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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) and precision stereotactic applications. The stereotactic applications may include single-session radiosurgery, fractionated stereotactic radiation therapy, or fractionated stereotactic intensity modulated radiation therapy for lesions, tumors and conditions anywhere in the head and body where radiation therapy is indicated.

The syngo® workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

The syngo® RT Therapist Connect Workspace v4.2, contains software applications that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace v4.2, can be interfaced with third party devices conforming to the DICOM Standard.

The syngo@RT Oncologist Workspace 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_VB50 Update to the ARTISTE family of medical linear accelerators is intend to update customers with optional new features and accessories for systems with the syngo® RT Therapist and RT Therapist Connect Workspaces (versions v4.1 or v4.2) for the ARTISTE systems. 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+ and v11.0+), the RT Therapist (v2.1a or v2.2) and Oncologist v2.0 workspaces.

The technological characteristics of the RT Therapist Connect Workspace v4.2 and Control Console 12 remain unchanged from the currently cleared product (K102671).

The syngo® Suite for Oncology Workspace 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 for the Siemens ARTISTE™ Solution with SYS_VB50 Update, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K103606) for the Siemens ARTISTE™ Solution with SYS_VB50 Update focuses on demonstrating substantial equivalence to predicate devices rather than providing specific, quantitative acceptance criteria and performance metrics for a novel claim.

Instead of a table with numerical acceptance criteria, the document states:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of clinical data used for performance evaluation, as this submission is primarily about software updates and feature additions for an existing device.

The "test set" for performance evaluation refers to production prototype devices and the testing was described as non-clinical test results which means it was not performed on human subjects.

• Sample Size for Test Set: Not explicitly stated as a number of devices/patients. The testing was performed on "production prototype devices."
• Data Provenance: Non-clinical (bench testing, system test level) rather than real-world patient data. The country of origin is Siemens Medical Solutions USA, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable/not stated. The ground truth for this type of non-clinical, software update validation is based on engineering specifications and adherence to design requirements, not expert clinical consensus on patient data.
• Qualifications of Experts: The testing was carried out by "appropriately trained and knowledgeable test personnel." No specific professional qualifications (e.g., radiologist, medical physicist) are mentioned for these personnel in the context of establishing ground truth, as they are validating the software's adherence to its design specifications.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is mentioned as this was non-clinical technical validation against pre-defined engineering requirements and acceptance criteria, not a clinical trial with ambiguous cases requiring expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technological characteristics and functional testing, not a direct comparison of human reader performance with and without AI assistance. This is a 510(k) for a software update to a radiation therapy system, not an AI-powered diagnostic device.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, in essence, standalone performance (algorithm only) was evaluated indirectly through the "Bench Testing" and "Non-Clinical Test Results" sections. These tests assess the software's functional performance against its requirements in an isolated manner, without direct human interaction as part of the core evaluation. The "algorithm" here refers to the software features and updates. The device itself (linear accelerator) operates with human-in-the-loop, but the validation of the software updates described here is akin to a standalone performance check against specifications.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Engineering Requirements Specifications (ERS), Sub-System Requirements Specifications (SSRS), and Risk Management Hazard keys: The software was tested to ensure it met these predefined technical and safety requirements.
• Test Plans: Acceptance criteria outlined in test plans served as the ground truth for software verification and validation.

This is a technical ground truth, not clinical ground truth derived from pathology, expert consensus on patient images, or patient outcomes data.

8. The Sample Size for the Training Set

• Not applicable/Not stated. This 510(k) pertains to a software update (SYS_VB50) for an existing medical linear accelerator system, not a de novo AI/ML algorithm that requires a "training set" in the context of machine learning model development. The software is likely deterministic and rule-based, or uses pre-defined algorithms, rather than being "trained" on data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not stated. As no training set for an AI/ML model is indicated, there is no discussion of how ground truth for such a set would be established. The "ground truth" for the device's technical functionality, as mentioned in point 7, is established through engineering design and safety specifications.

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