Search Results

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.

Ask a specific question about this device

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