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Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle3 Radiation Therapy Planning System incorporates a number of fully integrated subsystems, including Pinnacle3 Proton, which supports proton therapy planning. The full Pinnacle Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy techniques.

Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. Plans generated using this system is used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

Pinnacle3® Radiation Therapy Planning System (hereafter Pinnacle3 RTP) provides radiation treatment planning for the treatment of benign or malignant diseases. When using Pinnacle " RTP, qualified medical personnel may generate, review, verify, approve, print and export the radiation therapy plan prior to patient treatment. Pinnacle RTP can provide plans for various radiation therapy modalities including, utilizing photon, proton, electron and brachytherapy techniques Stereotactic Radiosurgery, and Brachytherapy.

The Proton module builds on the Pinnacle Photon Treatment Planning Solution. A substantial part of the software architecture, display, connectivity and planning tools are transferable or extensible to the Proton Treatment Planning module. Using Pinnacle® RTP as the base-line architecture will address the needs of operating and future treatment centers to seamlessly integrate photon with proton treatment planning.

Pinnacle® RTP is a software package that runs on a Oracle Server and accessed through one or more clients, or an Oracle UNIX workstation and consists of a core software module (Pinnacle') and optional software features (the Proton module requires the Oracle server and cannot be run on a workstation). These optional software features, commonly referred to as "plug-ins", are typically distributed separate from the core software product (separate CD or DVD). The device has network capability to other Pinnacle® RTP workstations, thin client, and to both input and output devices via local area network (LAN) or wide area network (WAN).

Image data is imported from CT, MR, PET, PET-CT and SPECT devices using a DICOM-compliant interface. A qualified medical professional uses the Pinnacle® RTP for functions such as viewing and analyzing the patient's anatomy, and generating a radiation therapy plan.

This 510(k) submission for the Philips Medical Systems (Cleveland), Inc. Pinnacle3 Radiation Therapy Planning System (Pinnacle3 RTP) primarily focuses on demonstrating substantial equivalence to a predicate device, the Computerized Medical Systems, Inc. Xio RTP System - Proton Spot Scanning (K102216), rather than detailing specific acceptance criteria and a study to prove they are met in a quantitative manner. Regulatory submissions for radiation therapy planning systems often rely on verification and validation activities to ensure the software performs as intended and is safe and effective when compared to a legally marketed predicate device.

However, based on the provided text, here's a breakdown of the information requested, with indications where details are not explicitly provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for features like dose calculation accuracy or planning capabilities, nor does it provide specific device performance metrics in a pass/fail format typical of quantitative studies. Instead, it relies on demonstrating similar functionalities and computational approaches to a predicate device.

The "Non-Clinical Tests" section mentions that "Verification tests were written and executed to ensure that the system is working as designed. Pass/fail requirements and results of this testing can be found in the Thunder Core Verification Test Report, which is included in section 16 of this submission. Pinnacle3 RTP successfully passed verification testing." This suggests that internal acceptance criteria and performance thresholds existed and were met, but these specific details are not included in the provided excerpt.

The comparison table (Table 5A) highlights technological characteristics and principles of operation, implying that similarity to the predicate device in these aspects serves as a primary "acceptance criterion" for substantial equivalence.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "algorithm testing was performed in a QA 'Phantom'" and "clinical orientated validation test cases were written and executed by PMS customers at External evaluation sites." However, the number of phantom configurations, patient cases (if simulated), or specific test sets used in these validations is not provided.
• Data Provenance:
  • Phantom Data: For "Algorithm testing... in a QA 'Phantom'", the data is synthetically generated or acquired in a controlled lab environment. This is typically internal, not from a specific country of origin in the clinical sense.
  • Clinical-Oriented Validation: For "clinical orientated validation test cases... executed by PMS customers at External evaluation sites," the data would likely be based on simulated or mock patient cases, or potentially anonymized clinical data provided by these "PMS customers." The countries of origin for these "External evaluation sites" are not specified, nor is whether the data was retrospective or prospective. It is implied to be retrospective or simulated to prevent patient exposure to risk.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: For the "clinical orientated validation test cases," it mentions "oversight by PMS customer support personnel." It also states that treatment plans "are to be evaluated, modified, and implemented by qualified medical personnel." While this implies that qualified personnel are involved in the validation, their specific roles (e.g., medical physicists, radiation oncologists, dosimetrists) and years of experience are not detailed as "experts establishing ground truth." For the QA phantom testing, the "ground truth" (measured doses) would be established by the physical measurements themselves, typically verified by medical physicists via dosimetry.

4. Adjudication Method for the Test Set

Not explicitly stated. The document refers to "oversight by PMS customer support personnel" for clinical validation, but it doesn't describe any formal adjudication process for disagreements or discrepancies. For phantom testing, the "ground truth" is measured data, and the comparison is usually direct.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical trials were not performed as part of the development of this product." Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers' improvement with AI vs. without AI assistance was not conducted or reported. The device is a planning system, not an AI-assisted diagnostic or interpretation tool in the typical sense of MRMC studies.

6. Standalone (Algorithm Only) Performance Study

Yes, in part. "Algorithm testing was performed in a QA 'Phantom' to compare calculated against measured doses to ensure dose calculation accuracy." This constitutes a standalone performance evaluation of the dose calculation algorithm.

7. Type of Ground Truth Used

• Algorithm Testing: "Measured doses" in a QA "Phantom." This refers to physical measurements in a controlled environment as the ground truth.
• Clinical-Oriented Validation: This implicitly relies on the consensus of "qualified medical personnel" and "PMS customer support personnel" validating that the plans generated by the system are clinically appropriate and meet intended goals. However, a formal "ground truth" establishment process for these cases is not described beyond this general validation.

8. Sample Size for the Training Set

Not applicable. This device is a radiation therapy planning system that uses established physics models and algorithms (e.g., pencil beam algorithm, dose model parameter fitting to published works and measured data) rather than a machine learning model that requires a distinct "training set" in the context of deep learning or AI. The algorithms are based on fundamental physics principles and validated against measured data and published literature.

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

Not applicable, as there isn't a "training set" in the machine learning sense. The models used (e.g., pencil beam algorithm) are derived from fundamental physics and validated against "measured data... fitted to models based on published works." This fitting process uses measured physical data (e.g., Bragg Peak, Spread Out Bragg Peak, Effective SAD, Virtual SAD, Effective Source Size, CT-Number to Stopping Power Tables) as its "ground truth" for parameter derivation.

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Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.

Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes.

The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care.

Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

Pinnacle3 Radiation Therapy Planning System version 7.2 (hereafter Pinnacle' RTP) provides radiation therapy planning for the treatment of benign or malignant diseases. When using Pinnacle3 RTP, qualified medical personnel may generate, review, verify, approve, print and export the radiation therapy plan prior to patient treatment. Pinnacle RTP can approvide plans for various radiation therapy modalities including External Beam Treatment, Stereotactic Radiosurgery, and Brachytherapy.

Pinnacle3 RTP is a software package that runs on a Sun UNIX (or UNIX compliant) computer and consists of a core software module (Pinnacle') and optional software features. These optional software features, commonly referred to as "plug-ins", are typically distributed separate from the core software product (separate CD-ROM). The device has network capability to other Pinnacle RTP workstations and to both input and output devices via local area network (LAN) or wide area network (WAN).

Image data is imported from CT, MR, PET, PET-CT and SPECT devices using a DICOMmage atta interface. A qualified medical professional uses the Pinnacles RTP for functions such as viewing and analyzing the patient's anatomy, and generating a radiation therapy plan. The viowing and analyzing are examples of tasks that may be performed by clinicians when using the Pinnacle' RTP system:

• Evaluate the treatment plan based on radiation-sensitive structures and the tumor. ◆
• Combine both geometric and dosimetric planning on the same platform, including CT . simulation data and plans. The CT simulation parts of the system are called AcQSim² and Simulation.
• Configure beam variables such as energy, geometry, and beam modifiers such as blocks, . wedges, multi-leaf collimators, bolus and compensators.
• Visualize the beam on a display, initiate the dose computation, and set the weight of each . beam.
• Obtain dose measurements from any Points of Interest (POI). .
• Perform photon and electron physics modeling, dose algorithm and machine ● commissioning. This functionality is supported by the Physics Utility Module.
• Evaluate images away from the workstation via a laptop or physician group workstation. . The feature that provides remote review is referred to as P3MD.
• Create data for use in conjunction with treatment QA systems. .
• Configure, backup, archive, restore, and scripting. .
• Evaluate Digitally Reconstructed Radiographs (DRRs) on Pinnacle RTP or remote system . using DICOM Secondary Capture (SC) Export.

Once complete, Pinnacle3 RTP has the ability to transfer the finished plan to other devices used in Onec comprete, I minute - Record and Verify, Linear Accelerator (Linac) Workstations and/or 310 Party QA systems.

The following Pinnacle³ RTP features are also available to assist the clinician with the radiation therapy planning process. These features are distributed on standalone CD-ROM media, and installed onto the Pinnacle' RTP workstation. Corresponding instructions for use such as User Guides or Release Notes are also provided to the clinician for each optional feature.

P3IMRT (Intensity Modulated Radiation Therapy):
P INKT (Incentines both forward and inverse planning functionality. The system determines a plan that satisfies the user's treatment goals through an optimization process. The user's treatment goals are specified as objectives and constraints based on dose distribution characteristics.

Syntegra (also referred to as AutoFusion):
Syntegra (utomates multi-modality image registration and fusion by overlaying images from CT, MR, PET, PET-CT and SPECT devices using a DICOM-compliant interface. This feature provides clinicians with the ability to relate, interpret and contour an image's anatomic and functional information.

In addition to the above, the following software options are available to facilitate image and/or data import and export between radiation therapy devices such as the imaging camera, Pinnacle' RTP, and Record & Verify system. DICOM is the acronym for Digital Imaging and Communications in Medicine and is an internationally recognized standard for transferring biomedical information such as images and data between devices or over a network.

DICOM RT:
DICOM RT software is used to support both Structure Set and Radiation Therapy Plan import and export functions. Structure Sets describe regions and points of interest to other systems. Plan information includes beam geometry and delivery information.

DICOM Image:
DICOM Image software is used to support image import and export to and from the Pinnacle RTP workstation according to the NEMA DICOM standard, version 3.0. This functionality allows diagnostic imaging devices supporting the DICOM 3.0 standard to interface with the Pinnacle system.

Mitsubishi DME:
A proprietary interface has been created within the Pinnacles Treatment Planning System to support plan export to Mitsubishi Record and Verify systems. This interface is called the "Mitsubishi DME" system. This is implemented as a simple file based interface according to a format specified by Mitsubishi.

P3 MD:
P3MD allows for treatment plan review and minor alternations by a physician from a PC-based workstation that is connected to the same network as the primary Pinnacle Treatment Planning workstation.

The provided text is a 510(k) Pre-market Notification for the Pinnacle3 Radiation Therapy Planning System version 7.2. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.

Key takeaway regarding "acceptance criteria" and "study proving acceptance criteria":

510(k) notifications, especially for software modifications to existing devices like this one, do not typically present formal "acceptance criteria" and "studies proving acceptance criteria" in the same way one would find for a novel device or a clinical trial. Instead, they focus on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of why and what information is available from the document:

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

• Not Applicable in a traditional sense for this document. The concept of "acceptance criteria" for this submission would be demonstrating that the new features (DMLC support, physics tool improvements) function as intended and do not raise new safety or effectiveness concerns compared to the predicate device.
• The document explicitly states: "Verification and Validation test plans were completed in compliance with ADAC Laboratories procedures and will be utilized to demonstrate that the Pinnacle Radiation Therapy Planning System version 7.2 has met its specifications, demonstrates substantially equivalent performance to the predicate device and is safe and effective for its intended use."
• The specific "reported device performance" against quantifiable "acceptance criteria" for the new features (e.g., DMLC accuracy within X%, physics model improvement by Y%) is NOT detailed in this summary. Such details would be part of the internal ADAC Laboratories verification and validation documentation, which is reviewed by the FDA but not typically fully included in the public 510(k) summary.

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

• Not specified in the publicly available summary. The summary refers to "Verification and Validation test plans" but does not detail the specifics of test sets, sample sizes, or data provenance.
• Given this is a software update and not a new diagnostic tool interacting directly with patient data, a "test set" in the sense of clinical images might not be the primary focus of the V&V. It would likely involve testing the software's computational accuracy and functionality.

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 specified. The document mentions the involvement of "qualified medical personnel" for using the system and evaluating plans, but does not detail their role in establishing ground truth for testing the device itself.
• For radiation therapy planning systems, "ground truth" often relates to known physics principles, phantom measurements, or comparisons to established planning systems for dose calculations.

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

• Not specified. This is typically relevant for studies involving human interpretation or subjective assessments, which are not directly described for this software update.

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:

• No, an MRMC comparative effectiveness study was explicitly NOT required. The document states: "Summary of Clinical Tests: Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness."
• This also means there is no reported effect size for human readers improving with AI, as the device is not presented as an "AI assistance" tool in this context, but rather an updated radiation therapy planning system.

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

• The "Verification and Validation test plans" would have involved standalone testing of the algorithms (e.g., dose calculation, DMLC path generation) to ensure they meet specifications. However, the details of these standalone tests are not provided in the summary. The device's function is inherently "algorithm only" in terms of its core computations, with human oversight for plan approval.

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

• Not explicitly stated in the summary. For a radiation therapy planning system, ground truth for dose calculation and DMLC functionality would likely involve:
  • Physics models: Comparison of calculated dose distributions to established physics models and phantom measurements.
  • Reference data: Comparison of DMLC movements to designed or theoretical paths.
  • Simulations against known parameters.
• It would not typically involve expert consensus on image interpretation, pathology, or patient outcomes data for device validation in a 510(k) for a dose planning system update.

8. The sample size for the training set:

• Not applicable. This device is a radiation therapy planning system, not a machine learning model that requires a "training set." It is based on deterministic physics algorithms and software logic.

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

• Not applicable, as there is no training set for this type of device.

In summary of the provided text:

The document is a 510(k) submission focused on demonstrating substantial equivalence of an updated radiation therapy planning system (Pinnacle3 version 7.2) to a previously cleared version (K032724). The primary changes are support for dynamic multileaf collimator (DMLC) treatment planning and improvements to the physics tool.

The "study that proves the device meets the acceptance criteria" is broadly referred to as:

"Verification and Validation test plans were completed in compliance with ADAC Laboratories procedures and will be utilized to demonstrate that the Pinnacle Radiation Therapy Planning System version 7.2 has met its specifications, demonstrates substantially equivalent performance to the predicate device and is safe and effective for its intended use."

However, the detailed methodology, specific acceptance criteria, test set sizes, ground truth establishment, or clinical study outcomes are not contained within this public 510(k) summary. These details would be part of the complete 510(k) submission reviewed by the FDA, but are not disseminated in the public summary. The FDA determined that clinical testing was "not required" for this particular device update.

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Pinnacle3 Radiation Therapy Planning System version 6.6 provides support for conformal arc treatment planning.

Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.

Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes.

The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care.

Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

Pinnacle Radiation Therapy Planning Software version 6.6 (hereafter Pinnacle RTP) provides radiation therapy planning for the treatment of benign or malignant diseases. When using Pinnacle3 RTP, qualified medical personnel may generate, review, verify, approve, print and export the radiation therapy plan prior to patient treatment. Pinnacle RTP can provide plans for various radiation therapy modalities including External Beam Treatment, Stereotactic Radiosurgery, and Brachytherapy.

Pinnacle RTP is a software package that runs on a Sun UNIX workstation and consists of a core software module (Pinnacle') and optional software features. These optional software features, commonly referred to as "plug-ins", are typically distributed separate from the core software product (separate CD-ROM). The device has network capability to other Pinnacle' workstations and to both input and output devices via local area network (LAN) or wide area network (WAN).

Image data is imported from CT, MR, PET, PET-CT and SPECT devices using a DICOM-compliant interface. A qualified medical professional uses the Pinnacle RTP for functions such as viewing and analyzing the patient's anatomy, and generating a radiation therapy plan.

The provided document is a 510(k) premarket notification for the Pinnacle3 Radiation Therapy Planning System version 6.6. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed acceptance criteria, specific study designs, or reported device performance metrics in the format requested.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed reported device performance in the format of a table. It states that "Verification and Validation test plans were completed in compliance with ADAC Laboratories procedures and will be utilized to demonstrate that the Pinnacle3® Radiation Therapy Planning Software version 6.6 software has met its specifications, demonstrates substantially equivalent performance to the predicate devices and is safe and effective for its intended use."

However, the specific metrics, thresholds, or outcomes of these verification and validation tests are not disclosed in this summary. The primary "performance" stated is that it "introduces support for conformal arc treatment planning" and "incorporates no technological characteristics not currently contained in the predicate devices."

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

The document does not mention a specific "test set" in the context of clinical data. The review is based on non-clinical tests (Hazard Analysis, Verification and Validation test plans). Therefore, there is no information on sample size for a test set (e.g., number of patient cases, images) or data provenance (country of origin, retrospective/prospective).

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

Given that clinical testing was "not required," there is no mention of experts establishing a ground truth for a test set. The validation would have been against software specifications and potentially comparison with predicate device outputs, rather than comparison against expert human performance on clinical cases.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set using expert judgment is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The submission states, "Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness." Therefore, there is no information on the effect size of AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study in the context of clinical outcomes or diagnostic accuracy is not explicitly detailed. The non-clinical tests (Verification and Validation) would have evaluated the algorithm's functionality and performance against its specifications and potentially against outputs from predicate devices. However, these are software engineering tests rather than clinical performance studies.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would likely be:

• Software Specifications: The predefined functional and performance requirements of the Pinnacle3 software.
• Predicate Device Output: Comparison of the new version's output (e.g., dose calculations, plan generation) against that of the predicate devices for equivalence, especially for the new "conformal arc treatment planning" feature.
• Expected Physics Principles: Ensuring that dose calculations and planning adhere to established radiation therapy physics.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for "clinical" performance, as clinical testing was not performed.

8. Sample Size for the Training Set:

This document is for a software update to a radiation therapy planning system. Radiation therapy planning systems are typically rule-based and physics-based software, or they might integrate machine learning components for specific tasks (e.g., auto-contouring, dose prediction). However, the document does not suggest the use of a machine learning model that would require a "training set" in the traditional sense. Therefore, no information on a training set size is provided.

9. How Ground Truth for the Training Set was Established:

Not applicable, as no training set for a machine learning model is mentioned.

Summary regarding acceptance criteria and study data:

The 510(k) notification for Pinnacle3 Radiation Therapy Planning System version 6.6 demonstrates substantial equivalence through non-clinical testing, hazard analysis, and comparison to predicate devices. It does not provide details on specific quantitative acceptance criteria or clinical study results with human expert involvement, as clinical testing was deemed unnecessary for this submission. The "study" referenced is the Verification and Validation test plans which demonstrated the software met its specifications and performed substantially equivalently to predicate devices.

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