Hybrid3D that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

Device Description

HERMES Hybrid3D is a reading and processing module for the advanced needs in medical imaging. It offers multi-modal (PET/CT/MR/SPECT) coregistration and interactive fusion of multiple datasets. HybridViewer 3D handles viewing and fusion of multi-sequence MRI studies with oblique orientation and allows switching between original and standard TCS view orientation as well as defining own slice directions. 3D seqmentation, cropping and interpolation techniques allow complex tasks in VOI definition and can cover cases like cavities, splitting structures into subsections or logic operations (compute intersections, merge, grow). Results can be imported and exported as DICOM and are therefore available for research in 3rd party tools. Additionally, it provides tools for advanced 3D fusion rendering of studies and VOIs.

Lung Lobe Quantification: The Lung Lobe Quantification module in Hybrid3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function. No changes have been made to Lung Lobar Quantification since the previous release.

TumorFinder: The Tumor Finder wizard provides automatic segmentation of lesions in a PET study or a combined PET/CT study pair, based on criteria relative to a background volume placed in the liver or mediastinum. This reduces the time required for tumor delineation. It also provides both visual and statistical evaluation of tumor burden, which helps with comparing follow up studies.

SIRT: Selective Internal Radionuclide Therapy (SIRT), is currently used in the treatment of liver tumors either from primary liver cancer or metastatic disease (e.g. colorectal primary cancer). The SIRT wizard provides processing for SIRT planning and verification.

AI/ML Overview

The provided text is a 510(k) summary for the medical device Hybrid3D v3.0. While it discusses software features, regulatory details, and some testing, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner typically expected for AI/Machine Learning-based medical devices.

Instead, the performance evaluation in this document focuses on:

Comparison to a predicate device (Hybrid3D v2.0): Stating "The proposed device will use similar technology and fundamental concepts and operation are also the same," and "The comparisons between Hybrid 3D v3.0 and Hybrid 3D v2.0 (K171719) were part of the test procedure for V3.0 and showed good results." This implies a functional equivalence rather than a new clinical performance study.
Validation of specific calculations for the SIRT module: This is a validation of the accuracy of mathematical computations within a specific module, not a broad clinical performance assessment of features like image processing or tumor finding from AI.

Therefore, for many of your specific questions, the information is not present in the provided text. I will address what is available and clearly state what is missing.

Here's a breakdown based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not present a formal table of general acceptance criteria for the entire Hybrid3D device, nor does it provide a comprehensive "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity, accuracy).

However, it does provide implicit acceptance criteria and reported "performance" for the SIRT (Selective Internal Radionuclide Therapy) module's calculations:

Acceptance Criteria (Implicit)	Reported Device Performance (SIRT Module Calculations)
Lung Shunt calculations accuracy	Identical to spreadsheet calculations.
Prescribed Activity (Resin Microspheres, BSA method)	Identical to 2 decimal places to spreadsheet calculations.
Activity to Implant (Glass Microspheres, PTV method)	Identical to 2 decimal places to spreadsheet calculations.
Voxel Dose (PETDose Map) accuracy	Identical to 2 decimal places to spreadsheet calculations.
Voxel Dose (SPECT Dose Map) accuracy	Varied by up to 5% compared to spreadsheet calculations (due to normalization differences).
Absence of fundamental errors in Vmax and D90% calculations (based on manual reading challenges)	Established that there were no fundamental errors in the calculations, despite noted variances due to manual reading inaccuracy.

2. Sample Size and Data Provenance

The document does not specify sample sizes (e.g., number of patients, number of images) used for any test set or the provenance (country of origin, retrospective/prospective) of any data used for testing. The validation described for the SIRT module appears to be a comparison of calculation results against a spreadsheet, not a clinical data set.

3. Number and Qualifications of Experts for Ground Truth

The document does not mention the use of experts or their qualifications for establishing ground truth for any test set, as the described validation is for calculation accuracy against spreadsheet formulae, not expert interpretation of images.

4. Adjudication Method

The document does not mention any adjudication method, as it does not describe a process involving multiple readers or complex ground truth establishment.

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

The document does not indicate that an MRMC comparative effectiveness study was performed, or any effect size of AI assistance on human readers. The device is primarily described as a software for processing, display, and management of imaging data, and specific quantification modules, not an AI-assisted diagnostic aid that directly impacts human reader performance in a comparative study.

6. Standalone (Algorithm Only) Performance

The document describes the device's functional capabilities (image processing, display, quantification for SIRT, TumorFinder, Lung Lobe Quantification), but it does not present a standalone performance study (e.g., sensitivity, specificity, accuracy) for these algorithmic features, especially for TumorFinder or Lung Lobe Quantification, against a clinical ground truth. The "testing results supports that all the software specifications have met the acceptance criteria" is a very general statement. The specific validation described is for the calculation accuracy of the SIRT module.

7. Type of Ground Truth Used

For the specific validation described for the SIRT module, the "ground truth" used was:

Spreadsheet calculations based on formulae published by SIRTEX for Resin Microspheres and BTG for Glass Theraspheres. This is a form of scientific/mathematical ground truth for the accuracy of internal calculations, not a clinical ground truth like expert consensus, pathology, or outcomes data.

For other modules like TumorFinder or Lung Lobe Quantification, the document does not describe how their performance was validated or what type of ground truth was used.

8. Sample Size for Training Set

The document does not mention any training set sample size, which suggests that the development did not involve a machine learning model that required a distinct training phase in the context of this 510(k) submission. Given the description focusing on image processing, co-registration, 3D segmentation, and rule-based quantification (TumorFinder "based on criteria relative to a background volume"), it's plausible the "AI" aspects are more algorithmic and rule-based rather than deep learning requiring large training sets.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned, this information is not applicable/provided.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 25, 2018

HERMES MEDICAL SOLUTIONS AB % Mr. Joakim Arwidson Vice President Quality & Regulatory Affairs Strandbergsgatan 16 STOCKHOLM SWEDEN 11251

Re: K181468

Trade/Device Name: Hybrid3D Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS Dated: August 20, 2018 Received: September 24, 2018

Dear Mr. Arwidson:

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/ofdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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,

Michael D.	Digitally signed by Michael D. O'hara -SDN: c=US, o=U.S. Government, ou=HHS,ou=FDA, ou=People,0.9.2342.19200300.100.1.1=1300226759,cn=Michael D. O'hara -SDate: 2018.10.25 18:03:53 -04'00'
O'hara -S	For
Robert A. Ochs, Ph.D.
Director
Division of Radiological Health
Office of In Vitro Diagnosticsand Radiological Health
Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181468

Device Name Hybrid3D

Indications for Use (Describe)

Hybrid3D that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

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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5.0 510 (k) SUMMARY

A. Submitted by:

Submitters name and address: ● Hermes Medical Solutions AB Strandbergsgatan 16 112 51 Stockholm Sweden

. Submitters telephone number

Phone:	+46 8 19 03 25
Cell:	+46 708 19 03 08
E-mail:	joakim.arwidson@hermesmedical.com

. Contact person

Joakim Arwidson VP Quality and Regulatory Hermes Medical Solutions AB Strandbergsgatan 16 112 51 Stockholm Sweden

. Registration number 9710645
B. Preparation date: 2018-05-30

C. Proprietary/Trade name, Common name, Classification name :

Proprietary/Trade name . Hybrid3D v3.0
. Common name Image processing systems
. Classification name Emission Computer Tomography System, Class II, 21CFR892.1200

D. Legally marketed device (predicate device):

Following legally marketed device has been used for comparison.

. Hybrid3D v2.0 (K171719)

E. Description of the device that is subject of this premarket notification :

Hvbrid3D

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complex tasks in VOI definition and can cover cases like cavities, splitting structures into subsections or logic operations (compute intersections, merge, grow). Results can be imported and exported as DICOM and are therefore available for research in 3rd party tools. Additionally, it provides tools for advanced 3D fusion rendering of studies and VOIs.

Lung Lobe Quantification

The Lung Lobe Quantification module in Hybrid3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function. No changes have been made to Lung Lobar Quantification since the previous release.

TumorFinder

The Tumor Finder wizard provides automatic segmentation of lesions in a PET study or a combined PET/CT study pair, based on criteria relative to a background volume placed in the liver or mediastinum. This reduces the time required for tumor delineation. It also provides both visual and statistical evaluation of tumor burden, which helps with comparing follow up studies.

SIRT

Selective Internal Radionuclide Therapy (SIRT), is currently used in the treatment of liver tumors either from primary liver cancer or metastatic disease (e.g. colorectal primary cancer). The SIRT wizard provides processing for SIRT planning and verification.

F. Intended use:

Hybrid3D that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

Warning! The results generated by the SIRT function cannot be used to change a treatment plan after the treatment has been delivered, nor can the results be used to impact future treatment planning for any type of radiation therapy or chemotherapy. The SIRT function cannot be used for prospective treatment planning of initial treatment with microspheres in contradiction to the labeling of Class III radiation microsphere devices.

Warning! The results from the SIRT function using the partition model for dose planning cannot be used to change a clinical Y90 SIRT treatment plan, either before or after treatment. Nor can the results be used to impact future clinical treatment planning for any type of radiation therapy or chemotherapy. The SIRT function cannot be used for prospective treatment planning, initial or retreatment, with Y90 microspheres in contradiction to the labeling of the Class III radiation microspheres devices.

G. Technological characteristics:

The proposed device Hybrid3D has the same technological characteristics as the predicate device and the same indication for use.

H. Testing:

The tests for verification and validation followed Hermes Medical Solutions AB design controlled procedures. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria.

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I. Substantially Equivalent/Conclusions:

The proposed device Hybrid3Dv3.0and the predicate device Hybrid 3D v2.0 (K171719) have the same indication for use.

The proposed device will use similar technology and fundamental concepts and operation are also the same, as described in the 510(k) submission.

The comparisons between Hybrid 3D v3.0 and Hybrid 3D v2.0 (K171719) were part of the test procedure for V3.0 and showed good results.

Validation of the Hybrid3D SIRT has been made between the calculations performed by Hybrid3D and the results from spreadsheet calculations based on the formulae published by SIRTEX for the Resin Microspheres and BTG for the Glass Theraspheres.

Lung Shunt was calculated from planar images. The results for Lung Shunt were identical.
. The Prescribed Activity for Planning using Resin Microspheres using the BSA method were identical to 2 decimal places
The Activity to Implant for Planning using Glass Microspheres using the PTV method were identical to 2 decimal places
The Voxel Dose measured from the PETDose Map was identical to 2 decimal places ●
The Voxel Dose measured from the SPECT Dose Map varied by up to 5% because the . methods used for normalization, by calculating the common field of view by the application and by the test procedure, differ slightly.
. The values for Maximum Dose and Dose at 90% Volume D90%(Gy) differ because of the inherent inaccuracy of reading values manually from the Dose Volume Histogram. The test was performed only to establish that there were no fundamental errors in the calculations.

In summary, the Hybrid3Dv3.0 described in this submission is in our opinion substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.