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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 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

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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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 contains software applications that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace is an option when third party OIS, Treatment Planning Systems and/or PACS devices conforming to the DICOM® Standard are intended to be used in conjunction with the Siemens branded Linear Accelerator system.

The syngo® Therapist Connect Workspace is an optional feature to the existing SIEMENS branded ARTISTE™ and ONCOR™ family of medical linear accelerator devices [LINAC]. The basic design, safety features and function of the LINAC control console and the linear accelerator treatment delivery, dosimetry, treatment recording and portal imaging subsystems remain unchanged.

The syngo® Therapist Connect Workspace differs from the predicate COHERENCE and syngo® Therapist Workspaces in that it does not contain a Oncology Information System (OIS) or Verify and Record (V&R) application such as PRIMEVIEW. These functions are located on the Third Party OIS system. The syngo® Therapist Connect Workspace receives the treatment plan from a Third Party OIS system or Third Party Treatment Planning System (TPS), supports the final review of the treatment parameters and enables the Radiation Therapist to initiate the delivery of the treatment prescription.

Upon completion of the treatment prescription, a report is submitted to the Third Party OIS or TPS system in the form of a DICOM RT Structured Report. All other features such as patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording that are supported by the predicate COHERENCE and syngo® Therapist Workspaces remain unchanged.

The provided text describes the "syngo® RT Therapist Connect Workspace" and its 510(k) submission to the FDA. However, it does not include detailed information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

The document primarily focuses on:

• Description of the Device: What it is, its purpose, and how it differs from predicate devices (it doesn't include a proprietary Verify & Record application, relying on third-party OIS).
• Intended Use and Indications for Use: Its role as an accessory to linear accelerator systems for radiation therapy.
• Safety and Effectiveness: General statements about risk management, adherence to industry standards, and the belief that it introduces no new safety risks and is substantially equivalent to predicate devices.
• Verification and Validation Testing: A very high-level statement that "Verification and Validation testing was performed to evaluate the performance and functionality of the syngo® RT Therapist Connect workspace software. This testing included software unit-level test, integration and system-level tests. The results demonstrate that the device satisfies all performance and functional requirements as stated in the Product Requirement Specifications."

Therefore, the specific information requested in your prompt (acceptance criteria table, detailed study information, sample sizes, expert qualifications, etc.) is not present in the provided text.

The text states that "The results demonstrate that the device satisfies all performance and functional requirements as stated in the Product Requirement Specifications," but it does not list these specifications or the raw performance results.

To answer your request based only on the provided text, I must state that this information is not available.

Here's what I can extract/infer from the text regarding your questions:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated. The document generically mentions "all performance and functional requirements as stated in the Product Requirement Specifications" but these specifications are not provided.
   • Reported Device Performance: No specific performance metrics (e.g., accuracy, speed, uptime) are reported in the provided text.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size (Test Set): Not mentioned.
   • Data Provenance: Not mentioned.

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):

   • Not mentioned. The device is a software workspace for managing radiation therapy, not typically one that requires expert-established ground truth in the way an AI diagnostic algorithm would.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not mentioned. Adjudication methods are typically relevant for diagnostic or image interpretation studies, which this is not.

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:

   • Not done, as this device is a workflow management system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The testing performed ("software unit-level test, integration and system-level tests") would be considered "standalone" in the sense that they evaluated the software's inherent functionality. However, the performance metrics are not given. The device itself is human-in-the-loop by design as it assists a Radiation Therapist.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable in the conventional sense for this type of device. "Ground truth" for this system would be conformance to its own "Product Requirement Specifications" and proper functionality of its features (patient selection/setup, positioning verification, treatment delivery/verification, recording, and DICOM interfacing). This is verified through software testing against those specifications.

8. The sample size for the training set:

   • Not applicable as this is not an AI/machine learning device that requires a training set. It is a software application designed to manage workflow.

9. How the ground truth for the training set was established:

   • Not applicable (see point 8).

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