(58 days)
The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUSTM 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® workspaces includes a number of syngo® based, clinically focused advanced software applications that include patient data management, remote user communication within a local network, and the viewing, processing, manipulation, filming, and archiving of medical images.
The syngo® RT Therapist Workspace v4.3, contains software applications that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Workspace v4.3, can be interfaced with third party devices conforming to the DICOM Standard.
The syngo® RT Oncologist Workspace v4.3 permits localization, contouring, segmentation, image calibration, and review of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and . prescription of radiation therapy.
The ARTISTE™ Solution SYS_VC10 is a software update to the ARTISTE family of medical linear accelerators and is intend to update customers with optional new fcatures for systems with the syngo® RT Therapist, v4.1 and RT Therapist Connect v4.2 Workspaces for the currently cleared ARTISTE systems. Additionally, the SYS VC10 software update also includes an (optional) software update for the syngo® RT Oncologist v4.2 workspace. The SYS VC10 update will bring the syngo® RT Therapist and the syngo® RT Oncologist workspaces to version 4.3.
This update is intended to be backwards compatible to the currently cleared ONCOR and PRIMUS family of medical linear accelerators and their Control Consoles (v9.0+ & v11.0. v12), the RT Therapist (v2.1a or v2.2+) and Oncologist v2.0 & v2.4 workspaces. These older versions can be migrated up to the current release (RTT / ONC. v4.3) and Control Console 13.
The technological characteristics and fundamental technology of the ARTISTE™ Solution remain unchanged from the currently cleared device (K103606).
The syngo® Suite for Oncology Workspace clinically focused software utilizes the proprietary syngo® software architecture design provides a method of delivering customized software applications based on the modality as clinically supporting packages. From these applications SIEMENS utilizes, as part of the Oncology clinical focus package, multiple 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 COHERENCE™ and syngo® products also include an array of image-oriented software tools, support for DICOM connectivity and the Siemens Remote Service option.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not present a table of specific numerical acceptance criteria with corresponding reported device performance metrics. Instead, it describes general categories of testing and conformity:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance and functionality of new features and software updates (bench verification testing). | "All testable requirements have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process (PDP)." |
| "The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the Test Plans." | |
| Meeting acceptance criteria for system-level validation and regression testing. | "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 and the Software Product Quality Management Plan (SwPQMP)." |
| Conformity to relevant industry standards. | "The Siemens branded Linear Accelerators with the new features have been tested to meet the requirements for conformity (where applicable) to multiple industry standards." |
| Not introducing new potential safety risks. | "In summary, it is SIEMENS' opinion that the ARTISTE with the Sys VC10 update does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as the predicate devices." |
| Substantial equivalence to predicate devices for new features and functional requirements. | "The successful verification and validation testing to the meet the new software features and device requirements of the syngo® RT Therapist and syngo® RT Oncologist workspaces software v4.3, in addition to the updated ARTISTE™ Solution Linear Accelerator functional requirements, is intended to support the claim of substantial equivalence to the currently cleared predicates as indicated above." |
| "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (FDA's conclusion) | |
| Ensuring safe and effective use (via labeling and risk management). | "The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards, SIEMENS adheres to recognized and established industry practice and relevant international standards." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of patient cases or specific data points. The testing mentioned (Unit, Integration, Sub-System Integration, System Integration, System Test, Validation, Regression) suggests a thorough testing process for the software updates and new features, but doesn't quantify a "test set" in the context of clinical data.
- Data Provenance: Not specified. Given that the testing is described as "bench verification testing" and validation "at the System test (ST) level on production prototype devices," it implies internal Siemens testing rather than external clinical data from specific countries or retrospective/prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The validation was performed by "appropriately trained and knowledgeable test personnel." No further details on their specific medical or technical qualifications are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The reported testing methodology focuses on software and system functionality rather than independent expert review of clinical results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. The document describes verification and validation testing of software updates and new features for a radiation therapy system, not a comparative effectiveness study involving human readers with and without AI assistance.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. Standalone Performance Study
- Standalone Study Done?: Yes, in a sense. The described "bench verification testing" (Unit, Integration, Sub-System Integration, System Integration) and "System level validation and regression testing" are essentially standalone tests of the algorithm/software's functionality and performance against predefined requirements and acceptance criteria, without human-in-the-loop performance being the primary focus of these tests. However, it's not "standalone" in the clinical diagnostic AI sense, but rather "standalone software/system functioning."
7. Type of Ground Truth Used
The "ground truth" for the various stages of testing appears to be:
- Pre-determined acceptance criteria/Test Plans: For Unit, Integration, Sub-System Integration, System Integration, and Software Verification/Regression testing, the ground truth is whether the software adheres to its specified requirements.
- System test plans and Software Product Quality Management Plan (SwPQMP): For system-level validation.
- Recognized and established industry practice and relevant international standards: For addressing electrical, mechanical, and radiation hazards.
- Predicate device characteristics: For establishing substantial equivalence.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The document describes updates to an existing medical device's software, not the development or training of a new AI model using a separate training dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no mention of a training set for an AI model.
§ 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.