(156 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 and 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, turnors 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 position, treatment delivery/verification. and treatment recording.
The syngo® RT Therapist Workspace v4.3.1, can be interfaced with third party devices conforming to the DICOM Standard.
The syngo® RT Therapist Workspace v4.3.1 release is intended to update customers with the currently released syngo® RT Therapist Workspace software with version v4.3 for ARTISTE, ONCOR & PRIMUS Linear Accelerator systems. The technological characteristics and the fundamental technology of the syngo® RT Therapist Workspace v4.3.1 remain unchanged from the currently cleared products.
The syngo® RT Therapist software utilizes the proprietary syngo® software architecture design that provides a method of delivering customized software applications based on the modality as clinically supporting packages. SIEMENS utilizes, as part of the Oncology clinical focus package, multiple syngo® software applications for patient set-up and position verification, treatment localization, treatment verification, portal imaging as well as data processing, image reformatting, display and printing. The currently cleared syngo® based software products also includes an array of image-oriented software tools, support for DICOM connectivity, Siemens Remote Service [SRS], and virus protection features.
The provided document K132935 describes the syngo® RT Therapist Workspace, v4.3.1. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the typical sense of performance metrics (like accuracy, sensitivity, specificity) for an AI/ML device.
This 510(k) submission is for an update to existing software that is a component of a medical linear accelerator system. The primary focus of the submission is to demonstrate substantial equivalence to previously cleared predicate devices and to show that the update does not introduce new safety risks or change the fundamental technological characteristics or intended use. The testing described is primarily focused on software verification, validation, and regression testing to ensure functionality and safety.
Therefore, many of the requested data points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used for performance validation, and training set details, are not applicable or not present in this type of 510(k) submission for a software update to a control system.
Here's a breakdown of the information that is available or can be inferred, and where the requested information is absent:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from submission) | Reported Device Performance and Study Findings (from submission) |
|---|---|
| Functional Requirements: The syngo® RT Therapist Workspace, v4.3.1 (with Control Console 13) must perform its intended functions for patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. | Bench Testing Results: |
- Unit, Integration, and System Integration testing performed to evaluate performance and functionality.
- All testable requirements in System Requirements Specifications (SRS) and Component Requirements (CRS) for Sys_VC10C project, and specific requirements for third-party OIS implementation, were successfully verified and traced.
- Software verification and regression testing performed successfully to meet "previously determined acceptance criteria as stated in the Test Concept."
Non-Clinical Test Results:
- Validation of syngo® RT Therapist Workspace v4.3.1, optional third-party OIS implementation, and regression testing with Control Consoles 13 performed at the System test level.
- System level validation and regression testing "performed successfully, demonstrating that the software meets the acceptance criteria as noted in the system test plans." |
| Safety: The update should not introduce any new potential safety risks. | Summary Statement: "In summary, it is SIEMENS' opinion that the syngo® RT Therapist Workspace update to v4.3.1 including the optional 3rd party OIS Connectivity system (ARIA OIS), does not introduce any new potential safety risks and is substantially equivalent to, and performs as well [as predicate devices]." |
| Compatibility/Interoperability: Interface with third-party devices conforming to the DICOM Standard and with specific OIS/V&R systems (ARIA, Varian Treatment, MOSAIQ, Sequencer). | Description: Explicitly states the device "can be interfaced with third party devices conforming to the DICOM Standard." The update directly addresses compatibility with specific OIS/V&R systems (e.g., ARIA, Varian Treatment). The validation activities would indirectly confirm this. |
| Compliance with Standards: Meet requirements for conformity to multiple industry standards. | Testing to Consensus Standards: "The syngo® RT Therapist Workspace v4.3.1 and the Control Console 13 supporting the third party OIS and V&R implementation have been tested to meet the requirements for conformity (where applicable) to multiple industry standards." (Details referred to Sections 9 and 17, which are not provided in the extracted text). |
| Substantial Equivalence: Maintain the same intended use and fundamental scientific and technical characteristics as predicate devices. | Substantial Equivalence Comparison: Claimed throughout the document. The general tone and purpose of a 510(k) is to demonstrate this. The FDA's clearance letter confirms their agreement with this claim. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The testing described is software verification and validation, not a clinical study on patient data. It's likely related to testing various software functionalities and integrations.
- Data Provenance: Not applicable, as it's not a data-driven AI/ML study.
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):
- Number of Experts/Qualifications: Not specified. This type of information is usually relevant for performance studies on diagnostic or therapeutic output, not for a software control system update focused on functionality and safety. The "ground truth" here is the correct functioning of the software according to its specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified and likely not applicable in this context. Software validation typically involves pass/fail criteria for specific test cases determined by engineering specifications.
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:
- MRMC Study: No. This is not an AI/ML device in the sense of providing diagnostic or interpretive outputs to human readers. It's a control system component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of an AI/ML diagnostic or therapeutic algorithm. The software performs its functions as part of a larger medical device system. The "System level validation" described is essentially the standalone performance of the software component within its intended environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: The "ground truth" for this type of software update is its adherence to engineering specifications, functional requirements, and safety standards. This is established through structured software verification and validation processes, not clinical reference standards like pathology or expert consensus on medical images.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is not described as an AI/ML system that learns from a training set of data. It's a deterministic software program.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no described training set.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.