SpotLight /SpotLight Duo (with DLIR option) 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, 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 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 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 device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

Device Description

The SpotLight / SpotLight Duo (with DLIR option) is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software and software for operator interface and image handling. The Deep Learning Image Reconstruction (DLIR) algorithm is a deep learning technology-based software sub-system that is integrated into the image reconstruction software. As in other CT scanners, a scanned subject is irradiated by X rays and a detector array measures attenuation data of X rays that have been attenuated by the subject from multiple view angles. This is achieved by rotation of the radiation source and the detector about the subject while acquiring the attenuation data. A computer is used to reconstruct cross sectional images of the subject from the attenuation data.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the SpotLight/SpotLight Duo (with DLIR option) CT system, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list specific quantitative acceptance criteria in a table format. However, it indicates that the DLIR (Deep Learning Image Reconstruction) algorithm was evaluated to demonstrate non-inferiority to the predicate device's ASiR-CV noise reduction algorithm in terms of image quality. The performance tests focused on several image quality parameters:

Image Quality Parameter	Reported Performance (DLIR vs. ASiR)
Image Noise	Bench tests demonstrated that DLIR decreases pixel-wise noise magnitude without losing features. Clinical evaluation confirmed no inferiority to ASiR.
Low Contrast Detectability	Bench tests concluded that DLIR with ASiR-CV in this parameter.
Water HU Accuracy	Bench tests concluded that DLIR with ASiR-CV in this parameter.
Image Flatness (Uniformity)	Bench tests concluded that DLIR with ASiR-CV in this parameter.
Spatial Resolution	Bench tests concluded that DLIR does not lose features or change High-contrast spatial resolution. Clinical evaluation confirmed no inferiority to ASiR.
Reconstruction Linearity (Contrast Scale)	Bench tests concluded that DLIR with ASiR-CV in this parameter.
Streak Artifact Suppression	Bench tests concluded that DLIR with ASiR-CV in this parameter.
Noise Power Spectrum (NPS)	Bench tests concluded that DLIR with ASiR-CV in this parameter.
Overall DiagnosticImage Quality	Clinical evaluation found DLIR to provide diagnostic image quality that is not inferior to ASiR.

2. Sample Size and Data Provenance for the Test Set

Sample Size (Test Set): Not explicitly stated as a number of cases, but implied to be a collection of "clinical cases of different anatomies, using different types of scans, from patients with a wide range of BMIs and clinical features."
Data Provenance: Retrospective clinical data acquired by SpotLight / CardioGraphe scanners. Collected from "multiple clinical sites with at least 50% of the cases performed in the US."

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Five (5) certified CT readers.
Qualifications of Experts: 3 radiologists and 2 cardiologists. "4 out 5 are US board certified." Specific years of experience are not mentioned.

4. Adjudication Method

Adjudication Method: The study was a "retrospective blinded image evaluation." Each exam was reviewed using both standard (ASiR-CV) and alternative (DLIR) methods. The data was "coded to avoid readers' bias." This suggests a comparative reading where readers likely assessed both image sets for the same patient without knowing which was which, and potentially without direct consensus discussions as a formal adjudication step, but rather an independent assessment that collectively informed the non-inferiority conclusion. No explicit "2+1" or "3+1" adjudication method is described.

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

Was an MRMC study done? Yes, a form of multi-reader evaluation was performed, comparing DLIR to ASiR-CV on clinical cases by five expert readers.
Effect Size (human readers improve with AI vs. without AI assistance): The document states that "DLIR was found to provide diagnostic image quality that is not inferior to ASiR." It does not provide a specific quantitative effect size or a measure of improvement for human readers with AI (DLIR) vs. without AI (ASiR-CV, which is also an algorithm, a noise reduction one). The focus was on non-inferiority rather than an enhancement measurement for the readers themselves.

6. Standalone Performance Study

Was a standalone study done? Yes, "DLIR bench tests were performed by applying DLIR and ASIR on phantoms." This represents a standalone evaluation of the algorithm's performance on objective image quality metrics using phantoms.

7. Type of Ground Truth Used

For Bench Tests: Physical phantoms (water phantoms, CATPHAN, QA phantom) with known properties were used.
For Clinical Evaluation: "Diagnostic image quality that is not inferior to ASiR" as determined by the expert readers serves as the ground truth/comparison metric. This is effectively expert consensus/opinion on diagnostic quality. There's no mention of pathology or outcomes data being used to establish ground truth for the clinical cases.

8. Sample Size for the Training Set

The document does not specify the sample size used for training the Deep Learning Image Reconstruction (DLIR) algorithm.

9. How Ground Truth for the Training Set Was Established

The document does not explicitly describe how ground truth for the training set was established. It only mentions that DLIR is a "deep learning technology-based software sub-system." For deep learning reconstruction, training typically involves pairs of noisy (or lower-dose) input images and corresponding high-quality (or higher-dose/reference standard) images, often reconstructed with a traditional full-dose, high-quality algorithm (not explicitly stated here, but common practice).

Summary

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October 13, 2023

Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

% John Smith Official Correspondent Hogan Lovells US LLP 555 Thirteenth Street, NW WASHTINGTON, DC 20004-1109

Re: K230370

Trade/Device Name: SpotLight/SpotLight Duo (with DLIR option) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 8, 2023 Received: September 8, 2023

Dear John Smith:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

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510(k) Number (if known) K230370

Device Name SpotLight / SpotLight Duo (with DLIR option)

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

മ Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Arineta's SpotLight Duo (with DLIR option)

K230370

Submitter

Arineta Ltd. 15 Halamish Street Caesarea 3088900 Israel Tel: +972-4-6374000 Fax: +972-4-6277006

Contact Person: Tanya Shalem, VP of QA&RA

Date Prepared: February 9, 2023

Name of Device: SpotLight / SpotLight Duo (with DLIR option)

Common or Usual Name: Computed Tomography X-ray System

Regulation Medical Specialty: Radiology

Regulation Number: 892.1750

Regulatory Class: Class II

Product Code: JAK

Predicate Device

Device Name	Manufacturer	510(k) Number	RegulationNumber	ProductCode
SpotLight Duo	Arineta Ltd.	K213465	892.1750	JAK

Device Description

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Intended Use

SpotLight / SpotLight Duo (with DLIR option) is intended for head, body, cardiac and vascular X-ray Computed Tomography applications.

Indications for Use

SpotLight / SpotLight Duo (with DLIR option) 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 trans-axial and reformatted planes.

Technological Characteristics

Deep Learning Image Reconstruction (DLIR) is a deep learning technology-based software subsystem that is integrated into the existing image reconstruction chain of the predicate device, SpotLight Duo (K213465), as an alternative to the current cleared ASIR-CV noise reduction algorithm. The intended use of SpotLight Duo (with DLIR option) remains the same as the predicate device SpotLight Duo with ASIR-CV.

Technologicalcharacteristics	Proposed device - SpotLight /SpotLight Duo (with DLIR option)	Predicate Device - SpotLight Duo(K213465)	Discussion
Detectortechnology andgeometry	Fast scintillator array coupled tophotodiode array.33 (WFOV) or 23 (EFOV) configurablehigh resolution (HR) modulescomprising 192 detector rows X pitch0.5mm (Z direction, measured atscanner center).10(WFOV)-20 (EFOV) configurable low	Fast scintillator array coupled tophotodiode array.33 (WFOV) or 23 (EFOV) configurablehigh resolution (HR) modulescomprising 192 detector rows X pitch0.5mm (Z direction, measured atscanner center).10(WFOV)-20 (EFOV) configurable low	Same
	resolution (LR). EFOV includes 10modules on each wing while WFOVincludes 10 modules on one wing.	resolution (LR). EFOV includes 10modules on each wing while WFOVincludes 10 modules on one wing.
Technologicalcharacteristics	Proposed device - SpotLight /SpotLight Duo (with DLIR option)	Predicate Device - SpotLight Duo(K213465)	Discussion
	comprising 48 detector rows X pitch2.0mm	comprising 48 detector rows X pitch2.0mm
	Analog to digital conversion per channelon the detection module.	Analog to digital conversion per channelon the detection module.
	1D antiscatter collimator.	1D antiscatter collimator.
Datatransmissionfrom rotor	Contactless transmission (capacitivecoupling).	Contactless transmission (capacitivecoupling).	Same
	Rate up to 6.25 GBit/sec	Rate up to 6.25 GBit/sec
Power andcontroltransmission torotor	Contact less transmission	Contact less transmission	Same
Rotation drive	Direct drive DC motor	Direct drive DC motor	Same
X Ray source	2 x MCS 2093 X ray tubes by VarexImaging Corp.	2 x MCS 2093 X ray tubes by VarexImaging 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 inX direction	Grid controlled focal spot modulation inX 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.
Imagereconstructionhardware	Multicore PC and GPU	Multicore PC and GPU	Same
Imagereconstructionalgorithm	Modified FDK cone beam algorithmadapted for dual tubes geometry.	Modified FDK cone beam algorithmadapted for dual tubes geometry.	Both devicesinclude ASiR-CV,while the
	Adaptive filter to reduce directionalnoise in low level raw data (MBAF).	Adaptive filter to reduce directionalnoise in low level raw data (MBAF)	proposed deviceincludes DLIR asan alternative
	Noise reduction algorithms:ASIR-CV or DLIR Al based image	Iterative reconstruction algorithm (ASIR-CV) to reduce image noise.	noise reductionalgorithm. DLIR
	reconstruction algorithm (DLIR only for250mm FOV and EFOV configuration).	For WFOV configuration, adapted toreconstruct high resolution imagesaccording to detector configuration,	can be applied to250mm FOV andEFOVconfiguration.
Technologicalcharacteristics	Proposed device - SpotLight /SpotLight Duo (with DLIR option)	Predicate Device - SpotLight Duo(K213465)	Discussion
	For WFOV configuration, adapted toreconstruct high resolution imagesaccording to detector configuration,lower resolution images outside FOVcovered by high resolution detectors.For extended FOV configuration,adapted to reconstruct high resolutionimages up to FOV250mm, lowerresolution images outside FOV250mm.	lower resolution images outside FOVcovered by high resolution detectors.For extended FOV configuration,adapted to reconstruct high resolutionimages up to FOV250mm, lowerresolution images outside FOV250mm.	The SpotLightwith DLIRdemonstrates theproductperformanceclaims (LCD,Noise, Highcontrast, Spatialresolution, NPS,accuracy anduniformity), asdid the SpotLightwith ASiR CV.
ConstructionMaterials	Metal parts (mostly steel and aluminum)	Metal parts (mostly steel and aluminum)	Same
	Lead and tungsten for X-ray shielding	Lead and tungsten for X-ray shielding
	PCB, electronic components andelectronic cables components	PCB, electronic components andelectronic cables components
	Table top made of carbon fiberreinforced resin	Table top made of carbon fiberreinforced resin
	Covers made pf molded polymers andreinforced resins	Covers made pf molded polymers andreinforced resins
	Oil in X-ray tubes cooling systems	Oil in X-ray tubes cooling systems
	Detector scintillators made of CdWO4and Gadolinium Oxysulfide (GOS) usedin other legally marketed CT scanners	Detector scintillators made of CdWO4and Gadolinium Oxysulfide (GOS) usedin other legally marketed CT scanners
Energy sources	Walt supply 380 to 480 V 3 phase	Wall supply 380 to 480 V 3 phase	Same
	Max power demand 115 kVA	Max power demand 115 kVA
	Max X ray power (total for two tubes)72kW	Max X ray power (total for two tubes)72kW
	Laser alignment lights: gantry boreexternal lasers. <0.1mW per laser	Laser alignment lights: gantry boreexternal lasers. <0.1mW per laser beam
	beam.Three lead ECG trigger module,powered by medical grade power supplythrough the system PDU.	Three lead ECG trigger module,powered by medical grade powersupply through the system PDU
Accessories	Head& hands and knees support	Head& hands and knees support	Same
	Optional operator desk (the site mayuse their own desk) carrying the displaymonitor, keyboard, mouse, scanoperation unit and optional accessories	Optional operator desk (the site mayuse their own desk) carrying the displaymonitor, keyboard, mouse, scanoperation unit and optional accessories
	Barcode reader	Barcode reader
	External Console UPS	External Console UPS
Technologicalcharacteristics	Proposed device - SpotLight /SpotLight Duo (with DLIR option)	Predicate Device - SpotLight Duo(K213465)	Discussion
Software	The SpotLight is provided with softwarein three domains:• Console software• Image reconstruction software,including the DLIR algorithm• Embedded software	The SpotLight Duo is provided withsoftware in three domains:• Console software• Image reconstruction software• Embedded software	Substantially thesame: thesoftware principalblock diagram isthe same, wherethe DLIR optionis a softwaresub-systemintegrated in theexisting imagereconstructionchain ofSpotLightDuo/CardioGraphe as alternativeto current theASIR-CV noisereductionalgorithm.
Max Rotationspeed	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 atFOV above 250mm for asymmetricdetector	0.16 sec (partial), 0.24 sec (full scan) -FOV up to 250mm0.24 sec (full scan) – HR imaging atFOV above 250mm for asymmetricdetector	Same
Max axialcoverage in asingle axialscan	140mm (280 slices x 0.5mm pitch)	140mm (280 slices x 0.5mm pitch)	Same
Field of View(FOV)	25cm - 250mm at high resolution, withDLIR optionEFOV - up to 450mm with lowerresolution outside FOV 250mm, withDLIR optionWFOV - high resolution images atconfigurable FOV between 250mm and450mm	25cm - 250mm at high resolutionEFOV - up to 450mm with lowerresolution outside FOV 250mmWFOV - high resolution images atconfigurable FOV between 250mm and450mm	Same aspredicate device,except DLIR asoptionalreconstruction for25cm and EFOVconfigurations
Max spatialresolution	17.5 lp/cm cutoff at center10.0 lp/cm cutoff at radius above125mm (outside FOV 250mm) coveredby HR detectors7.0 lp/cm cutoff at radius above 125mm(outside FOV 250mm) covered by LRdetectors	17.5 lp/cm cutoff at center10.0 lp/cm cutoff at radius above125mm (outside FOV 250mm) coveredby HR detectors7.0 lp/cm cutoff at radius above 125mm(outside FOV 250mm) covered by LRdetectors	Same
Bore size	60 cm	60 cm	Same
Max Patientweight	227 Kg (500 lbs)	227 Kg (500 lbs)	Same

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

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Non-Clinical Performance Testing

SpotLight is in compliance with the requirements of the following standards:

. IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and test
IEC 60601-1-3 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-2-44 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
. IEC 62304 Medical device software - Software life cycle processes
. ISO 14971 Medical devices - Application of risk management to medical devices

SpotLight was tested and is in compliance with AAMI/ES 60601-1 and its associated collateral standards and particular standards, 21CFR Subchapter J and NEMA XR-25, XR-28 and XR-29.

The device was developed under a rigorous quality system and has successfully completed design control activities, including risk management, verification and validation.

The performance evaluation used a variety of test methods, phantoms and scan conditions. Various mathematical, physics and statistical analyses were performed to demonstrate that performance specifications are met. Image quality evaluation of artifacts, spatial resolution, low contrast detectability, noise, uniformity and CT number accuracy.

DLIR bench tests were performed by applying DLIR and ASIR on phantoms: water phantoms, CATPHAN, and QA phantom. Both 250mm and 450mm FOV were tested. As a small body (pediatric), small water phantom was used as well as CATPHAN inserts without the housing, scanned with clinical pediatric protocol. As a large body, large water phantom was used. The tests included image noise (pixel standard deviation), low contrast detectability, water HU accuracy, image flatness (uniformity), spatial resolution, linearity)contrast scale, streak artifact suppression, and noise power spectrum (NPS). Generalizability tests of DLR in different scan and reconstruction parameters were performed in our bench test. In addition, image quality was performed by applying DLIR and ASIR on clinical data, including evaluation of pixel-wise noise magnitude, HU accuracy and high-contrast edge sharpness, in FOV 250 mm and FOV 450 mm. The bench test results demonstrate that use of DLIR decreases pixel-wise noise magnitude without losing features, changing High-contrast spatial resolution. The tests performed in this IQ report concluded with passed results and demonstrate that DLIR is substantially equivalent to ASIR in all defined parameters. including pixel-wise noise magnitude, HU accuracy and high-contrast spatial resolution.

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Clinical Testing

The proposed DLIR feature was evaluated in a retrospective blinded image evaluation that uses clinical cases acquired by SpotLight / CardioGraphe, using previous software versions. The clinical cases are of different anatomies, using different types of scans, from patients with a wide range of BMIs and clinical features. The data was collected from various SpotLight / CardioGraphe scanners, and the raw data was reconstructed using the DLIR algorithm. Data was collected from multiple clinical sites with at least 50% of the cases performed in the US. Five (5) certified CT readers (3 radiologists and 2 cardiologists. 4 out 5 are US board certified) examined the reconstructed series of different exams. Each exam was reviewed using standard (ASiR-CV) and alternative (DLIR) methods. The data was coded to avoid readers' bias. DLIR was found to provide diagnostic image quality that is not inferior to ASiR (the noise reduction algorithm used in the predicate device, K213465).

Based on non-clinical performance and clinical performance, as documented in the image quality validation testing, the SpotLight has a safety and effectiveness profile that is similar to the predicate device.

Conclusions

The SpotLight / SpotLight Duo (with DLIR option) is as safe and effective as the SpotLight Duo with ASiR-CV. SpotLight / SpotLight Duo (with DLIR option) has the same intended use and principles of operation as its predicate device, similar technological characteristics, and updated indications for use. In addition, the minor technological difference between SpotLight Duo (with DLIR option) and its predicate device raises no new issues of safety or effectiveness. Performance data demonstrate that SpotLight / SpotLight Duo (with DLIR option) is as safe and effective as the SpotLight Duo. Thus, SpotLight is substantially equivalent.

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.