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The intended use of Puma is to allow the radiation therapist to deliver treatment to the patient via linear accelerator (linac). This entails selection of the patient, selection of the day's correct treatment for the patient, set up, and delivery of the treatment fields and recording of the treatment. Puma supports auto-sequencing, a process of automatically downloading a group of fields or segments from the record and verify system to the control of the linear accelerator sequentially, without user intervention. In addition, Puma also supports IMRT (Intensity Modulated Radiation Therapy), a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

Puma is a medical device, which allows the user to deliver radiation treatment on linear accelerator to a patient. The software has been developed to be a record and verify system that also manages oncology medical information in order to simplify the oncologist administrative tasks and to optimize the quality of patient treatment. It is a Windows® based system, which uses a single database that can be accessed by any Puma client station in the treatment facility. Additionally, Puma is capable of performing such functions as:

• Importing treatment plans in DICOM or RTP format -
• Downloading of beams contained in the treatment plans to the linear accelerator -
• Verifying that the beams from the treatment plan are correctly set up on the linear accelerator -
• Recording treatments delivered by the linear accelerator ・
• Managing patient schedules -
• Managing schedules for resources such as treatment machines and personnel -
• Maintaining a central repository of treatment plans and records -

Here's an analysis of the provided text regarding the acceptance criteria and study for the Prowess Puma device:

The provided text (K100801 for the Puma device) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through extensive clinical trials. As such, the information on specific acceptance criteria and detailed study results, particularly for standalone performance or comparative effectiveness with human readers, is limited.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria or performance metrics in a table format. Instead, it relies on general statements of meeting specifications and being "as safe and effective" as predicate devices.

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

• Sample Size for Test Set: The document mentions "real patient cases" were used during beta testing at Auburn University, but does not specify the sample size (number of cases or patients) for this test set.
• Data Provenance: The beta testing was conducted at "Auburn University," which is in the USA. The data was from "real patient cases" and was likely retrospective as it refers to "clinical cases" used for testing a developed device.

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

• Number of Experts: The document states "medical physicists/dosimetrists at Auburn University" conducted functional testing and "clinical physicists contracted by Prowess" verified risk mitigation. It does not provide an explicit number of experts.
• Qualifications of Experts: "Medical physicists/dosimetrists" and "clinical physicists" are mentioned. No specific experience levels (e.g., "10 years of experience") are provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The testing involved "medical physicists/dosimetrists" and "clinical physicists" validating the system, implying their professional judgment served as the benchmark, but the process for resolving disagreements is not detailed.

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, an MRMC comparative effectiveness study involving human readers assisting with or without AI was not conducted or described.
• Effect Size: Therefore, no effect size for human reader improvement with AI assistance is reported. The Puma device is a record and verify system, not primarily an AI-driven diagnostic or interpretative tool designed to "assist human readers" in the typical sense of AI-enabled image analysis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: The non-clinical tests involved "Verification and validation of the software... Functional testing was conducted both in-house and by medical physicists/dosimetrists." This implies extensive standalone (algorithm only) testing against predetermined specifications. The core function of Puma is as a "record and verify system" that automates certain processes (like auto-sequencing), meaning its performance inherently relies on the algorithm operating correctly without continuous human intervention during those automated steps. The clinical physicist/dosimetrist involvement was to validate these functions.

7. The Type of Ground Truth Used

The ground truth for the testing appears to be based on:

• Predetermined Specifications: The software "has met its predetermined specifications."
• Expert Consensus/Clinical Judgment: Functional testing by "medical physicists/dosimetrists" and verification by "clinical physicists" against "real patient cases" implies that the correct operation and output were judged against established clinical practice and expert knowledge in radiation therapy planning and delivery.
• Comparison to Predicate Devices: The overall goal was to demonstrate substantial equivalence, meaning the device's performance aligned with that of legally marketed, safe, and effective predicate devices.

8. The Sample Size for the Training Set

The document does not specify any sample size for a training set. As a record and verify system, especially one cleared in 2010, it's highly unlikely that it relied on machine learning models requiring large "training sets" in the modern AI sense. Its development would have followed traditional software engineering and validation processes against designed specifications.

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

As no training set is described (due to the nature of the device and the development era), the method for establishing its ground truth is not applicable/not provided.

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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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The intended use of the ONCOR Avant-Garde linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. The ONCOR Avant-Garde includes an Electronic Portal Imaging Device (EPID) that will be marketed as OPTIVUE and is used for the verification of the treatment field and shielding blocks in relation to patient positioning markers and/or anatomical landmarks in radiotherapy treatment. OPTIVUE will also allow for verification of the exit dose in radiotherapy treatment. Additionally, the ONCOR Avant-Garde includes an 82 leaf multi-leaf collimator that will be marketed as OPTIFOCUS. The OPTIFOCUS MLC is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.

The COHERENCE Workspaces (Therapist and Oncologist) encompasses a number of syngo software applications for viewing, processing, filming, and archiving of medical images. The COHERENCE Therapist and Oncologist Workspaces are two of the software applications that are offered on the syngo workstation (K010938). COHERENCE Therapist Workspace is included in the ONCOR Avant-Garde product. The Therapist Workspace permits patient data management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording.

The COHERENCE Oncologist Workspace permits localization, contouring, image conditioning, and review of treatment parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

The ONCOR Avant-Garde is a medical linear accelerator based on the previously cleared PRIMUS design architecture (K993425) and includes an amorphous Silicon (aSi) flat panel electronic portal imaging device (EPID), an 82 leaf multi-leaf collimator (MLC), and COHERENCE Therapist Workspace software.

The aSi flat panel (marketed as OPTIVUE) is integrated into the ONCOR Avant-Garde system and aids in positioning verification by visualizing patient positioning markers and/or anatomical references. The flat panel detects radiation from the linear accelerator, this information is then interpreted via software to obtain visualization of patient positioning markers and/or anatomical structures. The OPTIVUE flat panel detector is a digital x-ray camera comprised of sensors. These sensors are amorphous Silicon (aSi) photo diodes that are placed on a glass substrate with scintillator coating. The incident x-rays are converted by the scintillator screen. The converted x-ray signals are then amplified and converted to a digital format. This digital formatted data is then transmitted to the data acquisition unit or frame grabber and interpreted into positioning images. The OPTIVUE includes automated deployment of the flat panel that eliminates the need to enter the treatment room to acquire portal images, thus improving the efficiency of patient treatments.

The 82 leaf multi-leaf collimator (marketed as OPTIFOCUS) is integrated into the ONCOR Avant-Garde system and allows for user definable optimization of resolution for target conformation. The OPTIFOCUS is based on the same architectural design as the previously cleared 58 leaf MLC (K953894). The increase in the number of leaves in the collimator allows for increased conformal shape resolution.

The COHERENCE Workspace software is based on the architecture of the previously cleared syngo software (K010938) and allows for a standard graphical user interface across Siemens medical products.

The COHERENCE Therapist Workspace software integrates the linear accelerator processes of setup. setup verification, patient positioning verification, treatment delivery, and recording. The COHERENCE Therapist Workspace provides a simple interface for 2D. 3D. and volumetric targeting of the radiation treatment. Patient management is facilitated by easy access to all pertinent patient data with the integration of previously cleared functionality. The Therapist Workspace integrates various functions from previously cleared products (ie. VSIM marketed as COHERENCE Dosimetrist (K022036), syngo Workstation (K010938), and LANTIS Treatstation marketed as PRIMEVIEW (K972275).

The COHERENCE Oncologist Workspace software is an option for the ONCOR Avant-Garde linear accelerator and provides access to patient data, images, and tools needed to help facilitate the Oncologist in performing accurate and timely clinical decisions. Multi-modality images can be loaded and manipulated with the advanced tools allowing for efficient localization and contouring of tumors and critical anatomical structures. The COHERENCE Oncologist Workspace provides access to all radiation therapy plans, visualization of suggested alternate plans, and comparisons with prior treatment plan data. In addition, it provides for treatment verification of patients with access to pertinent treatment data allowing for full treatment review. The COHERENCE Oncologist Workspace is based on the previously cleared syngo architecture (K010938). The COHERENCE Oncologist Workspace is also based on functionality cleared under VSIM via K022036 and permits localization, contouring, image conditioning, and review of treatment parameters. In addition, there are tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

The OPTIVUE, OPTIFOCUS, and COHERENCE Therapist Workspace, may also be available as individual purchased options to existing Siemens medical linear accelerators.

This document, K031764, is a 510(k) summary for the ONCOR Avant-Garde with COHERENCE Workspaces. It is primarily a filing for substantial equivalence to predicate devices, meaning it aims to show it's as safe and effective as existing, legally marketed devices. As such, it does not contain the detailed acceptance criteria and study data typical for a device proving novel performance or efficacy.

The document focuses on describing the device, its intended use, and identifying predicate devices it is substantially equivalent to. It explicitly states the intended uses remain unchanged from the predicate devices. This type of submission relies on the prior approval of the predicate devices rather than new, extensive performance studies for novel claims.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and comparative effectiveness studies are not present in this 510(k) summary because they are not required for a substantial equivalence determination to this extent.

However, I can extract the information that is present and explain why other information is absent.

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission, explicit quantitative acceptance criteria for new performance claims are not provided. Instead, the "acceptance criteria" can be inferred as demonstration that the device's components perform similarly or identically to their predicate devices. The "reported device performance" is essentially the device functioning as intended, mirroring the predicate's performance.

The submission emphasizes that the intended uses for all components (ONCOR Avant-Garde, OPTIVUE, OPTIFOCUS, COHERENCE Workspaces) remain unchanged from their respective predicate devices. This forms the basis of the substantial equivalence claim.

Specific Study Information (Not Present in this 510(k) Summary)

The following information is not provided in the given 510(k) summary, as it describes a substantial equivalence claim based on predicate devices, rather than a de novo submission or a claim of new performance.

• Sample size used for the test set and the data provenance: Not provided. Performance testing would have been done to ensure safety and functionality, but details about specific image or patient datasets for a "test set" demonstrating performance metrics are not included. Data provenance (country, retrospective/prospective) is also not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. This type of information is relevant for studies validating diagnostic or interpretive AI, which is not the primary focus of this submission, though the software aids these processes.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
• 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 provided. This type of study would be highly relevant for AI-assisted diagnostic devices, but this submission focuses on the safety and foundational functionality of radiation therapy equipment and software tools, not a primary diagnostic AI. The software "aids in the diagnosis, staging, and prescription" but is not explicitly making diagnostic claims that would require an MRMC study here.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. Given the nature of the device (radiation therapy system and associated software), human clinicians are always in the loop.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly provided for new studies. For devices claiming substantial equivalence, the "ground truth" for ensuring safety and effectiveness relies on the established performance and safety of the predicate devices.
• The sample size for the training set: Not applicable and not provided. This device is not presenting a novel AI model that requires a specific training set in the context of this 510(k). The software (COHERENCE Workspaces) is based on existing, cleared software architectures (syngo, VSIM, LANTIS).
• How the ground truth for the training set was established: Not applicable and not provided.

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