(268 days)
Not Found
Unknown
The document mentions "ABC and GCD algorithms" and performance metrics like AUC, Sensitivity, and Specificity, which are commonly associated with ML models. However, it does not explicitly state that these algorithms utilize AI or ML, nor does it provide details about the model architecture or training process that would confirm the use of AI/ML. The description of the "calibration dataset" and "test set" aligns with typical ML development workflows, but without explicit mention of AI/ML, it remains ambiguous.
No
Explanation: The device is an imaging system designed for diagnosis and assessment, not for treatment or therapy. Its intended uses include detection, assessment, and identification of risks related to coronary arteries, as well as ultrasound examination of intravascular pathology.
Yes
The device is intended for the detection, assessment, and identification of specific arterial conditions and risks, which are all diagnostic functions.
No
The device description explicitly states it is an "intravascular imaging device" and a "dual-modality instrument" that performs near-infrared spectroscopic analysis and generates high-resolution IVUS images. This indicates the device includes hardware components for image acquisition (NIRS and Ultrasound), not just software for processing or analysis.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Makoto Intravascular Imaging System™ directly examines the coronary and peripheral arteries within the patient's body using near-infrared light and ultrasound. It does not analyze samples like blood, urine, or tissue that have been removed from the body.
- The intended use describes direct imaging and assessment of structures within the body. The system is used for "near-infrared examination of coronary arteries," "ultrasound examination of coronary and peripheral intravascular pathology," and "assessment of vessel composition and structure." These are all in-vivo procedures.
Therefore, the Makoto Intravascular Imaging System™ is an in-vivo imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
- The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
a. The System is intended for the detection of lipid-core-containing plaques of interest.
b. The System is intended for the assessment of coronary artery lipid core burden.
c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. - The System is intended for ultrasound examination of coronary and peripheral intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.
Product codes (comma separated list FDA assigned to the subject device)
OBJ, OGZ, IYO
Device Description
The Makoto Intravascular Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid corecontaining plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near Infrared light, Ultrasound
Anatomical Site
Coronary arteries, coronary and peripheral intravascular pathology
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
The document refers to a "calibration dataset" distinct from the "test dataset" but does not provide a specific description of the training set (calibration dataset) in terms of sample size, data source, or annotation protocol, beyond mentioning that some annotators and sites overlapped with the test dataset, but no patient overlap. It also states the differences in the truthing process between calibration and test datasets were designed to reduce potential bias.
Description of the test set, sample size, data source, and annotation protocol
The test dataset consists of 18 unique patients and 29 total scans. Data sources include 12 scans from Japanese hospitals (5 patients across 3 sites) and 17 scans from US hospitals (13 patients across 3 sites). At the frame level, there were 981 frames total (381 from Japanese hospitals and 609 from US hospitals). The test dataset encapsulates clinically relevant disease states, with 38.9% calcium presence, 96.6% guidewire presence, 9.2% side branch presence, and 20.7% stent strut presence (percentages refer to % of frames).
The reference standard for the testing dataset was established using six expert IVUS readers who served as ground truth annotators. The annotation process was standardized through the use of IVUS Tracing Guidelines and a proprietary in-house developed tracing software to ensure consistency and reproducibility. Annotators followed specific instructions for contour and structure identification, including:
- Guide catheter and stent regions: Identification of relevant structures.
- Guidewire marking: Placement of marking points at the brightest point or closest GW position.
- Lumen and EEM contours: Marking points used to delineate the lumen and EEM boundaries.
- Calcium arcs: Placement of marks on the luminal edge of each calcified feature.
- Stent struts: Marking the center of each identifiable stent strut.
The test dataset was annotated by 6 expert readers, two of whom did not participate in annotating the calibration dataset. While four annotators were shared between calibration and test datasets, the impact of this overlap was mitigated through randomized site allocation and diverse annotation styles to ensure the model did not learn specific annotator tendencies. The test dataset remained blinded to algorithm developers.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Design verification and validation bench testing, software verification and validation testing. Animal and clinical testing were not performed.
Sample Size:
For ABC performance evaluation: This refers to the acceptance criteria which were established based on an inter- and intra-reader variability study with three expert readers, 30 samples, and two trials. The ABC Performance Evaluation on Test Data used a test dataset of 981 frames from 18 unique patients and 29 total scans.
For GCD results: The test dataset consists of 981 frames from 18 unique patients and 29 total scans.
Key Metrics (AUC, Sensitivity, Specificity):
ABC Performance Evaluation Results on Test Data:
- Bland-Altman Plot Diameter Difference Limits of Agreement (95% CI) (mm):
- Lumen: [-0.37, 0.41] (Acceptance Criteria: +/- 0.59) - PASS
- EEM: [-0.54, 0.52] (Acceptance Criteria: +/- 0.74) - PASS
- Bland-Altman Plot Area Difference Limits of Agreement (95% CI) (mm²):
- Lumen: [-2.3, 2.48] (Acceptance Criteria: +/- 3.46) - PASS
- EEM: [-4.5, 4.0] (Acceptance Criteria: +/- 6.18) - PASS
- Forward Hausdorff Distance 95% CI (mm):
- Lumen: [0.27, 0.29] (Acceptance Criteria:
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2025
Infraredx, Inc. Stephen Sum Senior Vice President R&D, Clinical, Quality, and Regulatory 28 Crosby Drive Suite 100 Bedford, Massachusetts 01730
Re: K241576
Trade/Device Name: Makoto Intravascular Imaging System™ (TVC-MC10/TVC-MC10); Dualpro™ IVUS + NIRS Imaging Catheter (TVC-C195-42); Clarispro™ 014 Imaging Catheter (TVC-E195-42) Regulation Number: 21 CFR 870.1200, 21 CFR 892.1560, Regulation Name: Diagnostic Intravascular Catheter, Ultrasonic Pulsed Echo Imaging System, Regulatory Class: Class II Product Code: OBJ, OGZ, IYO Dated: January 27, 2025 Received: January 27, 2025
Dear Stephen Sum:
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.
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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 System (OS) 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.
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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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-regulatory
2
assistance/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,
MARCO CANNELLA -S
for
Aneesh Deoras 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
3
Indications for Use
510(k) Number (if known) K241576
Device Name
Makoto Intravascular Imaging System™ (TVC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Clarispro™ HD-IVUS Imaging Catheter (TVC-E195-42)
Indications for Use (Describe)
- The Makoto Intravascular Imaging SystemTM is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
a. The System is intended for the detection of lipid-core-containing plaques of interest.
b. The System is intended for the assessment of coronary artery lipid core burden.
c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
- The System is intended for ultrasound examination of coronary and peripheral intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.
| 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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510(k) Summary
02/03/2025
Infraredx, Inc.
781.345.9651
Dr. Stephen Sum
01730 USA
28 Crosby Drive Suite 100, Bedford, MA
Prepared On Contact Details
Applicant Name Applicant Address
Applicant Telephone Applicant Contact Applicant Contact Email
Device Name
Device Trade Name Makoto Intravascular Imaging System™ (TVC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Clarispro™ HD-IVUS Imaging Catheter (TVC-E195-42) Common Name Diagnostic intravascular catheter Ultrasonic Pulsed Echo Imaging System Classification Name Catheter, Intravascular, Plaque Morphology Evaluation Regulation Number 870.1200, 892.1560 Product Code(s) OGZ, IYO, OBJ
Legally Marketed Predicate Devices
| Predicate Number | Predicate Trade Name | Product Code |
|---|---|---|
| K213303 | TVC-E195-42, TVC-C195- | |
| 42 & TVC-MC10/MC10i | OBJ, IYO, OGZ |
Device Description Summary
The Makoto Intravascular Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid corecontaining plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.
Intended Use/Indications for Use
-
- The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
- a. The System is intended for the detection of lipid-core-containing plaques of interest.
5
- b. The System is intended for the assessment of coronary artery lipid core burden.
- c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
-
- The System is intended for ultrasound examination of coronary and peripheral intravascular pathology.
- a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.
Indications for Use Comparison
The indications for use are the same.
Technological Comparison
The subject of this premarket notification is the addition of two software features on the Makoto Imaging System. These features are Automatic Border Contouring (referred to herein as ABC) and Guide Catheter Detection (referred to herein as GCD). The ABC software will assist physicians by automatically identifying the borders of the lumen and external elastic membrane (EEM) within the vasculature. The GCD software will assist physicians by automatically detecting the guide catheter edge during imaging procedures.
The proposed device has the same scientific principles of operation, principal technological characteristics, and safety profile as the currently marketed predicate device (K213303). Only minor design changes to the predicate device have been implemented. The tables below compare the general, catheter, controller, and console characteristics of the proposed and predicate devices.
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| General Characteristics | |||
|---|---|---|---|
| Characteristic | PROPOSED DEVICE | ||
| Infraredx | |||
| TVC-E195-42, TVC-C195-42 & TVC-MC10/ | |||
| MC10i | PREDICATE DEVICE | ||
| Infraredx | |||
| TVC-E195-42, TVC-C195-42 & TVC-MC10/ | |||
| MC10i | |||
| (K213303) | Comparison with | ||
| Predicate Device | |||
| Product Function | Near Infrared and Ultrasound Imaging System | Near Infrared and Ultrasound Imaging | |
| System | Same | ||
| Intended Use | The Makoto Intravascular Imaging System™ is | ||
| intended for the near-infrared examination of | |||
| coronary arteries in patients undergoing | |||
| invasive coronary angiography. The System is | |||
| intended for the detection of lipid-core- | |||
| containing plaques of interest. The System is | |||
| intended for the assessment of coronary artery | |||
| lipid core burden. The System is intended for | |||
| the identification of patients and plaques at | |||
| increased risk of major adverse cardiac events. | |||
| The System is intended for ultrasound | |||
| examination of coronary and peripheral | |||
| intravascular pathology. Intravascular | |||
| ultrasound imaging is indicated in patients who | |||
| are candidates for transluminal coronary and | |||
| peripheral interventional procedures. The | |||
| System is not indicated for use in the cerebral | |||
| vessels. | The Makoto Intravascular Imaging System™ is | ||
| intended for the near-infrared examination of | |||
| coronary arteries in patients undergoing | |||
| invasive coronary angiography. The System is | |||
| intended for the detection of lipid-core- | |||
| containing plaques of interest. The System is | |||
| intended for the assessment of coronary | |||
| artery lipid core burden. The System is | |||
| intended for the identification of patients and | |||
| plaques at increased risk of major adverse | |||
| cardiac events. | |||
| The System is intended for ultrasound | |||
| examination of coronary intravascular | |||
| pathology. Intravascular ultrasound imaging | |||
| is indicated in patients who are candidates | |||
| for transluminal coronary interventional | |||
| procedures. | Same | ||
| Where Used | Coronary and Peripheral | Coronary and Peripheral | Same |
| System Components | NIR/IVUS Catheter | ||
| Portable or Fixed Console (Laser, SBC, power | |||
| supply) and Controller | NIR/IVUS Catheter | ||
| Portable or Fixed Console (Laser, SBC, | |||
| power supply) and Controller | Same | ||
| Classification | Catheter - | ||
| Product Code OGZ, OBJ | |||
| 21 CFR 870.1200 | |||
| System | |||
| Product Code IYO | |||
| 21 CFR 892.1560 | Catheter - | ||
| Product Code OGZ | |||
| 21 CFR 870.1200 | |||
| System | |||
| Product Code IYO | |||
| 21 CFR 892.1560 | Same | ||
| Catheter Characteristics | |||
| Characteristic | PROPOSED DEVICE | ||
| Infraredx | |||
| TVC-E195-42, TVC-C195-42 & TVC- | |||
| MC10/ MC10i | PREDICATE DEVICE | ||
| Infraredx | |||
| TVC-E195-42, TVC-C195-42 & | |||
| TVC-MC10/ MC10i (K213303) | Comparison with Predicate | ||
| Device | |||
| Usable Length | 160 cm | 160 cm | Same |
| Sheath Distal Tip Profile | 2.4 F | 2.4 F | Same |
| Guidewire rail length | 1.2 cm | 1.2 cm | Same |
| Imaging window profile | 3.2 F | 3.2 F | Same |
| Imaging core pullback | 15 cm | 15 cm | Same |
| Number of RO Marker Bands | 1 RO marker | ||
| (0.5cm from distal tip) | 1 RO marker | ||
| (0.5cm from distal tip) | Same | ||
| Maximum guidewire OD | 0.014 in. | 0.014 in. | Same |
| Minimum guide catheter I.D. | 6 F | 6 F | Same |
| Method of Sterilization | EtO | EtO | Same |
| Materials supplied in sterile packaging | Intravascular NIR/IVUS catheter | ||
| Priming accessory | |||
| Controller sterile barrier | Intravascular NIR/IVUS catheter | ||
| Priming accessory | |||
| Controller sterile barrier | Same | ||
| Shelf Life | 36 months | 36 months | Same |
| Transducer Center Frequency | 50MHz | 50MHz | Same |
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| Controller and Console Characteristics | |||
|---|---|---|---|
| Characteristic | PROPOSED DEVICE | ||
| Infraredx | |||
| TVC-E195-42, TVC-C195-42 and TVC- | |||
| MC10/ MC10i | PREDICATE DEVICE | ||
| Infraredx | |||
| TVC-E195-42, TVC-C195-42 and TVC- | |||
| MC10/ MC10i | |||
| (K213303) | Comparison with Predicate | ||
| Device | |||
| Imaging Mode | Near Infrared light, Ultrasound | Near Infrared light, Ultrasound | Same |
| Output | NIR light | ||
| RF Ultrasound | NIR light | ||
| RF Ultrasound | Same | ||
| Hardware Components | CPU with 16GB RAM | ||
| 1 Monitor and 1 Touchscreen Monitor | |||
| Swept Source Laser | CPU with 16GB RAM | ||
| 1 Monitor and 1 Touchscreen Monitor | |||
| Swept Source Laser | Same | ||
| Laser Type | Swept Source Semiconductor Laser | Swept Source Semiconductor Laser | Same |
8
| Imaging element
| pullback speed | 0.5, 1.0, and 2.0 mm/s | 0.5, 1.0, and 2.0 mm/s | Same |
|---|---|---|---|
| Pullback Distance | 150mm | 150mm | Same |
| Controller Housing | Handle | Handle | Same |
| Controller RFID | Enabled for catheter type identification | Enabled for catheter type identification | Same |
| Controller User Interface | LCD screen | LCD screen | Same |
| Graphical User Interface | NIRS-IVUS image for coronary scanning | ||
| (TVC-C195-42) | |||
| IVUS image only for peripheral scanning | |||
| (TVC-E195-42) | NIRS-IVUS image for coronary scanning | ||
| (TVC-C195-42) | |||
| IVUS image only for peripheral scanning | |||
| (TVC-E195-42) | Same | ||
| Contouring of lumen and | |||
| EEM borders in IVUS | |||
| image | Automatic or manual contouring of vessel | ||
| borders | Manual contouring of vessel borders | Substantially equivalent | |
| Detection of guide | |||
| catheter edge | Automatic detection of guide catheter edge | ||
| based on IVUS | Automatic detection of guide catheter | ||
| edge based on NIRS | Substantially equivalent |
9
Non-Clinical and/or Clinical Tests Summary and Conclusions
Design verification and validation bench testing was conducted for the changes in scope of this premarket application. Animal and clinical testing were not performed.
The bench testing demonstrates that the proposed device is substantially equivalent to the predicate device.
The sterilization and shelf-life evaluations of the catheters reported in this premarket notification show that the sterilization process remains acceptable and that the proposed device maintains a 36-month shelf life, consistent with the predicate device.
The biocompatibility testing of the catheters was conducted for an external communicating device in circulating blood, with a limited contact duration of ≤ 24 hrs. The series of testing was conducted utilizing Good Laboratory Practice (GLP) following ISO 10993 and ASTM standards. Biocompatibility testing was performed for cytoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, and hemocompatibility. All tests met the pre-determined acceptance criteria, as specified in the test protocols and associated test standards.
Minor hardware changes to accommodate the subject changes (ABC and GCD features) in the imaging console presented a potential impact on the electromagnetic interference (EMI) performance of the Makoto system. Testing of the system showed no significant increase in EMI.
Software verification and validation testing was also conducted for the subject changes included in this premarket application. The ABC and GCD testing successfully met all the criteria specified in the test protocol.
The following tables present the performance evaluation of ABC and GCD algorithms on blinded test data.
The ABC acceptance criteria were established based on an approved protocol and report which conducted an inter- and intra-reader variability study with three expert readers, 30 samples, and two trials. This study provided a benchmark for expected variability in manual contouring, ensuring that the algorithm's performance aligns with clinical practice standards.
Performance was assessed using error metrics, including diameter difference, area difference, and Hausdorff distance (HD) for lumen and EEM contours. For guide catheter detection, performance was evaluated based on detection accuracy, sensitivity, and specificity.
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| ABC Performance Evaluation Results on Test Data | ||||
|---|---|---|---|---|
| Performance Metric | Contour | Acceptance Criteria | ABC Performance Evaluation on Test Data | Result |
| Bland-Altman Plot Diameter Difference Limits of Agreement (95% CI) (mm) | Lumen | +/- 0.59 | [-0.37, 0.41] | PASS |
| Bland-Altman Plot Diameter Difference Limits of Agreement (95% CI) (mm) | EEM | +/- 0.74 | [-0.54, 0.52] | PASS |
| Bland-Altman Plot Area Difference Limits of Agreement (95% CI) (mm²) | Lumen | +/- 3.46 | [-2.3, 2.48] | PASS |
| Bland-Altman Plot Area Difference Limits of Agreement (95% CI) (mm²) | EEM | +/- 6.18 | [-4.5, 4.0] | PASS |
| Forward Hausdorff Distance 95% CI (mm) | Lumen |