(90 days)
Not Found
Yes
The device description explicitly states that the product analyzes cases using an "artificial intelligence algorithm".
No
The device is a non-invasive post-processing software that evaluates calcified plaques and generates a calcium score; it does not provide any treatment or prevention.
No
The device description explicitly states: "The device is intended for use by the clinicians as a non-diagnostic analysis software in conjunction with additional patient information and professional judgment." Additionally, it clarifies that "The final diagnosis is made by the clinician after reviewing the scan independently of the software."
Yes
The device description explicitly states "HealthCCSng product is a software device" and details its function as analyzing CT scans using an algorithm and providing output to a hosting application. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, the HealthCCSng device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The HealthCCSng device analyzes medical images (CT scans) of the human body, not biological specimens like blood, urine, or tissue.
- The intended use is for image analysis and post-processing. The device evaluates calcified plaques in coronary arteries from CT scans. This is a form of medical image analysis, not a diagnostic test performed on a biological sample.
- The output is an estimated calcium score and category based on image features. The device quantifies calcium based on its appearance in the CT images. This is different from measuring biomarkers or other substances in a biological sample.
- The device is described as "non-invasive". IVDs typically involve obtaining a biological specimen, which can be invasive (e.g., blood draw) or non-invasive (e.g., urine collection), but the core of the test is the analysis of the specimen itself.
While the device provides information that can be used in the diagnostic process for coronary artery disease, its function is to analyze medical images, not biological specimens. Therefore, it falls under the category of medical imaging software or a medical device for image analysis, rather than an In Vitro Diagnostic.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
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:
-
- Estimated Coronary Calcium Detection, based on the measurement of calcium deposits in the coronary arteries.
-
- A corresponding Estimated Coronary Calcium Detection Category, based on the Estimated Coronary Calcium measurements.
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 |
| ≥ 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:
-
- 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.
-
- HealthCCSng algorithm: Once a study has been validated, the algorithm analyzes the CT for analysis and quantification.
-
- IMA Integration feature: The results of a successful study analysis are provided to the hosting application.
-
- 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:
-
- A CT scan is sent to the Image Analytics Platform (IMA).
-
- The Image Analytics Platform (IMA) forwards the scan to the HealthCCSng algorithm for analysis.
-
- The scan is analyzed, with the following possible results sent back to IMA:
- a. Non-compliant: the scan is not compliant with the input criteria of the product and is therefore not analyzed.
- b. Success -
-
- Success A Zero calcium, Low, Medium or High Coronary Calcium Detection has been identified.
-
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed tomography (CT)
Anatomical Site
coronary arteries (heart)
Indicated Patient Age Range
adult patients of age 30-85
Intended User / Care Setting
Radiologists, Interpretive Clinicians. 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.).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 validation dataset included 436 cases, of which the algorithm returned a result on 427 cases, a yield of 97.94%.
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.
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
§ 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.
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)
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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:
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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.
-
- Estimated Coronary Calcium Detection, based on the measurement of calcium deposits in the coronary arteries.
-
- 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:
-
- 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.
-
- HealthCCSng algorithm: Once a study has been validated, the algorithm analyzes the CT for analysis and quantification.
-
- IMA Integration feature: The results of a successful study analysis are provided to the hosting application.
-
- 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:
-
- A CT scan is sent to the Image Analytics Platform (IMA).
-
- The Image Analytics Platform (IMA) forwards the scan to the HealthCCSng algorithm for analysis.
-
- The scan is analyzed, with the following possible results sent back to IMA:
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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 -
-
- Success A Zero calcium, Low, Medium or High Coronary Calcium Detection has been identified.
-
- 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 |
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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. |
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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.
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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