Search Results

The product is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.

The OEC One CFD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end.

The OEC One CFD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock.

The subject device is labelled as OEC One CFD.

Here's a summary of the acceptance criteria and the study details for the OEC One CFD device, specifically focusing on the new "Deep learning-based Trajectory Pointer software" feature, as that's where the most detailed study information is provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance (for Trajectory Pointer)

2. Sample Size Used for the Test Set and Data Provenance

• Total image dataset: 3078 images
• Test set size: 307 images (approx. 10% of the total dataset)
• Data Provenance (Ethnicity/Country):
  • US: 51.1%
  • China: 35.8%
  • Phantom: 9.8%
  • EU/Australia: 3.3%
• Data type: The document states that sample clinical images were evaluated to demonstrate substantial equivalence, and "all images were collected from GE OEC Mobile C-arm devices," suggesting retrospective collection of clinical images, alongside phantom data. It also notes that the test data covers the "entire range of values for all confounders," implying it's representative of real-world scenarios.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: 3
• Qualifications: U.S. board-certified radiologists. (No specific years of experience are listed).

4. Adjudication Method for the Test Set

• The document states: "3 U.S. board certified radiologists check annotations to make sure the ground truth is correct."
• This implies a consensus or verification process by multiple experts to validate the initial manual annotations, but a specific method like "2+1" or "3+1" is not explicitly mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate human reader improvement with AI assistance. The performance metrics reported are for the algorithm's standalone performance.

6. If a Standalone (Algorithm Only) Performance Study was Done

• Yes, a standalone performance study was done for the Trajectory Pointer feature. The reported success rates of 98.8% for LIH images and 97.1% for Fluoroscopy images (both exceeding the 95% MAAP) are measures of the algorithm's performance.

7. The Type of Ground Truth Used

• For the Trajectory Pointer feature, the ground truth was established by expert consensus/manual annotation. Specifically, "the contours of K-wires were manually outlined by trained annotators," and "3 U.S. board certified radiologists check annotations to make sure the ground truth is correct."

8. The Sample Size for the Training Set

• Training set size: 2771 images (3078 total images - 307 test images = 2771 images). The document states: "Total dataset included 3078 images, 307 were used for test dataset and the rest for training/tuning."

9. How the Ground Truth for the Training Set was Established

• While not explicitly detailed for the training set, it is highly probable that the ground truth for the training data was established in a similar manner to the test set: through manual outlining of K-wire contours by trained annotators. The document mentions "comparing ground truth annotations" during deduplication, implying annotations were available for the training data.

Ask a specific question about this device

The Geelin500A/Geelin500M is a mobile digital X-ray C-Arm diagnostic system, which Is Intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The Geelin500A/Geelin500M permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.

The Dual-Mode Mobile C-Arm is divided into two models: Geelin500A and Geelin500M.

Both models comprise:

• X-ray generator (consisting of monoblock head, inverter, and collimator)
• X-ray imaging device (including digital image detector, image display, Touch Screen, and industrial computer)
• C-Arm retractable rack
• Accessories (consist of battery, movement control handle, exposure footswitch, and laser)
• Software: Digital image processing software CMXPS-500, software release version V1.0.0.

Differences between Geelin500A and Geelin500M:

• Base plate: The chassis of the Geelin500M is equipped with swivel casters and requires manual pushing to move the equipment. The chassis of the Geelin500A is equipped with an electric motor, allowing movement of the equipment using the movement control handle.
• SID (Source-to-Image Distance): Geelin500A has a variable SID (range: 0-250mm). Geelin500M has an invariable SID.
• Distance from the X-ray tube focus to the image intensifier (lateral view): The C-arm of Geelin500A is equipped with a retractable digital image detector mechanism, allowing for a variable SID from the tube focus to the detector plane (AP/LAT 1050 mm, variable (range 0-250mm)). For Geelin500M, SID is AP 1050mm /LAT 1200mm, invariable.

The Dual-Mode Mobile C-Arm is an X-ray device with dual-plane (A-vertical direction and B-horizontal direction) imaging function. Its main components are configured as follows:

1. Two E-40R HF/IMD XR05 combined X-ray generators (40kHz, using rotating anode X-ray tubes, suitable for fluoroscopy and digital radiography) produced by IMD CHINA CO.,LTD. Small focus: 0.3mm, nominal anode input power: 0.6kW; Large focus: 0.6mm, nominal anode input power: 5kW.
2. Two E-9040-5HF inverters produced by IMD CHINA CO.,LTD.
3. Two PaxScan2121DXV flat panel detectors produced by Varian Medical Systems.
4. The C-arm installs the two sets of X-ray systems on a 3/4 circular arc arm on the mechanical structure, and the ray directions of the two sets of systems are perpendicular to each other, showing an orthogonal relationship.
5. The ray control system of C-arm is composed of single chip microcomputer and configuration touch screen. The signals from the combined X-ray generator and inverter are converted into signals that can be received and processed by the single chip microcomputer through the exposure control board. At the same time, the AD\DA module of the microcontroller provides filament preheating signals and kV setting signals for the ray generator and the inverter, and receives feedback signals from the inverter and the filament board.
6. The exposure program is controlled by the relevant program in the microcontroller. After stepping on the foot brake exposure pedal, the foot brake signal will enter the single-chip microcomputer program, and the single-chip microcomputer will determine whether the ray system (flat panel detector state, inverter state and filament state, etc.) is abnormal (error or warning) in real time. Under the normal condition of the system and the inverter without abnormality, the single-chip microcomputer will continue to delay 0.8 seconds to give the exposure command signal to the inverter. After receiving the exposure command signal, the inverter immediately executes the exposure command and excites the X-ray generator to release X-rays. At the same time, the inverter will monitor the kV feedback signal in real time. When the feedback signal is abnormal or the inverter is abnormal, the inverter will immediately transmit the signal to the single chip microcomputer, and the relevant error information will be realized on the touch screen, and the exposure command will be immediately forced to end. The filament board will also monitor the filament status in real time. When the filament board is abnormal or the filament current preheating is abnormal, the filament board will immediately transmit the signal to the microcontroller, and the relevant error information will be realized on the touch screen, and the exposure will be forced to end immediately.
7. The image generated by exposure is transmitted to the image processing workstation through the flat panel detector, and the workstation displays the image on the display screen after proper image processing.

N/A

Ask a specific question about this device

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).

N/A

Ask a specific question about this device

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.

N/A

Ask a specific question about this device

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.

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).

• 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.

Ask a specific question about this device

Self-Propelled CT Scan Base Kit, CGBA-035A:
The movable gantry base unit allows the Aquilion ONE (TSX-308A) system to be installed in the same procedure room as the INFX-8000C system, enabling coordinated clinical use within a shared workspace. This configuration provides longitudinal positioning along the z-axis for image acquisition.

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP:
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. The Calculated Dose Area Product (DAP) feature provides an alternative method for determining dose metrics without the use of a physical area dosimeter. This function estimates the cumulative reference air kerma, reference air kerma rate, and cumulative dose area product based on system parameters, including X-ray exposure settings, beam hardening filter configuration, beam limiting device position, and region of interest (ROI) filter status. The calculation method is calibration-dependent, with accuracy contingent upon periodic calibration against reference measurements.

The Alphenix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system, Aquilion ONE, TSX-308A. This combination enables patient access and efficient workflow for interventional procedures. Self-Propelled CT Scan Base Kit, CGBA-035A, is an optional kit intended to be used in conjunction with an Aquilion ONE / INFX-8000C based IVR-CT system. This device is attached to the Aquilion ONE CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is installed, the standard CT patient couch is replaced with the fixed catheterization table utilized by the interventional x-ray system, INFX-8000C. The Self-Propelled CT Scan Base Kit, CGBA-035A, will be used as part of an Aquilion ONE / INFX-8000C based IVR-CT system. Please note, the intended uses of the Aquilion ONE CT System and the INFX-8000C Interventional X-Ray System remain the same. There have been no modifications made to the imaging chains in these FDA cleared devices and the base system software remains the same. Since both systems will be installed in the same room and to prevent interference during use, system interlocks have been incorporated into the systems.

The Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP, is an interventional x-ray system with a ceiling suspended C-arm as its main configuration. 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 INFX-8000C system incorporates a Calculated Dose Area Product (DAP) feature, which provides an alternative method for determining dose metrics without the use of a physical area dosimeter. This function estimates the cumulative reference air kerma, reference air kerma rate, and cumulative dose area product based on system parameters, including X-ray exposure settings, beam hardening filter configuration, beam limiting device position, and region of interest (ROI) filter status. The calculation method is calibration-dependent, with accuracy contingent upon periodic calibration against reference measurements.

N/A

Ask a specific question about this device

Intended for use by a qualified/trained physician or technician for obtaining fluoroscopic and radiographic images of the skull, spinal column, chest, abdomen, and extremities in adult and pediatric patients. Rx only.

The Insight Enhanced™ DRF is an upgrade package that is designed to be installed on existing fluoroscopic systems, referred to as host system, to convert the imaging chain from analog to digital. It is comprised of the Insight Enhanced™ DRF Digital Imaging chain and associated interfacing hardware. The Insight Enhanced™ DRF system includes medical grade monitors, computer, and flat panel detector. Interface boards, cabling, and signal converters are included for interfacing with the host system. The x-ray generator and x-ray tube are not modified in any way. A flat panel detector replaces the image intensifier and camera on the base system. All of the fundamental features and principles of operation Insight Enhanced™ DRF are identical to the predicate device, Insight Enhanced™ (K200369). Both systems are upgrade packages that replace an analog imaging chain with a new digital one. The main components of the product, the PC, software, and detector for the predicate device and for the subject device are identical. Mounting hardware and interfacing components differ to add compatibility to GE OEC 9800/9900 C-arms. Insight Enhanced™ DRF is designed as an upgrade package for General Electric Legacy and P500 fluoroscopy rooms. This submission adds compatibility to a device, the OEC 9800/9900.

N/A

Ask a specific question about this device

AngioWaveNet is indicated for use by qualified physicians or under their supervision to aid in the analysis and interpretation of X-ray coronary angiographic cines. AngioWaveNet is intended for use in adults during X-ray coronary angiographic imaging procedures as a clinically useful complement to the viewing of standard angiographic cines acquired during diagnostic coronary angiography procedures. AngioWaveNet software is intended for use to enhance the visibility of blood vessels, vascular structures, and related anatomical features within angiographic images, which may be clinically useful to the treating physician

AngioWaveNet spatio-temporal enhancement processing (STEP) is an artificial Intelligence (AI) and machine learning (ML) system designed to enhance the visibility of blood vessels in angiograms using the unique spatial and temporal information contained in the frames of angiographic cines. The Angiowave STEP method employs a neural network architecture in the form of an encoderdecoder, which sequentially takes multiple contiguous frames of an angiogram as input and uses this information to provide enhanced visualization of vessels in the central frame. Angiowave has developed a novel and versatile implementation of its processing in a DICOM node, which has the benefit of no additional on-premises hardware. In addition to the cine processing, the DICOM node handles other logistical tasks such as anonymization, image storage and retrieval (e.g. to/from a cloud location), communication and interoperability, data integrity and security, DICOM conformance, and data archiving and management. This full implementation utilizing a cloud location for processor intensive tasks is termed AngioWaveNet. The AI/ML model at the heart of STEP was trained on a comprehensive dataset of 300 anonymized angiograms, averaging 70 frames each, provided by a large non-profit healthcare organization that operates in Maryland and the Washington, D.C. region. The dataset spanned a range of clinical and demographic characteristics presenting to the catheterization laboratory and was acquired from 2003 to 2016 using Philips Allura Xper systems. The dataset was randomly sampled from a large clinical study population, whose baseline patient characteristics have been published and were consistent with a typical coronary catheterization lab population.

Here's a structured summary of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for AngioWaveNet:

Acceptance Criteria and Device Performance Study for AngioWaveNet

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size (Patients): 31 individual patients.
• Sample Size (Cines/Angiograms): 97 angiograms (cines), with each patient contributing 3-4 cines (mean 3.13 cines/patient).
• Sample Size (Vessels Assessed): 169 vessels.
• Sample Size (Tasks Performed): 3,211 tasks (detection, localization, quantification, characterization) performed across all cines.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but derived from the "Corewell Angiographic database," suggesting data from a healthcare system in the United States (potentially consistent with the "Maryland and the Washington, D.C. region" mentioned for training data, though this is for the test set).
  • Retrospective/Prospective: The data was "sourced from the Corewell Angiographic database," indicating it is retrospective. The cines were captured in "March of 2025," which seems to be a clerical error given the "Date Prepared: August 4, 2025" and "Dated: August 5, 2025" for the submission, and the study being "conducted in July and August of 2025." It is highly likely the data was captured prior to the study conduct date.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

• Number of Experts: Three (3).
• Qualifications of Experts: "Experienced interventional cardiologists." No specific years of experience are provided.

4. Adjudication Method for the Test Set

The document states, "Blinding of readers to each other's assessments... prevented influence of one reader on another." This suggests that the readers made their assessments independently. However, it does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for resolving discrepancies or establishing a single "ground truth" for the test set from the three readers' evaluations. The reported results (e.g., mean Likert score, percentage improvement) appear to be an aggregate of their individual assessments without a formal adjudication process to reconcile differences.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? Yes, a task-based reader study involving three interventional cardiologists evaluating patient cases with the software was conducted.
• Effect size of human readers improvement with AI vs. without AI assistance: The study focused on the impact of the software on decision-making and visualization, rather than a direct comparison of readers with and without AI assistance for a specific metric.
  • Clinical Decision Impact: Mean Likert score of 3.23 (neutral to positive impact).
  • Ease of Visualization: Improved in 99.4% of tasks.
  • False Positives/Negatives: 0% unresolved for most readers.
    While these indicate improvement in perception and influence on decisions, a direct "effect size" of how much readers improve in accuracy or efficiency due to AI assistance compared to no AI assistance is not quantified in the provided text (e.g., AUC difference, sensitivity/specificity gains). The study rather reports the performance when using the AI as a complement.

6. Standalone Performance Study

The information provided describes a "Task-Based Reader Study" where human readers (cardiologists) assessed the software's impact. The software's performance is reported in terms of its ability to enhance visualization and influence clinical decisions when used by these readers. This is not a standalone (algorithm only without human-in-the-loop performance) study. The results are intrinsically linked to human interpretation of the enhanced images.

7. Type of Ground Truth Used for the Test Set

The ground truth appears to be based on the expert consensus or interpretation of the three interventional cardiologists regarding the "angiographic pathologic determination tasks" and "ease of visualization." There is no mention of an independent, objective ground truth such as pathology reports or long-term outcomes data for the test set.

8. Sample Size for the Training Set

• Sample Size (Angiograms): 300 anonymized angiograms.
• Sample Size (Frames): Averaging 70 frames each (total of approximately 21,000 frames).

9. How the Ground Truth for the Training Set Was Established

The document states, "The AI/ML model at the heart of STEP was trained on a comprehensive dataset of 300 anonymized angiograms... provided by a large non-profit healthcare organization that operates in Maryland and the Washington, D.C. region."

It does not explicitly describe how the ground truth for this training set was established. It mentions the dataset "spanned a range of clinical and demographic characteristics" and was "randomly sampled from a large clinical study population." Typically, for training such models, ground truth would involve expert annotations (e.g., outlining vessels, identifying pathologies) on the original images, but this detail is missing from the provided text.

Ask a specific question about this device

The Cios Spin is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patients during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. The patient population may include pediatric patients.

The Cios Spin (VA31A) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Spin provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:
a. The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator.
b. The second unit is the image display station with a moveable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable.

The following modifications were made to the Predicate Device the Cios Spin Mobile X-ray System cleared under Premarket Notification K210054 on February 5, 2021. Siemens Medical Solutions USA, Inc. submits this Traditional 510(k) to request clearance for the Subject Device Cios Spin (VA31A). The following modification is incorporated in the Predicate Device to create the Subject Device, for which Siemens is seeking 510(k) clearance:

1. Software updated from VA30 to VA31A to support the below software features
   A. Updated Retina 3D for optional enlarged 3D Volume of 25cm x 25cm x 16cm
   B. Introduction of NaviLink 3D Lite
   C. Universal Navigation Interface (UNI)
   D. Updated InstantLink with Extended NXS Interface
2. Updated Collimator
3. Updated FLC Imaging system PC with new PC hardware Updated AppHost PC with High Performance Graphic Card
4. New Eaton UPS 5P 850i G2 as successor of UPS 5P 850i due to obsolescense

Based on the provided FDA 510(k) clearance letter for the Siemens Cios Spin (VA31A), here's an analysis of the acceptance criteria and the study proving the device meets them:

Important Note: The provided document is a 510(k) summary, which often summarizes testing without providing granular details on study design, sample sizes, and ground truth establishment to the same extent as a full clinical study report. Therefore, some information requested (e.g., specific number of experts for ground truth, adjudication methods) may not be explicitly stated in this summary. The focus of this 510(k) is primarily on demonstrating substantial equivalence to a predicate device, especially for software and hardware modifications, rather than a de novo effectiveness study.

Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating that the modifications to the Cios Spin (VA31A) do not introduce new safety or effectiveness concerns compared to its predicate device (Cios Spin VA30) and a reference device (CIARTIC Move VB10A) that incorporates some of the new features. The acceptance criteria are implicitly tied to meeting various industry standards and demonstrating functionality and safety through non-clinical performance testing.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

The study described is primarily a non-clinical performance testing and software verification and validation effort rather than a traditional clinical trial.

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patients or images for performance evaluation. The testing described is "Unit, Subsystem, and System Integration testing" and "software verification and regression testing." This type of testing uses a diverse set of test cases designed to cover functionality, performance, and safety requirements. For the "Enlarged Volume Field of View," it's a non-clinical test, likely using phantoms or simulated data.
   • Data Provenance: Not applicable in terms of patient data provenance for the non-clinical and software testing described. This is bench testing and software validation. Customer reports and feedback forms are mentioned for human factors, but specific details on their origin (country, etc.) are not provided. The manufacturing site is Kemnath, Germany.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

   • Not explicitly stated. For non-clinical performance and software testing, "ground truth" is typically established by engineering specifications, known correct outputs for given inputs, and compliance with industry standards. If clinical use tests involved subjective evaluation, the number and qualifications of experts are not detailed, but they are implied to be "healthcare professionals" (operators are "adequately trained").

3. Adjudication method for the test set:

   • Not applicable/Not explicitly stated. For software and bench testing, adjudication usually refers to a process of resolving discrepancies in ratings or measurements. Given the nature of this submission (software/hardware modifications and non-clinical testing), formal clinical adjudication methods (like 2+1, 3+1 for image reviews) are not described as part of the primary evidence. Acceptance is based on test cases meeting predefined engineering requirements.

4. 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:

   • No. An MRMC study was not conducted. This 510(k) is for a mobile X-ray system with software and hardware updates, not an AI-assisted diagnostic device where evaluating human reader performance with and without AI would be relevant. The "AI" mentioned (Retina 3D, NaviLink 3D) refers to advanced imaging/navigation features, not machine learning for diagnostic interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. The "non-clinical test 'Enlarged Volume Field of View' testing" and other "Unit, Subsystem, and System Integration testing" for functionality and performance are essentially standalone tests of the device's components and software without immediate human interpretation in a diagnostic loop. The acceptance criteria for these tests refer to technical performance endpoints, not diagnostic accuracy.

6. The type of ground truth used:

   • Engineering Specifications and Standard Compliance: For the performance and safety testing, the "ground truth" is adherence to predefined engineering requirements (e.g., image dimensions, system response times, electrical safety limits) and compliance with national and international industry standards (e.g., IEC 60601 series, ISO 14971, NEMA PS 3.1).
   • For the Human Factors Usability Validation, "customer reports and feedback forms" serve as a form of "ground truth" regarding user experience and usability.

7. The sample size for the training set:

   • Not applicable. This submission describes modifications to an X-ray imaging system, not the development of a machine learning algorithm that requires a separate training set. The existing software (VA30) was updated to VA31A. The "training" for the software itself would have occurred during its initial development, not for this specific 510(k) submission.

8. How the ground truth for the training set was established:

   • Not applicable. As above, this information is not relevant to this specific 510(k) submission, as it focuses on modifications to an existing device rather than the development of a new AI/ML algorithm requiring a training set and its associated ground truth.

Ask a specific question about this device

The software supports image guidance by overlaying vessel anatomy onto live fluoroscopic images in order to navigate guidewires, catheters, stents and other endovascular devices.

The device is indicated for use by physicians for patients undergoing endovascular PAD interventions of the lower limbs including iliac vessels.

The device is intended to be used in adults.

There is no other demographic, ethnic or cultural limitation for patients.

The information provided by the software or system is in no way intended to substitute for, in whole or in part, the physician's judgment and analysis of the patient's condition.

The Subject Device is a standalone medical device software supporting image guidance in endovascular procedures of peripheral artery disease (PAD) in the lower limbs, including the iliac vessels. Running on a suitable platform and connected to an angiographic system, the Subject Device receives and displays the images acquired with the angiographic system as a video stream. It provides the ability to save and process single images out of that video stream and is able to create a vessel tree consisting of angiographic images. This allows to enrich the video stream with the saved vessel tree to continuously localize endovascular devices with respect to the vessel anatomy.

The medical device is intended for use with compatible hardware and software and must be connected to a compatible angiographic system via video connection.

Here's a breakdown of the acceptance criteria and study information for the Vascular Navigation PAD 2.0, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance for Vascular Navigation PAD 2.0

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a single number.
  • For Latency Tests: Data from Siemens Cios Spin and Ziehm Vision RFD 3D.
  • For Level Selection and Overlay Alignment: Images acquired with Siemens Cios Spin, Ziehm Vision RFD 3D, and GE OEC Elite CFD.
  • For Modality Detection: Image data from Siemens Cios Spin, GE OEC Elite CFD, Philips Zenition, and Ziehm Vision RFD 3D.
  • For Roadmapping Accuracy: Image data from Siemens Cios Spin.
  • For Stitching Algorithm: Image data from Philips Azurion, Siemens Cios Spin, GE OEC Elite CFD, and Ziehm Vision RFD 3D.
• Data Provenance:
  • Retrospective/Prospective: Not explicitly stated for all tests. However, the Level Selection and Overlay Alignment and Roadmapping Accuracy tests mention using "cadaveric image data" which implies a controlled, likely prospective, acquisition for testing purposes rather than retrospective clinical data. Other tests reference "independent image data" or data "acquired using" specific devices, suggesting a dedicated test set acquisition.
  • Country of Origin: Not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The document mentions "manually achieved gold standard registrations" for Level Selection and Overlay Alignment and "manually comparing achieved gold standard (GS) stitches" for the Stitching Algorithm, implying human expert involvement in establishing ground truth, but specific details on the number or qualifications of these "manual" reviewers are absent. The phrase "if a human would consider the image pairs matchable" in the stitching section further supports human-determined ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described. The ground truth seems to be established through "manually achieved gold standard" or "manual comparison," implying a single expert or a common understanding rather than a formal adjudication process between multiple conflicting expert opinions (e.g., 2+1 or 3+1).

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• Was it done? No. The submission focuses on standalone technical performance measures and accuracy metrics of the algorithm rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

• Was it done? Yes. The entire "Performance Data" section details the algorithm's performance in various standalone tests, such as latency, stress/load, level selection and overlay alignment, modality detection, roadmapping accuracy, and stitching algorithm performance. The results are quantitative metrics of the device itself.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • Expert Consensus / Manual Gold Standard: For Level Selection and Overlay Alignment ("manually achieved gold standard registrations") and for the Stitching Algorithm ("manually comparing achieved gold standard (GS) stitches"). This implies human experts defined the correct alignment or stitch.
  • Technical Metrics: For Latency, Capture Process, Stitching Timespan, Roadmap/Overlay Display Timespan, and System Stability, the ground truth is based on objective technical measurements against defined criteria.
  • True Modality: For Modality Detection, the ground truth is simply the actual modality of the image (fluoroscopy vs. angiography) as known during test data creation or acquisition.

8. Sample Size for the Training Set

• Sample Size: Not provided. The submission focuses solely on the performance characteristics of the tested device and its algorithms, without detailing the training data or methods used to develop those algorithms.

9. How the Ground Truth for the Training Set Was Established

• How Established: Not provided. As with the training set size, the information about the training process and ground truth for training is outside the scope of the clearance letter's performance data section.

Ask a specific question about this device