UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.

For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.

Device Description

UniSyn Molecular Imaging (MI) is a Software as a Medical Device (SaMD) that supports the visualization, manipulation and analysis of medical image data acquired or used in radiology and nuclear medicine centers. UniSyn Ml is only intended to be used by qualified radiology and nuclear medicine professionals. Univer-interface components: a patient study browser and the UniSyn MI viewer. The software is available in both thick and can be integrated to launch from PACS software.

Using UniSyn MI users can coregister anatomical and visualize them in fused and/or standalone display, e.g. single or multi-modal combinations of PET, SPECT, CT, and MR images. Users can also visualize and process planar nuclear medicine (NM) images acquired as single of multi-frame images. The layout of the UniSyn MI viewer is highly customisable, a typical layout for a PET/CT study would include of the PET and CT series in multiplanar reformatted (MPR) views as well as a 3D maximum-intensity (MIP) projection rendering of the PET series.

UniSyn MI provides tools to zoom, pan, stack, and window-level the displayed series. Our triangulation tool can be used to localize a single anatomical point of interest among all MPR and MP views of the rest (RO) tools are available to delineate 2D and 3D regions and then compute image statistics within those regions, e.g. ROI area/volumes, minimum, mean and standard deviation of image pixel values. Various image segmentation tools are included with UniSyn MI to facilitate ROI delineation based on image pixel data.

UniSyn MI includes a tool for absorbed dose estimation associated with internally deposited with diagnostic and therapeutic medical procedures. Absorbed dose estimates are based on single- or multi-time point activity measurements of molecular images and absorbed dose coefficients (S-Values) that are based on computational human models.

Once a user has completed their review or analysis of a given study, UniSyn MI provides tools to generate reports and export exemplary image data to share with referring physicians to substantiate their findings.

AI/ML Overview

The medical device described in the document is "UniSyn Molecular Imaging (6-3-1)". It is a software application for image registration, fusion display, and analysis of medical image data (CT, PET, SPECT, MR) used by radiology and nuclear medicine professionals. It also estimates radiation dose from internalized radioactivity.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

Functionality Tested	Acceptance Criteria	Reported Device Performance
Normal Organ Dosimetry	Relative difference at or below 10% (compared to published data)	High overall agreement with published data, with mean relative differences < 2%. This was demonstrated for both male and female patients.
Tumor Dosimetry	Relative difference at or below 10% (compared to OLINDA/EXM v1.0, K033960)	Excellent overall agreement, with mean relative differences ranging from <1% up to 6.5%, depending on the radionuclide and tumor sizes (ranging from 3.9 to 600 cc).
Shared Predicate Functionality¹	Existing verification and validation testing protocols (implied)	Functionality shared with the predicate device (K081987) was verified and validated using existing protocols. Performance testing was not required for these shared functionalities, implying they met previously established criteria.

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

Normal Organ Dosimetry: "Published data" and "published literature" were used for comparison. The specific number of patients or organs within these published data sets is not specified. Data provenance is implied to be from existing medical literature.
Tumor Dosimetry: Comparisons were made using "tumor sizes ranging from 3.9 to 600 cc," implying a range of scenarios were tested against the OLINDA/EXM v1.0 sphere model. The specific number of tumor cases or datasets used is not specified. Data provenance is implied to be through comparison with an existing, cleared device (OLINDA/EXM v1.0).
Radionuclides Evaluated: Fluorine-18, Gallium-177, Technetium-99m, and Yttrium-90 were evaluated. The number of samples for each radionuclide is not specified.
The document does not specify countries of origin, nor whether the data was retrospective or prospective. It mainly focuses on comparison with existing validated models and literature.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. Ground truth was established by:

Comparison to "values from published data" for normal organ dosimetry.
Comparison to the "sphere model of OLINDA/EXM v1.0 (K033960)" for tumor dosimetry.

4. Adjudication method for the test set

The document does not specify an adjudication method for the test set. The testing involved direct comparison to reference values from published literature or a validated software model, rather than expert adjudication of device outputs.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned for the UniSyn Molecular Imaging device in this document. The study focused on the validation of the dosimetry model's accuracy against established references, not human-in-the-loop performance or improvement with AI assistance.

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

Yes, a standalone performance evaluation was done for the dosimetry model. The testing involved comparing the device's dose estimates directly against reference values from published data and another FDA-cleared device (OLINDA/EXM v1.0). This evaluates the algorithm's performance in isolation from human interpretation.

For functionalities shared with the predicate (image registration, visualization, measurements, etc.), "existing verification and validation testing protocols" were used, which would also likely be standalone performance evaluations of the software's capabilities.

7. The type of ground truth used

The ground truth used was:

Published Literature/Data: For normal organ dosimetry, comparison was made to established values in published literature.
Validated Software Model: For tumor dosimetry, comparison was made to the sphere model of an FDA-cleared device, OLINDA/EXM v1.0 (K033960), which itself serves as a recognized ground truth for dose estimation in that context.

8. The sample size for the training set

The document does not specify the sample size for any training set. Given that the testing methods involve comparisons to established models and published data, it is likely that the dosimetry model relies on pre-existing scientific understanding and computational models rather than a machine learning approach that requires a distinct "training set."

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

As no specific training set is mentioned (implying a non-machine learning approach for the core dosimetry calculations), the establishment of ground truth for a training set is not applicable in this document. The underlying principles and S-values used in the dosimetry model would be based on established scientific principles and data.

This includes functionalities like image registration, fusion display, creation of multi-planar reformat and maximum intensity projection displays, measurements (area, volume, SUV), ROI tools, image segmentation, and reporting/exporting image data. ↩

Summary

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September 1, 2023

Convergent Imaging Solutions Mathew Thomas President 36 Rideau River Lane Ottawa, Ontario K1S 0X1 Canada

Re: K231047

Trade/Device Name: UniSyn Molecular Imaging (6-3-1) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, IYX Dated: August 2, 2023 Received: August 2, 2023

Dear Mathew Thomas:

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

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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) 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 (OS) 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,

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

Enclosure

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Indications for Use

Submission Number (if known)

K231047

Device Name

UniSyn Molecular Imaging (6-3-1)

Indications for Use (Describe)

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) #: K231047	510(k) Summary	Prepared on: 2023-09-01
Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Convergent Imaging Solutions
Applicant Address	36 Rideau River Lane Ottawa ON K1S 0X1 Canada
Applicant Contact Telephone	1-613-212-0063
Applicant Contact	Mr. Mathew Thomas
Applicant Contact Email	mathew.thomas@convergentimaging.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	UniSyn Molecular Imaging (6-3-1)
Common Name	Medical image management and processing system
Classification Name	System, Image Processing, Radiological
Regulation Number	892.2050
Product Code	LLZ
Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K081987	UNISYN	LLZ
K033960	(Reference Device) OLINDA/EXM v1.0	IYX
K212587	(Reference Device) 3D-RD-S	IYX
K163687	(Reference Device) OLINDA/EXM V2.0	IYX

Device Description Summary

21 CFR 807.92(a)(4)

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image pixel data.

Intended Use/Indications for Use

For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure materials. UniSyn should not be used to deviate from approved product dosing and administrations. Refer to the product's prescribing information for instructions.

Indications for Use Comparison

This device has the same intended use as the predicate device (K081987) and the intended use of the reference device K163687 OLINDA/ EXM V2.0.

Technological Comparison

In all aspects except dosimetry, UniSyn Molecular Imaging has the same technological characteristics and functionality as the predicate device K081987. In the dosimetry aspect, Unisyn Molecular Imaging has the same technological characteristics of the reference device (OLINDA/EXM v2.0, K163687) as they both support whole organ / tissue absorbed dose estimates due to the administration of radiopharmaceuticals using S-Value calculations.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Performance testing was not required for functionality that is shared with the predicate (K081987). This functionality was verified and validated using existing verification and validation testing protocols.

Performance testing was completed to validate the technological characteristics of the dosimetry model used in UniSyn MI. Various radionuclides including Fluorine-18, Gallium-177, Technitium-99m, and Yttrium-90 were evaluated. For all tests, dose estimates were compared to reference values described below. Relative differences (reported as percentages) were used to characterize agreement. The acceptance criteria was set as a relative difference at or below 10%.

Validation of normal organ dosimetry was based on comparisons to values from published data. Data evaluated for both male and female patients demonstrated high overall aith published data demonstrating relative differences (mean relative differences < 2%) below the acceptance criteria.

Validation of tumor dosimetry was based on comparisons to the sphere model of OLINDA/EXM v1.0 (K033960). These comparisons included tumor sizes ranging from 3.9 to 600 cc. The overall across all tumor sizes was excellent with mean relative differences that ranged from <1% up to 6.5%, depending on the radionuclide.

The performance data exhibit high concordance with data found in published literature and generated by FDA-cleared devices and met the acceptance criteria. We have demonstry model implemented in UniSyn MI has been validated, and the performance data provided demonstrate that UniSyn Molecular Imaging (6-3-1) performs comparably to the predicate device that is currently marketed for the same intended use.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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).

Footnotes

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Device Description Summary

Intended Use/Indications for Use

Indications for Use Comparison

Technological Comparison

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

§ 892.2050 Medical image management and processing system.