Who is the manufacturer of HealthCCSng?

Nano-X AI , Ltd. filed the 510(k) submission for HealthCCSng (K241440).

What is the FDA product code for HealthCCSng?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for HealthCCSng?

510(k) clearance (submission type: Special).

Does HealthCCSng use AI or machine learning?

Yes. HealthCCSng (K241440) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for HealthCCSng?

Nano-X AI HealthCCSng device (K210085).

Who can help prepare an FDA 510(k) submission like HealthCCSng?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like HealthCCSng get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

HealthCCSng

K241440 · Nano-X AI , Ltd. · JAK · Aug 19, 2024 · Radiology

Device Facts

Record ID	K241440
Device Name	HealthCCSng
Applicant	Nano-X AI , Ltd.
Product Code	JAK · Radiology
Decision Date	Aug 19, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

The HealthCCSng device is intended for use as a non-mvasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The HealthCCSng device analyzes routine non-gated, non-contrast CT studies that include the entire heart of adult patients of age 30-85. The device generates an exact calcium soore and a four coronary artery calcium detection category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. A list of studies that received a successful algorithm analysis result will also be available for further clinician assessment (such as by a cardiologist, general practitioner etc.). The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies.

Device Story

Software device for automated estimation of coronary artery calcium (CAC) from non-gated, non-contrast CT scans; operates in parallel to standard radiology workflow. Inputs: DICOM CT studies. Processing: AI algorithm validates scan compliance, segments heart, detects/quantifies calcification (threshold 130 HU). Outputs: exact calcium score, four-category classification (Zero, Low, Medium, High), and annotated preview axial images. Used in inpatient/outpatient settings by radiologists/clinicians. Results provided via Imaging Analytics Platform (IMA) for integration into standard reporting. Assists clinicians in identifying patients with coronary calcification; not for stand-alone diagnosis or risk attribution.

Clinical Evidence

Retrospective, simulated-use, standalone performance study using 436 anonymized CT scans from 4 institutions. Ground truth established by majority agreement of 3 board-certified radiologists. Primary endpoint: overall agreement with ground truth (89.46%; 95% CI: 86.15%-92.21%). Category-specific agreement: Zero (86.63%), Low (87.65%), Medium (87.36%), High (98.85%). Pearson correlation between device and ground truth scores: 0.959 (p<0.0001). Validated across diverse CT manufacturers (GE, Philips, Siemens, Toshiba) and imaging parameters.

Technological Characteristics

Software-only device; DICOM-based. Deep-learning-based heart segmentation and automated calcification detection. Threshold: 130 HU. Supports non-gated, non-contrast CT scans. Connectivity: Integrates with Imaging Analytics Platform (IMA). Software development follows 21 CFR 820 design controls.

Indications for Use

Indicated for adult patients aged 30-85 undergoing routine non-gated, non-contrast CT scans of the heart to evaluate calcified plaques in coronary arteries.

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

Nano-X AI HealthCCSng device (K210085)

Related Devices

K240369 — CAC (gated) Algorithm · BunkerHill Health · Sep 27, 2024
K210085 — HealthCCSng · Zebra Medical Vision, Ltd. · Sep 15, 2021
K201034 — Syngo.CT CaScoring · Siemens Medical Solutions USA, Inc. · May 14, 2020
K233211 — AVIEW CAC · Coreline Soft Co., Ltd. · Mar 29, 2024
K221219 — syngo.CT CaScoring · Siemens Medical Solutions USA, Inc. · May 17, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ August 19, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle. The FDA acronym is in a blue square, and the full name is written in blue text. Nano-X AI Ltd. % Neta Sherman Associate VP Regulatory Affairs and Quality Shlomo Shmeltzer Road 94 Po Box 3486 PETAH TIKVA, 4970602 ISRAEL Re: K241440 Trade/Device Name: HealthCCSng Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 21, 2024 Received: May 21, 2024 Dear Neta Sherman: 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 (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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241440 Device Name HealthCCSng Indications for Use (Describe) The HealthCCSng device is intended for use as a non-mvasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The HealthCCSng device analyzes routine non-gated, non-contrast CT studies that include the entire heart of adult patients of age 30-85. The device generates an exact calcium soore and a four coronary artery calcium detection category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. A list of studies that received a successful algorithm analysis result will also be available for further clinician assessment (such as by a cardiologist, general practitioner etc.). The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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.gov "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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Nanox AI. The logo consists of a stylized, abstract symbol on the left and the text "NANOX AI" on the right. The symbol is composed of curved lines in shades of blue and yellow, arranged to form a symmetrical, geometric shape. The text "NANOX" is in blue, while "AI" is in a lighter shade of yellow. # 510 (k) Summary # 510(K) Summary - HealthCCSng Nano-X AI Ltd. ### 510(k) Number - K241440 | Applicant's Name: | Neta Sherman, AVP Regulatory Affairs and Quality Nano-X AI Ltd. Shefayim Commercial Center PO Box 25 Shefayim, 6099000 ISRAEL Telephone: +972-9-7897867 | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| - Date Prepared: August 16, 2024 - Trade Name: HealthCCSng # Modified Device: | Proprietary Name | Nano-X AI HealthCCSng device | |------------------------|-----------------------------------| | Premarket Notification | K241440 | | Classification Name | Computed tomography x-ray system. | | Regulation Number | 21 CFR §892.1750 | | Product Code | JAK | | Regulatory Class | II | # Cleared Device: The HealthCCSng V2.0 device is substantially equivalent to the following cleared Device: | Proprietary Name | Cleared Device: | |------------------------|-----------------------------------| | | Nano-X AI HealthCCSng device | | Premarket Notification | K210085 | | Classification Name | Computed tomography x-ray system. | | Regulation Number | 21 CFR §892.1750 | | Product Code | JAK | | Regulatory Class | II | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Nanox AI. The logo consists of a stylized, abstract symbol on the left and the text "NANOX AI" on the right. The symbol is composed of curved lines arranged in a symmetrical pattern, with the upper portion colored yellow and the lower portion colored blue. The text "NANOX AI" is written in a sans-serif font, with "NANOX" in blue and "AI" in yellow. #### Performance Standards: No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. ## Intended Use/Indication for Use: The HealthCCSng device is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The HealthCCSng device analyzes routine non-gated, non-contrast CT studies that include the entire heart of adult patients of age 30-85. The device generates an exact calcium score and a four coronary artery calcium detection category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. A list of studies that received a successful algorithm analysis result will also be available for further clinician assessment (such as by a cardiologist, general practitioner etc.). The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies. #### Device Description: HealthCCSng product is a software device that automatically estimates the coronary artery calcium category from non-cardiac-gated adult CT scans. The product is aimed to leverage the high utilization of CT scans in the medical care environment (both inpatient and outpatient), including lung cancer screening programs, in order to automatically detect calcification in the coronary arteries of patients in an opportunistic manner. The HealthCCSng product analyzes cases using an artificial intelligence algorithm for the automated detection and estimation of coronary calcium and outputs a result for review by the clinician. The device works in parallel to and in conjunction with the standard of care workflow. The final diagnosis is made by the clinician after reviewing the scan independently of the software. The device is intended for use by the clinicians as a non-diagnostic analysis software in conjunction with additional patient information and professional judgment. HealthCCSng receives a non-gated, non-contrast CT study from the storage application, Nanox AI's Imaging Analytics Platform (IMA)/ other platforms. For each CT study received, the software shall validate at least one compliant series in which the entire heart is present and performs an analysis. For each complaint study, the software shall output: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Nanox AI. The logo consists of a stylized, symmetrical graphic on the left and the text "NANOX AI" on the right. The graphic is composed of curved lines arranged in a circular or spherical pattern, with the upper portion colored in yellow and the lower portion in blue. The text "NANOX AI" is written in a sans-serif font, with "NANOX" in blue and "AI" in yellow. - 1. Estimated Coronary Calcium Detection, based on the measurement of calcium deposits in the coronary arteries. - 2. A corresponding Estimated Coronary Calcium Detection Category, based on the Estimated Coronary Calcium measurements. ### Product Output: The software output will include the following calcium categories: | Estimated Coronary Calcium Detection | Corresponding Estimated Coronary Calcium Detection Category | |-----------------------------------------|----------------------------------------------------------------| | 0 | Zero Calcium | | 1-99 | Low | | 100-399 | Medium | | $\u2265$ 400 | High | For patients in which calcium was detected, the user will be presented with representative key images - all the slices containing the measured coronary calcifications (130 HU and above). On these images, the calcified areas will be annotated. The following modules compose the HealthCCSng software: - 1) Data input and validation: DICOM validation receives imaging study from hosting application and the validation feature assessed the input data (i.e. age, modality, view, etc.) to ensure compatibility for processing by the algorithm. - 2) HealthCCSng algorithm: Once a study has been validated, the algorithm analyzes the CT for analysis and quantification. - 3) IMA Integration feature: The results of a successful study analysis are provided to the hosting application. - 4) Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system. The product operates in the following manner: - 1. A CT scan is sent to the Image Analytics Platform (IMA). - 2. The Image Analytics Platform (IMA) forwards the scan to the HealthCCSng algorithm for analysis. - 3. The scan is analyzed, with the following possible results sent back to IMA: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Nanox AI. The logo consists of two parts: a stylized graphic on the left and the text "NANOXAI" on the right. The graphic is a symmetrical design with a grid-like pattern, colored in shades of blue and yellow. The text "NANOXAI" is written in a sans-serif font, with the "NANOX" part in blue and the "AI" part in yellow. - a. Non-compliant: the scan is not compliant with the input criteria of the product and is therefore not analyzed. - b. Success - - 1. Success A Zero calcium, Low, Medium or High Coronary Calcium Detection has been identified. - 2. Success No Category Cause: metal artifact(s) suggestive of known cardiac disease is suspected. - c. Failure: the scan has been analyzed. An error prevented the device from completing the analysis and therefore there is no output available. In all cases of success. HealthCCSng will provide key images of visualization of the detected coronary calcium (except for zero category), the category name and the exact score. ## Technological Characteristics Compared to Cleared Device: We believe that the HealthCCSng modified device is substantially equivalent to the Nano-X AI HealthCCSng cleared device K210085. | | Modified Device: HealthCCSng Device | Cleared Device: Nano-X AI Ltd. HealthCCSng Device (K210085) | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ Indications for Use | The HealthCCSng device is intended for use as a non-invasive post- processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The HealthCCSng device analyzes routine non-gated, non-contrast CT studies that include the entire heart of adult patients of age 30-85. The device generates an exact calcium score and a four coronary artery calcium detection category output representing the estimated quantity of calcium detected together with preview axial images of the detected | The HealthCCSng device is intended for use as a non- invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The software generates an estimated coronary artery calcium detection category. The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output representing the estimated | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for NanoxAI. The logo consists of a stylized, abstract symbol on the left and the text "NANOXAI" on the right. The symbol is composed of curved lines in shades of blue and yellow, arranged in a symmetrical pattern. The text "NANOXAI" is written in a sans-serif font, with "NANOX" in blue and "AI" in yellow. | calcium meant for informational | quantity of calcium detected together | |-------------------------------------------|----------------------------------------| | purposes only. | with preview axial images of the | | The device output will be available to | detected calcium meant for | | the radiologist as part of their standard | informational purposes only. | | workflow. A list of studies that | The device output will be available to | | received a successful algorithm | the radiologist as part of their | | analysis result will also be available | standard workflow. The | | for further clinician assessment (such | HealthCCSng results are not intended | | as by a cardiologist, general | to be used on a stand-alone basis for | | practitioner etc.). | risk attribution, clinical decision- | | The HealthCCSng results are not | making or otherwise preclude clinical | | intended to be used on a stand-alone | assessment of CT studies. | | basis for risk attribution, clinical | | | decision-making or otherwise preclude | | | clinical assessment of CT studies. | | # Comparison of Technological Characteristics | Technological Characteristics | Modified Device: HealthCCSng Device | Cleared Device: Nano-X AI Ltd. HealthCCSng Device (K210085) | Summary | |--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation | | | | | Product Code | JAK | JAK | Same | | Regulation Number | 21 CFR §892.1750 | 21 CFR §892.1750 | | | General | | | | | Modality | Computed tomography (CT) | Computed tomography (CT) | Same | | Image format | DICOM | DICOM | Same | | Supported CT scan | Non-contrast CT scan | Non-cardiac-gated CT scan | Similar. The inclusion criteria are the same: in | | | | | both devices algorithm is intended to run on non-contrast non- gated CT scans. | | Slice thickness | Up to 5.1 mm | Up to 3.1 mm | Similar, the modified HealthCCSng supports all the slice thickness range as in the cleared device and in addition can support a wider variety of scans. The expansion of the slice thickness range was validated and performance was found similar to the cleared device. | | Intended users | Radiologists, Interpretive Clinicians | Radiologists, Interpretive Clinicians | Same | | Intended population | Patients aged 30-85 years | Patients aged 30 years and above | Similar, both modified and cleared devices are intended for adult population at the age of 30 and older; the modified device has an upper limit as part of product scope focus on relevant population. | | Analysis and Measurement | | | | | Detection of target organ | Yes, detection of the heart | Yes, detection of the heart | Same | | Segmentation of organ | Deep-learning-based segmentation of the heart | Deep-learning-based segmentation of the heart | Same | | Calcification detection | Automatic | Automatic | Same | | Default threshold of calcium | 130 HU (Hounsfield Units) | 130 HU (Hounsfield Units) | Same | | Coronary artery calcification quantification method | Coronary Calcium Detection Category and exact detected calcium score on side bar | Coronary Calcium Detection Category Detected and calcium score mark on side bar | Similar, both devices provide calcium category; both the cleared device and the modified device mark the calcium score on a side bar; the modified device also provides the detected calcium score number as an output, which was validated and was found similar to the cleared device. | | Reporting | | | | | Annotation of detected calcium | Yes | Yes | Same | | Generate patient report | Optional to add the results to the report, DICOM Secondary Capture, Insight UI application | DICOM Secondary Capture, Insight UI application | Similar, the modified device also enables the option to add the | | | | | results to the radiology report. | | Device output | 1) Estimated Coronary Calcium Detection, based on the measurement of calcium deposits in the coronary arteries, precise score is indicated besides the arrow on the side scale bar. 2) A corresponding Estimated Coronary Calcium Detection Category, based on the Estimated Coronary Calcium measurements 4 categories: 0 - Zero Calcium 1-99 - Low 100-399 - Medium ≥400 - High | 1) Estimated Coronary Calcium Detection, based on the measurement of calcium deposits in the coronary arteries, score is presented as an arrow on the side scale bar. 2) A corresponding Estimated Coronary Calcium Detection Category, based on the Estimated Coronary Calcium measurements 3 categories: 0-99 – Low 100-399 – Medium 400 - High | Similar, both devices provide calcium category; The modified HealthCCSng device provides a more precise representation of coronary calcium score, and separating the category 0 from the other from the 'low' category. | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for NanoX AI. The logo consists of two parts: a stylized butterfly-like icon on the left and the text "NANOXAI" on the right. The icon is composed of curved lines in shades of blue and yellow, arranged to resemble butterfly wings. The text "NANOXAI" is written in a sans-serif font, with "NANOX" in blue and "AI" in yellow. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for NanoX AI. The logo consists of a stylized, symmetrical design on the left, resembling two interconnected, curved shapes with a gradient from blue to yellow. To the right of the design, the text "NANOXAI" is displayed, with "NANOX" in blue and "AI" in yellow, matching the color scheme of the logo. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for NanoX AI. The logo consists of two parts: a stylized graphic on the left and the company name on the right. The graphic is an abstract design with blue and yellow colors, resembling a sphere or globe. The text "NANOXAI" is written in blue, except for the "AI" part, which is in yellow. ## Performance Data: The HealthCCSng was designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. Safety and performance of HealthCCSng has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation & Verification Process to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The HealthCCSng modified device performance was evaluated in a retrospective, simulated use, standalone performance study of its performance compared to the established ground truth and relative to the cleared device. The ground truth (Coronary Artery Calcium Category) was determined by the majority agreement of two out of three US board certified radiologists, experienced in identifying coronary calcium on non-gated CT studies. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the logo for Nanox AI. The logo consists of two parts: a stylized graphic on the left and the text "NANOX AI" on the right. The graphic is a symmetrical design with curved lines in shades of blue and yellow, resembling a stylized flower or butterfly. The text "NANOX" is in a bold, dark blue font, while "AI" is in a lighter, golden-yellow color. The validation dataset included a truthed and enriched sample of at least 400 anonymized CT scans that include the heart from 4 healthcare institutions: Intermountain Healthcare (US), Clalit Health System (OUS), Northewell Health (US) and USARAD (US). The sample was engineered to contain sufficient cases within all coronary artery calcium categories. The validation dataset included 436 cases, of which the algorithm returned a result on 427 cases, a yield of 97.94% (30-85 years old;mean age of 61.89 years; SD=13.11; male=58.31% (249). The validation dataset represented the following imaging parameters: Modality (CT), Slice Thickness (0.5, 0.6, 0.625, 1, 1.25, 1.5, 2, 2.5, 3.75, 4, and 5 mm), Slice Increment (0.625, 1, 1.25, 1.5, 2, 2.5 and 3 mm), Exposure in mAs (Radiation Dose) i(15-966), KVP (100, 120, 130, 135 and 140), and four (4) manufacturers of CT devices (GE, Philips, Siemens and Toshiba). CT data across all-slice thickness, slice increment, exposure, KVP and manufacturers were well supported by the HealthCCSng device. The HealthCCSng device demonstrated an overall agreement between HealthCCSng coronary calcium category and the ground truth category of 89.46% (95% CI: [86.15%, 92.21%]). The lower bound of the confidence interval for the primary endpoint of overall agreement is greater than the success criterion of 85%, thus the null hypothesis is rejected, and the acceptance criterion met. - Agreement for the Zero category was: 86.63% (95% CI: [80.61%, 91.33]), the point . estimate for the Zero category is greater than 85%, the acceptance criterion is met. - . Agreement for the Low category was: 87.65% (95% CI: [78.47%, 93.92%]), the point estimate for the Low category is greater than 85%, the acceptance criterion is met. - Agreement for the Medium category was: 87.36% (95% CI: [78.50%, 93.52%]), the point . estimate limit for the Medium category is greater than 76%, the acceptance criterion is met. - Agreement for the High category was: 98.85% (95% CI: [93.76%, 99.97%]), the point . estimate for the High category is greater than 60%, the acceptance criterion is met. The HealthCCSng estimated coronary calcium score was compared to the corresponding ground truth (GT) score. The HealthCCSng device demonstrated a statistically significant correlation (Pearson's correlation coefficient) between the GT and HealthCCSng scores of ==0.959 (95% CI: [0.9499, 0.9655], p<0.0001. The device validation also demonstrated good correlation between the algorithm results on paired non-gated and gated scans, as summarized in table 1 and figures 1-2 below. In addition, the device performed as well as radiologists did, however the user should note that Coronary Calcium Scoring on non-gated CT scans, is not as accurate as on gated CT scans. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for NanoX AI. The logo consists of two parts: a stylized graphic on the left and the text "NANOX AI" on the right. The graphic is a symmetrical design with blue and yellow elements, resembling a stylized flower or sun. The text "NANOX AI" is in blue, except for the "AI" which is in yellow. | | HealthCCSng CAC Category [HU] Non-Gated | | | | | | | | Total | | |-------------------------------------|-----------------------------------------|--------|------|--------|---------|--------|------|--------|-------|---------| | | 0 | | 1-99 | | 100-399 | | 400+ | | N | % | | | N | % | N | % | N | % | N | % | N | % | | HealthCCSng CAC Category [HU] Gated | | | | | | | | | | | | 0 | 16 | 88.89% | 1 | 5.56% | 1 | 5.56% | . | . | 18 | 100.00% | | 1-99 | 12 | 44.44% | 13 | 48.15% | 2 | 7.41% | . | . | 27 | 100.00% | | 100-399 | . | . | 8 | 36.36% | 12 | 54.55% | 2 | 9.09% | 22 | 100.00% | | 400+ | . | . | . | . | 6 | 18.18% | 27 | 81.82% | 33 | 100.00% | | Total | 28 | 28.00% | 22 | 22.00% | 21 | 21.00% | 29 | 29.00% | 100 | 100.00% | #### Table 1: Categorical Agreement Image /page/12/Figure/3 description: This image is a Bland Altman Plot, which is a scatter plot used to compare two sets of measurements. The y-axis represents the percentage difference in HealthCCSng CAC score between gated and non-gated measurements, ranging from -197 to 203. The x-axis represents the mean HealthCCSng CAC score in Hounsfield Units (HU) for gated and non-gated measurements, ranging from 0 to 5000. The plot includes horizontal lines indicating the mean bias, upper and lower limits of agreement (LOA), and upper and lower confidence limits (UCL and LCL) for the LOA. Figure 1: Paired Gated/ Non-Gated Bland Altman Plot {13}------------------------------------------------ Image /page/13/Picture/0 description: The image contains the logo for Nanox AI. On the left is a graphic of a sphere made of many lines. The top half of the sphere is yellow, and the bottom half is blue. To the right of the graphic is the text "NANOX AI" in blue and yellow. The "NANOX" part of the text is blue, and the "AI" part of the text is yellow. Image /page/13/Figure/1 description: The figure is a scatter plot titled "HealthCCSng Coronary Calcium Score: Gated vs. Non-Gated". The x-axis represents the HealthCCSng CAC Score [HU] Non-Gated, and the y-axis represents the HealthCCSng CAC Score [HU] Gated. The plot includes a solid line representing the line of equality and a dashed line representing the Passing-Bablok Regression Line. The correlation is 0.85, and the P-value is less than 0.0001. Figure 2: Scatter Plot of the HealthCCSng Algorithm Coronary Calcium Score in Hounsfield Units Gated versus non-Gated scans solid line is line of equality and the dotted line the Passing-Bablok regression line In conclusion, this study demonstrated the HealthCCSng agreement of calcium score category measurements with the ground truth and established its safety and effectiveness, while demonstrating substantial equivalence to the cleared device. It also validated the performance of the HealthCCSng device across important cohorts, and applicable subsets of imaging acquisition characteristics. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image contains the logo for NanoX AI. The logo consists of two parts: a stylized graphic on the left and the text "NANOXAI" on the right. The graphic is an abstract shape with a grid-like pattern, colored in shades of blue and yellow. The text "NANOXAI" is written in a sans-serif font, with "NANOX" in blue and "AI" in yellow. ### Conclusion: Based on the information submitted in this premarket notification, the modified HealthCCSng device does not constitute a new intended use. The modified device has very similar intended use and indications for use as the cleared device, with very similar technological characteristics and principles of operation. The minor differences supported by software and performance validation testing demonstrate that the modified device is as safe and effective as the cleared device and performs as intended. The minor technological differences between the modified HealthCCSng device and the cleared device raise no new issues or questions of safety or effectiveness, and the modified version is substantially equivalent.