Pinnacle3TM 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.

Pinnacle3 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 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.

Device Description

Pinnacle Radiation Treatment Planning Software is a system composed of a Sun Unix workstation running the Solaris operating system and software which provides the user with the capability to enter patient data into the system, use that data to construct a plan for radiation therapy, and evaluate the plan.

The system consists of a number of functional areas: physics, image import, image manipulation, contouring, point definition, photon and electron external beam treatment planning, stereotactic radiosurgery, brachytherapy, plan evaluation, file management and connectivity. Photons, electrons, stereotactic radiosurgery and brachytherapy functions are sold as separate options and may or may not be included in every system.

Pinnacle 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. 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.

AI/ML Overview

The provided text is a 510(k) summary for the Pinnacle3™ Radiation Therapy Planning Software. It outlines the device description, intended use, and comparison to predicate devices. However, it explicitly states that clinical testing was not performed as part of the development and thus, there isn't detailed information about acceptance criteria, performance data, or specific study methodologies for proving device performance in a clinical context.

Therefore, for aspects related to clinical acceptance criteria and studies (points 1-7, and 9) the information is limited or non-existent in this document.

Here's a breakdown based on the provided text:

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

Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The document instead refers to "specifications" for non-clinical testing.
Reported Device Performance: No clinical performance data is reported. The document states: "Verification and Validation testing were completed in compliance with ADAC Laboratories procedures to demonstrate that the Pinnacle Radiation Therapy Planning Software has met all its specifications, demonstrates substantially equivalent performance to its predicate devices, and is safe and effective for its intended use." This indicates regulatory compliance and substantial equivalence to predicates, not specific performance metrics against defined acceptance criteria.

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

Not applicable. No clinical test set details are provided.

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 applicable. No clinical test set details or ground truth establishment are provided.

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

Not applicable. No clinical test set details are provided.

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

Not applicable. No clinical studies, MRMC studies, or AI assistance details are mentioned. The device is a "Radiation Therapy Planning System," not an AI diagnostic tool.

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

The document implies standalone testing was done for "Verification and Validation" to ensure it met "specifications." However, this is in the context of a "Radiation Therapy Planning Software" which assists the clinician. The performance referred to is likely the accuracy and reliability of the planning algorithms themselves, not a diagnostic task where standalone performance is measured against human performance for comparison.

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

Not applicable for clinical ground truth. For the "Verification and Validation testing" of the software, the "ground truth" would likely be based on established physics principles, dose calculation algorithms, and comparisons to known accurate treatment plans (potentially from predicate devices or phantom studies). The document does not specify.

8. The sample size for the training set

Not applicable. As this is a 510(k) for a radiation therapy planning system (not an AI model in the modern sense), the concept of a "training set" for machine learning algorithms does not apply based on the provided information.

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

Not applicable for the same reasons as point 8.

Summary

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APR - 7 2000

K993923

510(k) SUMMARY

Device trade name:	Pinnacle3™ Radiation Therapy Planning Software
Common name:	Radiation Therapy Planning System
Classification name:	Accelerator, Linear, Medical (per 21CFR section892.5050)
Predicate Devices:	Pinnacle3 Apex Treatment Planning System, K951518ADAC Pinnacle3 Software, K926008ACQPlan System, K974770

Device Description:

Intended Use:

Pinnacle3 Radiation Therapy Planning System provides three-dimensional planning software for external beam (photons and electrons), stereotactic radiosurgery and brachytherapy planning.

Summary of Technological Characteristics Compared to Predicate Devices:

Pinnacle Radiation Therapy Planning Software has been designed to add new features and functions to the existing Pinnacle Apex Treatment Planning System, cleared under K951518, in 1995. Pinnacle Radiation Therapy Planning Software incorporates no technological characteristics not currently contained in the predicate devices, Pinnacle Apex System (K951518), ADAC Pinnacle Software (K926008S2),

000030

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ACQPlan 3D RTP System (K974770), MMS TherPac PLUS (K982821), and I.M.S. Dose Calc. 1.02 (K990833).

Summary of Non-clinical Tests

Verification and Validation testing were completed in compliance with ADAC Laboratories procedures to demonstrate that the Pinnacle Radiation Therapy Planning Software has met all its specifications, demonstrates substantially equivalent performance to its predicate devices, and is safe and effective for its intended use.

Summary of Clinical Tests

Clinical testing was not performed as part of the development of the device features described in this 510(k). Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing health, hope, and service. The figures are connected and appear to be reaching upwards.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2000

Janice E. Brown Corporate Director, Regulatory Affairs ADAC Laboratories 540 Alder Drive Milipitas, CA 85035

Re:

K993923 Radiation Therapy Planning System (RTP) Dated: February 18, 2000 Received: February 22, 2000 Regulatory Class: II 21 CFR 892.5050/Procode: 90 MUJ

Dear Ms. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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, Dryg, and Cosmetic Act (Act). 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Page 1 of 1

510 (k) NUMBER (IF KNOWN): K993923

DEVICE NAME: Pinnacle3 RTP Software

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 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

David C. Bryson

Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number

000020

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.