yes	Yes	No difference
User authentication	Yes	Yes	No difference
Window level	Yes	Yes	No difference
Rotate/pan/zoom/fit to screen	Yes	Yes	No difference
Image display operations	Flip horizontal, verticalRotate left, rightResetMagnificationScrollLayout 1x1 -3x3Thumbnails left, right, top,bottom	Flip horizontal, verticalRotate left, rightClear transformMagnificationScrollLayout 1x1 -3x3Thumbnails left, right,top, bottom	No difference

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	PET fusionVolumetric rendering	PET FusionVolumetric rendering
Measurement functions	Line, angle between lines,polyline, area, ellipticalarea, polygonal area, edit,delete	Line, angle, area,	Medilab has asubset ofmeasurementfunctions
Annotations	Text	Text	No difference
Report Generation	Yes	Yes	No difference
Print reports	PDF	PDF	No difference
Export	Yes	Yes	No difference
Export reports to CD	No	Yes	No difference
Share function	Yes	Yes	No difference
DICOM Windowing	Yes	Yes	No difference
Low Pass Filter	Yes	No	No difference
Imaging modalities	US, CT, MRI, XRay, PET	US, CT, MRI, XRay,PET	No difference
Communications	DICOM	DICOM	No difference
Operating System forDiagnostic Viewing	Windows, Linux, Mac	Windows, Linux, Mac	No difference
Browser supported	Edge, Firefox, Chrome	Edge, Firefox, Chrome	No difference
Mobile Device Support forViewing	No	No	No difference
Transfer/Storage/Display ofMedical images	Yes	Yes	No difference
Network access	Connects to existing PACS	Connects to existingPACS	No difference

Product comparison to reference predicate devices

Feature	IMPLANTERDENTAL PLANNINGSOFTWARE	aPROMISE X	MEDILAB	Comparisonto predicates
K#	K173083	K220590	K221065	N/A
Intended Use	Implanter Dental PlanningSoftware is a prescriptionuse software used by dentistand dental lab techniciansfor the visualization andimage segmentation ofDICOM data from medicalscanners such as CT. Thesoftware aids the users in	aPROMISE is intendedto be used by healthcareprofessionals andresearchers foracceptance,transfer, storage, imagedisplay, manipulation,quantification andreporting of digital	The MediLab softwareis intended for use as adiagnostic and analysistool for diagnosticimages for hospitals,imaging centers,radiologists, readingpractices and any userwho requires and is	SimilartoK220590

	the creation of 3D modelsof oral maxillofacial regionand in planning dentalsurgical treatments andplacement of dentalimplants	medical images. Thesystem is intended to beused with imagesacquired using nuclearmedicine (NM) imaging,using PSMA PET/CT.The device providesgeneral PictureArchiving anCommunications System(PACS) tools as well as aclinical application foroncology includingmarking of regions ofinterest and quantitativeanalysis.	granted access to patientimage, demographic andreportinformation. MediLabdisplays and managesdiagnostic qualityDICOMimages. MediLab is notintended for diagnosticuse with mammographyimages. Usage formammography is forreference and referralonly. MediLab is notintended for diagnostic use on mobile devices.Contraindications:MediLab is not intendedfor the acquisition ofmammographic imagedata and is meant to beused by qualifiedmedical personnel.
DICOM imageloading andvisualization	Yes	Yes	Yes	No difference
Patient search data	Yes	Yes	Yes	No difference
User authentication	Yes	Yes	Yes	No difference
Rotate/pan/zoom/fit	Yes	Yes	Yes	No difference
Image operations	Yes	Yes	Yes	No difference
Measurementfunctions	Line, angle between lines,polyline, area, ellipticalarea, polygonal area, edit,delete	Yes	Line, angle, area,	Similar toImplanter(subset ofmeasurements)
Report Generation	Yes	Yes	Yes	No difference
DICOMWindowing	Yes	Yes	Yes	No difference
Low Pass Filter	Yes	--	No	Difference
Imaging modalities	CT	PET, CT	US, CT, MRI, XRay,PET	No difference
Communications	DICOM	DICOM	DICOM	No difference
Operating System	Windows, Linux, Mac	Windows or mac OSwith Chrome browser	Windows, Linux, Mac	No difference
Browser supported	Edge, Firefox, Chrome	Chrome	Edge, Firefox,Chrome	No difference

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Evaluation of similarities and differences:

. MediLab and ZeeroMED View have similar intended use, functionality and similar Web technologies. In terms of use and functions both systems access, upload and display DICOM images and metadata and provide tools and resources to the physician for study review and analysis. Both systems are hosted in Web servers and are equipped with security features and user authentication. Medilab has similar performance metrics in terms of accuracy as compared to the reference device IMPLANTER. Medilab has also similar PET/SPECT/ SUV functionality as the aPROMISE X device cleared under K220590.
Differences between both systems consist in user interface layout, navigation, icon coloring . and overall system presentation. MediLab provides the functionality to export reports to CD. The primary predicate has a low pass filter functionality which Medilab does not offer. Medilab has a subset of measurements compared to the primary predicate devices. These differences do not impact safety or effectiveness of the Medilab system.

Conclusion:

The subject device has similar technology characteristics and has similar intended use and functionality as the predicate and reference devices. There are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness. The non-clinical performance test data and software verification and validation demonstrate that the MediLab system performs comparably to and it is as safe and effective as the predicate device. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, Medilab is substantially equivalent to the predicate that is currently marketed for the same intended use.

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).