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510(k) Data Aggregation
(26 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 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, is an additional option when third party OIS, Treatment Planning Systems and/or PACS devices are intended to be used in conjunction with the Siemens branded Linear Accelerator system. The syngo® RT Therapist Connect Workspace, v4.2 is a software application that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace can be interfaced with third party devices conforming to the DICOM Standard.
The addition of the syngo® RT Therapist Connect Workspace, v4.2, does not change the intended use of the Siemens branded Linear Accelerator System.
The syngo® RT Therapist Connect Workspace v4.2 release is intend to update customers with the syngo® RT Therapist Connect Workspace with versions v4.1 (ARTISTE systems) and v2.1a (ONCOR / PRIMUS systems). The technological characteristics of the syngo® RT Therapist Connect Workspace v4.2 remain unchanged from the currently cleared product.
The syngo® RT Therapist Connect 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 synqo® products also include an array of image-oriented software tools, support for DICOM connectivity and Siemens Remote Service.
This Siemens product, syngo® RT Therapist Connect Workspace, v4.2, is a software update for an existing medical device, not a new AI-based diagnostic tool. The document describes a traditional software update verification and validation process, not a clinical study to evaluate device performance against specific acceptance criteria in terms of accuracy, sensitivity, or specificity.
Therefore, many of the requested elements (like sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for training/testing) are not applicable in the context of this submission. The "acceptance criteria" here refer to successful completion of software testing against defined requirements, not clinical performance metrics.
Here's a breakdown of the available and relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested for) | Reported Device Performance (Outcome) |
|---|---|
| All testable requirements in the Software Requirements Specifications (SRS), Sub-System Requirements Specifications (SSRS), and Functional Specifications (FS) for the Control Console software and Function Controller firmware. | Successfully verified and traced in accordance with the Siemens product development (lifecycle) process (PDP). All testable requirements met. |
| Software verification and regression testing. | Performed successfully to meet their previously determined acceptance criteria as stated in the Test Plans. |
| System level validation and regression testing (on production prototype devices). | Performed successfully, demonstrating that the software meets the acceptance criteria as noted in the system test plans. |
| Conformity to relevant consensus standards: IEC 60601-1-4:1996+ A1: 1999 (Medical Electrical Equipment: Part 1-4: Collateral Standard: Programmable Electrical Medical Systems) and IEC 62304:2006 (Medical Device Software -- Software Life Cycle Processes). | Tested to meet the requirements for conformity (where applicable) to these standards. |
| No new potential safety risks introduced by the update. | Belief that the update does not introduce any new potential safety risks and performs as well as predicate devices. |
| Substantial equivalence to predicate devices (syngo® RT Therapist Connect Workspace, v4.1 and v2.1a (K090683); Control Consoles for ARTISTE (K072485) and ONCOR (K060226)). | Supported by verification testing, validation of intended use, and regression testing. FDA determined the device is substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of a clinical test set. The document refers to "testable requirements" and "system test plans," which would involve software modules and system functionalities, not medical images or patient data in a statistical sample.
- Data Provenance: Not applicable. This refers to software verification and validation, not analysis of medical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth for a clinical diagnosis or measurement is not relevant to a software update’s functional and performance testing.
- Qualifications of Experts: The testing was performed by "appropriately trained and knowledgeable test personnel." Their specific qualifications are not detailed beyond this.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This type of formal adjudication process is not used for software functional and performance testing.
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 a software update for a radiation therapy system, not an AI-assisted diagnostic device. The functionality described (patient selection/setup, positioning verification, treatment delivery/verification, recording) is primarily for operational support in a radiation therapy workflow.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not explicitly discussed in terms of an "algorithm only" performance study. The testing described is against software requirements and system functionality, which implicitly assesses the algorithm's performance within the system context. The device itself is a software application designed to be used in conjunction with linear accelerator systems, implying human interaction.
7. The type of ground truth used
- Type of Ground Truth: For this type of software update, the "ground truth" would be the defined and documented software requirements (SRS, SSRS, FS) and expected system behaviors. Successful completion of tests against these requirements indicates that the software performs as specified.
8. The sample size for the training set
- Sample Size: Not applicable. This is a software update, not a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable. This device does not involve a training set as it's not an AI/ML model being developed.
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