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The intended use of the PRIMUS and ONCOR Avant-Garde linear accelerator systems is to deliver x-ray radiation for the therapeutic treatment of cancer.

The SIMTEC IM-MAXX, software application is an optional software accessory to these devices and is indicated where a specific method of treatment delivery, commercially marketed as Fast Intensity Modulated Radiation Therapy (FIMRT), is prescribed by a licensed medical oncologist.

The SIMTEC IM-MAXX 2 software option is intended to further enhance the speed of delivery of the Fast Intensity Modulated Radiation Therapy (FIMRT) treatment delivery technique. The indications for use of this accessory has remained unchanged as a result of the modification.

The SIMTEC IM-MAXX 2 Option (also called IM-MAXX 2) is to be used in conjunction with Siemens PRIMUS and ONCOR Avant-Garde Linear Accelerators and its accessories and provides a method of delivering Fast Intensity Modulated Radiation Therapy (FIMRT) by modifications and a modification of the serial communication and jaw movements of the Multi-Leaf Collimator between treatment delivery.

The SIMTEC IM-MAXX 2 software incorporates no new technological characteristics not currently in the predicate SIMTEC IM-MAXX (FIMRT) option.

The SIMTEC IM-MAXX 2 software consists of:

• (1) The original SIMTEC IM-MAXX technology, also referred to as Automatic Field Sequencing (AFS), where the software architecture and design had not been modified. The serial communication consists of the Siemens proprietary communication interfaces based on a Gbit Ethernet. In accordance to the desired delivery speed of the FIMRT treatment delivery technique, the Serial Communication had been modified in these areas:
  • a. DMIP -- The serial communication path between the planning systems and the control console based on the proprietary DMIP (Delivery Machine Interface Protocol).
  • b. MLCIP -- The serial communication path between the control console and the 82 Leaf MLC based on the proprietary MLCIP (MLC Interface Protocol).
• (2) The DMIP and MLCIP serial communications design specifications has been used in the previously cleared ONCOR Avant-Garde with COHERENCE workspace (K031764) Linear Accelerator systems.
• (3) Setup and delivery of the SIMTEC IM-MAXX 2 (FIMRT) (treatment option) in the COHERENCE™ Therapist workspace or the PRIMEVIEW 3i workspace has been the same as for the original SIMTEC IM-MAXX option. The only Record and Verify (V & R) systems have been the previously cleared i.e. COHERENCE Therapist workspace as part of the ONCOR Avant-Garde (K031764) and the PRIMEVIEW (aka Treatstation, K972275). The current to existing V & R has undergone minor, evolutionary changes to the original V & R and has remained unchanged in their intended use.
• (4) Fast Intensity Modulation Therapy (FIMRT) is a component of the PRIMEVIEW3i (for PRIMUS Systems) record and verify interface. See Figure 1 Block Diagram, Tab 4.
• (5) The safety and control mechanism of system interlocks to stop treatment when the SIMTEC IM-MAXX 2 remains unchanged as for the original. Only one minor addition, an interest message has been added.

The provided text is a 510(k) summary for the SIMTEC IM-MAXX 2 Option, a software accessory for linear accelerators used in radiation therapy. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested items (e.g., specific acceptance criteria, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, MRMC study details, and standalone performance) are not explicitly present in the provided document. The 510(k) process for this type of device typically relies on demonstrating that the new device does not introduce new technological characteristics or safety risks compared to existing, legally marketed predicate devices, rather than new clinical effectiveness studies.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices (K993425 PRIMUS Linear Accelerator and K031764 ONCOR Avant-Garde with COHERENCE Workspaces) by stating that the SIMTEC IM-MAXX 2 Option:

• "incorporates no new technological characteristics not currently in the predicate SIMTEC IM-MAXX (FIMRT) option."
• "does not introduce any new potential safety risks, has the same intended use, similar technical characteristics and is substantially equivalent to the predicate devices."
• "is intended to further enhance the speed of delivery of the Fast Intensity Modulated Radiation Therapy (FIMRT) treatment delivery technique."

The "reported device performance" is implicitly that it functions equivalently to the predicate devices, but with enhanced speed for FIMRT delivery. No quantitative metrics for this enhancement are provided in this summary.

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

This information is not provided in the document. As a software accessory claiming substantial equivalence based on no new technological characteristics and same intended use, a formal "test set" in the context of clinical performance evaluation (like for diagnostic AI) is not detailed. The evaluation described refers to internal verification and validation of the software.

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

This information is not provided. Given the nature of a 510(k) for a software accessory that enhances speed of a pre-existing treatment delivery technique, the "ground truth" would likely be established through engineering and software validation against design specifications, rather than a clinical expert-driven process to establish a diagnostic "gold standard."

4. Adjudication Method for the Test Set

This information is not provided.

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

No, an MRMC comparative effectiveness study is not mentioned or suggested by the document. This type of study is typically performed for diagnostic devices where human reader performance is compared with and without AI assistance in interpreting medical images. The SIMTEC IM-MAXX 2 is a treatment delivery system accessory, not a diagnostic imaging interpretation tool.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done

The document describes the SIMTEC IM-MAXX 2 as a "software application" and an "optional software accessory." The "testing" mentioned includes "code review, verification of requirements and validation of user needs," which indicates standalone testing of the software's functionality. However, specific performance metrics for this standalone performance (e.g., speed increase quantified) are not detailed in this summary. The device's function is "with human-in-the-loop" as it operates in conjunction with linear accelerators and is prescribed by a medical oncologist.

7. The Type of Ground Truth Used

The "ground truth" in this context would be the successful and accurate delivery of the planned radiation therapy, consistent with established quality and safety standards for such devices. This is established through a combination of:

• Design specifications and user requirements: The software must perform as designed.
• Verification and validation testing: Ensuring the software's functionality, safety, and compatibility with the hardware and existing treatment planning/record & verify systems.
• Risk analysis: Identifying and mitigating potential hazards.

It is not based on expert consensus for diagnosis, pathology, or outcomes data in the way a diagnostic AI would be.

8. The Sample Size for the Training Set

This information is not provided. This device is a software accessory for a radiation therapy system, not a machine learning model that learns from a large "training set" of patient data in the typical sense. Its development would involve software engineering principles rather than AI model training datasets.

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

This information is not provided. As mentioned above, the concept of a "training set" and "ground truth" for it, as typically applied to machine learning or AI models, does not directly apply to the information presented for this software accessory. The "ground truth" for its development would be adherence to engineering specifications, safety standards, and validated functionality.

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