The Spectrum Dynamics Medical's VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring therapy.

SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; whole body and tomographic imaging.

CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles. The CT part is indicated for pediatric and adult patients.

SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.

Device Description

VERITON™ CT consists of Single Photon Emission Computed Tomography (SPECT) scanners and integrated X-Ray Computed Tomography (CT). The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates the CT's anatomical details for precise reference of the location of the metabolic activity. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as stand- alone diagnostic imaging devices.

AI/ML Overview

The provided text describes the VERITON™ CT whole body SPECT/CT system, a medical imaging device. However, it does not contain detailed information about specific acceptance criteria for a study, nor does it present a detailed study proving the device meets those criteria in the format requested.

The document discusses "Performance testing" and "Summary of Non-Clinical Testing" which state that "All testing has met the acceptance criteria for the proposed device." It also mentions a "Summary of Clinical Testing" where a radiologist evaluated sample images for diagnostic quality.

Based on the information provided, I can only generate a partial answer, focusing on the available details and explicitly stating when information is missing.

Here's the breakdown of what can be extracted:

A table of acceptance criteria and the reported device performance
- The document states that "All testing has met the acceptance criteria for the proposed device" for areas like energy resolution, count rate linearity, uniformity, system resolution, and lesion detectability. However, the specific numerical or descriptive acceptance criteria and the reported device performance values are not provided.

Acceptance Criteria (Specifics Not Provided)	Reported Device Performance
Non-Clinical Performance:
Energy resolution	Met acceptance criteria
Count rate linearity	Met acceptance criteria
Uniformity	Met acceptance criteria
System resolution	Met acceptance criteria
Lesion detectability	Met acceptance criteria
Clinical Performance:
Diagnostic quality of SPECT images	Confirmed by radiologist
Diagnostic quality of CT images	Confirmed by radiologist
Diagnostic quality of SPECT/CT images	Confirmed by radiologist

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for non-clinical testing. For clinical testing, it states "Sample clinical images" which implies an unspecified number, likely small, and not a statistically defined test set.
- Data Provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "a board-certified radiologist" (one expert).
- Qualifications: "board-certified radiologist." Specific experience (e.g., "10 years of experience") is not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: "None" or not applicable, as only one radiologist was used for evaluation.
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
- MRMC Study: No, there is no indication of an MRMC comparative effectiveness study involving human readers with and without AI assistance. This device is an imaging system, not explicitly a standalone AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The document describes the device (VERITON™ CT system) performance and capabilities. It doesn't detail an "algorithm only" performance separate from the integrated system. The clinical "evaluation" involved a human radiologist reviewing images produced by the system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For clinical evaluation, the ground truth was established by a "board-certified radiologist" confirming "diagnostic quality." This points to expert opinion/evaluation rather than a definitive "ground truth" like pathology for specific disease detection accuracy. For non-clinical testing, phantoms were used, but the specific "ground truth" for e.g. "lesion detectability" in phantoms is inherent to the phantom design.
The sample size for the training set
- Training Set Sample Size: Not applicable/not specified. The document describes a medical imaging device, not a machine learning model that would typically have a separate training set.
How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable, as there's no mention of a traditional "training set" for a machine learning model.

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 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.

November 9, 2018

Spectrum Dynamics Medical Ltd % Igor Naroditsky Director QA/RA 22 Bareket St. North Industrial Park CAESAREA 3088900 ISRAEL

Re: K182484

Trade/Device Name: VERITON CT whole body SPECT/CT system Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: August 15, 2018 Received: September 11, 2018

Dear Mr. Naroditsky:

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.

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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) 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 (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 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 medical devices and radiation-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,

Hol 2. Nils

for Robert A. 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)

K182484

Device Name

VERITON™ CT whole body SPECT/CT system

Indications for Use (Describe)

SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; whole body and tomographic imaging.

Type of Use (Select one or both, as applicable)
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☒ For use in connection with a PPE-related Settlement Program
☐ For use in connection with a PPE-related Settlement Claim

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo consists of a blue triangular prism on the left and the words "SPECTRUM" and "DYNAMICS MEDICAL" in blue on the right. The word "SPECTRUM" is in a larger font than "DYNAMICS MEDICAL". The logo is set against a white background with a curved blue line at the bottom.

PREMARKET NOTIFICATION 510(K) SUMMARY 7.

The Company's 510(k) summary as required by 21 CFR Part 807.87(h) and 21 CFR Part 807.92(c) is provided on the following pages.

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Image /page/5/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo consists of a blue triangular shape on the left and the words "SPECTRUM" and "DYNAMICS MEDICAL" in blue on the right. The word "SPECTRUM" is in a larger font than "DYNAMICS MEDICAL". The logo is clean and professional, and the colors are calming.

510(k) SUMMARY OF SAFETY AND EFFECTIVNESS

510(k) Number K182484

Date of submission:	July 31, 2018
Submitter:	Spectrum Dynamics Medical Ltd.22 Bareket St. North Industrial ParkCaesarea, Israel 3088900.
Submitter Contact:	Mr. Igor NaroditskyDirector QA/RATel: + (972) 73-737-4548Fax: + (972) 73-737-4502Email: igorn@spectrum-dynamics.com
Device Trade Name:	VERITON™ CT
CommonName/Classification:	Single Photon Emission Computed Tomography(SPECT)/Computed Tomography (CT) system
Class:	II
Product Code:	KPS and JAK
Classification Panel:	Radiology
Regulation No:	Emission Computed Tomography per 21 CFR892.1200 and Computed Tomography X-RaySystem per 21 CFR 892.1750

Marketed Devices:

The Spectrum Dynamics VERITON™ CT system is a modification to the VERITON™ NM system (K180514) with the addition of the CT component to extend system's intended use. All system parts which are not related to the CT component remain the same as in the VERITON™ NM system (K180514) and have the same functionality and performance.

Predicate device:

Spectrum Dynamics Medical's VERITON™ NM (K180514)

GE Healthcare Discovery NM_CT 670 CZT (K153402)

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Referenced device:

Analogic Corporation CT6485 (K172058) Computed Tomography (CT) Scanner to support CT part used.

Siemens Symbia 6.5 system (K162337) to support SPECT/CT combination and intended use.

Device Description:

Intended Use:

The Spectrum Dynamics Medical's VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring therapy.

SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; whole body and tomographic imaqing.

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SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) imaqes.

Technological characteristic:

Spectrum Dynamics' VERITON™ CT employs the same fundamental scientific technology as it's predicate device VERITON™ NM (K180514). The CZT detectors, system architecture and SPECT performance specifications have not changed between the commercially available VERITON™ NM (K180514) and proposed VERITON™ CT system.

The CT part is similar to the Analogic Corporation CT6485 (K172058) Computed Tomography (CT) Scanner.

Determination of substantial equivalence:

Performance testing

Verification & Validation includes testing for Biocompatibility, Software, Electrical Safety / EMC, Consensus Standard testing applicable for SPECT/CT scanners, mitigation measures set forth in device specific regulations (21CFR §1020.30, §1020.33), and usability. These tests were conducted to characterize the performance of the proposed device functionality against that of the predicate device. The supplementary non-clinical performance evaluations used a variety of test methods and phantoms appropriate for the performance metric/claim that was to be tested and evaluated. Mathematical and physics analysis were performed to demonstrate that each performance metric/claim was successfully verified and substantiated. The areas additionally evaluated included energy resolution, count rate linearity, uniformity, system resolution and lesion detectability. All testing has met the acceptance criteria for the proposed device.

Summary of Non-Clinical Testing:

The device has successfully completed all design control testing as per our quality system. No new hazards were identified, and no unexpected test results were obtained. The VERITON™ CT system was designed and will be manufactured under the Quality System Requlations of 21CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system:

. Risk Analysis

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Design Reviews ●
. Software Development Lifecycle
Testing on unit level (Module verification) ●
. Integration testing (System verification)
. Performance testing (Verification)
. Safety testing (Verification)

Spectrum Dynamics believes that the VERITON™ CT system is substantially equivalent to the VERITON™ NM system (K180514). The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.

Summary of Clinical Testing:

Sample clinical images of the SPECT, CT and SPECT/CT modalities were evaluated by a board-certified radiologist to confirm that the images were of diagnostic quality.

Conclusion:

Based on the conformance to standards, development under Spectrum Dynamics quality system, the successful verification testing, additional engineering testing, and the clinical evaluation, Spectrum Dynamics Medical believes that the VERITON™ CT is substantially equivalent to the predicate device, VERITON™ NM (K180514) and hence is safe and effective for its intended use.

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.