Quantitative Total Extensible Imaging (QTxI) is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modalities of these medical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0.

QTxI assists in the following indications:

Receive, store, retrieve, display and process digital medical images.
Create, display and print reports from those images.
Provide medical professionals with the ability to display, register, and fuse medical images.
Identify Regions of Interest (ROIs) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans.
Evaluate quantitative change in ROIs (total or partial body; individual ROI within individual) with 3D interactive rendering of images with highlighted ROIs.

Device Description

Quantitative Total Extensible Imaging (QTxl) is a software tool designed for use in medical imaging. It is stand-alone software which operates on Windows 7 and Windows 10. Its intended function and use is to provide medical professionals with the means to display, register and fuse medical images from multiple modalities including DICOM PET and CT. Additionally, it identifies Regions of Interest (ROIs) and performs ROI contouring allowing quantitative/statistical analysis of full or partial-body scans through registration to template space.

QTxl is designed to support multiple image analysis modules. Each module is designed for a specific image analysis purpose. Currently QTxl includes only the Quantitative Total Bone Imaging (QTBI) module, which is designed to identify and measure hot-spots on PET scans. QTBI aids the efficiency of medical professionals through automatic quantification of ROIs and changes in those ROIs, including 3D interactive rendering of the patient skeleton with highlighted Regions of Interest.

QTxI also functions as a Picture Archive and Communications System (PACS) intended to receive, store, retrieve, display and process digital medical images, as well as create, display and print reports from those images. It also provides platform features for security, workflow and integration.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification from the FDA regarding the Quantitative Total Extensible Imaging (QTxI) device. However, it does not contain the specific details about a study proving the device meets acceptance criteria as described in your request.

The document primarily focuses on establishing "substantial equivalence" of QTxI to a predicate device (Exini Diagnostics AB; EXINI, K122205) and a supporting predicate device (MIMvista Corp. MIM4.1 (Seastar), K071964). It mentions "Performance Data (Nonclinical)" but only in very general terms:

"Software verification testing that demonstrates the device meets product performance and functional specifications."
"Software verification testing demonstrating that DICOM information collected with medical imaging systems and transmitted through manual or virtual input are captured, transmitted, and stored properly to maintain data integrity (e.g., no loss of data)."

It concludes that "QTxl met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols." However, it does not detail these acceptance criteria or the specific study results.

Therefore, I cannot provide the requested information based solely on the provided text. The document states that performance data was submitted and implies successful verification and validation, but it does not present the data itself or the specifics of the study design.

To answer your request, if the information were present in the document, it would look something like this (speculative, based on typical FDA submissions, but not found in the provided text):

Acceptance Criteria and Device Performance Study

While the provided 510(k) summary indicates that QTxI met all predetermined acceptance criteria through non-clinical performance bench tests and simulated clinical performance tests, the specific details of these criteria and the study results are not explicitly enumerated in the document. The general nature of the "Performance Data (Nonclinical)" section suggests that detailed quantitative data on performance was likely submitted separately as part of the full 510(k application.

Based on the general statements, a hypothetical structure of the requested information, if it were present, would be:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric (Hypothetical)	Acceptance Criteria (Hypothetical)	Reported Device Performance (Hypothetical)	P-value/Confidence Interval (Hypothetical)
ROI Contouring Accuracy (Jaccard Index)	≥ 0.90 (vs. Expert Consensus)	0.92 ± 0.03	< 0.001
Quantitative Analysis Precision (CV% for ROI Volume)	≤ 5%	3.8%	N/A (precision measure)
Image Registration Accuracy (Target Registration Error)	≤ 2 mm (mean)	1.5 mm ± 0.5 mm	N/A (accuracy measure)
DICOM Data Integrity (Loss/Corruption Rate)	0%	0% (in 1000 transfers)	N/A
Software Functionality (Pass Rate of Test Cases)	100%	100%	N/A

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

Test Set Sample Size: The document does not specify. Hypothetically, for a software general purpose imaging device, it might be in the range of 50-200 cases per test type (e.g., for ROI contouring accuracy on different anatomies, or for image registration tasks).
Data Provenance: The document does not specify. Hypothetically, for devices of this nature, data could be retrospectively collected clinical DICOM images from various institutions (e.g., U.S. and European hospitals) to ensure variability in scanners and patient demographics.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: The document does not specify. Hypothetically, typically 2-3 experts for consensus, or more for an MRMC study.
Qualifications of Experts: The document does not specify. Hypothetically, e.g., Three Board-Certified Radiologists with 10+ years of experience in oncological imaging and PET/CT interpretation, specializing in bone metastases.

4. Adjudication Method for the Test Set

Adjudication Method: The document does not specify. Hypothetically, for ground truth establishment, a common method is 2+1 (two experts independently annotate, and a third adjudicates disagreements). If no disagreements, the consensus of the two is the ground truth. Alternatively, 3+0 (majority vote of three independent experts) or a defined consensus meeting might be used.

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

MRMC Study: The document does not explicitly state that an MRMC study was performed to assess human reader improvement with AI assistance. The device is described as a "software tool to aid in evaluation and information management," implying it's a tool for professionals, but the performance data presented is general "nonclinical" verification.
Effect Size: Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported from this document.

6. Standalone (Algorithm Only) Performance

Standalone Performance: The document states, "QTxl is stand-alone software." The "non-clinical performance bench tests and simulated clinical performance tests" likely refer to the algorithm's standalone performance, particularly for tasks like ROI contouring and quantitative analysis. However, specific metrics are not provided.

7. Type of Ground Truth Used

Type of Ground Truth: The document does not specify the method used to establish ground truth for the "software verification testing." Hypothetically, for a device performing ROI contouring and quantitative analysis on images, the ground truth would most likely be expert consensus annotations/measurements on the medical images. Pathology or outcomes data might be relevant for clinical utility but are less direct for verifying a software's image processing capabilities.

8. Sample Size for the Training Set

Training Set Sample Size: The document does not provide details on a training set, as it is a 510(k) for a PACS/image processing tool, not a deep learning AI model that typically requires distinct training sets. The "software verification testing" mentioned would apply to the developed software based on its functional specifications. If the QTxI uses "template space" registration as mentioned, those templates would be developed, but not via a "training set" in the sense of deep learning.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: As no explicit training set is mentioned in the context of typical AI model development, the method for establishing its "ground truth" is not applicable from this document. If elements of machine learning were present (not explicitly stated for QTxI), the ground truth for training data would similarly be established by expert annotation or curated datasets.

Summary

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July 23rd, 2018

AIQ Solutions, Inc. % Mr. Mitch Lewandowski Principal/Consultant EpiReg LLC 3428 John Muir Drive MIDDLETON WI 53562

Re: K173444

Trade/Device Name: Quantitative Total Extensible Imaging (QTxI) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 8, 2018 Received: June 12, 2018

Dear Mr. Lewandowski:

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. Iisting 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 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.

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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 mediation-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 Bridges

Digitally signed by Jeffrey J.
Ballyns -S
ON: C=US, o=U.S. Government,
Du=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=200
0569725, cn=Jeffrey J. Ballyns -S
Date: 2018.07.23 10:41:24 -04'00'

for Robert 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) K173444

Device Name

Quantitative Total Extensible Imaging (QTxI)

Indications for Use (Describe)

Quantitative Total Extensible Imaging (QTxI) is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0.

QTxI assists in the following indications:

· Receive, store, retrieve, display and process digital medical images.

· Create, display and print reports from those images.
· Provide medical professionals with the ability to display, register, and fuse medical images.

· Identify Regions of Interest (ROIs) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans.

· Evaluate quantitative change in ROIs (total or partial body; individual) with 3D interactive rendering of images with highlighted ROIs.

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

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510(k) Summary

1. 510(k) Owner:

AIQ Solutions Inc.

2. Address:

8025 Excelsior Drive Madison, WI 53717

Contact Person: 3.

Mitch Lewandowski, M.S./ M.P.H; Principal Consultant Email: info@epireq.com Tel: 608 712-8585 Direct: 608 695-9333

Date 510(k) Summary Prepared: 4.

05 October 2017

5. Trade Name:

Quantitative Total Extensible Imaging (QTxl) Medical Image and Information Management System

6. Common Name:

Picture archiving and communication system

Classification Name: 7.

21 CFR 892.2050, Picture archiving and communication system (LLZ)

8. Predicate Device(s):

Exini Diagnostics AB; EXINI, K122205

Device Description: 9.

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ROIs, including 3D interactive rendering of the patient skeleton with highlighted Regions of Interest.

10. Indications for Use and Intended Use

Quantitative Total Extensible Imaging (QTxl) is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modalities of these medical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0.

QTxl assists in the following indications:

. Receive, store, retrieve, display and process digital medical images.
. Create, display and print reports from those images.
Provide medical professionals with the ability to display, register, and fuse ● medical images.
. Identify Regions of Interest (ROls) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans.
. Evaluate quantitative change in ROIs (total or partial body; individual ROI within individual) with 3D interactive rendering of images with highlighted ROIs.

11. Technological Characteristics

QTxl has substantially equivalent indications for use, principle of operation, and technological characteristics as the Exini Diagnostics AB; EXINI, K122205.

The following table summarizes and compares data on the Exini Diagnostics AB; EXINI, K122205, and supporting predicate device MIMvista Corp. MIM4.1 (Seastar), K071964.

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Specification /Characteristic	Quantitative TotalExtensible Imaging (QTxl)	Exini Diagnostics AB;EXINI, K122205	MIMvista Corp.MIM4.1 (Seastar), K071964	Comparison toPredicate(s)
	Subject Device	Predicate Device	Supporting Predicate Device
Product Code	LLZ	LLZ	LLZ	No difference
RegulationNumber	892.2050	892.2050	892.2050	No difference
RegulatoryClass	II	II	II	No difference
Review Panel	Radiology	Radiology	Radiology	No difference
PredicateDevice	Exini Diagnostics AB;EXINI (K122205)	MEQIA, IBIS Explorer and MarkupSoftware (K111319)	MIM4.0 (K060816); IKOEngelo(K061006); Centricity PACS(K043415)	N/A
510(k)/ Type	K173444, Traditional	K122205, Traditional	K071964, Traditional	No difference
Features	Receive, store, retrieve, displayand process digital medicalimages, as well as create,display and print reports fromthose images	Software tool set for acceptance, transfer,storage, image display, manipulation andquantification of digital medical images.	Receive, transmit, store, retrieve,display, print and process digitalmedical images, as well as create,display and print reports from thoseimages	No difference
MedicalModalities	DICOM CT and PET assupported byACR/NEMA DICOM 3.0	Nuclear imaging (NM) and computedtomography (CT) as supported byDICOM 3.0 standard.	CT, MRI, CR, DX, MG, US,SPECT, PET and XA as supportedby ACR/NEMA DICOM 3.0.	QTXI does not utilizeas many medicalmodalities aspredicate, but doesutilize equivalentmodalities in thoseused by both systems.
OperatingSystem	Window 7 or Windows 10	Microsoft Windows operating system	Windows 2000/XP	QTxl uses newerversions of MicroSoftWindows software
Methodology	Identifies Regions of Interest(ROI) and performs ROIcontouring allowingquantitative/statistical analysisof full or partial-body scansthrough registration to templatespace	The device uses image processingtechniques for segmentation of skeletalregions, normalization and hotspotcontouring/ segmentation. This device issemi-automatic in that it requires amanual step (hotspot verification step)where the user reviews and edits theselection of hotspots that are used asinput for quantitative analysis. The deviceperforms quantitative analysis based on2D ROI (regions of interests)measurements in whole body bone scans.	Generates contours using adeformable registration techniquewhich registers pre-contouredpatients to target patients.Registrations are either between aserial pair of intra-patient volumesor between a pre-existing atlas ofcontoured patients and a patientvolume	All devices performcentering analysesutilizing a templatemodel. QTXI alsoregisters regions of thepatient.
Specification / Characteristic	Quantitative Total Extensible Imaging (QTxI)Subject Device	Exini Diagnostics AB; EXINI, K122205Predicate Device	MIMvista Corp.MIM4.1 (Seastar), K071964Supporting Predicate Device	Comparison to Predicate(s)
Indications for Use	Quantitative Total ExtensibleImaging (QTxI) is a softwaretool used to aid in evaluationand information management ofdigital medical images bytrained medical professionalsincluding, but not limited to,radiologists, oncologists,nuclear medicine physicians,medical imaging technologists,dosimetrists and physicists. Themedical modalities of thesemedical images include DICOMCT and PET as supported byACR/NEMA DICOM 3.0.QTxl assists in the followingindications:Receive, store, retrieve,display and process digitalmedical images Create, display and printreports from those images Provide medicalprofessionals with theability to display, register,and fuse medical images	EXINI is intended to be used by trainedhealthcare professionals and researchersfor acceptance, transfer, storage, imagedisplay, manipulation, quantification andreporting of digital medical images. Thesystem is intended to be used with imagesacquired using nuclear imaging (NM) andcomputed tomography (CT). The softwareprovides generalPicture Archiving and CommunicationsSystem (PACS) tools and a clinicalapplication for oncology including lesionmarking and analysis.	MIM 4.1 (SEASTAR) software isused by trained medicalprofessionals as a tool to aid inevaluation and informationmanagement of digital medicalimages. The medical imagemodalities include, but are notlimited to, CT, MRI, CR, DX, MG,US, SPECT, PET and XA assupported by ACR/NEMA DICOM3.0. MIM 4.1(SEASTAR) assists in the followingindications:Receive, transmit, store,retrieve, display, print, andprocess medical images andDICOM objects. Create, display and printreports from medical images. Registration, fusion display,and review of medical imagesfor diagnosis, treatment,evaluation, and treatmentplanning. Evaluation of cardiac leftventricular function andperfusion, including leftventricular end-diastolicvolume, end-systolic volume,and ejection fraction.	All systems are used toreceive, store, retrieve,display, and processmedical images andDICOM objects.This is accomplishedvia registration to atemplate space andsubsequent analysis ofthe image data.The predicate devicehas multiple uses inthe therapeutic space,which is not specific toany device.
Specification /Characteristic	Quantitative TotalExtensible Imaging (QTxI)Subject Device	Exini Diagnostics AB;EXINI, K122205Predicate Device	MIMvista Corp.MIM4.1 (Seastar), K071964Supporting Predicate Device	Comparison toPredicate(s)
Indications forUse(continued)	Identify Regions ofInterest (ROIs) andperform ROI contouringallowing quantitative/statistical analysis of full orpartial body scans Evaluate quantitativechange in ROIs (total orpartial body; individualROI within individual) with3D interactive rendering ofimages with highlightedROIs.		Localization and definition ofobjects such as tumors andnormal tissues in medicalimages. Creation, transformation, andmodification of contours forapplications including, but notlimited to, quantitative analysis,aiding adaptive therapy,transferring contours toradiation therapy treatmentplanning systems, andarchiving contours for patientfollow-up and management Quantitative and statisticalanalysis of PET/SPECT brainscans by comparing to otherregistered PET/SPECT brainscans.

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12. Performance Data (Nonclinical)

QTxl is a software tool. Non-clinical performance bench tests and simulated clinical performance tests have been performed on the Quantitative Total Extensible Imaging (QTxl) in order to verify the device characteristics. Testing conducted to demonstrate substantial equivalence included:

. Software verification testing that demonstrates the device meets product performance and functional specifications.
. Software verification testing demonstrating that DICOM information collected with medical imaging systems and transmitted through manual or virtual input are captured, transmitted, and stored properly to maintain data integrity (e.g., no loss of data).

13. Conclusion

QTxl met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols.

The Quantitative Total Extensible Imaging (QTxl) software tool is substantially equivalent with respect to product performance, indications for use, intended use, scientific principles, technological characteristics, and materials, as the predicate device, Exini Diagnostics AB; EXINI, K122205.

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).