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510(k) Data Aggregation
(113 days)
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(196 days)
The Cara System is intended for preplanning and guidance of medical interventions in an area known to contain or be adjacent to the cardiac conduction system, such as percutaneous or surgical procedures, for example, transcatheter aortic valve replacement (TAVR), as well as medical procedures where the physician desires to deliver therapy to the patient's cardiac conduction system or to a targeted location within it (CSP).
The Cara System uses computed tomography angiography (CTA)-based and user manually marked landmarks to identify the cardiac conduction axis and generate a three-dimensional (3D) map of the individual patient's cardiac conduction system. The system also overlays the anatomical location of the cardiac conduction system (generated by the Cara Metis Simulator using pre-procedure CT data) onto live fluoroscopic images.
The software utilizes AI/ML algorithms to provide OCR detection, automated segmentation of anatomical structures, and detection of catheters.
The CARA System is intended for use in adult patients (18 years of age and older).
The CARA System is a medical device comprising two integrated functions. The CARA System device components include the CARA Metis Simulator and the CARA Atlas Navigator. Both components provide diagnostic imaging software and hardware functions that identify the personalized anatomical location of the cardiac conduction system in relation to other heart anatomies based on a patient's computed tomographic angiography (CTA). The former is intended for preplanning (1) a medical intervention in an area known to contain or be adjacent to the cardiac conduction system or (2) a medical procedure(s) where the physician desires to deliver therapy to the patient's cardiac conduction system. The latter identifies the personalized anatomical location of the cardiac conduction system overlaid on real-time, intra-procedural, fluoroscopic imaging and provides guidance during interventional structural heart disease procedures in an area known to contain or be adjacent to the cardiac conduction system or where the physician desires to deliver therapy to the patient's cardiac conduction system.
The CARA Metis Simulator uses computed tomography angiography (CTA)-based landmarks to accurately identify the cardiac conduction axis and run a simulation generating the personalized three-dimensional (3D) map of the individual patient's cardiac conduction system.
This 3D map is then utilized by the clinical operator to plan any procedure to either target, as in direct pacing, or avoid as in structural heart disease interventions, the cardiac conduction system. As described below, this technology is based on methodical translational studies investigating the 3D location of the cardiac conduction system relative to cardiac structures visible by clinical imaging with initial assessment and validation in the clinical setting.
The CARA Atlas Navigator is designed to overlay the personalized anatomical location of the cardiac conduction system (generated by the Cara Metis Simulator using pre-procedure CT data) onto live fluoroscopic images. This functionality assists clinicians during fluoroscopy-guided interventional heart procedures.
The Cara Atlas Navigator consists of both software and hardware components:
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Fluoroscopy Splitter (F-Splitter) – This device splits the live fluoroscopy image for integration with the CARA System.
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CARA Box – A standard workstation that receives live fluoroscopy images from the Fluoroscopy Splitter and enhances them by adding anatomical landmarks. The CARA Box acts as the system's central processing unit, handling data analysis and image processing. It is equipped with user interface devices, such as a mouse and keyboard.
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CARA Monitor – Displays the enhanced fluoroscopy images, including the analysis performed by the CARA Box. This monitor is typically located in the control room. The same output is also projected onto the main display in the operating room.
The CARA System utilizes a specific on-premises workflow to ensure data integrity and clinical accuracy. Prior to physician use, a certified CARA Clinical Expert (CCE) must be physically present on-site. The CCE logs into the CARA Box workstation to prepare the CARA Metis pre-planning process. This includes initiating the automated segmentation, verifying the anatomical output, annotating landmarks, and saving the results to the local storage.
The physician subsequently logs into the same workstation using distinct credentials to load, review, and confirm the pre-planned case. This workflow ensures that all generated outputs are professionally prepared and verified before clinical review.
The CARA System utilizes AI/ML algorithms to provide OCR (Optical Character Recognition), automated segmentations and device tracking:
- OCR detection - is used to automatically extract metadata from the live feed of the fluoroscopy machine (e.g., c-arm position, focal distance, etc.).
- Segmentations - the system utilizes deep learning models to automatically generate anatomical segmentations of the heart chambers and aorta.
- Device Detection - using a segmentation model the system detects the distal tips of specific interventional devices (e.g., Pigtail catheters, CS catheters, pacing leads) within the fluoroscopic image to support real-time tracking and present overlay.
AI-based segmentations are provided to assist the workflow but may contain inaccuracies. The AI output should not be used as the sole basis for clinical decision-making. Clinical oversight is mandatory.
Here's a breakdown of the acceptance criteria and study details for the CARA System, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance Study for the CARA System
The CARA System's performance was evaluated through non-clinical, AI/ML validation, and retrospective clinical performance testing to demonstrate substantial equivalence to the predicate device, Cydar EV (K212442).
1. Acceptance Criteria and Reported Device Performance
| Feature / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance | ||
| CT-to-fluoroscopy registration error | Mean ≤ 2.0 mm; Max ≤ 3.0 mm | Mean registration error ≤ 2.0 mm; Maximum error ≤ 3.0 mm |
| System latency (95% upper bound) | ≤ 133 ms | ≤ 133 ms |
| Image fidelity (PSNR) | ≥ 35 dB | ≥ 35 dB |
| Image fidelity (SSIM) | ≥ 0.95 | ≥ 0.95 |
| AI/ML Performance | ||
| OCR Error rate | 0 errors (≤5% upper 95% CI bound) | 0 failures observed |
| Anatomical Segmentation (Cardiac Chambers) - Dice Similarity Coefficient (DSC) | ≥ 0.85 | All evaluated structures met criteria |
| Anatomical Segmentation (Cardiac Chambers) - Average Surface Distance (ASD) | ≤ 1.5 mm | All evaluated structures met criteria |
| Aortic Segmentation (DSC) | ≥ 0.85 | Mean DSC = 0.962 |
| Catheter & Lead Detection - Median distal tip localization error | ≤ 0.9 mm | All evaluated catheter types met criteria |
| Clinical Performance | ||
| TAVR Cohort: Association between CARA-visualized CSA and Permanent Pacemaker Implantation (PPI) rates | Association observed consistent with clinical expectations | Implantation above CARA-visualized CSA: 11.2% PPI vs. 33.9% PPI when not above |
| CSP Cohort: Association between CARA-visualized LBBP and LVEF improvement | Association observed consistent with clinical expectations | Pacing at CARA-identified LBBP: +11.2% LVEF improvement vs. +0.3% for non-specific septal pacing |
2. Sample Size and Data Provenance for AI/ML Test Set
- OCR Test Set: 61 fluoroscopic images (retrospective, multi-site clinical datasets).
- Anatomical Segmentation (Cardiac Chambers) Test Set: 50 retrospective CT scans (retrospective, multi-site clinical datasets).
- Aortic Segmentation Test Set: 480 fluoroscopic images (retrospective, multi-site clinical datasets).
- Catheter & Lead Detection Test Set: 2,139 fluoroscopic images (retrospective, multi-site clinical datasets).
The specific country of origin for the retrospective, multi-site clinical datasets is not detailed in the provided information.
3. Number and Qualifications of Experts for Ground Truth
- Anatomical Segmentation (Cardiac Chambers) Ground Truth: Manual segmentation by trained technologists, adjudicated by a U.S. Board-Certified Interventional Cardiologist.
- Aortic Segmentation Ground Truth: Manual contour annotation, adjudicated by a U.S. Board-Certified Interventional Cardiologist.
- Catheter & Lead Detection Ground Truth: Manual distal tip annotation, adjudicated by a U.S. Board-Certified Interventional Cardiologist.
- OCR Ground Truth: Manual verification of extracted parameters (no specific expert qualifications mentioned beyond "manual verification").
The number of experts (U.S. Board-Certified Interventional Cardiologists) used for adjudication is not specified (e.g., whether it was one individual or a panel).
4. Adjudication Method for the Test Set
The adjudication method clearly states "adjudicated by a U.S. Board-Certified Interventional Cardiologist." This implies a single expert review of the preliminary ground truth established by trained technologists/manual annotators. It does not indicate a 2+1 or 3+1 consensus method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned in the provided document. The study described focuses on the device's standalone performance and a retrospective clinical correlation, not on comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done for the AI/ML algorithms. The "AI/ML Performance Summary" table directly details the performance of the OCR, anatomical segmentation, and catheter/lead detection algorithms on independent test datasets, measured against ground truth.
7. Type of Ground Truth Used
- AI/ML Algorithms: Expert consensus (adjudication by a U.S. Board-Certified Interventional Cardiologist) applied to initial manual annotations by trained technologists for anatomical segmentations and catheter/lead detection. Manual verification for OCR.
- Clinical Performance Data: Retrospective clinical outcomes data (Permanent Pacemaker Implantation rates, Left Ventricular Ejection Fraction improvement) associated with the CARA-visualized Conduction System Axis and Left Bundle Branch Pacing.
8. Sample Size for the Training Set
The document states, "Algorithms were trained using retrospective, multi-site clinical datasets," but does not specify the sample size used for the training set. It only mentions that "Training and test datasets were independent."
9. How the Ground Truth for the Training Set was Established
The document states, "Algorithms were trained using retrospective, multi-site clinical datasets." While it describes how ground truth was established for the validation/test set (manual segmentation by trained technologists with physician adjudication), it does not explicitly detail how the ground truth for the training set was established. It is implied that similar methods would have been used, but it's not directly stated.
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(229 days)
The ArmSure Fluoroscopic Positioning System is a software-enabled manual Assist Arm intended for use with fluoroscopic systems to assist in the visualization of the spatial relationship of attached compatible surgical instruments and interventional accessories on X-ray images, and to maintain the corresponding spatial position to hold the attached instrument or accessory.
The ArmSure system is intended to be used by trained healthcare professionals in a clinical environment, and is indicated for use during fluoroscopically-guided procedures involving the spine and long bones in patients whose anatomical size is suitable for the compatible instruments and the host fluoroscopic system.
The ArmSure Fluoroscopic Positioning System combines a software application with an Assist Arm to provide real-time visualization of surgical instrument locations within X-ray images. The visualization is derived from data transmitted by the Assist Arm to the ArmSure software, which performs calculations based on image coordination to superimpose the instrument's position onto the fluoroscopic X-ray images.
The Assist Arm is a manual, non-actuated device designed to be operated by the surgeon at the patient's side. The surgeon manually manipulates the Assist Arm in response to the interactive feedback displayed on the external screen, enabling precise instrument positioning through this real-time interface.
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(24 days)
The Azurion series (within the limits of the used Operating Room table) are intended for use to perform:
- Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedures.
- Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Additionally:
- The Azurion series can be used in a hybrid Operating Room.
- The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
The Azurion R3.1 is classified as an interventional fluoroscopic X-Ray system. The primary performance characteristics of the Azurion R3.1 include:
- Real-time image visualization of patient anatomy during procedures
- Imaging techniques and tools to assist interventional procedures
- Post processing functions after interventional procedures
- Storage of reference/control images for patient records
- Compatibility with hospital information systems (HIS) and image archiving systems via DICOM
- Built in radiation safety controls.
The only changes to the subject device, Azurion R3.1 includes the design change to the mattress accessory for all the existing mattresses of the predicate device (Azurion R3.1, K251827, 24 October 2025) and introduction of new gray color mattress. The change includes the addition of a hook and loop fastener (Velcro) solution for use between the mattress and the system integrated patient table (AD7X), to ensure that the mattress does not slip from the patient table.
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(174 days)
The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult and pediatric patients for:
- Handheld orthopedic radiographic procedures of the extremities.
- Handheld orthopedic serial radiographic procedures of the extremities, excluding the shoulder, hip, and knee. Handheld serial radiographic imaging is limited to forward holding position only.
- Stand-mounted orthopedic radiographic, serial radiographic, fluoroscopic, and orthopedic interventional procedures of the extremities, inclusive of shoulders and knees.
The device is NOT intended for use during surgery. The device is NOT intended to replace a stationary radiographic or fluoroscopic system, which may be required for optimization of image quality and radiation exposure.
The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).
The device is NOT intended to be used in environments with the following characteristics:
- Aseptic or sterile fields, such as in surgery
- Home or residential settings or other settings where qualified operators are not present
- Vehicular and moving environments
- Environments under direct sunlight
- Oxygen-rich environments, such as near an operating oxygenation concentrator
The MC2 Portable X-ray System ("MC2 System" or "MC2") is a portable and handheld X-ray system designed to aid clinicians with point-of-care visualization through diagnostic X-rays of the shoulders to fingertips and knees to toes. The device allows clinicians to select desired technique factors best suited for their patient's anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and are charged via a wired charger. The system is intended to interface wirelessly to an external tablet when used with the OXOS Device App or to a monitor with an off-the-shelf ELO Backpack and the OXOS Device App. The MC2 utilizes an Infrared Tracking System to allow the emitter to be positioned above the patient's anatomy and aligned to the cassette by the operator. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance.
The MC2 is capable of three X-ray imaging modes: single radiography, serial radiography, and fluoroscopy. In single and serial radiography modes, the user can utilize the entire range of kV values (40-80kV), while fluoroscopy mode is limited to 40-64kV. In single radiography mode, the user can utilize the entire range of mAs values, while serial radiography and fluoroscopy are limited to 0.04-0.08 mAs.
The MC2 contains various safety features to ensure patient and operator safety. The primary interlocks that ensure system geometry is maintained include a source-to-image distance interlock, an active area interlock, a source-to-skin distance interlock, and a stand-mounted interlock.
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(179 days)
The SKAN C Pulsar, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic images of patients during Diagnostic, Surgical and Interventional procedures. SKAN C Pulsar is to be used by adequately trained, qualified and authorized healthcare professionals. Clinical Applications may include Orthopedic, GI Procedure, Neurology, Urology Procedures, Vascular in Critical Care and Emergency Room Procedures.
SKAN C Pulsar is not recommended for Cardiac Applications.
SKAN C Pulsar surgical C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.
The SKAN C Pulsar, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of patients during Diagnostic, Surgical and Interventional procedures. SKAN C Pulsar is to be used by adequately trained, qualified and authorized healthcare professionals. Clinical Applications may include Orthopedic, GI Procedure, Neurology, Urology Procedures, Vascular in Critical Care and Emergency Room Procedures.
SKAN C Pulsar is a Mobile fluoroscopy C-Arm consisting of two main units:
a) C-arm main unit
b) A Workstation or Monitor Cart
The C-arm unit is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and a Console. C-arm has provision for mechanical movement of C-arm for Orbital and Yoke Rotation along with vertical and wig-wag movements.
Workstation or Monitor cart is composed of a monitor, keyboard and computing system.
The operating principle of the device is to expose X-ray, which are passed through the human body and falls on the sensor. The intensity of X-ray can be adjusted to required level. Detector follows two step conversion. It converts X-ray into light and Light is converted into electrical signal. Electrical signal is than digitized and stored. This stored information is processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device.
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(235 days)
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
GE HealthCare interventional x-ray systems are designed to perform monoplane fluoroscopic X-ray examinations to provide the imaging information needed to perform minimally invasive interventional X-Ray imaging procedures. Additionally, with an OR table, these systems allow to perform surgery and X-Ray image guided surgical procedures in a hybrid Operating Room.
Allia™ Moveo is a GE HealthCare interventional X-Ray system product model. It consists of a C-arm positioner, an X-ray table, an X-ray tube assembly, an X-ray power unit with its exposure control unit, an X-ray imaging chain (including a digital detector and an image processing unit).
Allia™ Moveo is a monoplane system (C-arm with mobile AGV gantry), with a square 41cm digital detector and the InnovaIQ table (with an option to make it an OR table).
Allia™ Moveo is an image acquisition system requiring connection to the GE HealthCare Advantage Workstation (AW) for 3D reconstruction. When a 3D acquisition is performed on the Allia™ Moveo system, the acquired 2D images are transferred to the Advantage Workstation (AW) to be processed by 3DXR (reference device K243446) for 3D reconstruction.
The purpose of this Premarket Notification is the introduction of a new C-arm with a modified detector mount.
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(281 days)
The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care, and in Veterinary Medicine.
The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
The Cios Select (VA21F) Mobile X-ray System is designed for the surgical environment. The Cios Select (VA21F) is a modification of the Cios Select (VA21) Flat Panel originally cleared under Premarket Notification K223410 on December 7, 2022.
The Cios Select consists of two major units:
The Siemens Healthineers Cios Select mobile fluoroscopy C-arm system is an X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station.
The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector, and user controls.
The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Imaging Processing System, user controls and image storage devices (USB).
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(133 days)
The Azurion series (within the limits of the used Operating Room table) are intended for use to perform:
- Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
- Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Additionally:
- The Azurion series can be used in a hybrid Operating Room.
- The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
Patient Population:
All human patients of all ages. Patient weight is limited to the specification of the patient table.
The Azurion R3.1 is classified as an interventional fluoroscopic X-Ray system. The primary performance characteristics of the Azurion R3.1 include:
- Real-time image visualization of patient anatomy during procedures
- Imaging techniques and tools to assist interventional procedures
- Post processing functions after interventional procedures
- Storage of reference/control images for patient records
- Compatibility with hospital information systems (HIS) and image archiving systems via DICOM
- Built in radiation safety controls
This array of functions offers the physician the imaging information and tools needed to perform and document minimally invasive interventional procedures.
The Azurion R3.1 is available in identical models and configurations as the predicate device Azurion R2.1. Configurations are composed of detector type, monoplane (single C-arm) or biplane (dual arm), floor or ceiling mounted geometry, standard or OR table type and available image processing.
Identical to the predicate device, the FlexArm option is available for the 7M20 configuration in Azurion R3.1 to increase flexibility in stand movement.
Additionally, identical to the predicate device, Azurion R3.1 can be used in a hybrid operating room when supplied with a compatible operating room table.
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(136 days)
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
αEvolve Imaging is an imaging chain intended for adults, with Artificial Intelligence Denoising (AID) designed to reduce noise in real-time fluoroscopic images and signal enhancement algorithm, Multi Frequency Processing (MFP).
The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging, is an interventional X-ray system with a floor mounted C-arm as its main configuration. An optional ceiling mounted C-arm is available to provide a bi-plane configuration where required. Additional units include a patient table, X-ray high-voltage generator and a digital radiography system. The C-arms can be configured with designated X-ray detectors and supporting hardware (e.g. X-ray tube and diagnostic X-ray beam limiting device). The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging includes αEvolve Imaging, an imaging chain intended for adults, with Artificial Intelligence Denoising (AID) designed to reduce noise in real-time fluoroscopic images and signal enhancement algorithm, Multi Frequency Processing (MFP).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided FDA 510(k) summary:
Overview of the Device and its New Feature:
The device is the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging. It's an interventional X-ray system. The new feature, αEvolve Imaging, includes Artificial Intelligence Denoising (AID) to reduce noise in real-time fluoroscopic images and a signal enhancement algorithm, Multi Frequency Processing (MFP). The primary claim appears to be improved image quality (noise reduction, sharpness, contrast, etc.) compared to the previous version's (V9.5) "super noise reduction filter (SNRF)."
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes various performance evaluations and their successful outcomes. For the clinical study, the success criteria are clearly defined.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Bench Testing (Image Quality) | |
| 1. Change in Image Level, Noise & Structure: AID to be better at preserving mean image intensity, improved denoising, and image structure preservation compared to SNRF. | AID determined to be better at preserving mean image intensity and suggested to have improved denoising and image structure preservation (using student's t-test). |
| 2. Signal-to-Variance Ratio (SVR) and Signal-to-Noise Ratio (SNR): AID to show improved ability to preserve image signal while decreasing image noise compared to SNRF. | AID determined to have improved ability to preserve image signal while decreasing image noise (using student's t-test). |
| 3. Modulation Transfer Function (MTF): Improved performance for low-to-mid frequencies and similar high-frequency region compared to SNRF. | Results showed improved performance for low-to-mid frequencies in all test cases, and high-frequency region of MTF curve was similar for AID and SNRF in majority of cases (using student's t-test). |
| 4. Robustness to Detector Defects: Detector defects to be sufficiently obvious to inform clinician of service need, and image quality outside the defect area to remain visually unaffected, facilitating procedure completion. | Detector defects were sufficiently obvious, and image quality outside the area of the detector defect remained visually unaffected, facilitating sufficient image quality to finish the procedure. |
| 5. Normalized Noise Power Spectrum (NNPS): AID to have smaller noise magnitude in the frequency range of ~0.1 cycles/mm to 1.4 cycles/mm, with negligible differences above 1.4 cycles/mm. | AID had a smaller noise magnitude in the frequency range of ~0.1 cycles/mm to 1.4 cycles/mm. Noise magnitudes above 1.4 cycles/mm were very small and differences considered negligible. |
| 6. Image Lag Measurement: AID to perform better in reducing image lag compared to SNRF. | AID determined to perform better in reducing image lag (using student's t-test). |
| 7. Contrast-to-Noise Ratio (CNR) of Low Contrast Object: AID to show significantly higher CNR for low-contrast elements compared to SNRF. | AID had a significantly higher CNR than images processed with SNRF for all elements and test cases (using student's t-test). |
| 8. Contrast-to-Noise Ratio (CNR) of High Contrast Object: AID to show significantly higher CNR for high-contrast objects (guidewire, vessels) compared to SNRF. | AID had a significantly higher vessel and guidewire CNR than images processed with SNRF for all test cases (using student's t-test). |
| Clinical Study (Reader Study) | |
| Overall Preference (Binomial Test): Image sequences denoised by AID chosen significantly more than 50% of the time over SNRF. | The Binomial test found that image sequences denoised by AID were chosen significantly more than 50% of the time (indicating overall preference). |
| Individual Image Quality Metrics (Wilcoxon Signed Rank Test): Mean score of AID images significantly higher than SNRF for sharpness, contrast, confidence, noise, and absence of image artifacts. | The mean score of AID imaging chain images was significantly higher than that of the SNRF imaging chain for sharpness, contrast, confidence, noise, and the absence of image artifacts. |
| Generalizability: Algorithm to demonstrate equivalent or improved performance compared to the predicate with diverse clinical data. | Concluded that the subject algorithm demonstrated equivalent or improved performance, compared to the predicate device, as demonstrated by the results of the above testing. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary provides the following information about the clinical test set:
- Clinical Dataset Source: Patient image sequences were acquired from three hospitals:
- Memorial Hermann Hospital (Houston, Texas, USA)
- Waikato Hospital (Hamilton, New Zealand)
- Saiseikai Kumamoto Hospital (Kumamoto, Japan)
- Data Provenance: The study used retrospective "patient image sequences" for side-by-side comparison. The summary does not specify if the acquisition itself was prospective or retrospective, but the evaluation of pre-existing sequences makes it a retrospective study for the purpose of algorithm evaluation.
- Sample Size: The exact number of patient image sequences or cases used in the clinical test set is not specified in the provided document. It only mentions that the sequences were split into four BMI subgroups.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states the clinical comparison was "reviewed by United States board-certified interventional cardiologists." The exact number of cardiologists is not specified.
- Qualifications: "United States board-certified interventional cardiologists." No mention of years of experience or other specific qualifications is provided.
4. Adjudication Method for the Test Set
The document describes a "side-by-side comparison" reviewed by experts in the clinical performance testing section. For the overall preference and individual image quality metrics, statistical tests (Wilcoxon signed rank test and Binomial test) were used. This implies that the experts rated or expressed preference for both AID and SNRF images, and these individual ratings/preferences were then aggregated and analyzed.
The exact adjudication method (e.g., 2+1, 3+1 consensus) for establishing a ground truth or a final decision on image quality aspects is not explicitly stated. It seems each expert provided their assessment, and these assessments were then statistically analyzed for superiority rather than reaching a consensus for each image pair.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
-
MRMC Study: Yes, a type of MRMC comparative study was conducted. The clinical performance testing involved multiple readers (US board-certified interventional cardiologists) evaluating multiple cases (patient image sequences).
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Effect Size of Human Readers' Improvement with AI Assistance: The study directly compared AID-processed images to SNRF-processed images in a side-by-side fashion. It doesn't measure how much humans improve with AI assistance in a diagnostic task (e.g., how much their accuracy or confidence improves when using AI vs. not using AI). Instead, it measures the perceived improvement in image quality of the AI-processed images when evaluated by human readers.
- The study determined: "the mean score of the AID imaging chain images was significantly higher than that of the SNRF imaging chain with regard to sharpness, contrast, confidence, noise, and the absence of image artifacts."
- And for overall preference, "the Binomial test found that the image sequences denoised by AID were chosen significantly more than 50% of the time."
This indicates a statistically significant preference for and higher perceived image quality in AID-processed images by readers. However, it does not quantify diagnostic performance improvement with AI assistance, as it wasn't a study of diagnostic accuracy but rather image quality assessment. The "confidence" metric might hint at improved reader confidence using AID images, but it's not a direct measure of diagnostic effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, extensive standalone performance testing of the AID algorithm was conducted through "Performance Testing – Bench" and "Image Quality Evaluations." This involved objective metrics and phantom studies without human subjective assessment.
Examples include:
- Change in Image Level, Noise and Structure
- Signal-to-Variance Ratio (SVR) and Signal-to-Noise Ratio (SNR)
- Modulation Transfer Function (MTF)
- Robustness to Detector Defects (visual comparison, but the algorithm's output is purely standalone)
- Normalizes Noise Power Spectrum (NNPS)
- Image Lag Measurement
- Contrast-to-Noise Ratio of a Low Contrast Object
- Contrast-to-Noise Ratio of a High Contrast Object
7. The Type of Ground Truth Used
- For Bench Testing: The ground truth for bench tests was primarily established through physical phantoms and objective image quality metrics. For example, the anthropomorphic chest phantom, low-contrast phantom, and flat field fluoroscopic images provided known characteristics against which AID and SNRF performance were measured using statistical tests.
- For Clinical Study: The ground truth for the clinical reader study was established by expert opinion/subjective evaluation (preference and scores for sharpness, contrast, noise, confidence, absence of artifacts) from "United States board-certified interventional cardiologists." There is no mention of a more objective ground truth like pathology or outcomes data for the clinical image evaluation.
8. The Sample Size for the Training Set
The document does not provide any information about the sample size used for the training set of the Artificial Intelligence Denoising (AID) algorithm.
9. How the Ground Truth for the Training Set was Established
The document does not provide any information about how the ground truth for the training set was established. It describes the AID as "Artificial Intelligence Denoising (AID) designed to reduce noise," implying a machine learning approach, but details on its training are missing from this summary.
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