Elucid FFR-IQ (B.1)

K262015 · Elucid Bioimaging, Inc. · PJA · Sep 29, 2026 · Cardiovascular

Device Facts

• Record ID: K262015
• Device Name: Elucid FFR-IQ (B.1)
• Applicant: Elucid Bioimaging, Inc.
• Product Code: PJA · Cardiovascular
• Decision Date: Sep 29, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1415
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K262015 · Sep 29, 2026	Elucid FFR-IQ (B.1)	Elucid Bioimaging, Inc.	Retrospective clinical medical records (paired CCTA and invasive FFR)	The ELUCIDATE study utilized retrospective clinical data from 11 sites to validate the performance of the Elucid FFR-IQ device against invasive FFR measurements, reflecting real-world clinical conditions and patient populations.	Retrospective study; Clinical validation; FFR-CT; Real-world performance

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
ELUCIDATE (NCT06018194); Retrospective, multicenter study; Follow-up/Duration: Invasive FFR performed within 60 days of CCTA; Study Period: Data collected from 2012 onwards	Clinically stable patients with suspected coronary artery disease requiring CCTA and invasive FFR; Sample Size: 491 vessels across 347 patients; Number of Sites: 11 (9 US, 2 OUS)	Invasive FFR	Sensitivity and specificity of FFR-IQ compared to invasive FFR

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
FFR-CT	Deep learning neural networks	Sensitivity > 75% and Specificity > 75%	Sensitivity 92.2% [87.5, 96.5], Specificity 93.1% [90.2, 95.6]	—	—	ELUCIDATE (NCT06018194): 491 vessels across 347 patients	—

Indications for Use

Elucid FFR-IQ is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable patients with known or suspected coronary artery disease. It provides FFR-CT (CT-derived FFR) values estimated from coronary CTA images using AI-enabled algorithms. FFR-IQ is intended to support the functional evaluation of coronary artery disease. The FFR-IQ results are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. FFR-IQ results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

Device Story

Elucid FFR-IQ is a SaaS-based coronary physiological simulation software. It takes previously acquired coronary CTA DICOM images as input. The device uses deep learning neural networks to integrate coronary anatomy and biology (plaque composition/amount) to estimate FFR-CT values along the coronary tree. It utilizes 3D segmentation results from the Plaque-IQ algorithm. The device is used in healthcare facilities, hospitals, or physician offices. Qualified clinicians access the output—graphics and text results—via an internet-connected device. The output supports clinical decision-making by providing non-invasive functional evaluation of coronary artery disease, aiding in the assessment of coronary arteries in conjunction with patient history, symptoms, and other diagnostic tests.

Clinical Evidence

Clinical validation was performed via the ELUCIDATE retrospective, multicenter study (NCT06018194) involving 491 vessels across 347 patients. The study compared FFR-IQ simulated values against invasive FFR (ground truth). Overall results: Sensitivity 92.2% [87.5, 96.5], Specificity 93.1% [90.2, 95.6], PPV 84.4%, NPV 96.7%. US cohort (N=257) showed Sensitivity 90.9% and Specificity 89.2%. The study population was enriched for borderline disease (FFR 0.75-0.85). No adverse events were observed due to the retrospective study design.

Technological Characteristics

Software-as-a-Service (SaaS) coronary vascular physiologic simulation software. Utilizes deep learning neural networks for 3D segmentation and FFR-CT estimation. Requires input from previously acquired CCTA (K241524). Connectivity: Internet-based access for end-users. Complies with ISO 14971 for risk management and FDA software/cybersecurity guidance.

Indications for Use

Indicated for clinically stable adult patients (22 years and older) with known or suspected coronary artery disease requiring functional evaluation of coronary arteries via analysis of previously acquired coronary CTA images.

Regulatory Classification

Identification

A coronary vascular physiologic simulation software device is a prescription device that provides simulated functional assessment of blood flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated metrics of physiologic information (e.g., blood flow, coronary flow reserve, fractional flow reserve, myocardial perfusion). A coronary vascular physiologic simulation software device is intended to generate results for use and review by a qualified clinician.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Adequate software verification and validation based on comprehensive hazard analysis, with identification of appropriate mitigations, must be performed, including: (i) Full characterization of the technical parameters of the software, including: (A) Any proprietary algorithm(s) used to model the vascular anatomy; and (B) Adequate description of the expected impact of all applicable image acquisition hardware features and characteristics on performance and any associated minimum specifications; (ii) Adequate consideration of privacy and security issues in the system design; and (iii) Adequate mitigation of the impact of failure of any subsystem components ( *e.g.,* signal detection and analysis, data storage, system communications and cybersecurity) with respect to incorrect patient reports and operator failures.(2) Adequate non-clinical performance testing must be provided to demonstrate the validity of computational modeling methods for flow measurement; and (3) Clinical data supporting the proposed intended use must be provided, including the following: (i) Output measure(s) must be compared to a clinically acceptable method and must adequately represent the simulated measure(s) the device provides in an accurate and reproducible manner; (ii) Clinical utility of the device measurement accuracy must be demonstrated by comparison to that of other available diagnostic tests ( *e.g.,* from literature analysis);(iii) Statistical performance of the device within clinical risk strata ( *e.g.,* age, relevant comorbidities, disease stability) must be reported;(iv) The dataset must be adequately representative of the intended use population for the device ( *e.g.,* patients, range of vessel sizes, imaging device models). Any selection criteria or limitations of the samples must be fully described and justified;(v) Statistical methods must consider the predefined endpoints: (A) Estimates of probabilities of incorrect results must be provided for each endpoint, (B) Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification, and (C) The report must provide appropriate confidence intervals for each performance metric; (vi) Sensitivity and specificity must be characterized across the range of available measurements; (vii) Agreement of the simulated measure(s) with clinically acceptable measure(s) must be assessed across the full range of measurements; (viii) Comparison of the measurement performance must be provided across the range of intended image acquisition hardware; and (ix) If the device uses a cutoff threshold or operates across a spectrum of disease, it must be established prior to validation, and it must be justified as to how it was determined and clinically validated; (4) Adequate validation must be performed and controls implemented to characterize and ensure consistency ( *i.e.,* repeatability and reproducibility) of measurement outputs:(i) Acceptable incoming image quality control measures and the resulting image rejection rate for the clinical data must be specified, and (ii) Data must be provided within the clinical validation study or using equivalent datasets demonstrating the consistency ( *i.e.,* repeatability and reproducibility) of the output that is representative of the range of data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment;(A) Testing must be performed using multiple operators meeting planned qualification criteria and using the procedure that will be implemented in the production use of the device, and (B) The factors ( *e.g.,* medical imaging dataset, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data;(5) Human factors evaluation and validation must be provided to demonstrate adequate performance of the user interface to allow for users to accurately measure intended parameters, particularly where parameter settings that have impact on measurements require significant user intervention; and (6) Device labeling must be provided that adequately describes the following: (i) The device's intended use, including the type of imaging data used, what the device measures and outputs to the user, whether the measure is qualitative or quantitative, the clinical indications for which it is to be used, and the specific population for which the device use is intended; (ii) Appropriate warnings specifying the intended patient population, identifying anatomy and image acquisition factors that may impact measurement results, and providing cautionary guidance for interpretation of the provided measurements; (iii) Key assumptions made in the calculation and determination of simulated measurements; (iv) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance. Per-vessel clinical performance, including where applicable localized performance according to vessel and segment, must be included as well as a characterization of the measurement error across the expected range of measurement for key parameters based on the clinical data; (v) A detailed description of the patients studied in the clinical validation ( *e.g.,* age, gender, race or ethnicity, clinical stability, current treatment regimen) as well as procedural details of the clinical study (*e.g.,* scanner representation, calcium scores, use of beta-blockers or nitrates); and(vi) Where significant human interface is necessary for accurate analysis, adequately detailed description of the analysis procedure using the device and any data features that could affect accuracy of results.

In combination with the general controls of the FD&C Act. the Coronary Physiologic Simulation Software Device is subject to the following special controls:

Predicate Devices

• Heartflow FFRct (DEN130045)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG
ADMINISTRATION

September 29, 2026

Elucid Bioimaging, Inc.
Windi Hary
Chief Quality and Regulatory Officer
399 Boylston St., Suite 400
Boston, Massachusetts 02116

Re: K262015

Trade/Device Name: Elucid FFR-IQ (B.1)

Regulation Number: 21 CFR 870.1415

Regulation Name: Coronary Vascular Physiologic Simulation Software Device

Regulatory Class: Class II

Product Code: PJA

Dated: August 28, 2026

Received: August 31, 2026

Dear Windi Hary:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K262015 - Windi Hary

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Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. 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).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K262015 - Windi Hary

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

STEPHEN C. BROWNING -S

CDR Stephen Browning

Assistant Director

Division of Cardiac Electrophysiology,

Diagnostics, and Monitoring Devices

Office of Cardiovascular Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262015 | ? |
| Please provide the device trade name(s). | | ? |
| Elucid FFR-IQ (B.1) | | |
| Please provide your Indications for Use below. | | ? |
| Elucid FFR-IQ is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable patients with suspected coronary artery disease. It provides FFR-CT (CT-derived FFR) values computed from coronary CTA images using AI-enabled algorithms. FFR-IQ is intended to support the functional evaluation of coronary artery disease.The FFR-IQ results are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. FFR-IQ results are intended to be used by qualified clinicians in conjunction with the with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment. | | |
| Please select the types of uses. | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? |

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Elucid FFR-IQ Traditional 510(k)

510(k) Summary

# 510(k) Summary

## Submitter Information

| Submitter / Manufacturer Name | Elucid Bioimaging, Inc. 399 Boylston Street, Suite 400, Boston, MA 02116 |
| --- | --- |
| Primary Correspondent & Contact Information | Windi Hary Chief Regulatory and Quality Officer Email ID: [e-mail] |
| Secondary Correspondent & Contact Information | Hiral Vora Lead Quality and Regulatory Affairs Specialist Email ID: [e-mail] |
| Date Prepared | September 29, 2026 |

## Device Identification

| Proprietary Name | Elucid FFR-IQ (B.1) |
| --- | --- |
| Device Classification Name | Coronary vascular physiologic simulation software device |
| Regulation Description | Coronary vascular physiologic simulation software device |
| Regulation Number | 870.1415 |
| Device Class | Class II |
| Product Code | PJA |
| Device Characteristics | Device is software as a service |
| Environment of Use | Healthcare Facility / Hospital / Physician Office |

## Predicate Device

| Proprietary Name | Heartflow FFRct |
| --- | --- |
| Device Classification Name | Coronary vascular physiologic simulation software device |
| Regulation Description | Coronary vascular physiologic simulation software device |
| 510(k) Number | DEN130045 |
| Regulation Number | 870.1415 |
| Device Class | Class II |
| Product Code | PJA |
| Device Characteristics | Device is software as a service |
| Environment of Use | Healthcare Facility / Hospital / Physician Office |

ELUCID BIOIMAGING, INC.

K262015

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Elucid FFR-IQ Traditional 510(k)

510(k) Summary

## Intended Use

Elucid FFR-IQ is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable patients with known or suspected coronary artery disease. It provides FFR-CT (CT-derived FFR) values estimated from coronary CTA images using AI-enabled algorithms. FFR-IQ is intended to support the functional evaluation of coronary artery disease.

The FFR-IQ results are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. FFR-IQ results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

## Device Description

FFR-IQ is a BioIntegrated coronary physiological software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable patients with known or suspected coronary artery disease. It integrates anatomy and biology (such as plaque composition and amount which impacts vasodilation) to estimate FFR-CT values from static coronary CTA images with extracted coronary tree structures using deep learning neural networks. Elucid's FFR-IQ analysis is intended to support the functional evaluation of Coronary Artery Disease. Using the 3D segmentation results of Plaque-IQ, an AI-enabled algorithm assesses FFR-CT (CT-derived FFR) values along the coronary tree.

Elucid's FFR-IQ is deployed and controlled by Elucid. FFR-IQ is AI-enabled.

## Summary of Technological Characteristics

| Comparison Criteria | Subject Device | Predicate Device | Comparison Assessment |
| --- | --- | --- | --- |
| | Elucid FFR-IQ (B.1) | HeartFlow FFRct v1.4 | - |
| 510(k) | K262015 | DEN130045 | - |
| Manufacturer | Elucid Bioimaging, Inc | HeartFlow, Inc. | - |
| Product Code | PJA | PJA | Same as predicate |
| Regulation | 870.1415 | 870.1415 | Same as predicate |
| Device Classification Name | Coronary vascular physiologic simulation software device | Coronary vascular physiologic simulation software device | Same as predicate |
| Device Class | II | II | Same as predicate |
| Input / Data Source | CT / K241524 (CT) | CT | Similar, however Elucid FFR-CT requires the output of K241524 as input |
| Output | Graphics and text results of noninvasively derived FFR-CT that can be | Graphics and text results of noninvasively derived FFR-CT that can be | Same as predicate |

ELUCID BIOIMAGING, INC.

K262015

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Elucid FFR-IQ Traditional 510(k)

510(k) Summary

| Comparison Criteria | Subject Device | Predicate Device | Comparison Assessment |
| --- | --- | --- | --- |
| | accessed by end users/physicians using a device with internet connectivity | accessed by end users/physicians using a device with internet connectivity | |
| Ground Truth for Model Training | Paired CT and invasive FFR data | Paired CT and invasive FFR data | Same |

## Summary of Nonclinical Performance Data

Software verification and validation testing was conducted and documentation provided as recommended in FDA guidance *Content of Premarket Submissions for Device Software Functions*.

Cybersecurity testing was conducted and documentation provided as recommended in FDA guidance document *Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions*.

Human Factors and Usability testing was conducted and documentation provided as recommended in FDA guidance document *Applying Human Factors and Usability Engineering to Medical Devices*.

Results of all current and previously referenced testing concludes the device is acceptable for use.

## Risk Management

Risk management was conducted and documentation provided as recommended in FDA guidance *Content of Premarket Submissions for Device Software Functions* and in accordance with *ISO 14971 Medical Devices – Applications of risk management to medical devices*.

ELUCID BIOIMAGING, INC.

K262015

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Elucid FFR-IQ Traditional 510(k)

510(k) Summary

## Summary of Clinical Validation

### Study Design

ELUCIDATE (NCT06018194) is a retrospective, multicenter study that included eleven study sites in the US (9) and OUS (2), representative of a generalized population and real-world use conditions.

Elucid designed this retrospective study to reflect expected commercial performance, rather than the performance of a prospective study where CT image acquisition and invasive FFR data collection protocols are rigorously supervised, controlled, and unlikely to represent real-world conditions.

The retrospective study design required paired CCTA and invasive FFR for validation purposes; however, the population receiving invasive FFR is necessarily narrower than the population receiving FFR-CT due to the referral pathway that produces both diagnostic tests on the same patient. Under AHA/ACC guidance (Lawton et al. 2021) invasive FFR is performed only when non-invasive assessment cannot resolve the clinical question, predominantly intermediate 40-69% diameter stenosis. The retrospective validation cohort requiring paired CCTA and invasive FFR is therefore drawn from that referred subset and is enriched for borderline disease and significantly weighted in the FFR gray zone of 0.75 - 0.85. The US dataset reflects this enriched population; therefore, the US dataset and subsequent performance reflect a more challenging intended use population than the broader population expected commercially.

Elucid enrolled data from an OUS site which previously collected the data prospectively to represent the portion of the population that is deferred from further invasive assessment. The prospective study protocol under which the data was originally acquired encouraged invasive FFR measurement in all territories regardless of disease state. Thus, clearly non-obstructive, non-ischemic vessels are supplemented where retrospective data is sparse. Differences in the prospective data collection (as defined by the collection protocol for that study) drive differences in the disease prevalence between the US and OUS sites, as well as between the retrospectively and prospectively collected data. To this end, the performance results are reported for the US cohort, the OUS cohort, and the overall validation cohort respectively.

Subjects ages 18 and over with clinically indicated CCTA and invasive FFR performed within 60 days of CCTA. Study design ensured blinding of FFR-CT processing to invasive FFR. The study analyzed 491 vessels across 347 patients.

Enrollment exclusion criteria for patients included:

- Prior coronary artery bypass graft (CABG) or percutaneous intervention (PCI)
- History of myocardial infarction prior to CCTA and/or invasive FFR
- Known complex congenital heart disease
- Existing pacemaker or internal defibrillator lead implantation
- Existing prosthetic heart valve
- Interval clinical myocardial infarction, diagnosis of decompensated heart failure, stroke, or coronary revascularization between CCTA and invasive FFR

ELUCID BIOIMAGING, INC.

K262015

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Elucid FFR-IQ Traditional 510(k)

510(k) Summary

Additional exclusion criteria related to data necessary for analysis included:

- Missing CCTA for analysis
- Missing invasive coronary angiography imaging or adequate description defining the position of the invasive FFR wire location
- Non-diagnostic CCTA or invasive FFR
- Poor CCTA image quality that does not meet Elucid image processing requirements for plaque and FFR-CT
- CCTA or invasive FFR performed prior to January 1, 2012
- Absence of study date for CCTA or invasive FFR
- Patients who had IFR or CFR, and not measured FFR

FFR-IQ was used to simulate FFR-CT from the subject's CT. The FFR-CT was then compared to the invasively collected FFR to assess the device performance.

## Primary Safety and Effectiveness Endpoints

The primary endpoints regarding this study were sensitivity and specificity to have the lower limits of their 95% CI to be > 75%. These performance goals were not necessarily determined to be sufficient for substantial equivalence, but the performance demonstrated by the results was.

## Study Results

The ELUCIDATE overall study results as well as the separate US cohort met the primary endpoints.

| Per vessel | US cohort results | Overall Results |
| --- | --- | --- |
| Sensitivity | 90.9 [85.1, 96.5] | 92.2 [87.5, 96.5] |
| Specificity | 89.2 [83.9, 93.7] | 93.1 [90.2, 95.6] |
| Unadjusted PPV | 84.1 [77.7, 90.5] | 84.4 [79.2, 89.3] |
| Unadjusted NPV | 94.0 [90.0, 97.6] | 96.7 [94.8, 98.5] |
| Bland-Altman LoA | 0.19 [-0.09 - 0.10] | 0.23 [-0.10 - 0.13] |
| Sample size | N = 257 | N = 491 |

| NXT Predicate results |
| --- |
| 84 [75, 89] |
| 86 [82, 89] |
| 61 [53, 69] |
| 95 [93, 97] |
| 0.30 [-0.12 - 0.18] |
| N = 484 |

Due to the retrospective nature of the study, there were no adverse events or complications observed in the study.

## Conclusion

While there are differences noted in the technological characteristics of the proposed device and the predicate device, namely that the predicate uses computational fluid dynamics and the subject device does not, the differences do not raise different questions of safety or effectiveness. Non-clinical verification and validation, along with clinical performance data, collectively support substantial equivalence of the subject device to the predicate.

ELUCID BIOIMAGING, INC.

K262015

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