The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLR is limited for patient use of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.

The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols (for medium and large patients) that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) - resources and technical specification American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.

The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

Device Description

The Low Dose Lung Cancer Screening (LD LCS) option is an indication being added to the existing Arineta scanners for SpotLight and SpotLight Duo, previously cleared by the FDA (K230370, K213465).

There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied.

This option includes scan protocols with CTDI that comply with AAPM's requirements for Low Dose Lung Cancer Screening.

No Hardware modifications and minor Software modifications (for compatibility with the Low-Dose Lung Cancer Screening protocols) are required for the subject device, which includes the following LD LCS protocol characteristics:

• Lung Cancer Screening protocols for medium and large patients according to AAPM's definitions.

· Lung Cancer Screening protocols option will be activated by service or production personnel (no need for additional installation, option activation only).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing)	Reported Device Performance
Image Quality Metrics
CT Number Accuracy	Maintained in LCS protocol, comparable to predicate, within ~3 Hounsfield Units.
CT Number Uniformity	Comparable to predicate.
Image Noise (Standard Deviation)	NPS curve comparable to predicate, with noise reduction slightly shifting the NPS curve to lower frequencies.
Modulation Transfer Function (MTF)	Resolution for LCS protocols maintained compared to predicate.
Visual Resolution/Image Artifacts	Not explicitly quantified, but generally assessed as part of overall image quality.
Noise Power Spectrum (NPS)	NPS curve comparable to predicate, with noise reduction slightly shifting the NPS curve to lower frequencies.
Slice Thickness	Not explicitly quantified in performance, but implied to be maintained for effective nodule bounding.
Contrast to Noise Ratio (CNR)	Linearly related among LCS protocol and predicate device (with/without MBAF2). Comparable to reference device.
Nodule Detectability (smallest)	All nodule types in Lung Phantom, including smallest (4mm) and lowest contrast nodules, are detectable.
Nodule Sizing Accuracy	Nodule size similar between LCS protocol, predicate, and reference devices, and according to LCS phantom specification.
Clinical Acceptability
Diagnostic Quality of Images for LD LCS	All fourteen (14) cases evaluated as diagnostic for the indications for use.
Detectability of Relevant Findings	Readers reported various pathologies, including very small nodules (2mm), enabling detection of findings relevant to LD LCS.
Compliance with AAPM guidelines for medium and large patients	Protocols comply with AAPM's requirements for Low Dose Lung Cancer Screening.

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

Test Set Sample Size:
- Bench Testing: Not explicitly stated as a number of phantom scans, but described as "extensive bench testing" using "standard phantoms" and a "semi-anthropomorphic clinical simulation lung phantom."
- Clinical Image Quality Assessment: Fourteen (14) cases.
Data Provenance:
- Bench Testing: Internal laboratory testing ("extensive bench testing").
- Clinical Image Quality Assessment: Collected from two (2) U.S. sites. The text doesn't specify if it was retrospective or prospective, but the phrasing "were collected" often implies retrospective.

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

Number of Experts: Two (2) U.S. board-certified radiologists.
Qualifications: U.S. board-certified radiologists. No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

The provided text only states "a clinical image quality assessment was performed by two U.S. board-certified radiologists." It does not specify an adjudication method (e.g., 2+1, 3+1, none). It implies both radiologists performed the assessment, but not how disagreements (if any) were resolved or if their readings were merged.

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

No MRMC comparative effectiveness study was mentioned. The study described focuses on whether the device's low-dose protocols produce diagnostic-quality images and maintain image quality compared to the predicate device, not on human reader performance with or without AI assistance.

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

The "device" in this context is the CT scanner itself with an added low-dose lung cancer screening option, which includes specific scan protocols and minor software modifications for compatibility. The "acceptance criteria" and "study" described are for the performance of the CT system under these low-dose conditions, as an image acquisition and reconstruction device. It is not an AI algorithm that provides diagnostic readings independently. Therefore, the concept of a "standalone" AI performance study is not directly applicable here. The performance evaluated is the image quality produced by the system.

7. The Type of Ground Truth Used

Bench Testing: Phantom specifications or known values within the phantoms (e.g., specific nodule sizes, CT number values of materials). Comparison was also made against a "reference device" (GE Revolution CT).
Clinical Image Quality Assessment: The "ground truth" for the clinical evaluation was the qualitative assessment by the two board-certified radiologists that the images were "diagnostic for the indications for use" and "enable the detection of findings relevant to LD LCS," including 2mm nodules. This is essentially expert consensus on clinical diagnostic utility. It does not refer to histopathological ground truth for nodules, for example.

8. The Sample Size for the Training Set

The document does not mention any training set size. This is because the submission describes an option for an existing CT system (SpotLight/SpotLight Duo) to perform Low Dose Lung Cancer Screening. It does not describe a new AI algorithm that requires a separate training set. The changes are primarily in scan protocols and minor software adjustments for compatibility. The core image reconstruction algorithms (Modified FDK, MBAF, MBAF2) are pre-existing.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned (since it's not a new AI algorithm being trained), this information is not applicable.

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

January 13, 2025

Arineta Ltd. % Tanya Shalem VP QA&RA 15 Halamish St. Caesarea, 3088900 ISRAEL

Re: K241200

Trade/Device Name: SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: April 30, 2024 Received: December 13, 2024

Dear Tanya Shalem:

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.

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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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products 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

510(k) Number (if known) K241200

Device Name

SpotLight/ SpotLight Duo with Low Dose Lung Cancer Screening Option

Indications for Use (Describe)

The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

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 (K241200)

Arineta's SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

I. SUBMITTER

Arineta Ltd. 15 Halamish Street Caesarea 3088900 Israel

Phone: +972-4-6374000

Contact Person: Tanya Shalem, VP of QA&RA, E-mail: tanya.shalem@arineta.com 510k Number: K241200 Date Prepared: January 13, 2025

II. DEVICE

Name of Device: SpotLight/ SpotLight Duo with Low Dose Lung Cancer Screening Option Common Name: System, X-ray, Tomography, Computed Classification Name: Computed tomography x-ray system Regulation Number: 892.1750 Product Code(s): JAK

III. PREDICATE DEVICE

Predicate Device Name: SpotLight/ SpotLight Duo (with DLIR option) Manufacturer: Arineta Ltd. 510(k) Number: K230370 Common Name: System, X-ray, Tomography, Computed Classification Name: Computed tomography x-ray system Regulation Number: 892.1750 Product Code(s): JAK

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IV. DEVICE DESCRIPTION

The Low Dose Lung Cancer Screening (LD LCS) option is an indication being added to the existing Arineta scanners for SpotLight and SpotLight Duo, previously cleared by the FDA (K230370, K213465).

There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied.

This option includes scan protocols with CTDI that comply with AAPM's requirements for Low Dose Lung Cancer Screening.

• Lung Cancer Screening protocols for medium and large patients according to AAPM's definitions.

· Lung Cancer Screening protocols option will be activated by service or production personnel (no need for additional installation, option activation only).

V. INTENDED USE

The SpotLight Computed Tomography X-ray system is intended for head, body, cardiac and vascular X-ray computed tomography applications.

VI. INDICATIONS FOR USE

The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of transaxial and reformatted planes.

The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.

The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols (for medium and large patients) that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) - resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409)

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and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.

The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

VII. INDICATIONS FOR USE COMPARISON

The proposed devices do not constitute a new intended use. There is a minor change in the indication for use - the addition of the LD LCS Option, references to ACR and AAPM guidelines, and specific DLIR and ASIR-CV limitations for that option.

VIII. TECHNOLOGICAL COMPARISON

The technological characteristics of the SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening (LD LCS) option and the predicate currently marketed SpotLight/ SpotLight Duo are substantially the same, with no functional, performance, feature, or design changes, except for the added LD LCS scan protocols. The proposed LD LCS option has substantially the same reconstruction technology compared to the predicate currently marketed device. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option, as reflected in the Indications for Use.

There is no new technology related to these LCS protocols or their operation. There are no significant differences that may raise new issues of safety or effectiveness. The proposed LD LCS scan protocols have low dose characteristics for medium and large patients and comply with the relevant AAPM CTDI dose values. These parameters were chosen to optimize image quality while minimizing the dose.

The determination of substantial equivalence of the proposed new LD LCS protocols to the cleared predicate device was further evaluated on the bench testing. The new LDCT LCS protocols for Arineta systems were tested and validated by using traditional Image Quality (IQ) metrics on standard phantoms, and compared to the IQ results of the cleared predicate standard dose device. The results indicate maintaining the proposed device's LD LCS protocols for all IQ metrics, including accuracy, uniformity, resolution, contrast scale, and NPS frequencies. Testing was also performed using a semi-anthropomorphic clinical simulation lung phantom where the CNR and nodule sizing comparisons were performed for Arineta systems using their new LDCT LCS protocols. The results showed that the nodules' level of conspicuity and accurate sizing were maintained for the proposed device LDCT LCS protocols. Therefore, it indicated that the proposed devices LD LCS protocols and predicate devices were substantially equivalent.

A table comparing the key features of the subject and predicate device is provided below.

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	Proposed devices –Low Dose CT Lung Cancer Screening (LD LCS) Optionfor Qualified Arineta Systems	Primary Predicate devices –The Cleared Arineta's SpotLight / SpotLight Duo(K230370) CT X-ray System (with DLIR option)	Discussion
Indications for Use
Indications for use	The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction ofX-ray transmission projection data taken at different angles.The system has the capability to image cardiovascular andthoracic anatomies, including the heart, in a single rotation.The system may acquire data using Axial, Cine and Cardiacscan techniques from patients of all ages (DLIR is limited forpatient use above the age of 2 years). These images may beobtained either with or without contrast. This device mayinclude signal analysis and display equipment, patient andequipment supports, components and accessories.This device may include data and image processing toproduce images in a variety of trans-axial and reformattedplanes.The system is indicated for x-ray Computed Tomographyimaging of cardiovascular and thoracic anatomies that fit inthe scan field-of-view.The Low Dose CT Lung Cancer Screening Option forSpotLight / SpotLight Duo is indicated for using low dose CTfor lung cancer screening. The screening must be conductedwith the established program criteria and protocols (formedium and large patients) that have been approved andpublished by a governmental body or a professional medicalsociety. Information from professional societies related tolung cancer screening can be found but is not limited to:American College of Radiology® (ACR) – resources andtechnical specification; accreditation American Association ofPhysicists in Medicine (AAPM) - Lung Cancer ScreeningProtocols; radiation management. Please refer to clinicalliterature, including the results of the National LungScreening Trial (N Engl J Med 2011; 365:395-409) andsubsequent literature, for further information.The DLIR and ASIR-CV options are not compatible with theLow Dose Lung Cancer Screening option.The device output is useful for diagnosis of disease orabnormality and for planning of therapy procedures.	The SpotLight / SpotLight Duo (with DLIR option) is intendedto produce cross-sectional images of the body by computerreconstruction of x-ray transmission projection data taken atdifferent angles. The system has the capability to imagecardiovascular and thoracic anatomies, including the heart,in a single rotation. The system may acquire data usingAxial, Cine, and Cardiac scan techniques from patients of allages (DLIR is limited for patient use above the age of 2years). These images may be obtained either with or withoutcontrast. This device may include signal analysis and displayequipment, patient and equipment supports, componentsand accessories.This device may include data and image processing toproduce images in a variety of trans-axial and reformattedplanes.The system is indicated for X-ray Computed Tomographyimaging of cardiovascular and thoracic anatomies that fit inthe scan field of view.The device output is useful for diagnosis of disease orabnormality and for planning of therapy procedures.	The indications for use aresimilar, with the sameindications for the entiredevice, except for minordifferences; the indicationsfor use for the proposedSpotLight/SpotLight Duodevices include Low DoseLung Cancer ScreeningOption with additionalreferences to ACR andAAPM guidelines, andspecific DLIR and ASIR-CVlimitation for that option. LCSindication for use does notconstitute a new intendeduse for the CT.
	Proposed devices -Low Dose CT Lung Cancer Screening (LD LCS) Optionfor Qualified Arineta Systems	Primary Predicate devices -The Cleared Arineta's SpotLight / SpotLight Duo(K230370) CT X-ray System (with DLIR option)	Discussion
Technological Characteristics
Detector technologyand geometry	Fast scintillator array coupled to photodiode array.	Fast scintillator array coupled to photodiode array.	Same
	33 (WFOV) or 23 (EFOV) configurable high resolution (HR)modules comprising 192 detector rows X pitch 0.5mm (Zdirection, measured at scanner center).	33 (WFOV) or 23 (EFOV) configurable high resolution (HR)modules comprising 192 detector rows X pitch 0.5mm (Zdirection, measured at scanner center).
	10 (WFOV) or 20 (EFOV) configurable low resolution (LR).EFOV includes 10 modules on each wing while WFOVincludes 10 modules on one wing. comprising 48 detectorrows X pitch 2.0mm	10 (WFOV)-20 (EFOV) configurable low resolution (LR).EFOV includes 10 modules on each wing while WFOVincludes 10 modules on one wing. comprising 48 detectorrows X pitch 2.0mm
	Analog to digital conversion per channel on the detectionmodule.	Analog to digital conversion per channel on the detectionmodule.
	1D antiscatter collimator.	1D antiscatter collimator.
Data transmissionfrom rotor	Contactless transmission (capacitive coupling). Rate up to6.25 GBit/sec	Contactless transmission (capacitive coupling). Rate up to6.25 GBit/sec	Same
Power and controltransmission to rotor	Brush contact slipring	Brush contact slipring	Same
Rotation drive	Direct drive DC motor	Direct drive DC motor	Same
X Ray source	2 x MCS 2093 X ray tubes by Varex Imaging Corp.	2 x MCS 2093 X ray tubes by Varex Imaging Corp.	Same
	Single ended grounded rotating anode	Single ended grounded rotating anode
	Anode angle 13 degrees	Anode angle 13 degrees
	1.0 MHU anode heat capacity	1.0 MHU anode heat capacity
	Grid controlled focal spot modulation in X direction	Grid controlled focal spot modulation in X direction
	Small and large focal spots	Small and large focal spots
	Max kVp: 140 kV	Max kVp: 140 kV
	Max power: 72 KW	Max power: 72 KW
Patient table	Motorized vertical and horizontal motion.	Motorized vertical and horizontal motion.	Same
	Optional lateral motion	Optional lateral motion.
	Cantilever carbon fiber patient cradle.	Cantilever carbon fiber patient cradle.
	Proposed devices -Low Dose CT Lung Cancer Screening (LD LCS) Optionfor Qualified Arineta Systems	Primary Predicate devices -The Cleared Arineta's SpotLight / SpotLight Duo(K230370) CT X-ray System (with DLIR option)	Discussion
Image reconstructionhardware	Multicore PC and GPU	Multicore PC and GPU	Same
Image reconstructionalgorithm	Modified FDK cone beam algorithm adapted for dual tubesgeometry.Adaptive filter to reduce directional noise in low level rawdata (MBAF).Non-local means algorithm MBAF2 (optional).For WFOV configuration, adapted to reconstruct highresolution images according to detector configuration, lowerresolution images outside FOV covered by high resolutiondetectors.For extended FOV configuration, adapted to reconstruct highresolution images up to FOV250mm, lower resolutionimages outside FOV250mm.	Modified FDK cone beam algorithm adapted for dual tubesgeometry.Adaptive filter to reduce directional noise in low level rawdata (MBAF).Non-local means algorithm MBAF2 (optional).For WFOV configuration, adapted to reconstruct highresolution images according to detector configuration, lowerresolution images outside FOV covered by high resolutiondetectors.For extended FOV configuration, adapted to reconstruct highresolution images up to FOV250mm, lower resolutionimages outside FOV250mm.ASIR-CV or DLIR AI based image reconstruction algorithm.	Substantially the samereconstruction technology,except the ASIR-CV and AI-based DLIR imagereconstruction algorithms.The proposed LD LCSoption is not compatible withDLIR and ASIR-CV.The LD LCS option isavailable with or withoutMBAF2.
Construction Materials	Metal parts (mostly steel and aluminum)Lead and tungsten for X-ray shieldingPCB, electronic components and electronic cablescomponentsTable top made of carbon fiber reinforced resinCovers made pf molded polymers and reinforced resinsOil in X-ray tubes cooling systemsDetector scintillators made of CdWO4 and GadoliniumOxysulfide (GOS) used in other legally marketed CTscanners	Metal parts (mostly steel and aluminum)Lead and tungsten for X-ray shieldingPCB, electronic components and electronic cablecomponentsTable top made of carbon fiber reinforced resinCovers made pf molded polymers and reinforced resinsOil in X-ray tubes cooling systemsDetector scintillators made of CdWO4 and GadoliniumOxysulfide (GOS) used in other legally marketed CTscanners	Same
Energy sources	Wall supply 380 to 480 V 3 phaseMax power demand 115 kVAMax X ray power (total for two tubes) 72kW	Wall supply 380 to 480 V 3 phaseMax power demand 115 kVAMax X ray power (total for two tubes) 72kW	Same
	Proposed devices -Low Dose CT Lung Cancer Screening (LD LCS) Optionfor Qualified Arineta Systems	Primary Predicate devices -The Cleared Arineta's SpotLight / SpotLight Duo(K230370) CT X-ray System (with DLIR option)	Discussion
	Laser alignment lights: gantry bore external lasers. <0.1mWper laser beam	Laser alignment lights: gantry bore external lasers. <0.1mWper laser beam
	Three lead ECG trigger module, powered by medical gradepower supply through the system PDU	Three lead ECG trigger module, powered by medical gradepower supply through the system PDU
Software	Provided with software in three domains:Console softwareImage reconstruction softwareEmbedded software	Provided with software in three domains:Console softwareImage reconstruction softwareEmbedded software	Substantially the same, withminor changes in the addedLD LCS protocols (formedium and large patients)per AAPM guidelines.
Max Rotation speed	250 RPM (0.24 sec per rotation)	250 RPM (0.24 sec per rotation)	Same
Min scan time	0.16 sec (partial), 0.24 sec (full scan) - FOV up to 250mm0.24 sec (full scan) - HR imaging at FOV above 250mm forasymmetric detector	0.16 sec (partial), 0.24 sec (full scan) - FOV up to 250mm0.24 sec (full scan) - HR imaging at FOV above 250mm forasymmetric detector	Same
Max axial coverage ina single axial scan	140mm (280 slices x 0.5mm pitch)	140mm (280 slices x 0.5mm pitch)	Same
Field of View (FOV)	25cm - 250mm at high resolutionWFOV - High resolution images at configurable FOVbetween 250mm and 450mmEFOV - Lower resolution in the FOV between HR coverageand 450mm	25cm - 250mm at high resolutionWFOV - High resolution images at configurable FOVbetween 250mm and 450mmEFOV - Lower resolution in the FOV between HR coverageand 450mm	Same
Max spatial resolution	17.5 lp/cm cutoff at center10.0 lp/cm cutoff at radius above 125mm (outside FOV250mm) covered by HR detectors7.0 lp/cm cutoff at radius above 125mm (outside FOV250mm) covered by LR detectors	17.5 lp/cm cutoff at center10.0 lp/cm cutoff at radius above 125mm (outside FOV250mm) covered by HR detectors7.0 lp/cm cutoff at radius above 125mm (outside FOV250mm) covered by LR detectors	Same
Bore size	60 cm	60 cm	Same
Max Patient weight	227 Kg (500 lbs)	227 Kg (500 lbs)	Same
	Proposed devices –Low Dose CT Lung Cancer Screening (LD LCS) Optionfor Qualified Arineta Systems	Primary Predicate devices –The Cleared Arineta's SpotLight / SpotLight Duo(K230370) CT X-ray System (with DLIR option)	Discussion
Add on parts andaccessories	Operator console table	Operator console table	Same
	NG2000 Table slickers	NG2000 Table slickers
	Bar code reader	Bar code reader
	Uninterruptible Power Supply	Uninterruptible Power Supply
	Head& hands and knees support	Head& hands and knees support

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Image Quality Metrics

CT number accuracy - In a low signal situation such as with LD LCS, the CT nurser measured in LCS, the CT number may be a reference against potentially calcified nodules.

CT number unformity - In a low signal studiont CT number unformity throughout the lung and various structures is imporant for more robust detectability of nodules. Uniformity is needed to maintain CT number separation between structures.

Image nose (standard deviation) - As dose in the image inceases. If this noise becomes tool arge, nodule deceability and sizing mesurement may be compromised.

Modulation Transfer Function (MTF) - MTF is a measure of the system. Notules in the lung are high contrast objects and therefor, MTF should be preserved at lower dose conditions.

Visual Resolution/Image Artiacion of images to assess their visual resolution using high ontrast bar patterns and evaluation of the degree of affiacts (e.g., lov signal streaks, bean hardening), These test of the high contrast delection task of relatively small objects for this application. Streak or beam hardening may obscure pathology and affect CT number accuracy.

Noise Power Spectrum (NPS) - Sinilar to standes in nose texture may result in nodule detection becoming more challenging especially if there is a significant shift in the frequency of the noise, and/or an increase in amplitude of the NPS plot.

Sice Thickness - The ability to produce sice think of the sice sensibility profile) that are close to thiskness is important in defining der edges and boundaries of the nodule and in nodule sizing.

Contrast to Noise (CNR) - Sufficient (JNR is needid nodules in the lung. This metric is similar o SMR but accums for the contrast between an object and the background. Arineta believes this is the primary figure of metric to evaluate nodule detectability.

The image quality netirs were used for evalual equivalence. Each metric is provided with a description of the impactiererance of the metir for LCS . All IQ metrics used for both the proposed and the predicate device are the same.

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IX. NON-CLINICAL TESTING SUMMARY

Arineta Ltd. has conducted extensive bench testing on the Low Dose CT Lung Cancer Screening (LCS) option for the Spotlight Duo CT systems. Additional testing was conducted on Arineta's current qualified SpotLight Duo CT systems cleared in K230370 (the predicate device) and the LCS option of GE Revolution CT (the reference device) for comparison.

Non-clinical tests of the LCS protocols for Spotlight/Spotlight Duo systems have demonstrated that all image quality metrics are substantially equivalent to the predicate:

Uniformity and CT numbers for LCS protocols are maintained in the LCS protocol, comparable to the predicate device, and are within ~3 Hounsfield Units.
The Noise Power Spectrum (NPS) curve is comparable to the predicate device, with noise reduction slightly shifting the NPS curve to the lower frequencies in both LCS protocol and in the predicate device.
Resolution for LCS protocols is maintained compared to the predicate device.
Contrast to Noise Ratio (CNR) was measured using the LCS phantom, which includes nodules with different types, HU and sizes. The CNR is linearly related among the LCS protocol and the predicate device, with and without noise reduction (MBAF2). The CNR is comparable to the reference device.
All nodule types in the Lung Phantom, including the smallest (4mm) and lowest contrast nodules, are detectable. The nodule size is similar between LCS protocol, predicate, and reference devices, and is according to the LCS phantom specification.

X. CLINICAL TESTING SUMMARY

To confirm that images are clinically acceptable for use, a clinical image quality assessment was performed by two U.S. board-certified radiologists. The data evaluated were collected from two (2) U.S sites and included Low-Dose lung screening exams scanned with Arineta's SpotLight systems. The results show that all fourteen (14) cases, representing medium and large patient sizes per AAPM guidelines (0.25 to 2.8 mGy range has not been clinically evaluated), were evaluated as diagnostic for the indications for use. Moreover, the readers reported various pathologies, including very small nodules (2mm), therefore, the images enable the detection of findings relevant to LD LCS.

Based on the image assessment, it can be concluded that LCS using Low-Dose protocols on the SpotLight/ SpotLight Duo systems generates sufficient diagnostic-quality images.

The clinical image evaluation resulted in the expected detectability of the proposed SpotLight/ SpotLight Duo with LD LCS option, without raising any new safety and/or effectiveness concerns compared to the currently marketed predicate device.

XI. CONCLUSIONS

Based on the Indications for Use and technological characteristics comparisons, non-clinical performance bench testing, and clinical image quality evaluation, the SpotLight Duo with LD LCS option has a safety and effectiveness profile, that is similar to the predicate device. Thus, the proposed SpotLight/ SpotLight Duo with Low Dose Lung Cancer Screening Option is substantially equivalent to the predicate marketed Arineta's CT systems.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.