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

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.

AI/ML Overview

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.

Summary

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OCT = 9 2003

K032724

Pinnacle3 Radiation Therapy Planning System version 6.6 510(k) Notification

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Device Trade Name:	Pinnacle3 Radiation Therapy Planning Software
Common Name:	Radiation Therapy Planning System
Classification Name:	Accelerator, Linear, Medical (per 21CFR section 892.5050)
Predicate Devices:	Pinnacle3 Radiation Therapy Planning Software (K993923)P3 IMRT (K002237)

Device Description: 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.

Image data is imported from CT, MR, PET, PET-CT and SPECT devices using a DICOMcompliant 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 following are examples of tasks that may be performed by clinicians when using the Pinnacles 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 part of the system is called SmartSim.
. 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.

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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 P'MD.
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. Pinnacle has the ability to transfer the finished plan to other devices used in the therapy process such as Record and Verify, Linear Accelerator (Linac) Workstations and/or 3rd Party QA systems.

The following Pinnacle software 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 Pinnacle3 RTP workstation. Corresponding instructions for use such as User Guides or Release Notes are also provided to the clinician for each optional feature.

PIMRT (Intensity Modulated Radiation Therapy):

P IMRT combines 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 automates 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.

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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 Pinnacle2 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 Pinnacle3 Treatment Planning software 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.

P MD:

P MD 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:

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

Pinnacle' Radiation Therapy Planning Software 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 software 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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Intended Use:

Pinnacle Radiation Therapy Planning Software version 6.6 provides support for conformal arc treatment planning.

Summary of Technological Characteristics Compared to Predicate Devices:

Pinnacle Radiation Therapy Planning Software version 6.6 introduces support for conformal arc treatment planning to the existing Pinnacle Radiation Therapy Planning System (K993923 and K002237). A conformal arc treatment plan calculates new sets of multi-leaf collimator (MLC) positions at specified intervals through a treatment arc.

Pinnacle Radiation Therapy Planning Software version 6.6 incorporates no technological characteristics not currently contained in the predicate devices: Pinnacle® Radiation Therapy Planning Software (K993923) and P IMRT (K002237). Pinnacle 'RTP functionality is contained in one workstation.

Summary of Non-Clinical Tests:

A Hazard Analysis was completed for Pinnacle3 Radiation Therapy Planning Software version 6.6 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 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.

Summary of Clinical Tests:

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

Conclusions:

The Pinnacle Radiation Therapy Planning Software version 6.6 is substantially equivalent to the predicate devices. It has the same intended use as the predicates and its use does not raise any new or different issues of safety or effectiveness when compared to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a bird-like figure with three lines representing the wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2003

ADAC Laboratories, Inc. % Mr. Jeff Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, NC 27709

Re: K032724

Trade/Device Name: Pinnacle3 Radiation Therapy Planning System, Version 6.6 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: September 19, 2003

Received: September 24, 2003

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 may be subject to additional controls. Existing major regulations affecting your device can be found in the Code 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 contact the Office of Compliance at one 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and 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 vours.

Nancy C. Brogdon

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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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Pinnacle3 Radiation Therapy Planning System version 6.6

Indications for Use:

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

Pinnacled 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.

Pinnacle 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	✓
	OR
	Over-The-Counter-Use ______
(Per 21 CFR 801.109)	(Optional Format 1-2-96)

Proprietary and Confidential

Pinnacle3 RTP version 6.6 - 510(k) Notification

ADAC Laboratories, Inc.

August, 2003

	(Division Sign-Off)
	Division of Reproductive, Abdominal,
	and Radiological Devices

000019510(k) Number J

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.