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Prism Acquire® / Prism Process® software is used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets.

Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion.

Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI).

The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments.

Prism Acquire provides a scripted approach to performing fMRI and other imaging studies. Prism Process performs post-processing and quality assurance of fMRI and other imaging data sets. The processed data is prepared for report generation utilizing the Prism View product, supporting the visualization and manipulation of clinical imagery of multiple kinds. It provides a flexible set of display, analysis, and export options for utilizing the imagery relationships.

These applications may communicate in the healthcare IT environment via Prism Flow®, server-based software facilitating DICOM communications, authorization/authentication, audit logging, and other infrastructure functions.

The provided 510(k) summary for Prism Acquire®, Prism Process®, and Prism View® does not contain information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics.

However, based on the available information, here's what can be extracted and what is explicitly not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "FDA has not established special controls or performance standards for this device." Therefore, the primary "acceptance criteria" appear to hinge on substantial equivalence to predicate devices and general software verification and validation. Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not reported.

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

This information is not provided in the document.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This information is not provided in the document. The document focuses on technological and safety equivalence to predicate devices, not on comparative effectiveness studies involving human readers.

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

This information is not provided in the document. The general statement "Software verification and validation was conducted to confirm proper function of the device's features" is broad and does not detail specific standalone performance studies.

7. The Type of Ground Truth Used

This information is not provided in the document. Since specific performance metrics are not given, the type of ground truth against which those metrics would be compared is also absent. The device's output is intended to "assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments" when "interpreted by a trained physician," implying clinical interpretation as the ultimate reference, but how this translates to a ground truth for device performance is not detailed.

8. The Sample Size for the Training Set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of Study Details Provided:

The document primarily relies on:

• Substantial Equivalence: The core of the performance "proof" is that Prism Acquire, Process, and View are technologically and safely equivalent to their own previous versions (BrainAcquireRx™, BrainProcessRx™, BrainViewRx™) and to other legally marketed predicate devices (Syngo® Multimodality Workstation, Advantage Windows with FuncTool Option).
• Software Verification and Validation: A general statement is made that "Software verification and validation was conducted to confirm proper function of the device's features." This typically covers testing for functionality, reliability, and security, but specific details or quantitative results are not included in this summary.

This type of 510(k) submission often focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo clinical trial data with detailed performance metrics.

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S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.

S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The indications for use of the S-scan system, as described in its labeling, are the same as those of the unmodified S-scan system cleared via K063207.

The changes performed on the modified S-scan device, with respect to the cleared version - S-scan K063207 -, are due to the improvement of the system performance. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. A device that locks the patient table in the current position, unless the user disconnects the coil cable.
• 2. A limb protection for patient table.
• 3. Modified pulse sequences.
• 4. A new software release.

The provided text is a 510(k) summary for the S-scan System, a Magnetic Resonance Imaging (MRI) device. It details modifications to an existing device (K063207) and compares its technological characteristics to several predicate devices.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any performance metrics from such a study.

The submission focuses on establishing substantial equivalence to previously cleared devices based on technological characteristics and intended use, rather than presenting new performance study data for approval. Therefore, I cannot complete the requested tables and information based on the input provided.

Here's a breakdown of what is present in the document, and what is not:

What is present:

• Device Name: S-scan System, Nuclear Magnetic Resonance Imaging
• Intended Use: Produces transversal, sagittal, coronal, and oblique cross-section images of limbs, joints, and the spinal column for diagnostic information when interpreted by a medical expert.
• Predicate Devices: S-scan (K063207), G-scan (K042236), Siemens Magnetom C! (K043030), Esaote Dynamic MRI Software (K061429), Siemens Syngo Multimodality Workstation (K010938).
• Modifications to the S-scan (K063207):
  • Device that locks the patient table.
  • Limb protection for the patient table.
  • Modified pulse sequences.
  • A new software release.
• Technological Characteristics Comparison: Detailed lists of pulse sequences and their parameters for the modified S-scan compared to the predicate S-scan (K063207), G-scan (K042236), and Siemens Magnetom C! (K043030). Also details image processing functions, networking functions, system access management, and accessories compared to predicate devices.

What is NOT present (and therefore cannot be provided in the requested format):

• Table of Acceptance Criteria and Reported Device Performance: No acceptance criteria or performance metrics are stated. The submission relies on demonstrating substantial equivalence to predicates, implying that if the technological characteristics and intended use are similar, the performance is also considered similar.
• Study details (Sample size, data provenance, number of experts, adjudication method, MRMC, standalone performance, ground truth type, training set size, ground truth for training set): The document does not describe any specific performance study conducted to assess the diagnostic accuracy or clinical effectiveness of the modified S-scan device. The "study" here is essentially a technical comparison for substantial equivalence.

In summary, the provided 510(k) summary focuses on demonstrating that the modified S-scan device is substantially equivalent to existing cleared devices based on its technological characteristics and intended use, rather than providing the results of a clinical performance study with specific acceptance criteria.

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The COHERENCE Dosimetrist Workspace v2.2 is a comprehensive oncology workflow software package that allows for both CT simulation as well as inverse radiation therapy treatment planning and optimization in one software package to aid in oncology clinical workflow. This workspace is comprised of two major components, the CT Simulation component (VSIM) and the inverse radiation therapy treatment planning component (KonRad).

The VSIM component permits CT simulation to be performed on the syngo workstation. The CT scans are first loaded into the VSIM software component and the user is able to create three-dimensional models of targets and organs. The user is able to identify the patient isocenter, place treatment beams, and identify beam modifiers (blocks, apertures, and MLCs). The information is then available for radiation treatment planning for dose calculation via the KonRad software component or other treatment planning systems. The plans are then reviewed and approved by the clinician prior to transfer to the delivery system for the actual treatment.

The KonRad software component is intended to optimize multi-leaf (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). Once the optimization is complete the dose distribution and dose volume histogram curves are displayed for the user to evaluate. After approval the results are exported to the delivery equipment, linear accelerator, or record and verify system, for final verification prior to treatment delivery. The KonRad software component allows for efficient inverse radiation therapy treatment planning and optimization.

The COHERENCE Dosimetrist Workspace v2.2 integrates the functionality of two previously released Siemens Medical Solutions USA, Inc. products (VSIM and KonRad, Model v2.0) with the addition of further enhancements to this pre-existing functionality. The integration allows for the sharing of data with all other application components within the COHERENCE Dosimetrist Workspace v2.2. This new software package is based on the syngo user interface standard which was cleared via K010938.

The existing functionality (as previously cleared by VSIM (K022036) and KonRad (K022307)) is described by the following components:

VSIM component: The VSIM component is intended to give the user general viewing and examination tools for viewing medical diagnostic images. Computed Tomography (CT) scans are the centerpiece of the diagnostic images used by the VSIM part of this component and it is possible to load other modality images, in conjunction with the CT images for treatment planning. The VSIM component is intended to provide tools for delineating and representing targets and critical structures. The component enables the user to design complex beam profiles and place them for optimum radiation therapy treatment. A three dimensional graphical representation allows for a virtual setup and treatment of the patient without involving the patient.

KonRad component: The KonRad component is a radiation therapy treatment planning package designed to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). The KonRad component uses defined anatomical structures for the optimization and treatment planning process. The images or contours are based on tomographic images imported via DICOM RT protocols from various sources such as CT. The site-specific treatment machine beam data is utilized for plan calculation. The user defines the desired dose to be delivered to the target and the surrounding structures. Values are entered to weight the optimization calculations according to the importance of reaching the dose objectives for the target and other structures. The KonRad component will calculate the required MLC or partial attenuation block shapes needed to achieve the dose objectives. This process is done for each beam simultaneously and the resulting dose distribution and DVH are displayed. The input parameters can be modified and the optimization repeated until the user obtains their desired results. Once the desired treatment plan results are obtained, the user can store the final treatment plan for export. The final treatment plan can be exported to the appropriate delivery equipment, linear accelerator, and/or record and verify system. The export of the final treatment plan does not activate the radiation therapy delivery equipment, all information must be verified by the user prior to the initiation of radiation therapy treatment.

The new functionality that is being added with COHERENCE Dosimetrist Workspace v2.2 is described as follows:

VSIM component: DICOM RT Plan and RT structure set can be imported and converted into VSIM compatible objects; Functionality to allow contours/ports editing; Beams eye view (BEV), collimator is rotated as opposed to the underlying image; Improvements to the service user interface; Support for DRR presets for organ-based windowing; Spline fitting mode enabled for editing of contours/blocks; Support for copying of plans is provided; Verify and Record system taskcard integrated; Various tool enhancements within the Localization Mode; Auto fit functionality enhancements.

KonRad component: Compensator support; Plan combination support to combine two IMRT plans to support multiple isocenters or large treatment volumes; DICOM RT dose import and consideration of pre-planned/treated dose; Plan and constraint template editor; Allow to optimize with MLC field size constraints; Support IMRT for Siemens MLC (without using 6.5 cm leaves); Export DVH data in a easily readable format.

Syngo: The original COHERENCE Dosimetrist Workspace software (K022036) was based on the software architecture of the previously cleared syngo software (K010938) and allows for a standardized graphical user interface across Siemens medical products. The syngo-based software design consists of task cards allowing for a selection of modules of common software applications for image acquisition, reconstruction, post-processing, display, and archiving across the Siemens medical product lines.

As part of the Siemens Medical Solutions family of workstations, the syngo based workstations (Oncology Care System calls a "workspace") offers a configurable selection of software applications depending on the type of syngo package that is required for a specific modality. There are multiple applications in common across all Siemens imaging modalities as previously mentioned.

The COHERENCE Dosimetrist Workspace v2.2, will be available as individual purchased options to medical linear accelerator product lines upon receipt of FDA market clearance notification.

This looks like a 510(k) premarket notification for a medical device called COHERENCE Dosimetrist Workspace v2.2. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device identification and contact information.
• Description of the device: How it integrates and enhances functionalities of previously cleared products (VSIM and KonRad).
• Intended Use: As an accessory to linear accelerator systems for radiation therapy planning.
• FDA correspondence: The substantial equivalence determination letter.

There is no mention of specific performance metrics, clinical studies, or engineering studies that would typically be used to demonstrate that the device meets defined acceptance criteria. This submission seems to rely on the substantial equivalence of the combined and enhanced functionalities to previously cleared predicate devices, rather than presenting a de novo performance study with explicit acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

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The intended use of the COHERENCE Workspaces are as optional accessories to the linear accelerator systems to aid and support in the quality assurance, planning and delivery of x-ray radiation for the therapeutic treatment of cancer.

The COHERENCE Workspaces encompasses a number of syngo software applications who's indication for use include the viewing, manipulation, filming, communications, and archiving of medical images and data on exchange media.

The COHERENCE Oncologist Workspace permits localization, contouring, image calibration and conditioning, and review of treatment parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy. The indications for use for the COHERENCE Oncologist 2.0 workspace remain unchanged from the previously cleared COHERENCE Oncologist workspace (K031764).

The COHERENCE Physicist Workspace is a syngo software application package for the use with radiation therapy devices for viewing, manipulation and conditioning, communication and storage of medical images and data on exchange media; and as a quality assurance tool for radiation therapy linear accelerators and their accessories.

The COHERENCE Physicist Workspace is an optional accessory to a medical linear accelerator and is based on the previously cleared ONCOR Avant-Garde with COHERENCE Workspaces (K031764) and syngo™ software design architecture previously cleared on the LEONARDO workstation (K040970). The Quality Assurance software applications support the COHERENCE Data Conditioner and customer configurable Quality Assurance applications that Siemens believes are substantially equivalent to those previously cleared on the RIT 113 Film Analysis System (K935928).

The Physicist workspace will support the current manual methodologies for managing quality assurance data using the ONCOR COHERENCE Therapist (or PRIMEVIEW3) workspace) as sources of QA data. The Physicist WS will also offer a suite of customizable QA test protocols (user created and configured macros), test analysis and documentation tools.

The Physicist Workspace will support the COHERENCE Data Conditioner software application which allows the input of DICOM and non-DICOM conforming data objects that have been converted from electronically scanned film (bitmap or TiFF format), EPID data and electronic data from analyzers and The new COHERENCE Data Conditioning application will provide a method of film digitizers. importing non-DICOM data from a variety of electronic media, as mentioned above, and provide the user a method of converting the non-DICOM data into DICOM RT standard images. The DICOM RT standard images can then be processed using a combination of the previously cleared syngo software applications and the new conditioning, calibration and analysis software applications as described in this submission.

The previously cleared COHERENCE Oncologist Workspace provided a syngo based interface for 2D, 3D, and volumetric targeting of the radiation treatment using the Portal Imaging application for the purposes of patient position and setup. This revision to the Oncologist workspace adds.

COHERENCE Data Conditioner: The same syngo based software application module to enable the medical physicist and/or oncologist a method to convert non-DICOM data into DICOM RT conforming data where non image dependent information is missing such as gantry angle, collimator angle, etc.

Adaptive Targeting TM: Improvements to the volume targeting application for advanced Image Guided Radiation Therapy (IGRT) is featured in the new syngo based Adaptive Targeting application module, which supports alignment of 3D planning data for the purposes of patient setup and patient position localization. The Adaptive Targeting application supports the automatic calculation of the table offsets when comparing 3D planning data and current 2D or 3D portal imaging.

Here's an analysis of the provided text regarding the acceptance criteria and study for the COHERENCE™ Workspaces (Physicist, Oncologist) device:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission typically does not include detailed performance studies with explicit acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies in the way a de novo or PMA submission might. The "study that proves the device meets the acceptance criteria" in a 510(k) context is primarily the demonstration of substantial equivalence by comparing the new device's features and safety/effectiveness to a predicate device.

Given this context, I will extract what information is available and highlight what is not present in the document.

Acceptance Criteria and Reported Device Performance

• Processing of QA data.
• Support for DICOM and non-DICOM conforming data.
• Customizable QA test protocols, analysis, and documentation.
• Viewing, manipulation, archiving of medical images and data.
• Localization, contouring, image calibration, review of treatment parameters (for Oncologist Workspace).
• Enhanced patient positioning accuracy through Adaptive Targeting. | The device, COHERENCE™ Workspaces (Physicist, Oncologist), successfully provides these functionalities. It enables the input, conversion, processing, and display of various QA data types (DICOM and non-DICOM), offers tools for QA practices, and enhances treatment planning and patient setup. | The entire submission implies that the device meets these functional requirements, as it claims substantial equivalence to predicate devices (K031764, K040970, K935928) and describes its new features (Data Conditioner, Adaptive Targeting) as performing these tasks. Page 2-4 describe the new functionalities in detail. |
  | Safety and Effectiveness Equivalence:
• The new device should be as safe and effective as the predicate device(s) for its intended use. | The FDA cleared the device, stating it is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." | Page 5, FDA clearance letter. |
  | Compliance with Standards (implicit):
• Adherence to medical physics standards (AAPM Task Group 40). | The rationale for development cites AAPM standards as defining current QA practices, implying the device supports these. | Page 1, "The American Association of Physicist in Medicine, (AAPM) currently defines the standard of care for the quality assurance practices..." |
  | Conversion of Non-DICOM to DICOM RT:
• Ability to convert electronically scanned film (bitmap/TiFF), EPID data, and electronic data from analyzers/film digitizers into DICOM RT standard images. | The COHERENCE Data Conditioning application is described as providing "a method of importing non-DICOM data from a variety of electronic media... and provide the user a method of converting the non-DICOM data into DICOM RT standard images." | Page 2-3, "COHERENCE Data Conditioner" section. |
  | Automatic Calculation of Table Offsets (Adaptive Targeting):
• Ability to automatically calculate table offsets by comparing 3D planning data and current 2D or 3D portal imaging. | The Adaptive Targeting application "supports the automatic calculation of the table offsets when comparing 3D planning data and current 2D or 3D portal imaging." | Page 3, "Adaptive Targeting™" section. |

Detailed Study Information from the Provided Text:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not explicitly stated. A 510(k) submission primarily relies on demonstrating equivalence to predicate devices and describing the new features. It does not typically involve new clinical performance studies with specific test sets and data provenance as would be seen in a PMA or de novo submission. The document describes functionalities and claims equivalence to previously cleared software.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not explicitly stated. Since there is no mention of a formal "test set" or ground truth establishment process for a new performance study in this 510(k), information regarding experts for ground truth is absent. The document mentions that Medical Physicists, Medical Oncologists, Dosimetrists, and Radiation Therapists define and perform QA practices per AAPM and JCAHO guidelines, implying these professionals use and interpret the data generated by such systems.

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

   • Not explicitly stated. No adjudication method is mentioned as a formal test set was not described.

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 comparative effectiveness study was not done according to the provided document. This document is a 510(k) for an accessory to a linear accelerator, which is software for managing and processing radiation therapy data and QA. It's not an AI diagnostic or assistive device in the sense that would typically warrant an MRMC study comparing human reader performance with and without AI assistance. The "Adaptive Targeting" feature offers automated calculations for position offsets, but this is presented as a functional improvement rather than an AI-driven diagnostic aid requiring MRMC.

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

   • Not explicitly mentioned as a formal "standalone" study. The device's functionalities, such as calculating table offsets and converting non-DICOM to DICOM, are inherently automated processes. However, these are presented as features of the software accessory rather than a standalone algorithm performance study. The device is an "accessory to a medical linear accelerator" and designed to "aid and support" human users (physicists, oncologists, therapists).

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

   • Not explicitly stated. Since a new performance study with a dedicated "test set" and ground truth establishment is not described, the type of ground truth is not detailed. The "ground truth" for radiation therapy QA and planning would generally derive from established clinical protocols, dosimetry measurements, and expert interpretation, which the software aims to facilitate and automate where possible.

7. The sample size for the training set:

   • Not applicable / Not explicitly stated. This device is software for managing and processing radiotherapy data, not a machine learning model that relies on "training sets" in the conventional sense of AI. Its development relies on established physics principles and software engineering practices, ensuring compatibility with existing radiotherapy systems and data standards.

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

   • Not applicable / Not explicitly stated. As there's no mention of a "training set" for a machine learning model, the establishment of its ground truth is not discussed.

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To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

• Multiplanar Reconstruction (MPR) .
• Maximum/Minimum Intensity Projection (MIP) .
• Image Contrast Manipulation .
• Image Zoom Manipulation .
• Automatic registration with Mutual Information Technique .

Clarity PET is PET intage review software. Clarity PET offers a comprehensive software solution for medical imaging tasks and applications. Clarity PET is a medical diagnostic workstation designed for display, review, 3D MPR, communication and archiving of medical images

This 510(k) submission (K032866) for the Clarity PET device does not contain a study demonstrating that the device meets specific acceptance criteria based on its performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance metrics in the provided document. The submission relies on establishing equivalency rather than meeting new performance benchmarks.

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

Not applicable. No new performance study (test set, data provenance) is conducted for this 510(k) submission.

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

Not applicable. No new performance study is conducted that involved establishing ground truth with experts.

4. Adjudication Method:

Not applicable. No new performance study requiring adjudication is conducted.

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

No, an MRMC comparative effectiveness study was not done. The submission does not present a study comparing human reader performance with and without AI assistance, as the device is image review software, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done. The Clarity PET is described as image review software and thus its "performance" is implicitly tied to its ability to display and manipulate images, similar to predicate devices. It's not an algorithm providing a diagnostic output independently.

7. Type of Ground Truth Used:

Not applicable. No ground truth for a new performance study is established or used in this submission.

8. Sample Size for the Training Set:

Not applicable. The provided document does not describe a training set for an algorithm, as the device is image review software, not a machine learning model.

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

Not applicable.

Summary of the K032866 Submission's Approach:

The K032866 submission for Clarity PET establishes substantial equivalence by demonstrating:

• Equivalent Indications for Use: The device can "detect or image the distribution of radionuclides in the body or organ, using the following techniques: Multiplanar Reconstruction (MPR), Maximum/Minimum Intensity Projection (MIP), Image Contrast Manipulation, Image Zoom Manipulation, Automatic registration with Mutual Information Technique." These are explicitly stated as equivalent to the Medical Image Merge™ device.
• Equivalent Technological Characteristics, Performance Characteristics, and Instructions for Use: The submission asserts that Clarity PET shares these equivalencies with the Medical Image Merge™ device and other predicate devices like Syngo Multi-Modality Workstation, ADAC Laboratories Image Fusion and Review System, and GE Advantage Windows Workstation.

The core of this 510(k) is a comparison to legally marketed predicate devices, asserting that Clarity PET performs the "same functions" and has "equivalent" characteristics, rather than providing new performance data against a specific set of acceptance criteria. The FDA's letter confirms that they reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

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The intended use of the ONCOR Avant-Garde linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. The ONCOR Avant-Garde includes an Electronic Portal Imaging Device (EPID) that will be marketed as OPTIVUE and is used for the verification of the treatment field and shielding blocks in relation to patient positioning markers and/or anatomical landmarks in radiotherapy treatment. OPTIVUE will also allow for verification of the exit dose in radiotherapy treatment. Additionally, the ONCOR Avant-Garde includes an 82 leaf multi-leaf collimator that will be marketed as OPTIFOCUS. The OPTIFOCUS MLC is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.

The COHERENCE Workspaces (Therapist and Oncologist) encompasses a number of syngo software applications for viewing, processing, filming, and archiving of medical images. The COHERENCE Therapist and Oncologist Workspaces are two of the software applications that are offered on the syngo workstation (K010938). COHERENCE Therapist Workspace is included in the ONCOR Avant-Garde product. The Therapist Workspace permits patient data management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording.

The COHERENCE Oncologist Workspace permits localization, contouring, image conditioning, and review of treatment parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

The ONCOR Avant-Garde is a medical linear accelerator based on the previously cleared PRIMUS design architecture (K993425) and includes an amorphous Silicon (aSi) flat panel electronic portal imaging device (EPID), an 82 leaf multi-leaf collimator (MLC), and COHERENCE Therapist Workspace software.

The aSi flat panel (marketed as OPTIVUE) is integrated into the ONCOR Avant-Garde system and aids in positioning verification by visualizing patient positioning markers and/or anatomical references. The flat panel detects radiation from the linear accelerator, this information is then interpreted via software to obtain visualization of patient positioning markers and/or anatomical structures. The OPTIVUE flat panel detector is a digital x-ray camera comprised of sensors. These sensors are amorphous Silicon (aSi) photo diodes that are placed on a glass substrate with scintillator coating. The incident x-rays are converted by the scintillator screen. The converted x-ray signals are then amplified and converted to a digital format. This digital formatted data is then transmitted to the data acquisition unit or frame grabber and interpreted into positioning images. The OPTIVUE includes automated deployment of the flat panel that eliminates the need to enter the treatment room to acquire portal images, thus improving the efficiency of patient treatments.

The 82 leaf multi-leaf collimator (marketed as OPTIFOCUS) is integrated into the ONCOR Avant-Garde system and allows for user definable optimization of resolution for target conformation. The OPTIFOCUS is based on the same architectural design as the previously cleared 58 leaf MLC (K953894). The increase in the number of leaves in the collimator allows for increased conformal shape resolution.

The COHERENCE Workspace software is based on the architecture of the previously cleared syngo software (K010938) and allows for a standard graphical user interface across Siemens medical products.

The COHERENCE Therapist Workspace software integrates the linear accelerator processes of setup. setup verification, patient positioning verification, treatment delivery, and recording. The COHERENCE Therapist Workspace provides a simple interface for 2D. 3D. and volumetric targeting of the radiation treatment. Patient management is facilitated by easy access to all pertinent patient data with the integration of previously cleared functionality. The Therapist Workspace integrates various functions from previously cleared products (ie. VSIM marketed as COHERENCE Dosimetrist (K022036), syngo Workstation (K010938), and LANTIS Treatstation marketed as PRIMEVIEW (K972275).

The COHERENCE Oncologist Workspace software is an option for the ONCOR Avant-Garde linear accelerator and provides access to patient data, images, and tools needed to help facilitate the Oncologist in performing accurate and timely clinical decisions. Multi-modality images can be loaded and manipulated with the advanced tools allowing for efficient localization and contouring of tumors and critical anatomical structures. The COHERENCE Oncologist Workspace provides access to all radiation therapy plans, visualization of suggested alternate plans, and comparisons with prior treatment plan data. In addition, it provides for treatment verification of patients with access to pertinent treatment data allowing for full treatment review. The COHERENCE Oncologist Workspace is based on the previously cleared syngo architecture (K010938). The COHERENCE Oncologist Workspace is also based on functionality cleared under VSIM via K022036 and permits localization, contouring, image conditioning, and review of treatment parameters. In addition, there are tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

The OPTIVUE, OPTIFOCUS, and COHERENCE Therapist Workspace, may also be available as individual purchased options to existing Siemens medical linear accelerators.

This document, K031764, is a 510(k) summary for the ONCOR Avant-Garde with COHERENCE Workspaces. It is primarily a filing for substantial equivalence to predicate devices, meaning it aims to show it's as safe and effective as existing, legally marketed devices. As such, it does not contain the detailed acceptance criteria and study data typical for a device proving novel performance or efficacy.

The document focuses on describing the device, its intended use, and identifying predicate devices it is substantially equivalent to. It explicitly states the intended uses remain unchanged from the predicate devices. This type of submission relies on the prior approval of the predicate devices rather than new, extensive performance studies for novel claims.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and comparative effectiveness studies are not present in this 510(k) summary because they are not required for a substantial equivalence determination to this extent.

However, I can extract the information that is present and explain why other information is absent.

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission, explicit quantitative acceptance criteria for new performance claims are not provided. Instead, the "acceptance criteria" can be inferred as demonstration that the device's components perform similarly or identically to their predicate devices. The "reported device performance" is essentially the device functioning as intended, mirroring the predicate's performance.

The submission emphasizes that the intended uses for all components (ONCOR Avant-Garde, OPTIVUE, OPTIFOCUS, COHERENCE Workspaces) remain unchanged from their respective predicate devices. This forms the basis of the substantial equivalence claim.

Specific Study Information (Not Present in this 510(k) Summary)

The following information is not provided in the given 510(k) summary, as it describes a substantial equivalence claim based on predicate devices, rather than a de novo submission or a claim of new performance.

• Sample size used for the test set and the data provenance: Not provided. Performance testing would have been done to ensure safety and functionality, but details about specific image or patient datasets for a "test set" demonstrating performance metrics are not included. Data provenance (country, retrospective/prospective) is also not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. This type of information is relevant for studies validating diagnostic or interpretive AI, which is not the primary focus of this submission, though the software aids these processes.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
• 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: Not provided. This type of study would be highly relevant for AI-assisted diagnostic devices, but this submission focuses on the safety and foundational functionality of radiation therapy equipment and software tools, not a primary diagnostic AI. The software "aids in the diagnosis, staging, and prescription" but is not explicitly making diagnostic claims that would require an MRMC study here.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. Given the nature of the device (radiation therapy system and associated software), human clinicians are always in the loop.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly provided for new studies. For devices claiming substantial equivalence, the "ground truth" for ensuring safety and effectiveness relies on the established performance and safety of the predicate devices.
• The sample size for the training set: Not applicable and not provided. This device is not presenting a novel AI model that requires a specific training set in the context of this 510(k). The software (COHERENCE Workspaces) is based on existing, cleared software architectures (syngo, VSIM, LANTIS).
• How the ground truth for the training set was established: Not applicable and not provided.

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syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions. shape and position.

Due to all these capabilities the syngo Colonography software has the advantage of non-invasive evaluation of colonic lesions as compared to conventional colonoscopy.

syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

I apologize, but the provided text does not contain detailed information about acceptance criteria or specific study results that prove the device meets said criteria.

The document is a 510(k) summary for the Syngo Colonography software package, primarily focused on establishing substantial equivalence to previously cleared predicate devices. It describes the device's intended use, general safety and effectiveness concerns, and its relationship to other Siemens software.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions regarding:

• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of detailed study information is typically found in the full 510(k) submission, not necessarily in the public summary. The summary focuses on the regulatory aspects of equivalence rather than a detailed performance report against specific acceptance criteria.

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The AXIOM Sensis system is intended for use as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The system is equipped by modules, enabling various configurations ranging from a stand-alone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the administrative tools.
The AXIOM Sensis system has functions for:

• External communication via the DICOM interface by using Siemens Medical Platform 1. syngo ™and AXIOM Sensis VC00A DICOM Conformance Statement
• External Communication via the HL7 interface by using AXIOM Sensis Interface description 2: · HL7 Interface.
• 3. Local communication by using the Siemens HICOR interface
• Local communication by using the Siemens AXIOM Artis FC/BC interface 4.
• Local communication with Medtronic Model 4803, Atakr® II RF Power Generator, Boston ર. Scientific EP Technologies EPT-100 TC. and Stockert EP-Shuttle Ablator devices

AXIOM Sensis is a multi-channel computer-based stationary system for the measurement, display, and printout of biophysiological events. Hemodynamic and electrophysiological signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system. AXIOM Sensis software provides the ability to monitor and assess invasive blood pressure, ECG signals, and optionally intracardiac electrograms (ICEG). With the AXIOM Sensis system the user can perform a number of calculations based on the input signals and other hemodynamic parameter values entered by the user.

This 510(k) summary describes a diagnostic and administrative tool for hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The submission focuses on substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, many of the requested sections regarding acceptance criteria, study details, and ground truth establishment cannot be fully populated from the provided text.

Here is the information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

The provided document does not explicitly state acceptance criteria or present a performance table as would be typical for a new standalone device. Instead, the focus is entirely on demonstrating substantial equivalence to existing legally marketed predicate devices. The implied "acceptance criterion" is that the device's technological characteristics, intended use, and safety/effectiveness are comparable to the identified predicate devices.

The "reported device performance" is essentially the statement of substantial equivalence itself, based on:

• Technological Characteristics: "AXIOM Sensis goes one-step beyond the currently available systems to create modular units with component commonality, streamlined user interface and use, and performance and reliability improvement." This is a general claim, not specific performance metrics.
• Communication Interfaces: Support for DICOM, HL7, Siemens HICOR, Siemens AXIOM Artis, and communication with specific ablation devices (Medtronic Model 4803 Atake® II RF Power Generator, Boston Scientific EP Technologies EPT-100 TC, and Stockert EP-Shuttle ablation devices).
• Platform: Based on the Syngo platform, which itself received 510(k) clearance (K010938).
• Safety/Effectiveness: Reliance on "recognized and established industry practice" and "all equipment is subject to final performance testing," with instructions for use to allow trained healthcare professionals to operate it safely and efficaciously.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission describes a device based on substantial equivalence and does not detail a study involving a test set of data or human performance evaluation. There is no mention of data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no test set for clinical performance evaluation is described, there's no mention of experts establishing ground truth.

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

Not applicable. No test set requiring adjudication is described.

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

Not applicable. The device is a diagnostic and administrative tool for hemodynamic and electrophysiology studies, not an AI-assisted diagnostic tool for interpretation by human readers. No MRMC study is described.

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

This refers to a standalone performance study. The document confirms that "all equipment is subject to final performance testing." However, specific details about such testing (e.g., protocols, acceptance criteria, results for individual measurements) are not provided in this 510(k) summary. The submission relies on the substantial equivalence to predicate devices, which generally means that if the core functionalities and measurements are within acceptable ranges (implicitly, similar to the predicates), then it is deemed safe and effective.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the context of a clinical performance study. For the measurements the device performs (e.g., invasive blood pressure, ECG signals, intracardiac electrograms), the "ground truth" would be established by the physical sensing and measurement principles, calibrated against known standards, similar to the predicate devices.

8. The sample size for the training set

Not applicable. This device is not described as involving machine learning or AI that would require a "training set" in the conventional sense.

9. How the ground truth for the training set was established

Not applicable, as no training set is described.

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The SYNGO workstation encompasses a number of software applications for viewing, processing, filming, and archiving of medical images. VSim is one of the software applications that are offered on the SYNGO workstation, K010938.

VSim permits CT Simulation to be performed on the SYNGO workstation. The CT scans are first loaded into the VSim software. On VSim the user is able to create 3D models of targets and organs. On VSim the user is able to identify the patient isocenter, place treatment beams and identify beam modifiers (blocks, apertures, and MLCs). This information is then sent to a radiation treatment planning system for dose calculation. The plans are then reviewed and approved by the clinician prior to transfer to the delivery system for the actual treatment.

Siemens Virtual Simulation (VSim) is a software application that runs on Siemens Medical Workstation, Syngo (K010938). It is intended to give the user general Viewing & Examination tools for viewing medical diagnostic images. Computed Tomography (CT) scans are the centerpiece of the diagnostic images used by the VSim. It will be possible to load other modality images, Positron Emission Tomography (PET) and Magnetic Resonance (MR), in conjunction with the CT images for treatment planning.

VSim is intended to provide tools for delineating and representing targets and critical Structures. It takes specifications and dimension for the dose delivery system (Siemens and other vendors). It will then enable the user to design complex beam profiles and place them for optimum treatment of the discase. 3D Graphical representation and visualization of all the relevant objects allow for a virtual setup and treatment of the patient without involving the patient.

VSim is a 3D post-processing software application that uses CT planning images as input and creates the following data objects as output:

1. Structure sets stored in the form of DICOM-RT Structure-Set,
2. Reference Points (including isocenters) stored in the form of DICOM-RT Structure-Set.
3. Plans, including beams stored in the form of DICOM-RT-Plan, and
4. Reference Images in the form of Digitally Reconstructed Radiographs (DRRs), (one DRR for each beam in the plan) stored in the form of DICOM-RT-Image.

This Siemens 510(k) submission for the Virtual Simulation (VSIM) Release 1.0 software does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a specific study proving the device meets those criteria. The provided document is a summary for regulatory clearance, primarily focused on demonstrating substantial equivalence to predicate devices, rather than a detailed technical report or performance study.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or quantified in this document. The focus is on functionality and equivalence to predicate devices, implying that if it functions similarly, it meets an unstated "acceptable" level of performance.
• Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, precision, processing speed benchmarks) are reported. The document describes the capabilities of the software rather than its measured performance against specific targets.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. This document does not detail any specific clinical or technical testing data.
• Data Provenance: Not specified.

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

• Not specified. There is no mention of a formal ground truth establishment process or the use of experts for a test set in this summary.

4. Adjudication method for the test set:

• Not applicable/specified. No test set or adjudication method is detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No. This document describes a treatment planning software, not an AI-assisted diagnostic or interpretative tool. MRMC studies are not relevant to this type of device as described here. The software provides tools for the user, but its "intelligence" is not framed as an AI for diagnosis or interpretation that would improve human reader performance in a statistical sense.

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

• No. The device is explicitly described as a software application with a "human-in-the-loop" where the user performs actions like creating models, identifying isocenters, and placing beams. There's no mention of a standalone algorithm performance evaluation.

7. The type of ground truth used:

• Not applicable/specified for performance testing. The "ground truth" for radiation therapy planning is ultimately expert clinical judgment and treatment outcomes, but this document does not refer to using these for a formal validation study of the software itself. The output of VSim (structure sets, plans, DRRs) becomes input for further clinical processes.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set in the conventional sense. It's a software application providing tools for users.

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

• Not applicable, as there is no training set for this type of software.

In summary: The provided 510(k) summary for Siemens Virtual Simulation (VSIM) is a regulatory document focused on demonstrating equivalency to existing devices based on functional descriptions. It does not contain the detailed information about performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment that would be present in a comprehensive device performance study report. This kind of information is typically part of internal validation reports or more detailed technical documentation, not usually included in the high-level 510(k) submission summary.

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Lung CARE CT is a self-contained image analysis software package for evaluating CT volume data sets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence of absence of physician-identified lung lesions (eg. nodules) in addition to evaluation, documentation and follow-up of any such lesions using standard or low-dose spiral CT scanning. This evaluation tool allows for volumetric analysis of pulmonary nodule or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

This premarket notification covers Siemens LungCARE CT software package. It is based on Siemens syngo software platform. Lung CARE CT is a self-contained image analysis software package for cvaluating CT volume data sets. Combining enhanced commercially available digital image processing tools (MIP, MPR, SSD, VRT), evaluation tools (volumetric estimation using consistent standardized measurement protocol, comparator tool for nodule matching by synchronization of two datasets, classification of nodules using configurable descriptors) and reporting tools (targeted presets, saved lesion) with optimized workflow palette, the software package is designed to support the physician in confirming the presence of physician identified lung lesions (eg. nodulcs) in addition to evaluation, documentation and follow-up of any such lesions using standard or low-dose spiral CT scanning. This visualization tool allows for volumetric analysis of pulmonary nodule or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and and position.

This document describes the LungCARE CT software package, a 3D CT reconstruction software designed to assist physicians in evaluating lung lesions. The submission includes a summary of pre-clinical and clinical information, and a declaration of substantial equivalence to previously cleared devices.

Here's an analysis of the provided information concerning acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific quantitative acceptance criteria for performance metrics (e.g., minimum accuracy, sensitivity, or reproducibility thresholds). Instead, the studies focus on demonstrating the capabilities and reproducibility of the device's volumetric measurements under various conditions.

• Volumetric estimation using standardized measurement protocol.
• Nodule matching by synchronization of two datasets (comparator tool).
• Classification of nodules using configurable descriptors.
• Targeted presets and saved lesion reporting tools.
• Visualization for volumetric analysis of pulmonary nodule or lesion size over time to assess growth.
• Classification of conspicuous tissue regions by size, dimensions, shape, and position. (Implied, as these are features of the device, not an evaluated performance metric in the studies described). |

2. Sample Sizes and Data Provenance

A. Lung Phantom Bench Testing Study (Kohl et al.):

• Sample Size: Not explicitly stated, but it's a bench testing study using a lung phantom, implying manufactured phantoms rather than patient data.
• Data Provenance: Not applicable as it's a phantom study.

B. Clinical Evaluation (Wormanns et al.):

• Sample Size (Test Set): 10 patients with pulmonary metastatic disease. A total of 150 pulmonary nodules were manually marked and evaluated across these patients.
• Data Provenance: Not explicitly stated (e.g., country of origin), but it is a clinical evaluation, therefore retrospective patient data since the study was conducted to evaluate the software.

3. Number of Experts and their Qualifications for Ground Truth

• A. Lung Phantom Bench Testing Study (Kohl et al.): Not applicable, as this was a phantom study and did not involve human interpretation or ground truth establishment in the traditional sense for medical imaging. The "ground truth" would be the known physical dimensions or changes in the phantom.
• B. Clinical Evaluation (Wormanns et al.): Not explicitly stated how many experts were involved in manually marking the 150 pulmonary nodules. The qualifications of these individuals are also not specified (e.g., "radiologist with 10 years of experience").

4. Adjudication Method

• The information provided does not specify an adjudication method for either study (e.g., 2+1, 3+1, none).
• For the clinical study, it states that "150 pulmonary nodules were manually marked and then evaluated," which implies a single expert or a non-adjudicated process unless specified otherwise.

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

• No MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is compared. The clinical study focused on the reproducibility of the software's volumetric measurements, not on the human reader's improvement with the software.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone study was performed. The "Wormanns et al." clinical evaluation assessed the reproducibility of volumetric measurements using LungCARE CT where "The proposed segmentation results, provided by the software package, were not modified by the user." This indicates the study evaluated the algorithm's performance in segmenting and measuring nodules without human intervention to adjust its output.

7. Type of Ground Truth Used

• A. Lung Phantom Bench Testing Study (Kohl et al.): The ground truth would be based on the known physical properties and dimensions of the phantom and the controlled changes applied to it.
• B. Clinical Evaluation (Wormanns et al.): The ground truth for the 150 pulmonary nodules was established by manual marking. This implies expert human identification and marking of the nodules, which then serves as a reference for the software's measurements. This is a form of expert consensus or expert-derived ground truth, though the number and qualifications of experts are not specified, nor is an explicit consensus process mentioned.

8. Sample Size for the Training Set

• The document does not provide any information about the training set used for the LungCARE CT software. The studies described are evaluation studies of an already developed product.

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

• Since there is no information about the training set, there is also no information on how its ground truth was established.

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