Search Results

CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The device automatically generates calcium scores for the coronary arteries (combined LM+LAD, RCA, LCX) and highlights the segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the context of reference data from the MESA and Hoff-Kondos databases.

The segmented arteries include combined LM+LAD, RCA, and LCX. To obtain separate LM and LAD results, the user must perform manual segmentation. The segmentation map of calcifications is intended for informational use only and is not intended for detection or diagnostic purposes. The 3D Calcium View output is provided strictly as an informational and supplementary output and should never be used alone as the method of reviewing the calcium segmentation.

CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The application runs on the Vitrea platform.

The device automatically generates Agatston and volume calcium scores for each of the coronary arteries (combined LM+LAD, RCA, LCX) based on the volume and density of the calcium deposits and highlights the Segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the context of reference data from the MESA and Hoff-Kondos databases.

The software uses deep learning-based segmentation methods. Users can edit the automated segmentation, including manually assigning calcifications to anatomical structures.

The device automatically outputs a combined LM+LAD score as the final automated output. To obtain separate LM and LAD results, the user must perform manual segmentation using the provided editing tools.

The device is Software as a Medical Device (SaMD) that operates on ECG-gated, non-contrast cardiac CT DICOM images.

The device does not interact directly with the patient. The device is a software application that runs on the Vitrea platform and processes ECG-gated non-contrast cardiac CT DICOM images. The device automatically generates Agatston and volume calcium scores for each of the coronary arteries (LAD+LM, RCA, LCX) based on the volume and density of the calcium deposits and highlights the segmented calcium on the original CT image. Results can be exported to image management, archival, or reporting systems that support DICOM standards for further review and interpretation.

Results can also be saved in DICOM Structured Reports (DICOM SR) format.

The CT VScore+ device is a software application for non-invasive evaluation of calcified lesions of the coronary arteries from ECG-gated, non-contrast cardiac CT images. The study presented demonstrates the analytical validity and performance of the device against predefined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): 236 independent cases.
• Data Provenance: The pivotal validation dataset was sourced from diverse U.S. sites and scanner vendors. The development dataset, from which the test set was independent, included data from four institutions (two US sites and two Japanese sites). The 236 cases for validation were "independent" at both the patient level and the site level from the development dataset. It is retrospective data.

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

• Number of Experts: Three.
• Qualifications of Experts: U.S. board-certified radiologists/cardiologists. (Specific years of experience are not mentioned).

4. Adjudication Method for the Test Set

• Adjudication Method: A "2+1 consensus process" was used. This typically means that if two experts agree, their consensus defines the ground truth. If there's a disagreement between two, the third expert acts as a tie-breaker or adjudicator.

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

• The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess the effect size of human readers improving with AI vs. without AI assistance. The study focuses on the standalone performance of the AI algorithm against a consensus ground truth.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was conducted. The metrics listed in the table (ICC, Kappa, Dice Score) directly assess the performance of the CT VScore+ algorithm in isolation against the established ground truth.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus. Specifically, the reference standard ground truth was established by consensus manual scoring on an FDA-cleared device (Vitrea CT VScore, K243240) and a 2+1 consensus process by three U.S. board-certified radiologists/cardiologists.

8. Sample Size for the Training Set

• Sample Size (Training Set): 94 cases (part of the 210 cases used for development).

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

• The document implies that the ground truth for the training set (part of the development dataset) was established similarly to the validation set's ground truth, i.e., "by consensus manual scoring on an FDA-cleared device (Vitrea CT VScore, K243240)" by experts, given that the development process involved ensuring "robust and unbiased performance." However, the exact details of ground truth establishment specifically for the training set are not explicitly broken out as they are for the pivotal validation dataset. It's reasonable to infer a similar rigorous process if the data was used for deep learning model development.

Ask a specific question about this device

syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.

The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.

The general functionality of the syngo.CT Dual Energy application is as follows:

• Bone Marrow ²⁾
• Bone Removal ¹⁾
• Brain Hemorrhage ¹⁾
• Gout Evaluation ¹⁾
• Hard Plaques ¹⁾
• Heart PBV
• Kidney Stones ¹⁾ ²⁾ ³⁾
• Liver VNC ¹⁾
• Lung Mono ¹⁾
• Lung Perfusion ¹⁾
• Lung Vessels ¹⁾
• Monoenergetic ¹⁾ ²⁾
• Monoenergetic Plus ¹⁾ ²⁾
• Optimum Contrast ¹⁾ ²⁾
• Rho/Z ¹⁾ ²⁾
• SPP (Spectral Post-Processing Format) ¹⁾ ²⁾
• SPR (Stopping Power Ratio) ¹⁾ ²⁾
• Virtual Non-Calcium (VNCa) ¹⁾ ²⁾
• Virtual Unenhanced ¹⁾

The availability of each feature depends on the Dual Energy scan mode.

¹⁾ This functionality supports data from Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPlus modes.

²⁾ This functionality supports data from Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPeak modes.

³⁾ Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone, additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis upon consideration of all available information. The accuracy of identification is decreased in obese patients.

Dual energy offers functions for qualitative and quantitative post-processing evaluations. syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT. Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms.

Different body regions require specific tools that allow the correct evaluation of data sets. syngo.CT Dual Energy provides a range of application classes that meet the requirements of each evaluation type. The different application classes for the subject device can be combined into one workflow.

The product is intended to be used for at least 21-year-old humans.

N/A

Ask a specific question about this device

Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium.

The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast CT scan; both are still available to be viewed and used at the discretion of the physician.

The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results.

Bunkerhill MAC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill MAC detects, localizes, and quantifies mitral annulus calcification in non-gated, non-contrast chest CT studies. The core features of the product are:

• Detection of mitral annulus calcification at an Agatston-equivalent score threshold of 0 AU.
• Quantification of the overall mitral annulus calcification burden in the form of an estimated Agatston Score up to 5000 Agatston-equivalent units
• Localization of estimated calcium burden in the form of circular region of interest applied to a copy of the original CT scan.

Here's a detailed breakdown of the acceptance criteria and the study proving the Bunkerhill MAC device meets them, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number of cases, but referred to as "the pivotal dataset."
   • Data Provenance: "curated from multiple sites across three geographical regions in the United States." (Retrospective study).

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

   • The document states "agreement of the device output compared to the established reference standard." It does not explicitly state the number of experts used or their qualifications for establishing this "established reference standard." It only refers to "clinical literature in high impact journals that investigate the inter-reader agreement of manual segmentation" as informing the acceptance criteria.

3. Adjudication method for the test set:

   • The document does not explicitly state an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set. It refers to an "established reference standard."

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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not conducted or reported in this document. The study was a "stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard."

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

   • Yes, a standalone study was performed. The document explicitly states: "The Bunkerhill MAC performance was validated in a stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard."

6. The type of ground truth used:

   • The ground truth was an "established reference standard" which was used for comparison against the device's output. The document implies this reference standard is based on non-gated CT reference measurements and potentially "manual segmentation" informed by clinical literature. It does not explicitly state pathology confirmation or direct outcomes data as the primary ground truth.

7. The sample size for the training set:

   • The sample size for the training set is not provided in the document.

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

   • The document does not provide information on how the ground truth for the training set was established. It only refers to the performance validation on a "pivotal dataset" (test set).

Ask a specific question about this device

The Thirona LungQ software provides reproducible CT values for pulmonary tissue and specified endobronchial implants which is essential for providing quantitative support for diagnosis, treatment planning and follow up examination. The LungQ software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, estimated chronic perfusion defect analysis, fissure evaluation and reporting tools are provided.

The LungQ software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. LungQ is a docker image with a standalone command-line software which must be run from a command-line interpreter and does not have a graphical user interface.

N/A

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

The OmniTom Elite with PCD computed tomography (CT) system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.

The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast. The PCD CT system has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI).

The subject OmniTom Elite with PCD Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K233767). Both computed tomography systems are identical in terms of the high resolution, 16 row, 40 cm bore, and 30 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360-degree movement and electrical drive system so the system can be moved easily to different locations.

OmniTom Elite system with photon counting detector (PCD) provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images.

N/A

Ask a specific question about this device

CT:VQ software is a non-invasive image post-processing technology, using CT lung images to provide clinical decision support for thoracic disease diagnosis and management in adult patients. It utilizes two non-contrast chest CT studies to quantify and visualize ventilation and perfusion.

Quantification and visualizations are provided as DICOM images. CT:VQ may be used when Radiologists, Pulmonologists, and/or Nuclear Medicine Physicians need a better understanding of a patient's lung function and/or respiratory condition.

CT:VQ is a Software as a Medical Device (SaMD) technology, which can be used in the analysis of a paired (inspiratory/expiratory) non-contrast Chest CT. It is designed to measure regional ventilation (V) and regional perfusion (Q) in the lungs.

The Device provides visualization and quantification to aid in the assessment of thoracic diseases. These regional measures are derived from the lung tissue displacement, the lung volume change, and the Hounsfield Units of the paired (inspiratory/expiratory) chest CT.

The Device outputs DICOM images containing the ventilation output and perfusion output, consisting of a series of image slices generated with the same slice spacing as the expiration CT. In each slice the intensity value for each voxel represents either the value of ventilation or the value for perfusion, respectively, at that spatial location. Additional Information sheet is also generated containing quantitative data, such as lung volume.

Here's a breakdown of the acceptance criteria and the study details for the CT:VQ device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for CT:VQ are implicitly demonstrated through its strong performance in clinical studies, showing agreement with established gold standards. While explicit numerical acceptance criteria are not provided in a table format within the summary, the narrative describes the goals of the study:

• Consistency/Agreement with Nuclear Medicine Imaging (SPECT/CT): The device's regional ventilation and perfusion measurements should align well with SPECT/CT findings.
• Correlation with Pulmonary Function Tests (PFTs): CT:VQ metrics should statistically correlate with standard PFTs like DLCO and FEV1/FVC ratio.
• Interpretability and Clinical Actionability: The outputs should be clear, understandable, and useful for clinicians.
• Safety and Effectiveness Profile: The device should have a safety and effectiveness profile similar to the primary predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):

Study Details

Here's a breakdown of the specific information requested about the studies:

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

• Test Set Sample Sizes:
  • Reader Performance Study: n=77
  • Standalone Performance Assessment: n=58 (a subset of the overall clinical studies data)
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is from 4DMedical Limited in Australia, and the FDA clearance is in the US. The description mentions "clinically-acquired data included paired chest CTs acquired on CT scanners across a range of manufacturers and models and at different institutions, across a diverse range of patients." This suggests multi-institutional data, potentially from various geographic locations, but this is not confirmed.
  • Retrospective or Prospective: Not explicitly stated whether the studies were retrospective or prospective. The description "clinical studies were also conducted to demonstrate the safety and efficacy... in the context of clinical care" and comparing with "gold-standard and best practice measures for respiratory diagnosis" often implies retrospective analysis of existing data combined with prospective data collection, but this is not definitive in the text.

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

• Number of Experts: Not explicitly stated for establishing ground truth, although for the Reader Performance Study, "clinicians with expertise in thoracic imaging and pulmonary care" were involved in rating the outputs. The implication is that these experts, along with SPECT/CT and PFT results, contributed to the ground truth.
• Qualifications of Experts: "Clinicians with expertise in thoracic imaging and pulmonary care." No specific number of years of experience or board certifications (e.g., radiologist with 10 years of experience) is provided.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method: Not explicitly stated. The summary mentions "Inter-reader variability was not significantly different for CT:VQ than for SPECT," which implies multiple readers, but the method for resolving discrepancies or establishing a final ground truth from multiple readers is not detailed.

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:

• MRMC Study: A "Reader Performance Study" was conducted with n=77 cases, involving "clinicians with expertise in thoracic imaging and pulmonary care." This aligns with the characteristics of an MRMC study.
• Effect Size of Human Reader Improvement with AI vs. without AI assistance: The summary does not provide an effect size or direct comparison of human reader performance with CT:VQ assistance versus without it. The study focused on assessing:
  • Agreement between CT:VQ outputs and SPECT.
  • Interpretability and clinical actionability of CT:VQ outputs.
  • Inter-reader variability of CT:VQ vs. SPECT.
    It does not quantify an improvement in reader accuracy or efficiency due to AI assistance.

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

• Standalone Performance: Yes, a "Standalone Performance Assessment" was performed with a subset of 58 cases. The findings indicated strong regional agreement between CT:VQ and SPECT VQ measurements and stronger associations of CT:VQ perfusion metrics with DLCO compared to SPECT.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: A combination of established clinical diagnostics was used:
  • Nuclear Medicine Imaging (Single photon emission computed tomography, SPECT/CT): Used as a "gold-standard and best practice measure" for regional ventilation and perfusion.
  • Pulmonary Function Tests (PFTs): Specifically Diffusing capacity of the lung for carbon monoxide (DLCO) and FEV1/FVC ratio, used to correlate with CT:VQ outputs.
  • Clinical Diagnosis/Findings: Implied through "Case Studies further illustrated key advantages of CT:VQ... successfully replicated the diagnostic findings of SPECT."

7. The sample size for the training set:

• Training Set Sample Size: Not explicitly stated in the provided text. The summary only mentions the sample sizes for the clinical validation studies (test sets).

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

• Training Set Ground Truth Establishment: Not explicitly stated how the ground truth for the training set was established, as the training set size and characteristics are not detailed. Typically, it would involve similar rigorous processes (e.g., expert annotation, gold-standard imaging modalities, clinical outcomes) as the test set, but this information is absent in this document.

Ask a specific question about this device

The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

If the spectral imaging option is included on the system, the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

The CT system is indicated for low dose CT for lung cancer screening. The screening must be performed within the established inclusion criteria of programs/ protocols that have been approved and published by either a governmental body or professional medical society.

This proposed device Revolution Vibe is a general purpose, premium multi-slice CT Scanning system consisting of a gantry, table, system cabinet, scanner desktop, power distribution unit, and associated accessories. It has been optimized for cardiac performance while still delivering exceptional imaging quality across the entire body.

Revolution Vibe is a modified dual energy CT system based on its predicate device Revolution Apex Elite (K213715). Compared to the predicate, the most notable change in Revolution Vibe is the modified detector design together with corresponding software changes which is optimized for cardiac imaging providing capability to image the whole heart in one single rotation same as the predicate.

Revolution Vibe offers an accessible whole heart coverage, full cardiac capability CT scanner which can deliver outstanding routine head and body imaging capabilities. The detector of Revolution Vibe uses the same GEHC's Gemstone scintillator with 256 x 0.625 mm row providing up to 16 cm of coverage in Z direction within 32 cm scan field of view, and 64 x 0.625 mm row providing up to 4 cm of coverage in Z direction within 50 cm scan field of view. The available gantry rotation speeds are 0.23, 0.28, 0.35, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, and 1.0 seconds per rotation.

Revolution Vibe inherits virtually all of the key technologies from the predicate such as: high tube current (mA) output, 80 cm bore size with Whisper Drive, Deep Learning Image Reconstruction for noise reduction (DLIR K183202/K213999, GSI DLIR K201745), ASIR-V iterative recon, enhanced Extended Field of View (EFOV) reconstruction MaxFOV 2 (K203617), fast rotation speed as fast as 0.23 second/rot (K213715), and spectral imaging capability enabled by ultrafast kilovoltage(kv) switching (K163213), as well as ECG-less cardiac (K233750). It also includes the Auto ROI enabled by AI which is integrated within the existing SmartPrep workflow for predicting Baseline and monitoring ROI automatically. As such, the Revolution Vibe carries over virtually all features and functionalities of the predicate device Revolution Apex Elite (K213715).

This CT system can be used for low dose lung cancer screening in high risk populations*.

The provided FDA 510(k) clearance letter and summary for the Revolution Vibe CT system does not include detailed acceptance criteria or a comprehensive study report to fully characterize the device's performance against specific metrics. The information focuses more on the equivalence to a predicate device and general safety/effectiveness.

However, based on the text, we can infer some aspects related to the Auto ROI feature, which is the only part of the device described with specific performance testing details.

Here's an attempt to extract and describe the available information, with clear indications of what is not provided in the document.

Acceptance Criteria and Device Performance for Auto ROI

The document mentions specific performance testing for the "Auto ROI" feature, which utilizes AI. For other aspects of the Revolution Vibe CT system, the submission relies on demonstrating substantial equivalence to the predicate device (Revolution Apex Elite) through engineering design V&V, bench testing, and a clinical reader study focused on overall image utility, rather than specific quantitative performance metrics meeting predefined acceptance criteria for the entire system.

1. Table of Acceptance Criteria and Reported Device Performance (Specific to Auto ROI)

Note: The document does not provide the explicit numerical value for the "pre-established acceptance criteria" or the actual "success rate" achieved for the Auto ROI feature.

2. Sample Size and Data Provenance for the Test Set (Specific to Auto ROI)

• Sample Size: 1341 clinical images
• Data Provenance: "real clinical practice" (Specific country of origin not mentioned). The images were used for "Auto ROI performance" testing, which implies retrospective analysis of existing clinical data.

3. Number of Experts and Qualifications to Establish Ground Truth (Specific to Auto ROI)

• Number of Experts: Not specified for the Auto ROI ground truth establishment.
• Qualifications of Experts: Not specified for the Auto ROI ground truth establishment.

Note: The document mentions 3 readers for the overall clinical reader study (see point 5), but this is for evaluating the diagnostic utility and image quality of the CT system and not explicitly for establishing ground truth for the Auto ROI feature.

4. Adjudication Method for the Test Set (Specific to Auto ROI)

• Adjudication Method: Not specified for the Auto ROI test set.

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

• Was an MRMC study done? Yes, a "clinical reader study of sample clinical data" was carried out. It is described as a "blinded, retrospective clinical reader study."

• Effect Size of Human Readers Improvement with AI vs. without AI assistance: The document states the purpose of this reader study was to validate that "Revolution Vibe are of diagnostic utility and is safe and effective for its intended use." It does not report an effect size or direct comparison of human readers' performance with and without AI assistance (specifically for the Auto ROI feature within the context of reader performance). The study seemed to evaluate the CT system's overall image quality and clinical utility, possibly implying that the Auto ROI is integrated into this overall evaluation, but a comparative effectiveness study of the AI's impact on human performance is not described.

  • Details of MRMC Study:
    • Number of Cases: 30 CT cardiac exams
    • Number of Readers: 3
    • Reader Qualifications: US board-certified in Radiology with more than 5 years' experience in CT cardiac imaging.
    • Exams Covered: "wide range of cardiac clinical scenarios."
    • Reader Task: "Readers were asked to provide evaluation of image quality and the clinical utility."

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes, for the "Auto ROI" feature, performance was tested "using 1341 clinical images from real clinical practice," and "the tests results in success rates exceeding the pre-established acceptance criteria." This implies an algorithm-only evaluation of the Auto ROI's ability to successfully identify and monitor ROI.

7. Type of Ground Truth Used (Specific to Auto ROI)

• Type of Ground Truth: Not explicitly stated for the Auto ROI. Given the "success rates" metric, it likely involved a comparison against a predefined "true" ROI determined by human experts or a gold standard method. It's plausible that this was established by expert consensus or reference standards.

8. Sample Size for the Training Set

• Sample Size: Not provided in the document.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not provided in the document.

In summary, the provided documentation focuses on demonstrating substantial equivalence of the Revolution Vibe CT system to its predicate, Revolution Apex Elite, rather than providing detailed, quantitative performance metrics against specific acceptance criteria for all features. The "Auto ROI" feature is the only component where specific performance testing (standalone) is briefly mentioned, but key details like numerical acceptance criteria, actual success rates, and ground truth methodology for training datasets are not disclosed. The human reader study was for general validation of diagnostic utility, not a comparative effectiveness study of AI assistance.

Ask a specific question about this device

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Siemens intends to update the software version syngo CT VB20 (update) for the following NAEOTOM Alpha class CT systems:

Dual Source NAEOTOM CT scanner systems:

• NAEOTOM Alpha (trade name ex-factory CT systems: NAEOTOM Alpha.Peak; trade name installed base CT systems with SW upgrade only: NAEOTOM Alpha)

For simplicity, the product name of NAEOTOM Alpha will be used throughout this submission instead of the trade name NAEOTOM Alpha.Peak.

• NAEOTOM Alpha.Pro

Single Source NAEOTOM CT scanner system:

• NAEOTOM Alpha.Prime

The subject devices NAEOTOM Alpha (trade name ex-factory CT systems: NAEOTOM Alpha.Peak) and NAEOTOM Alpha.Pro with software version SOMARIS/10 syngo CT VB20 (update) are Computed Tomography X-ray systems which feature two continuously rotating tube-detector systems, denominated as A- and B-systems respectively (dual source NAEOTOM CT scanner system).

The subject device NAEOTOM Alpha.Prime with software version SOMARIS/10 syngo CT VB20 (update) is a Computed Tomography X-ray system which features one continuously rotating tube-detector systems, denominated as A-system (single source NAEOTOM CT scanner system).

The detectors' function is based on photon-counting technology.

In this submission, the above-mentioned CT scanner systems are jointly referred to as subject devices by "NAEOTOM Alpha class CT scanner systems".

The NAEOTOM Alpha class CT scanner systems with SOMARIS/10 syngo CT VB20 (update) produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors. The CT images can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. The radiation therapy planning support includes, but is not limited to, Brachytherapy, Particle Therapy including Proton Therapy, External Beam Radiation Therapy, Surgery. The computer system delivered with the CT scanner is able to run optional post-processing applications.

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.

The platform software for the NAEOTOM Alpha class CT scanner systems is syngo CT VB20 (update) (SOMARIS/10 syngo CT VB20 (update)). It is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform provides plugin software interfaces that allow for the use of specific commercially available post-processing software algorithms in an unmodified form from the cleared stand-alone post-processing version.

Software version syngo CT VB20 (update) (SOMARIS/10 syngo CT VB20 (update)) shall support additional software features compared to the software version of the predicate devices NAEOTOM Alpha class CT systems with syngo CT VB20 (SOMARIS/10 syngo CT VB20) cleared in K243523.

Software version SOMARIS/10 syngo CT VB20 (update) will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha class systems.

The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.

The provided document describes the acceptance criteria and a study that proves the device meets those criteria for the NAEOTOM Alpha CT Scanner Systems. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness based on non-clinical testing and adherence to standards, rather than detailing a specific clinical performance study with defined acceptance criteria for a diagnostic aid.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics in the way one would typically find for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, it states that:

• Acceptance Criteria for Software: "The test specification and acceptance criteria are related to the corresponding requirements." and "The test results show that all of the software specifications have met the acceptance criteria."
• Acceptance Criteria for Features: "Test results show that the subject devices...is comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices."
• Performance Claim: "The conclusions drawn from the non-clinical and clinical tests demonstrate that the subject devices are as safe, as effective, and perform as well as or better than the predicate devices."

The closest the document comes to defining and reporting on "performance criteria" for a specific feature, beyond basic safety and technical functionality, are for the HD FoV 5.0 and ZeeFree RT algorithms.

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

The document mentions "physical and anthropomorphic phantoms" for HD FoV 5.0 and "homogeneous water phantom" and "phantom with tissue-equivalent inserts," and "dynamic thorax phantom" for ZeeFree RT. It also refers to "retrospective blinded rater studies of respiratory 4D CT examinations performed at two institutions" for ZeeFree RT, but does not specify the sample size (number of cases/patients) or the country of origin for these real-world examination datasets. The data provenance (retrospective/prospective) is stated for the rater study for ZeeFree RT as retrospective, but not for the HD FoV 5.0 rater study (though implied by "retrospective blinded rater study").

3. Number of Experts and Qualifications for Ground Truth

For the HD FoV 5.0 and ZeeFree RT rater studies, the experts were "board-approved radio-oncologists and medical physicists." The number of experts is not specified, nor is their specific years of experience.

4. Adjudication Method for the Test Set

The document explicitly states "retrospective blinded rater study" for HD FoV 5.0 and ZeeFree RT. However, it does not specify the adjudication method (e.g., 2+1, 3+1, none) if there were multiple raters and disagreements.

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

The document states that for HD FoV 5.0 and ZeeFree RT, "the performance of the algorithm was evaluated by board-approved radio-oncologists and medical physicists by means of retrospective blinded rater study." This indicates a reader study, which is often a component of an MRMC study.

However, the study described does not appear to be comparing human readers with AI assistance vs. without AI assistance. Instead, for HD FoV 5.0, it's comparing the new algorithm's results to its predecessor, HD FoV 4.0. For ZeeFree RT, it's comparing the reconstruction to "Standard reconstruction" and assessing if it introduces errors or new artifacts. It's an evaluation of the algorithm's output, not necessarily a direct measure of human reader improvement with AI assistance. Therefore, no effect size for human reader improvement with AI vs. without AI assistance is reported because this specific type of comparative effectiveness study was not described.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone (algorithm only) performance was conducted. The bench testing described for both HD FoV 5.0 and ZeeFree RT involves detailed evaluations of the algorithms' outputs using phantoms and comparing them to established standards or previous versions. For example, for ZeeFree RT, the bench test objectives include demonstrating that it "introduces no relevant errors in terms of CT values and noise levels measured in a homogeneous water phantom" and "does not introduce relevant new artefacts." This is an assessment of the algorithm's direct output.

7. Type of Ground Truth Used

The ground truth used primarily appears to be:

• Phantom-based measurements: For HD FoV 5.0 (physical and anthropomorphic phantoms) and ZeeFree RT (homogeneous water phantom, tissue-equivalent inserts, static torso phantom, dynamic thorax phantom). These phantoms have known properties which serve as ground truth for evaluating image quality metrics.
• Expert Consensus/Interpretation: For HD FoV 5.0 and ZeeFree RT, it involved "board-approved radio-oncologists and medical physicists" in "retrospective blinded rater studies." This suggests the experts' interpretations (potentially comparing image features or diagnostic quality) formed a part of the ground truth or served as the primary evaluation method. The text doesn't specify if there was a pre-established "true" diagnosis or condition for these clinical cases, or if the experts were rating image quality or agreement with a reference standard.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set for any of the algorithms or software features. This document is a 510(k) summary, which generally focuses on justification for substantial equivalence rather than detailed algorithm development specifics.

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

The document does not describe how the ground truth for the training set was established, as it does not provide information about the training set itself.

Ask a specific question about this device

The Marie Imaging System is indicated for the acquisition of CT images and the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.

The Marie System is intended to acquire CT images and enable the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.

The Marie System is intended to be used by healthcare professionals to image patients in an upright position rather than conventional supine treatments, to enable precise treatment planning and patient positioning for radiotherapy.

Specifically, it is intended to:

• Image the patient to provide image-guided radiation therapy
• Image the patient to acquire images for the purpose of treatment planning
• Immobilize patients in an upright position for upright radiotherapy.

The Marie System is comprised of two major sub-systems: a computed tomography (CT) imaging system that performs pretreatment imaging and treatment simulation in the upright positions and a beam agnostic, patient positioning system that supports the patient in the upright positions.

The Marie Imaging System is used with compatible devices for treatment delivery and patient immobilization. The positioning system is designed with six degrees of freedom of motion and a patient positioning system to provide the desired posture for each cancer site to achieve accurate, reproducible patient setups, while the imaging system acquires helical scans by translating and rotating up the patient.

The provided text solely describes the Leo Cancer Care Marie System as a Computed Tomography X-ray System with its features, safety, and performance details. It outlines the regulatory clearance (FDA 510(k)) based on substantial equivalence to a predicate device (P-ARTIS K160611). It describes the device's characteristics and the non-clinical tests performed to demonstrate its performance and functionality against design and risk management requirements.

Crucially, the provided text does not contain any information about acceptance criteria for AI performance, clinical study design, sample sizes for test or training sets, ground truth establishment using experts, or any MRMC comparative effectiveness studies. The document is a 510(k) clearance summary for a medical device (a CT imaging and patient positioning system), not for an AI diagnostic or assistive software. The "performance testing" section refers to hardware and software system performance, not AI model performance.

Therefore, I cannot answer most of your questions based on the provided input. The questions you've asked are typically relevant for AI/ML-based medical devices or diagnostics that involve image interpretation and require rigorous validation against human expert performance. The Marie System, as described, is a physical imaging system for patient positioning and CT image acquisition, not an AI software.

If this were an AI device, the answers would need to be extracted from sections detailing clinical performance studies, AI model validation, or similar. Since those sections are absent, I am unable to provide the requested information.

Ask a specific question about this device