SpotLight/SpotLight Duo (with DLIR option)

K230370 · Arineta , Ltd. · JAK · Oct 13, 2023 · Radiology

Device Facts

• Record ID: K230370
• Device Name: SpotLight/SpotLight Duo (with DLIR option)
• Applicant: Arineta , Ltd.
• Product Code: JAK · Radiology
• Decision Date: Oct 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended 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, 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 Story

Multi-slice (192 detector rows), dual-tube CT scanner; acquires X-ray transmission projection data via rotating radiation source and detector array; reconstructs cross-sectional images using computer algorithms. Includes Deep Learning Image Reconstruction (DLIR) as an alternative to ASIR-CV noise reduction. Used in clinical settings by physicians/technicians for cardiovascular and thoracic imaging. Input: raw attenuation data; Output: trans-axial and reformatted images. DLIR processes raw data to reduce pixel-wise noise magnitude while maintaining high-contrast spatial resolution and HU accuracy. Output assists clinicians in diagnosing disease/abnormality and planning therapy. Benefits include improved image quality and noise reduction for diagnostic confidence.

Clinical Evidence

Retrospective blinded image evaluation using clinical cases from various anatomies and patient BMIs. Five certified readers (3 radiologists, 2 cardiologists) compared images reconstructed with standard (ASiR-CV) vs. alternative (DLIR) methods. Results demonstrated DLIR provides diagnostic image quality non-inferior to ASIR-CV.

Technological Characteristics

Dual-tube CT scanner; 192 detector rows; fast scintillator array (CdWO4/GOS); direct drive DC motor; 1.0 MHU anode heat capacity; 72 kW max power. Software includes console, image reconstruction (with DLIR), and embedded modules. Connectivity via DICOM/standard protocols. DLIR is a deep learning-based reconstruction subsystem. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-44, IEC 62304, ISO 14971, NEMA XR-25, XR-28, XR-29.

Indications for Use

Indicated for X-ray CT imaging of cardiovascular and thoracic anatomies in patients of all ages (DLIR limited to patients >2 years).

Regulatory Classification

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.

Predicate Devices

• SpotLight Duo (K213465)

Submission Summary (Full Text)

{0}------------------------------------------------

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).

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

510(k) Number (if known) K230370

Device Name SpotLight / SpotLight Duo (with DLIR option)

#### Indications for Use (Describe)

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.

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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) SUMMARY

## Arineta's SpotLight Duo (with DLIR option)

K230370

#### Submitter

Arineta Ltd. 15 Halamish Street Caesarea 3088900 Israel Tel: [phone] Fax: [phone]

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 | Regulation<br>Number | Product<br>Code |
|---------------|--------------|---------------|----------------------|-----------------|
| SpotLight Duo | Arineta Ltd. | K213465 | 892.1750 | JAK |

## 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.

{4}------------------------------------------------

## 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.

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.

## 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.

| Technological<br>characteristics | Proposed device - SpotLight /<br>SpotLight Duo (with DLIR option) | Predicate Device - SpotLight Duo<br>(K213465) | Discussion |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Detector<br>technology and<br>geometry | Fast scintillator array coupled to<br>photodiode array.<br>33 (WFOV) or 23 (EFOV) configurable<br>high resolution (HR) modules<br>comprising 192 detector rows X pitch<br>0.5mm (Z direction, measured at<br>scanner center).<br>10(WFOV)-20 (EFOV) configurable low | Fast scintillator array coupled to<br>photodiode array.<br>33 (WFOV) or 23 (EFOV) configurable<br>high resolution (HR) modules<br>comprising 192 detector rows X pitch<br>0.5mm (Z direction, measured at<br>scanner center).<br>10(WFOV)-20 (EFOV) configurable low | Same |
| | resolution (LR). EFOV includes 10<br>modules on each wing while WFOV<br>includes 10 modules on one wing. | resolution (LR). EFOV includes 10<br>modules on each wing while WFOV<br>includes 10 modules on one wing. | |
| Technological<br>characteristics | Proposed device - SpotLight /<br>SpotLight Duo (with DLIR option) | Predicate Device - SpotLight Duo<br>(K213465) | Discussion |
| | comprising 48 detector rows X pitch<br>2.0mm | comprising 48 detector rows X pitch<br>2.0mm | |
| | Analog to digital conversion per channel<br>on the detection module. | Analog to digital conversion per channel<br>on the detection module. | |
| | 1D antiscatter collimator. | 1D antiscatter collimator. | |
| Data<br>transmission<br>from rotor | Contactless transmission (capacitive<br>coupling). | Contactless transmission (capacitive<br>coupling). | Same |
| | Rate up to 6.25 GBit/sec | Rate up to 6.25 GBit/sec | |
| Power and<br>control<br>transmission to<br>rotor | 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 Varex<br>Imaging Corp. | 2 x MCS 2093 X ray tubes by Varex<br>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<br>X direction | Grid controlled focal spot modulation in<br>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. | |
| Image<br>reconstruction<br>hardware | Multicore PC and GPU | Multicore PC and GPU | Same |
| Image<br>reconstruction<br>algorithm | Modified FDK cone beam algorithm<br>adapted for dual tubes geometry. | Modified FDK cone beam algorithm<br>adapted for dual tubes geometry. | Both devices<br>include ASiR-CV,<br>while the |
| | Adaptive filter to reduce directional<br>noise in low level raw data (MBAF). | Adaptive filter to reduce directional<br>noise in low level raw data (MBAF) | proposed device<br>includes DLIR as<br>an alternative |
| | Noise reduction algorithms:<br>ASIR-CV or DLIR Al based image | Iterative reconstruction algorithm (ASIR-<br>CV) to reduce image noise. | noise reduction<br>algorithm. DLIR |
| | reconstruction algorithm (DLIR only for<br>250mm FOV and EFOV configuration). | For WFOV configuration, adapted to<br>reconstruct high resolution images<br>according to detector configuration, | can be applied to<br>250mm FOV and<br>EFOV<br>configuration. |
| Technological<br>characteristics | Proposed device - SpotLight /<br>SpotLight Duo (with DLIR option) | Predicate Device - SpotLight Duo<br>(K213465) | Discussion |
| | For WFOV configuration, adapted to<br>reconstruct high resolution images<br>according to detector configuration,<br>lower resolution images outside FOV<br>covered by high resolution detectors.<br>For extended FOV configuration,<br>adapted to reconstruct high resolution<br>images up to FOV250mm, lower<br>resolution images outside FOV250mm. | lower resolution images outside FOV<br>covered by high resolution detectors.<br>For extended FOV configuration,<br>adapted to reconstruct high resolution<br>images up to FOV250mm, lower<br>resolution images outside FOV250mm. | The SpotLight<br>with DLIR<br>demonstrates the<br>product<br>performance<br>claims (LCD,<br>Noise, High<br>contrast, Spatial<br>resolution, NPS,<br>accuracy and<br>uniformity), as<br>did the SpotLight<br>with ASiR CV. |
| Construction<br>Materials | 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 and<br>electronic cables components | PCB, electronic components and<br>electronic cables components | |
| | Table top made of carbon fiber<br>reinforced resin | Table top made of carbon fiber<br>reinforced resin | |
| | Covers made pf molded polymers and<br>reinforced resins | Covers made pf molded polymers and<br>reinforced resins | |
| | Oil in X-ray tubes cooling systems | Oil in X-ray tubes cooling systems | |
| | Detector scintillators made of CdWO4<br>and Gadolinium Oxysulfide (GOS) used<br>in other legally marketed CT scanners | Detector scintillators made of CdWO4<br>and Gadolinium Oxysulfide (GOS) used<br>in 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)<br>72kW | Max X ray power (total for two tubes)<br>72kW | |
| | Laser alignment lights: gantry bore<br>external lasers. <0.1mW per laser | Laser alignment lights: gantry bore<br>external lasers. <0.1mW per laser beam | |
| | beam.<br>Three lead ECG trigger module,<br>powered by medical grade power supply<br>through the system PDU. | Three lead ECG trigger module,<br>powered by medical grade power<br>supply through the system PDU | |
| Accessories | Head& hands and knees support | Head& hands and knees support | Same |
| | Optional operator desk (the site may<br>use their own desk) carrying the display<br>monitor, keyboard, mouse, scan<br>operation unit and optional accessories | Optional operator desk (the site may<br>use their own desk) carrying the display<br>monitor, keyboard, mouse, scan<br>operation unit and optional accessories | |
| | Barcode reader | Barcode reader | |
| | External Console UPS | External Console UPS | |
| Technological<br>characteristics | Proposed device - SpotLight /<br>SpotLight Duo (with DLIR option) | Predicate Device - SpotLight Duo<br>(K213465) | Discussion |
| Software | The SpotLight is provided with software<br>in three domains:<br>• Console software<br>• Image reconstruction software,<br>including the DLIR algorithm<br>• Embedded software | The SpotLight Duo is provided with<br>software in three domains:<br>• Console software<br>• Image reconstruction software<br>• Embedded software | Substantially the<br>same: the<br>software principal<br>block diagram is<br>the same, where<br>the DLIR option<br>is a software<br>sub-system<br>integrated in the<br>existing image<br>reconstruction<br>chain of<br>SpotLight<br>Duo/CardioGrap<br>he as alternative<br>to current the<br>ASIR-CV noise<br>reduction<br>algorithm. |
| Max Rotation<br>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) -<br>FOV up to 250mm<br>0.24 sec (full scan) - HR imaging at<br>FOV above 250mm for asymmetric<br>detector | 0.16 sec (partial), 0.24 sec (full scan) -<br>FOV up to 250mm<br>0.24 sec (full scan) – HR imaging at<br>FOV above 250mm for asymmetric<br>detector | Same |
| Max axial<br>coverage in a<br>single axial<br>scan | 140mm (280 slices x 0.5mm pitch) | 140mm (280 slices x 0.5mm pitch) | Same |
| Field of View<br>(FOV) | 25cm - 250mm at high resolution, with<br>DLIR option<br>EFOV - up to 450mm with lower<br>resolution outside FOV 250mm, with<br>DLIR option<br>WFOV - high resolution images at<br>configurable FOV between 250mm and<br>450mm | 25cm - 250mm at high resolution<br>EFOV - up to 450mm with lower<br>resolution outside FOV 250mm<br>WFOV - high resolution images at<br>configurable FOV between 250mm and<br>450mm | Same as<br>predicate device,<br>except DLIR as<br>optional<br>reconstruction for<br>25cm and EFOV<br>configurations |
| Max spatial<br>resolution | 17.5 lp/cm cutoff at center<br>10.0 lp/cm cutoff at radius above<br>125mm (outside FOV 250mm) covered<br>by HR detectors<br>7.0 lp/cm cutoff at radius above 125mm<br>(outside FOV 250mm) covered by LR<br>detectors | 17.5 lp/cm cutoff at center<br>10.0 lp/cm cutoff at radius above<br>125mm (outside FOV 250mm) covered<br>by HR detectors<br>7.0 lp/cm cutoff at radius above 125mm<br>(outside FOV 250mm) covered by LR<br>detectors | Same |
| Bore size | 60 cm | 60 cm | Same |
| Max Patient<br>weight | 227 Kg (500 lbs) | 227 Kg (500 lbs) | Same |

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

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

## 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.

{9}------------------------------------------------

## 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.