Search Results

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.

Ask a specific question about this device