cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data.

cNeuro™ cDAT enables visual evaluation and quantification of ioflupane I 123 (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of ioflupane I 123 (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB).

cNeuro™ cDAT has not been demonstrated to improve ioflupane I 123 reader performance for distinguishing positive from negative patients. This device should not be used to deviate from ioflupane I 123 dosing and administration instructions. Refer also to ioflupane I 123 prescribing information for instructions.

Device Description

cNeuro™ cDAT is Software as a Medical Device (SaMD) intended to aid physicians in the evaluation of the loss of functional dopaminergic neuron terminals in the striatum through the quantification of ioflupane I 123 (DaTscan™) images. cNeuro™ cDAT is a fully automated image analysis software tool that provides tools for viewing DaTscan™ images and quantification of tracer uptake in the striatum with comparison to reference data from healthy controls. The results are summarized in a PDF-report.

cNeuro™ cDAT quantifies DaTscan™ brain images and computes Striatal Binding Ratios (SBRs) for different volumes of interest (VOIs). SBRs are computed by subtracting the uptake in a background VOI from the tracer uptake in the target VOI and then dividing this value with uptake in a background VOI. Results are compared with normative values in a reference database and z-scores are presented.

cNeuro™ cDAT quantifies the data by registering the images to a template where VOIs are defined. Quantification results are summarized in PDF-reports that are sent to the organization's PACS. cNeuro™ cDAT also offers interactive review of the DaTscan™ images and the quantification results in a browser-based viewer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Requirement)	Reported Device Performance (cNeuro™ cDAT)
Percentage of patients with paired z-value outputs differing by >0.5 from the predicate device	Ranged from 5.4% to 7.6% for the left and right putamen, caudate, anterior putamen, and posterior putamen. This implies 92.4% to 94.6% of patients had z-value outputs within ±0.5 of the predicate.
Compliance with DICOM Standard (NEMA PS 3.1 - 3.20 (2021))	Complies with NEMA PS 3.1 - 3.20 (2021) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.
Adequate quality of displayed images and other software functions to not present a hazardous situation.	Failure or latent flaw of software functions would not present a hazardous situation with a probable risk of death or serious injury. (This is a safety assessment rather than a specific performance metric, but it functions as an acceptance criterion for safety).

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Imaging from 370 patients was initially available. A subset of 48 images could not be processed with the predicate device and were excluded. Therefore, the effective test set size used for comparison was 322 patients (370 - 48).
Data Provenance: The imaging data was obtained from third-party clinical investigations (NCT01952678, NCT01141023). The text does not explicitly state the country of origin, but clinical trial identifiers common in the US suggest it could be US-based or international. The data is retrospective as it was available following these completed clinical investigations.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. The performance testing was a comparison against a predicate device's output (z-values), not against a separate expert-defined ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set in the context of expert review. As noted above, the testing involved a direct comparison of z-value outputs between the subject device and the predicate device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess human reader improvement with AI assistance. The Indications for Use section explicitly states: "cNeuro™ cDAT has not been demonstrated to improve ioflupane I 123 reader performance for distinguishing positive from negative patients."

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The performance testing described involved the cNeuro™ cDAT software (the algorithm) independently processing patient images and generating z-value outputs, which were then compared to the predicate device's z-value outputs. There is no mention of a human-in-the-loop component in this specific performance comparison.

7. Type of Ground Truth Used

The "ground truth" for the performance comparison was the output values (z-scores) generated by the predicate device (DaTQUANT Application / GE Medical Systems, LLC.) for the same patient images. This is a comparison against an established, legally marketed device's quantitative outputs, rather than a clinical ground truth (like pathology or outcomes data) directly determining disease status. The device "assists in detection of loss of functional dopaminergic neuron terminals," but the performance study focused on agreement with the predicate's quantification.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set used to develop the cNeuro™ cDAT algorithm. It mentions that "Data from DaTscan™ studies of healthy controls is used to define a reference normal database," which is part of the device's functionality, but this is distinct from the training data for the image processing and quantification algorithm itself.

9. How Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for the training set was established for the image processing and quantification algorithm. It does mention that the "Normal Database" used for comparison within the device is defined from "Data from DaTscan™ studies of healthy controls." This normal database would have its own "ground truth" definition (i.e., these individuals were determined to be healthy controls), but this isn't directly the ground truth for training the core quantification algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 1, 2024

Combinostics OY % Erin Gontang Senior Consultant Ram+ 2790 Mosside Boulevard, #800 Monroeville, PA 15146

Re: K233908

Trade/Device Name: cNeuro™ cDAT Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: May 30, 2024 Received: May 30, 2024

Dear Erin Gontang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

D.G.K.

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233908

Device Name cNeuro™ cDAT

Indications for Use (Describe)

cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data.

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 K233908

DATE PREPARED

July 3, 2024

MANUFACTURER AND 510(k) OWNER

Combinostics OY Hatanpään valtatie 24 FI 33100 Tampere, Finland Telephone: Official Contact: Lennart Thurfjell, CEO

REPRESENTATIVE/CONSULTANT

Erin A. Gontang, Ph.D. Allison C. Komiyama, Ph.D., RAC RQM+ 2790 Mosside Boulevard, #800 Monroeville, PA 15146, United States Telephone: +1 (877) 652-0830 Email: egontang@rqmplus.com akomiyama@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	cNeuro™ cDAT
Common Name:	System, Image Processing, Radiological
Regulation Number:	21 CFR §892.2050
Class:	Class II
Product Code:	LLZ
Premarket Review Panel:	Radiology

PREDICATE DEVICE IDENTIFICATION

The cNeuro™ cDAT is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K201103	Xeleris V Processing and Review Systems(DaTQUANT Application) / GE Medical Systems, LLC.	✓

The predicate device have not been subject to a design related recall.

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DEVICE DESCRIPTION

INDICATIONS FOR USE

cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data.

cNeuro™ cDAT enables visual evaluation and quantification of ioflupane l 123 (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of ioflupane I 123 (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB).

cNeuro™ cDAT has not been demonstrated to improve ioflupane | 123 reader performance for distinguishing positive from negative patients. This device should not be used to deviate from ioflupane I 123 dosing and administrations. Refer also to ioflupane I 123 prescribing information for instructions.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Combinostics believes that the cNeuro™ cDAT is substantially equivalent to the predicate device based on the information summarized here:

The subject device and predicate device are software for the automated quantification, visualization, and reporting of ioflupane I 123 (DaTscan™) images. Both devices compute Striatal Binding Ratios (SBRs) where the uptake in a background region is subtracted from the uptake in a target region or voxel and then the difference is divided with the value in a background region. In addition to SBRs, both devices compute asymmetry between striatal

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regions as well as putamen/caudate ratios. Both devices compute z-scores by comparing extracted features with corresponding values in reference data from healthy controls.

The subject device and predicate device achieve their intended use based on the identical principle, which is the quantification system relies on registering the SPECT data to a template space where a volume of interest template is defined.

	Subject Device	Predicate Device	ProductCode(s)	LLZ - System, Image Processing,Radiological	LLZ - System, Image Processing,Radiological
	Combinostics OYcNeuro™ cDAT	GE HealthcareXeleris V Processing and Review Systems(DaTQUANT Application)	Regulation	21 CFR 892.2050 / Medical image	21 CFR 892.2050 / Medical image
	K233908	K201103	Number/Description	management and processing system	management and processing system
Indicationsfor Use	cNeuro™ cDAT is intended for use byNuclear Medicine or Radiologypractitioners and referring physicians fordisplay, processing, and reporting ofNuclear Medicine Imaging data.cNeuro™ cDAT enables visual evaluationand quantification of ioflupane I 123(DaTscan™) images. The softwareenables automated quantification oftracer uptake and comparison with thecorresponding tracer uptake in healthysubjects as provided by normalpopulation databases of ioflupane I 123(DaTscan™) images. cNeuro™ cDATassists in detection of loss of functionaldopaminergic neuron terminals in thestriatum, which is correlated withParkinson disease or Dementia withLewy Bodies (DLB).	The system is intended for use byNuclear Medicine (NM) or Radiologypractitioners and referring physicians fordisplay, processing, archiving, printing,reporting and networking of NMI data,including planar scans (Static, WholeBody, Dynamic, Multi-Gated) andtomographic scans (SPECT, Gated SPECT,dedicated PET or Camera-Based-PET)acquired by gamma cameras or PETscanners. The system can run ondedicated workstation or in a server-client configuration. The NM or PET datacan be coupled with registered and/orfused CT or MR scans, and withphysiological signals in order to depict,localize, and/or quantify the distributionof radionuclide tracers and anatomicalstructures in scanned body tissue forclinical diagnostic purposes.	Import ofSPECTImages	Can only take reconstructed DaTscan™SPECT images as input.	Can take both raw and reconstructedDaTscan™ SPECT images as input. If rawimages are provided, there is areconstruction pre-processing step.
	cNeuro™ cDAT has not beendemonstrated to improve ioflupane I123 reader performance fordistinguishing positive from negativepatients. This device should not be usedto deviate from ioflupane I 123 dosingand administration instructions. Referalso to ioflupane I 123 prescribinginformation for instructions.	The DaTQUANT optional applicationenables visual evaluation andquantification of 123I-ioflupane(DaTscan™) images. DaTQUANT NormalDatabase option enables quantificationrelative to normal population databasesof 123 I ioflupane (DaTscan™) images.These applications may assist indetection of loss of functionaldopaminergic neuron terminals in thestriatum, which is correlated withParkinson disease.	SupportedTracers	DaTscan™ only	DaTscan™ only
Method forQuantification	A VOI template outlining caudate,anterior putamen, posterior putamenand a background region is defined intemplate space. The patient's SPECTimage is registered to the template andthe regions are applied to the data andcounts within each region.	A VOI template outlining caudate,anterior putamen, posterior putamenand a background region is defined intemplate space. The patient's SPECTimage is registered to the template andthe regions are applied to the data andcounts within each region.
QualityCheck ofRegistration	There is an automated check of theregistration parameters and if they areoutside the expected range, the image isautomatically repositioned, and a newregistration is started. This is repeated 5times. There is also a check if theoccipital reference region is outside thebrain.If registration was not successful, noquantification results are presented.If registration is successfully completed,the user is provided with images toreview the quality of the imageregistration and fitting of the VOIs, butthere is no explicit "I have approved"button.	The user needs visually checkregistration and click "Passed" beforequantification results are shown. Ifregistration was not successful, the userhas the ability to manually reposition theimages and rerun the image registration.
Ability forUser toMoveRegions	User does not have the ability tointeractively move regions.	User has the ability to interactively moveregions.
NormalDatabase	Data from DaTscan™ studies of healthycontrols is used to define a referencenormal database.	Data from DaTscan™ studies of healthycontrols is used to define a referencenormal database.

A comparison of the subject device and predicate device is provided below.

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Formula forNormalValues	By default, a line is fitted to the meanof values in the normal database. Fromthe user interface, it is possible to enablevisualization of z-scores for normativedata at ±1.0, ±1.5, ±1.7, and ±2.0. Thelines are fitted using theordinary least squares (OLS) method, i.e.,linear regression, and was performedseparately for two age segments ([31,55] and [68, 84]). Additionally, quadraticBezier curves are fitted to connect thetwo linear segments.The mean and standard deviation for acertain age are defined from thesefitted curves.	By default, a line is fitted to the meanof values in the normal database. Fromthe user interface, it is possible toenable visualization of z-scores fornormative data at ±1.0, ±1.5, ±1.7, and±2.0. The lines are fitted using theordinary least squares (OLS) method, i.e.,linear regression, and was performedseparately for two age segments ([31,55] and [68, 84]). Additionally, quadraticBezier curves are fitted to connect thetwo linear segments.The mean and standard deviation for acertain age are defined from thesefitted curves.
User CreatedNormalDatabase	User does not have the ability to createtheir own database.	User has the ability to create their owndatabase.
Output fromQuantification	Striatal Binding Ratios (SBRs) arecomputed for Caudate, anteriorPutamen, posterior Putamen, Putamenas a whole, and Striatum as a whole. Inaddition, asymmetry is computed for theStriatum as a whole, for the Caudate andfor the Putamen.Z-scores are computed for each featureby comparing the value with thecorresponding mean and standarddeviation in the normal database.	Striatal Binding Ratios (SBRs) arecomputed for Caudate, anteriorPutamen, posterior Putamen, Putamenas a whole, and Striatum as a whole. Inaddition, asymmetry is computed for theStriatum as a whole, for the Caudate andfor the Putamen.Z-scores are computed for each featureby comparing the value with thecorresponding mean and standarddeviation in the normal database
Databaseselectionandwarnings	The recommended reconstructionmethod is OSEM, 2 iterations, 10subsets, Butterworth 3D post-filteringwith power factor = 10, cut off = 0.6.The default normal database isconfigured in the organizations settings.The reconstruction method used isdisplayed in the UI and in the report andif the user selects a different database, awarning is shown in the UI and in thereport.	The recommended reconstructionmethod is OSEM, 2 iterations, 10subsets, Butterworth 3D post-filteringwith power factor = 10, cut off = 0.6.If data is reconstructed within thedevice, i.e., reconstruction methods isknown, the system will select the correctdatabase. If already reconstructedimages are imported, the user will haveto enter information so a database canbe selected unless the necessaryinformation can be derived from DICOMtags.The reconstruction method used isdisplayed in the UI and in the report and ifthe user selects a different database, awarning is shown in the UI and in thereport.
Graphical UserInterface(GUI)	The GUI allows the user to scroll images,view images with and without regionsoutlined, change color scale and windowlevels, view regional results and plotswith comparison to the normaldatabase.	The GUI allows the user to scroll images,view images with and without regionsoutlined, change color scale and windowlevels, view regional results and plotswith comparison to the normaldatabase.
Report	A PDF report is generated. The reportformat is fixed.	A PDF report can be generated. The userhas some flexibility in the tailoring of thereport.

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SUMMARY OF PERFORMANCE TESTING

The cNeuro™ cDAT software complies with NEMA PS 3.1 - 3.20 (2021) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.

cNeuro™ cDAT employs the same fundamental scientific technology as its predicate device, Xeleris/DaTQUANT. cNeuro™ cDAT uses the equivalent DICOM image data input requirements. It has equivalent display, formatting, archiving and visualization technologies compared to the predicate device. cNeuro™ cDAT utilizes the same methodology to quantify and assess uptake in ioflupane I 123 (DaTscan™) images. The information is presented using volumes of interest. Thorough testing of these capabilities has not raised any safety or effectiveness issues.

The following quality assurance measures were applied to the development of the system:

Risk Analysis
Requirements Reviews
Design Reviews
Integration testing (System verification)
Performance testing (Bench testing, verification)
Safety testing (Verification)

Combinostics believes that a failure or latent flaw of the cNeuro™ cDAT software function, such as inadequate quality of displayed images, would not present a hazardous situation with a probable risk of death or serious injury to either a patient, user of the device, or others in the environment of use, prior to the implementation of risk control measures. Based on the implementation of the Documentation Level risk-based approach, Combinostics has provided Basic Documentation in support of the cNeuro™ cDAT premarket notification.

Combinostics has conducted testing on the cNeuro™ cDAT software. For performance testing, imaging of 370 patients was available to Combinostics following third-party clinical investigations (NCT01952678, NCT01141023). A subset of 48 images could not be processed with the predicate device and were excluded from further testing. Combinostics used the imaging from each included patient as input to both the subject and predicate devices so that paired z-value outputs from each device could be compared. The upper bound of the 95% confidence interval for the percentage of patients with paired z-value outputs differing by >0.5 was tested. This patient percentage ranged from 5.4% to 7.6% for the left and right putamen, caudate, anterior putamen, and posterior putamen, suggesting 92.4% to 94.6% of patients representative of the studied population have equivalent-to-predicate (±0.5) z-value outputs.

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The software passed all performance requirements and met specifications.

CONCLUSION

The subject device does not raise different issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed cNeuro™ cDAT are assessed to be substantially equivalent to the predicate device.

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).