(176 days)
BriefCase-Quantification is a software intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart in adult patients aged 30 and older.
The device is intended to assist physicians by providing the user with a four-category Coronary Artery Calcification (CAC) of plaques, which present a risk for coronary artery disease, together with preview axial images of the detected calcium meant for informational purposes only.
The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. Clinicians are responsible for viewing full images per the standard of care.
BriefCase-Quantification is a standalone software as a medical device intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart to assist hospital networks and appropriately trained medical specialists. The software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.
The BriefCase-Quantification receives filtered routine, non-gated computed tomography (CT) scans, and processes them chronologically by running the algorithm on relevant series to evaluate calcified plaques in the coronary arteries. Following the AI processing, the output of the algorithm analysis is transferred to an image review software (the PACS or a desktop application).
The device generates a four-category output corresponding with the estimated quantity of calcium detected: very low, low, medium, and high. The categories composing the output of the device correspond with a validated visual assessment categorization of none, mild, moderate, and severe [1] in agreement with categorized Agatston scores indicated in the literature (very low: 0; low: 1-100; medium: 101-400; high: ≥400). In addition, the categories accord with the 2016 SCCT/STR guidelines for coronary artery calcium scoring of non-contrast non-cardiac chest CT scans and are used as standard of care in clinical practice during CAC assessment in NCCT scans.
The BriefCase-Quantification software generates a preliminary summary report that is provided in the desktop application that includes applicable user warnings, the CAC detection category and number of slices that include CAC. The report presents preliminary results only and instructs the user to review the full image and any other clinical information before making a clinical decision. For all analyzed scans, the user will be presented in the PACS with all the slices containing the measured coronary calcifications. On these images, the calcified areas will be represented to provide the user visibility on the areas which supported the category output. These slices will be presented along with the original slices. Preview images of the represented calcium are non-diagnostic and are available in the PACS for informational purposes only.
Here's an analysis of the acceptance criteria and the study for the BriefCase-Quantification device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|---|
| Overall Agreement (Primary Endpoint) | "up to the prespecified performance goal" | 87.1% |
| Agreement for 'Very Low' CAC (Secondary Endpoint) | "up to the prespecified performance goal" | 95.1% |
| Agreement for 'Low' CAC (Secondary Endpoint) | "up to the prespecified performance goal" | 81.3% |
| Agreement for 'Medium' CAC (Secondary Endpoint) | "up to the prespecified performance goal" | 81.5% |
| Agreement for 'High' CAC (Secondary Endpoint) | "up to the prespecified performance goal" | 89.3% |
Note: The document states that the primary and secondary endpoints were achieved because the reported performance was "up to the prespecified performance goal," but it does not explicitly state the numerical value of the prespecified performance goal for each criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 433 cases
- Data Provenance: Retrospective, multicenter study from 6 US-based clinical sites (both academic and community centers). The cases were distinct in time or center from the cases used to train the algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: At least one, potentially more. The text states "In cases where the reviewers disagree on the level of CAC, the senior US board-certified radiologist provided a final opinion which has established the ground truth." This implies primary reviewers and a senior radiologist for adjudication.
- Qualifications of Experts: Senior US board-certified radiologist (for final opinion/adjudication). The qualifications of initial reviewers are not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: 2+1 (or similar) where a "senior US board-certified radiologist provided a final opinion" in cases of disagreement among initial reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
- A standalone performance study of the algorithm against ground truth was performed.
- The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess how much human readers improve with AI vs without AI assistance. The study focuses on the algorithm's agreement with expert-established ground truth.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The pivotal study evaluated "the software's performance in providing estimated coronary artery calcification detection category ... compared to the ground truth." The performance metrics (overall agreement and agreement per category) are for the algorithm's output directly compared to ground truth.
7. The Type of Ground Truth Used
- Type of Ground Truth: Expert consensus/adjudication. The text states, "In cases where the reviewers disagree on the level of CAC, the senior US board-certified radiologist provided a final opinion which has established the ground truth." The ground truth categories ([very low, low, medium, high] corresponding to Agatston scores) are also aligned with "validated visual assessment categorization of none, mild, moderate, and severe" and "2016 SCCT/STR guidelines."
8. The Sample Size for the Training Set
- The sample size for the training set is not provided in the document. The text only mentions that "The cases collected for the pivotal dataset were all distinct in time or center from the cases used to train the algorithm."
9. How the Ground Truth for the Training Set was Established
- The document does not explicitly describe how the ground truth for the training set was established. It only ensures that the training and test sets were distinct. While it's implied that similar expert-based ground truth would be used, the specifics are not detailed.
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November 28, 2023
Aidoc Medical, Ltd. % John Smith Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW WASHINGTON, DC 20004
Re: K231631
Trade/Device Name: BriefCase-Quantification Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: October 30, 2023 Received: October 30, 2023
Dear John Smith:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Food and Drug Administration
Indications for Use
See PRA Statement below
510(k) Number (if known)
Device Name
BriefCase-Quantification
Indications for Use (Describe)
BriefCase-Quantification is a software intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart in adult patients aged 30 and older.
The device is intended to assist physicians by providing the user with a four-category Coronary Artery Calofication (CAC) of plaques, which present a risk for coronary artery disease, together with preview axial images of the detected calcium meant for informational purposes only.
The BriefCase-Quantification results are not intended to be used on a stand-alone basis for dinical decision-making or otherwise preclude clinical assessment of cases. Clinicians are responsible for viewing full images per the standard of care.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Aidoc. The logo is in blue and consists of the word "aidoc" in lowercase letters. There is a small orange circle to the right of the letter "c".
510(k) Summarv Aidoc Medical, Ltd.'s BriefCase-Quantification K231631
Submitter:
| Aidoc Medical, Ltd.3 Aminadav St.Tel-Aviv, IsraelPhone: +972-73-7946870 | |
|---|---|
| Contact Person: | Amalia Schreier, LL.M. |
| Date Prepared: | November 27, 2023 |
| Name of Device: | BriefCase-Quantification |
| Classification Name: | Computed Tomography X-ray System |
| Regulatory Class: | Class II |
| Product Code: | JAK (21 CFR 892.1750) |
| Primary Predicate Device: | HealthCCSng (K210085) |
| Reference Device: | iCAC (K230223) |
Device Description
BriefCase-Quantification is a standalone software as a medical device intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart to assist hospital networks and appropriately trained medical specialists. The software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.
The BriefCase-Quantification receives filtered routine, non-gated computed tomography (CT) scans, and processes them chronologically by running the algorithm on relevant series to evaluate calcified plaques in the coronary arteries. Following the Al processing, the output of the algorithm analysis is transferred to an image review software (the PACS or a desktop application).
The device generates a four-category output corresponding with the estimated quantity of calcium detected: very low, low, medium, and high. The categories composing the output of the device correspond with a validated visual assessment categorization of none, mild, moderate, and severe [1] in agreement with categorized Agatston scores indicated in the literature (very low: 0; low: 1-100; medium: 101-400; high: ≥400). In addition, the categories accord with the 2016 SCCT/STR guidelines for coronary artery calcium scoring of non-contrast non-cardiac chest CT scans and are used as standard of care in clinical practice during CAC assessment in NCCT scans.
The BriefCase-Quantification software generates a preliminary summary report that is provided in the desktop application that includes applicable user warnings, the CAC detection category and number
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of slices that include CAC. The report presents preliminary results only and instructs the user to review the full image and any other clinical information before making a clinical decision. For all analyzed scans, the user will be presented in the PACS with all the slices containing the measured coronary calcifications. On these images, the calcified areas will be represented to provide the user visibility on the areas which supported the category output. These slices will be presented along with the original slices. Preview images of the represented calcium are non-diagnostic and are available in the PACS for informational purposes only.
References:
[1] Shemesh, J., Henschke, C.I., Shaham, D., Yip, R., Farooqi, A.O., Cham, M.D., McCauley, D.I., Chen, M., Smith, J.P., Libby, D.M. and Pasmantier, M.W., 2010. Ordinal scoring of coronary artery calcifications on low-dose CT scans of the chest is predictive of death from cardiovascular disease. Radiology, 257(2), pp.541-548.
Intended Use / Indications for Use
BriefCase-Quantification is a software intended for use in the analysis of non-cardiac-gated noncontrast CT (NCCT) images that include the heart in adult patients aged 30 and older.
The device is intended to assist physicians by providing the user with a four-category Coronary Artery Calcification (CAC) of plaques, which present a risk for coronary artery disease, together with preview axial images of the detected calcium meant for informational purposes only.
The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. Clinicians are responsible for viewing full images per the standard of care.
Comparison of Technological Characteristics
The subject BriefCase-Quantification for Coronary Artery Calcification (CAC) is substantially similar to primary predicate HealthCCSng (K210085) and to reference device iCAC (K230223), as explained below.
The subject, predicate and the reference devices are radiological computer-aided non-invasive postprocessing software. All devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners, PACS, and radiology workstations. The predicate HealthCCSng and the reference iCAC evaluate images from CT scanners as does the proposed device for BriefCase-Quantification for Coronary Artery Calcification (CAC). The reference and subject devices have four coronary calcium levels and detection categories.
The proposed device for BriefCase-Quantification for Coronary Artery Calcification (CAC) has similar technology and design as the predicate and reference devices, and similar indications for use - as all devices are intended to aid in the evaluation of radiological images. The subject, predicate and reference devices raise the same types of safety and effectiveness questions. A table comparing the key features of the subject device predicate and reference devices is provided below.
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| Primary PredicateDevice HealthCCSng(K210085) | Reference Device iCAC(K230223) | BriefCase-Quantificationfor Coronary ArteryCalcification (CAC) | |
|---|---|---|---|
| Intended Use /Indications for Use | The HealthCCSng deviceis intended for use as anon-invasive post-processing software toevaluate calcified plaquesin the coronary arteries,which present a risk forcoronary artery disease.The software generates anestimated coronary arterycalcium detectioncategory. TheHealthCCSng deviceanalyzes existing non-cardiac-gated CT studiesthat include the heart ofadult patients above theage of 30. The devicegenerates a three-category outputrepresenting the estimatedquantity of calciumdetected together withpreview axial images of thedetected calcium meant forinformational purposesonly. The device output willbe available to theradiologist as part of theirstandard workflow. TheHealthCCSng results arenot intended to be used ona stand-alone basis for riskattribution, clinicaldecision-making orotherwise preclude clinicalassessment of CT studies. | iCAC is a software deviceintended for use inestimating presence andquantity of coronary arterycalcium for patients aged30 years and above duringroutine care. The deviceautomatically analyzesnon-gated, non-contrastchest computedtomography (CT) imagescollected during routinecare and outputs a visualrepresentation ofestimated coronary arterycalcium segmentation(intended for informationalpurposes only) and bothexact and four-categoryquantitative estimates ofthe patient's coronaryartery calcium burden inAgatston units.The output of the subjectdevice is made available tothe physician on-demandas part of his or herstandard workflow. Thedevice-generated calciumscore or score group canbe viewed in the patientreport at the discretion ofthe physician, and thephysician also has theoption of viewing thedevice-generated calciumsegmentation in a | BriefCase-Quantification is asoftware intended for use inthe analysis of non-cardiac-gated non-contrast CT(NCCT) images that includethe heart in adult patientsaged 30 and older.The device is intended toassist physicians byproviding the user with a four-category Coronary ArteryCalcification (CAC) ofplaques, which present a riskfor coronary artery disease,together with preview axialimages of the detectedcalcium meant forinformational purposes only.The BriefCase-Quantificationresults are not intended to beused on a stand-alone basisfor clinical decision-making orotherwise preclude clinicalassessment of cases.Clinicians are responsible forviewing full images per thestandard of care. |
| Primary PredicateDevice HealthCCSng(K210085) | Reference Device iCAC(K230223) | BriefCase-Quantificationfor Coronary ArteryCalcification (CAC) | |
| diagnostic image viewer.The subject device outputin no way replaces theoriginal patient report orthe original chest CT scan;both are still available to beviewed and used at thediscretion of the physician. | |||
| The device is intended toprovide information to thephysician to provideassistance during review ofthe patient's case. Resultsof the subject device arenot intended to be used ona stand-alone basis andare solely intended to aidand provide information tothe physician. In all cases,further action taken on apatient should only comeat the recommendation ofthe physician after furtherreviewing the patient'sresults. | |||
| User population | Radiologists | Interpreting physicians | Hospital networks andappropriately trained medicalspecialists |
| Anatomical regionof interest | Chest | Chest | Chest |
| Data acquisitionprotocol | Non-cardiac-gated CTstudies that include theheart | Non-gated, non-contrastchest CT images | Non-cardiac-gated non-contrast CT images thatinclude the heart |
| Primary PredicateDevice HealthCCSng(K210085) | Reference Device iCAC(K230223) | BriefCase-Quantificationfor Coronary ArteryCalcification (CAC) | |
| Calcified plaquesevaluation | Yes | Yes | Yes |
| Interference withstandard workflow | No | No | No |
| Algorithm | Artificialintelligencealgorithm with database ofimages. | Artificialintelligencealgorithm with database ofimages. | Artificialintelligencealgorithm with database ofimages. |
| Slice Thickness | Up to 3.0 mm | Up to 5.0 mm | Up to 5.0 mm |
| Patient population | Patients aged 30 and older | Patients aged 30 and older | Patients aged 30 and older |
| Default thresholdof calcium | 130 HU (Hounsfield Units) | 130 HU (Hounsfield Units) | 130 HU (Hounsfield Units) |
| Report of thecalcium score -output | Yes, Coronary CalciumDetection Category.3 categories:• 0-99• 10-399• >400 | Yes, Coronary CalciumDetection Category andexact Agatston score.4 categories (for detectioncategory):• 0• 1-99• 100-399• >_400 | Yes, Coronary CalciumDetection Category: very low,low, medium, and high.• The categoriescomposing the outputof the devicecorrespond with avalidated visualassessmentcategorization ofnone, mild, moderate,and severe inagreement withcategorized Agatstonscores indicated inthe literature (verylow: 0; low: 1-100;medium: 101-400;high: ≥400). |
| Structure | -HealthCCSng is analgorithm modulethat receives anon-cardiac-gatedCT study from the | -The iCAC Devicetakes as an inputnon-contrast, non-gated chest CTscans via DICOM | -BriefCase-Quantification, ishosted on a cloudserver, analyzesapplicable CT images |
| Primary PredicateDevice HealthCCSng(K210085) | Reference Device iCAC(K230223) | BriefCase-Quantificationfor Coronary ArteryCalcification (CAC) | |
| storageapplication,Zebra's ImagingAnalytics Platform(IMA). | transfer from theclinicians imagingdatabase such asPACS or DICOMrouter. | that are acquired onCT scanner that areforwarded toBriefCase-Quantification | |
| - For each CT studyreceived, thesoftware shallvalidate there is atleast one compliantseries in which theentire heart ispresent, andperform ananalysis. | - The device uses adeep learning-based computervision algorithm forits assessment. | - The results of theanalysis are exportedin DICOM format, andare sent to a PACSdestination for reviewby medicalspecialists, to assistin the evaluation ofCAC. |
Table 1. Key feature comparison
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Performance Data
Pivotal Study Summary
Aidoc conducted a retrospective, blinded, multicenter, study with the BriefCase-Quantification software to evaluate the software's performance in providing estimated coronary artery calcification detection category from non-cardiac-gated NCCT images that include the heart in 433 cases from 6 US-based clinical sites, both academic and community centers, compared to the ground truth. In cases where the reviewers disagree on the level of CAC, the senior US board-certified radiologist provided a final opinion which has established the ground truth. The cases collected for the pivotal dataset were all distinct in time or center from the cases used to train the algorithm.
Primary Endpoint
The algorithm performance showed that the overall agreement between the ground truth and algorithm across estimated CAC scores was 87.1%. Because the overall agreement estimate was up to the prespecified performance goal, the study's primary endpoint was achieved.
Secondary Endpoint
The algorithm performance between the ground truth and algorithm, in individual categories, was as follows: very low = 95.1%; low = 81.3%; medium = 81.5%; and high =89.3% . Because the overall agreement estimate was up to the prespecified performance goal across all individual categories, the study's secondary endpoint was achieved.
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Thus, the reported similar overall agreement for subject, predicate and reference devices demonstrates that when using the subject BriefCase-Quantification for Coronary Artery Calcification (CAC) the appropriately trained medical specialists may have the same benefits as when using the HealthCCSng and iCAC.
As can be seen in Table 2 the mean age of patients whose scans were reviewed for BriefCase-Quantification for Coronary Artery Calcification (CAC) was 67.4 years, with a standard deviation of 12.8 years. Gender distribution was 50% male, and 50% female (Table 3). Scanner distribution can also be found in Table 4 below.
| Mean | Std | Min | Median | Max | N | |
|---|---|---|---|---|---|---|
| Age(Years) | 67.4 | 12.8 | 30 | 69 | 90 | 432* |
Table 2. Descriptive Statistics for Age
- 1 case did not have any age information in the DICOM metadata
| Table 3. Frequency Distribution of Gender | |||
|---|---|---|---|
| ------------------------------------------- | -- | -- | -- |
| Ground | Gender | |||||
|---|---|---|---|---|---|---|
| TruthResults | Female | Male | All | |||
| N | % | N | % | N | % | |
| VeryLow | 64 | 62% | 39 | 38% | 103 | 100% |
| Low | 50 | 47% | 57 | 53% | 107 | 100% |
| Medium | 47 | 51% | 45 | 49% | 92 | 100% |
| High | 54 | 41% | 77 | 59% | 131 | 100% |
| All | 215 | 50% | 218 | 50% | 433 | 100% |
Table 4. Frequency Distribution of Manufacturer
| Manufacturer | Very Low | Low | Medium | High | All |
|---|---|---|---|---|---|
| GE | 30 (25%) | 27 (23%) | 29 (24%) | 33 (28%) | 119 (100%) |
| Philips | 20 (18%) | 36 (33%) | 28 (25%) | 26 (24%) | 110 (100%) |
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Image /page/10/Picture/0 description: The image shows the logo for "aidoc.". The logo is written in a sans-serif font, and the letters are a dark blue color. There is a small orange circle to the right of the "c" in "aidoc.". The logo is simple and modern.
| Manufacturer | Very Low | Low | Medium | High | All |
|---|---|---|---|---|---|
| Siemens | 12 (23%) | 13 (25%) | 6 (12%) | 21 (40%) | 52 (100%) |
| Toshiba | 41 (27%) | 31 (20%) | 29 (19%) | 51 (34%) | 152 (100%) |
| Total | 103 (24%) | 107 (25%) | 92 (21%) | 131 (30%) | 433 (100%) |
Clinical Subgroups and Confounders: Fully negative; Inflammatory; Neoplastic; Heart and Vascular; Trauma, Chronic diseases and None of the above.
In summary, performance validation data, combined with a comparison of overall agreement metric with the reference device demonstrated equivalent performance.
Conclusions
The subject BriefCase-Quantification for Coronary Artery Calcification (CAC), the predicate HealthCCSng and the reference iCAC are software devices intended to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The subject, predicate and the reference devices are not intended to be used as diagnostic devices. All three devices are software packages with similar technological characteristics and principles of operation, incorporating deep learning Al algorithms that process images. In all devices, the labeling instructs the results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CT studies.
The subject, predicate and reference devices operate in parallel to the standard of care workflow in the sense that they have the potential to allow accurate evaluation and facilitate the standard manual workflow. The BriefCase-Quantification for Coronary Artery Calcification (CAC) device is thus substantially equivalent and as safe and effective to the HealthCCSng and iCAC devices.
§ 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.