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The intended use of the ONCOR Expression™ linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

The ONCOR Expression includes an Electronic Portal Imaging Device (EPID) that will be marketed as OPTIVUE™ 1000ST. The indications for use for the OPTIVUE 1000ST is the acquisition of portal images for the purpose of verification of the treatment field and shielding blocks in relation to patient positioning markers and/or anatomical landmarks in radiotherapy treatment. OPTIVUE 1000ST will also allow for verification of the exit dose in radiotherapy treatment. The indications for use remain unchanged from the previously cleared OPTIVUE EPID (K031764).

Additionally, the ONCOR Expression includes as a standard feature, an 82 leaf multi-leaf collimator that is 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. The indications for use of the OPTIFOCUS MLC remains unchanged from the previously cleared OPTIFOCUS MLC (K031764).

The COHERENCE™ Workspaces:

The COHERENCE Therapist workspace includes a number of syngo™ based software applications who's indication for use include the viewing, processing, filming, and archiving of medical images. The COHERENCE Therapist Workspace also permits patient data management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording.

The Therapist Workspace in this release includes MVision™ which consists of the Megavoltage Cone Beam imaging method for acquiring 2D projection data that is reconstructed by the Cone Beam reconstruction method into 3D data for use by the Adaptive Targeting™ application for advanced treatment localization and patient positioning. Adaptive Targeting can also use 3D data imported from other devices. The indications for use for the COHERENCE Therapist workspace remains unchanged from the previously cleared COHERENCE Therapist workspace (K031764).

The ONCOR Expression is a medical linear accelerator based on the previously cleared ONCOR Avant-Garde (K031764) and PRIMUS (K993425) design architecture and includes as standard these features:

• New generation amorphous Silicon (aSi) flat panel electronic portal imaging device (EPID) . marketed as OPTIVUE 1000ST.
• . COHERENCE Therapist Workspace
• Release 2 software including MVision™ the Megavoltage Cone Beam Imaging Package . o Megavoltage Cone Beam acquisition
  • Megavoltage Cone Beam reconstruction
    • . MVCB Geometry Calibration
    • . 3D Image Phantom
  • o Adaptive TargetingTM
• . an 82 leaf multi-leaf collimator (MLC) marketed as OPTIFOCUS, and
• . the patient treatment couch; 550 TxT (K050422), or the ZXT (K910971),

The provided text is a 510(k) summary for the Siemens ONCOR Expression™ with COHERENCE™ Workspaces. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.

Therefore, many of the requested sections (e.g., specific acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study results, standalone study details, and training set information) are not explicitly present in the provided document. The document describes the device, its intended use, and claims substantial equivalence to predicate devices based on unchanged functionality and integration of previously cleared components.

However, I can extract the available information and state where information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document does not describe a new performance study with a distinct test set.
• Data Provenance: Not applicable, as no new performance study with a test set is described. The submission relies on the established performance of predicate devices and components.

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

• Number of Experts: Not applicable, as no new performance study with a test set requiring expert ground truth establishment is described.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as no new performance study with a test set is described.

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

• MRMC Study Done: No. The document does not describe an MRMC comparative effectiveness study.
• Effect Size of Human Reader Improvement with AI vs. without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: No. The document does not describe a standalone algorithm performance study. The device is a linear accelerator system with imaging and software components, not a standalone AI algorithm in the context typically described by these studies.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable. The submission does not describe a new study requiring the establishment of ground truth for performance evaluation of a novel algorithm. Instead, it relies on the established performance and intended use of its predicate devices and incorporated technologies.

8. Sample Size for the Training Set

• Sample Size: Not applicable. The document does not describe an AI/ML training process requiring a training set. The software components are described as "syngo based applications" and "previously cleared" modules, indicating established software rather than newly trained AI models.

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

• Ground Truth Establishment: Not applicable, as no training set for an AI/ML model is described.

Summary of Approach in the Document:

The provided 510(k) summary for the Siemens ONCOR Expression with COHERENCE Workspaces demonstrates substantial equivalence by showing that:

1. The device is a linear accelerator system based on previously cleared designs (ONCOR Avant-Garde K031764, PRIMUS K993425).
2. It incorporates an upgraded Electronic Portal Imaging Device (OPTIVUE 1000ST), but its intended use remains unchanged from the previously cleared OPTIVUE (K031764).
3. It includes an 82-leaf multi-leaf collimator (OPTIFOCUS) whose design, functionality, and intended use are unchanged from a previously cleared MLC (K031764).
4. The COHERENCE Therapist Workspace (K031764) now includes Release 2 software and a new MVision™ package. The MVision package utilizes:
   • A Megavoltage Cone Beam imaging method for acquiring 2D projection data, which serves the same purpose of patient positioning reference data as the previous EPID.
   • A 3D reconstruction software application that was previously cleared in the Siemens Siremobile Iso-C 3D C-Arm product (K040347), and its intended use remains unchanged.
   • An Adaptive Targeting application that enhances the utilization of patient position localization data, intended to improve treatment positioning accuracy.
5. The overall intended use of the ONCOR Expression with COHERENCE Workspaces remains unchanged from its predicate devices.

This type of 510(k) submission typically relies on demonstrating that the new device or system either has the same technological characteristics and intended use as a predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness. It often doesn't involve new clinical trials or performance studies with novel acceptance criteria and reported metrics in the way an innovative AI/ML device might.

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The X-LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The X-LEONARDO can be configured as a stand-alone diagnostic post-processing and reporting workstation.

The X-LEONARDO can be configured with a variety of syngo- or Windows -based software options which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques and OEM options

This Premarket Notification covers Siemens X-LEONARDO syngo-based multimodality workplace. syngo is a universal imaging platform based on Windows XP. The X-LEONARDO Workstation offers a comprehensive solution to view, optimize, and post-process diagnostic information and to aid the doctors in the evaluation of digital radiological examinations and patient information.

Due to special customer requirements based on the modality image type and the clinical focus, the X-LEONARDO Workstation can be configured with different combinations of clinical applications. syngo applications can be added to the X-LEONARDO multi-modality workplace either individually or as clinical focus packages.

The X-LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The X-LEONARDO can be configured with a variety of syngo- or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available OEM applications.

The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The submission, K042995 for the Siemens X-LEONARDO Workstation, is a 510(k) Premarket Notification. For this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a formal clinical study with performance metrics.

Instead, the submission focuses on:

• Device Description and Intended Use: Defining what the X-LEONARDO Workstation is and what it's used for (viewing, manipulation, communication, and storage of medical images and data).
• Technological Characteristics: Describing its software (syngo-based, Windows XP), DICOM compatibility, and how it's marketed (software-only or complete workstation).
• General Safety and Effectiveness Concerns: Mentioning risk management through risk analysis, software development, verification, and validation testing, and adherence to industry standards to minimize hazards.
• Substantial Equivalence: Explicitly stating that the X-LEONARDO Workstation is substantially equivalent to the LEONARDO Workstation (K040970) because it has the "same intended use and similar technical characteristics."

Therefore, I cannot populate the table or provide the requested study details as this information is not present in the given text. A 510(k) submission for a PACS workstation typically does not include detailed performance acceptance criteria or a comparative effectiveness study in the way an AI diagnostic device might. The "performance" is implicitly tied to its function as a viewing and processing workstation, and its substantial equivalence to a predicate device already on the market.

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The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The LEONARDO syngo Cardiology Workstation can be configured as a stand-alone diagnostic review and post-processing workstation with a variety of syngo or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

This premarket notification covers Siemens LEONARDO syngo Cardiology Workstation syngo is a universal imaging platform based on Windows XP. LEONARDO syngo Cardiology offers a comprehensive cardiology solution to view, optimize, post-process diagnostic information and aid the doctors in the evaluation of digital cardiological and radiological examinations and patient information.

Due to special customer requirements based on the modality image type and the clinical focus, the LEONARDO syngo Cardiology Workstation can be configured with different combinations of clinical applications. syngo applications can be added to the LEONARDO syngo Cardiology Workstation either individually or as clinical focus packages.

The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The LEONARDO syngo Cardiology Workstation can be configured with a variety of syngo- or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

The provided document (K042203 for Siemens LEONARDO syngo Cardiology) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than outright performance against specific acceptance criteria for a new device.

Therefore, the information typically found in an acceptance criteria study (like detailed performance metrics, sample sizes for test/training sets, expert qualifications, and specific ground truth methodologies) is largely absent in this type of submission. The primary "study" is the comparison to the predicate device.

Let's address each point based on the available information:

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

Since this is a substantial equivalence submission, there are no explicit quantitative "acceptance criteria" presented in the document itself with corresponding "reported device performance" in the way a de novo or PMA submission would have for a novel device.

The acceptance criteria for a 510(k) is generally that the new device has the same intended use and similar technical characteristics to a legally marketed predicate device, and does not raise new questions of safety and effectiveness.

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

This information is not provided in the 510(k) summary. A 510(k) for a workstation like this typically relies on predicate device equivalence and internal verification/validation, rather than a clinical "test set" in the sense of patient data used for performance comparison.

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)

This information is not provided in the 510(k) summary.

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

This information is not provided in the 510(k) summary.

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

An MRMC study was not mentioned or performed as part of this 510(k) submission. This device is a workstation for viewing and post-processing, not an AI-powered diagnostic aid that would directly impact human reader performance through assistance.

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

This device is described as a "medical diagnostic workstation" with various "software options" and "commercially available post-processing techniques" intended to "assist the physician." It is not an algorithm performing a standalone diagnostic function without human involvement. Therefore, a standalone algorithm-only performance study as typically understood for AI-based devices was not applicable or performed.

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

The document does not detail specific "ground truth" establishment methods because it's focused on workstation functionality and equivalence rather than a diagnostic algorithm's accuracy against a clinical truth. Any internal verification and validation would be against functional specifications and existing image data, but not typically characterized as "ground truth" in this context.

8. The sample size for the training set

This workstation does not appear to employ machine learning or AI in a way that would require a "training set" in the context of deep learning models. It primarily provides tools for physicians. Therefore, a training set as understood for AI development was not applicable or mentioned.

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

As there's no mention of a training set for machine learning, this information is not applicable.

In summary:

This 510(k) pertains to a medical workstation that provides tools for viewing and post-processing cardiological and radiological examinations. Its clearance is based on substantial equivalence to an existing predicate device (LEONARDO K040970), meaning it has the same intended use and similar technological characteristics without raising new questions of safety and effectiveness. The document does not contain the detailed performance study information typically associated with novel diagnostic algorithms or AI-driven devices that would have specific acceptance criteria, test/training sets, or ground truth methodologies for performance evaluation.

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