Search Results
Found 1 results
510(k) Data Aggregation
(84 days)
The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
The linear accelerator systems are high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), modulated arc therapy (mARC) and precision stereotactic radiation therapy for lesions, tumors and conditions anywhere in the head and body where radiation therapy is indicated.
The syngo® RT Therapist Workspace is a component of the linear accelerator system and is based on the syngo® architecture. The syngo® RT Therapist workspace contains software applications to support patient selection/setup. patient positioning verification. treatment delivery/verification, and treatment recording.
The syngo® RT Oncologist Workspace is an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
The syngo@ RT Therapist and the syngo@ RT Oncologist Workspaces v4.3.1 MR1, can be interfaced with third party OIS, V&R, TPS, and PACS devices conforming to the DICOM Standard.
The project Sys_VC10C, Phase 2 software update for the ARTISTE™ Solution linear accelerator system with Control Console v13.0.301 with the syngo® RT Therapist Workspace v4.3.1 MR1 release is intended to update customers with the currently cleared and released syngo® RT Therapist Workspace software with versions v4.1, v4.2, v4.3 or v4.3.1 for ARTISTE, and is backwards compatible with the ONCOR & PRIMUS Linear Accelerator systems with the COHERENCE RT Therapist v2.3. The currently cleared syngo® RT Therapist workspace software v4.3.1 supports Siemens branded and third party OIS, V&R, TPS, and PACS systems.
Additionally, the Phase 2 software update includes software modifications and defect fixes for the syngo® RT Oncologist workspace. The Oncologist software is developed on the same syngo® software code platform as the RT Therapist and the workspace differentiation is license key controlled for clinically focused workspace options. The syngo® RT Oncologist workspace is considered a medical device in its own right had has multiple previous FDA 510(k) clearances.
Note: Several syngo® clinical modules are considered medical devices in their own right and may have separate clearances. For example, the syngo® VSim module, v2.7 received FDA clearance under K101119 and is licensed on several syngo® workspaces for different modalities. The syngo® RT Oncologist Workspace has hosted this module under multiple clearances with the latest being the current predicate, K121295.
These previous software versions can be directly migrated to the current release (syngo® RTT/ONC v4.3.1 MR1) and Control Console v13.0.301. The ARTISTE Solution with VC10C. Phase 1 and the syngo® RT Therapist v4.3.1 cleared under K132935 serves as a predicate in this submission.
The syngo® RT Oncologist workspace is an optional system for Siemens Linac customers. The syngo® RT Oncologist also hosts software based products such as the VSim v2.7 feature [VSIM] and other oncology based features. The syngo® RT Oncologist workspace v4.3 was previously cleared under K121295 which serves as a predicate in this submission.
The technological characteristics and the fundamental technology of the LINAC Control Console and the syngo® RT Therapist Workspace v4.3.1 MR1 and the syngo® RT Oncologist Workspace v4.3.1 MR1 (including the syngo® VSim module) remain unchanged from the currently cleared products. This is a software update only. The materials of use remain unchanged from the predicate devices.
The provided text describes a 510(k) premarket notification for a software update to a medical device, specifically the Siemens ARTISTE Solution. The document contains information about acceptance criteria and how the device meets them through verification and validation activities.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Performance & Functionality | All testable requirements in the System Requirements Specifications (SRS), Sub-system Requirements Specifications (SSRS), and Component Requirements (CRS) for Sys VC10C project, Phase 2, and specific requirements for third-party OIS implementation have been successfully verified and traced. Software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the Test Concept. |
| System Level Validation (Clinical Workflow) | Validation of the syngo® RT Therapist Workspace v4.3.1 MR1, the syngo® RT Oncologist Workspace v4.3.1 MR1 with hosting of optional third-party OIS, and regression testing with Control Consoles 13.0.301 has been performed at the System test level on production prototype devices. System level validation and regression testing has been performed successfully, demonstrating that the software meets the acceptance criteria as noted in the system test plans. |
| Risk Management & Safety | Risk management is ensured via a risk analysis, identifying potential hazards and mitigations. These hazards are controlled by software means, user instructions, verification of requirements, and validation of clinical workflow. The update does not introduce any new potential safety risks. |
| Compliance to Industry Standards | The software update and Control Console have been tested (as needed) to meet the requirements for conformity (where applicable) to multiple industry standards. The R&D evaluation of relevant testing to consensus standards is documented. |
| Substantial Equivalence (to Predicate Devices) | The verification testing to system requirements, validation of intended use, and regression testing to existing functional requirements, support the claim of substantial equivalence to previously cleared predicate devices (K121295 and K132935). The update has the same intended use, indications for use, and fundamental scientific technical characteristics as the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "production prototype devices" were used for system-level validation and regression testing. However, it does not specify the sample size for the test set (e.g., number of cases, number of devices tested).
Regarding data provenance, the document does not provide information on the country of origin of the data or whether the testing was retrospective or prospective. It focuses on in-house engineering and system-level validation.
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)
The document mentions that validation was performed by "appropriately trained and knowledgeable test personnel." However, it does not specify the number of experts used to establish ground truth or their specific qualifications (e.g., radiologists, oncologists with specific years of experience).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set. The validation appears to be based on successful completion of predefined test criteria by test personnel.
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
The document does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study nor any AI assistance to human readers. This submission is for a software update to a linear accelerator system and related workspaces, focusing on functionality, safety, and equivalence to predicate devices, not on AI-driven diagnostic or interpretative performance by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a linear accelerator system and its associated software workspaces for radiation therapy planning and delivery. The testing described (unit, integration, system integration, and system-level validation) assesses the performance of the software and system components. While this is "algorithm only" in the sense that it's testing the software's inherent function, it's not a standalone diagnostic algorithm being evaluated for sensitivity/specificity in a clinical context. It's the performance of the tools that support human operators in delivering radiation therapy. The document does not present metrics typical of standalone diagnostic algorithm performance (e.g., AUC, sensitivity, specificity).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the verification and validation activities appears to be based on pre-defined system requirements, specifications, and established acceptance criteria as outlined in the "Test Concept" and "system test plans." This does not involve clinical ground truth like pathology or outcomes data, as the device is not an AI diagnostic tool but a control and planning system for radiation therapy.
8. The sample size for the training set
The document does not mention a training set as this is a software update for a medical device control and planning system, not a machine learning or AI algorithm submission that typically requires training data.
9. How the ground truth for the training set was established
As no training set is mentioned or implied, the document does not describe how ground truth for a training set was established.
Ask a specific question about this device
Page 1 of 1