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.

Device Description

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.

AI/ML Overview

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.

Summary

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JUN 2 5 2004

Pinnacle3 Radiation Therapy Planning System version 7.2 510(k) Notification

K$\phi$41577

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

ADAC Laboratories, Inc. Submitters Name: 6400 Enterprise Lane, Suite 201 Submitters Address: Madison, WI 53719 (608) 288-6945 Submitter Telephone: (608) 298-2101 Submitter Fax: Randy Vader Contact Person: Director, Quality & Regulatory May 3, 2004 Date Summary Prepared:

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K041577

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Device Trade Name:	Pinnacle3 Radiation Therapy Planning System
Common Name:	Radiation Therapy Planning System
Classification Name:	Accelerator, Linear, Medical (per 21CFR section 892.5050)
Predicate Devices:	Pinnacle3 Radiation Therapy Planning System (K032724)

Device Description: 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.

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.

{2}------------------------------------------------

K$\phi$41577

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.

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.

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Kq41577

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.

Indications for Use:

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 gencrated 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.

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Kø41577-

Intended Use:

Pinnacle 3 Radiation Therapy Planning System version 7.2 provides support for dynamic multileaf collimator treatment planning.

Summary of Technological Characteristics Compared to Predicate Devices:

Pinnacle' Radiation Therapy Planning System version 7.2 makes two modifications to the existing Pinnacle3 Radiation Therapy Planning System (K032724):

The addition of support for dynamic multileaf collimator (DMLC) treatment planning. I Dynamic multileaf collimator (also known as sliding window) is a technique in which the MLC leaves are continuously moving while the beam is on.
The addition of improvements to the physics tool by updating the machine parameter . definitions and enhancing the capabilities of the auto-modeling feature.

Pinnacle3 Radiation Therapy Planning System version 7.2 incorporates no technological characteristics not currently contained in the predicate device: Pinnacle3 Radiation Therapy Characteristies not carrences RTP functionality is contained in one workstation.

Summary of Non-Clinical Tests:

Sunning J of Nort Chillers of Pinnacle Radiation Therapy Planning System version 7.2 and hazards were mitigated as appropriate. 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.

Summary of Clinical Tests:

Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness.

Conclusions:

Pinnacle' Radiation Therapy Planning System version 7.2 is substantially equivalent to the predicate device. It has the same intended use as the predicate device and its use does not raise any new or different issues of safety or effectiveness when compared to the predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines. The symbol is black, and the text is also in black.

JUN 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ADAC Laboratories, Inc. % Mr. William J. Sammons Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709 Re: K041577 Trade/Device Name: Pinnacle3 Radiation Therapy Planning System Version 7.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 LNH and MUJ Dated: June 8, 2004 Received: June 14, 2004

Dear Mr. Sammons:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conniner of the the may 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmotion (110.) that the device, subject to the general controls provisions of the Act. The I ou may, the economisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may be subject to back to back to back of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I fours of a nove a determination that your device complies with other requirements of the Act that 1 Dr. I has master and regulations administered by other Federal agencies. You must comply or any 1 orear eattler managing, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough tinding of substantial equivalence of your device to a legally premarket notincation. "The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your and of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions 011 594-4639. Also, please note the regulation entitled, "Misbranding Other of Othphanes an (a notification" (21CFR Part 807.97) you may obtain. Other general of Icierched to promative nextilities under the Act may be obtained from the Division of Small information on your rosponsional Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Ogden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Planning System version 7.2 Pinnacle3 Radiation 510(k) Notificatio

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Pinnacle3 Radiation Therapy Planning System version 7.2

Indications for Use:

Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan I innuolo "Radianal "The treatment volume while minimizing the dose to the surrounding mat maximizes the dose to 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.

Prescription Use V

Over-The-Counter-Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Layman

(Division Sign-Off Division of Reproductive. and Radiological Devi 510(k) Numbe

Proprietary and Confidential Pinnacle3 RTP version 7.2 - 510(k) Notification ADAC Laboratories, Inc. May, 2004

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.