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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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