Prowess Pro-Sim is a modularly designed radiation therapy treatment planning computer program used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop treatment plans for Brachytherapy and External Beam (photon or electron) therapy. Completed treatment plans can displayed in 3D prior to treatment.

Device Description

The Prowess treatment-planning product is a series of independent software programs used to plan a course of radiation therapy. The treatment plan includes an estimated dose distribution for a patient. The dose is calculated by applying known and tested algorithms. Measured treatment machine data combined with geometric and tissue information, for a particular patient, are processed by the algorithm into a dose distribution.

The Prowess Treatment Planning System (TPS) is separated into three major components:

Incorporating patient data into a patient model.
Creating treatment plans for each set of patient data.
Calculating the treatment plans.

Pro-Sim TPS has all of the features of Pro-Sim VPS with the dose calculation capability of P3000. In this program the dose distribution can be shown in the 2D and 3D views.

AI/ML Overview

The provided submission K984196 is a 510(k) premarket notification for the Prowess Pro-Sim Radiation Therapy Treatment Planning System. This submission focuses on establishing substantial equivalence to a predicate device (SSGI Prowess Pro-Sim, K980379). The document does not describe a study to prove acceptance criteria in the typical sense of a clinical trial or performance study with quantified metrics. Instead, it relies on a comparison table and a summary of differences to demonstrate that the modified device (Pro-Sim TPS) performs equivalently to or better than the predicate device.

Here's an analysis based on the provided information, addressing your questions to the best extent possible given the nature of the submission (a 510(k) for a treatment planning system from 1998):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the features and performance of the predicate device (Prowess Pro-Sim, K0980379). The "Prowess Pro-Sim TP-Modified Device" column indicates that the modified device either meets or exceeds these capabilities.

Feature Category	Acceptance Criteria (from Predicate Device K0980379)	Reported Device Performance (Prowess Pro-Sim TP-Modified Device)
Basic Features	- Receive info from any DICOM 3.0 CT scanner. - Create DRR in any plane. - Define tumor volume with multiple interior structure outlines. - Simulate blocks/MLC on grayscale DRR. - Advanced tools for 3D visualization (transverse planes, wireframe contours, 3D renderings).	All predicate features met (X). Improved: As computer simulation is performed, actual dose generated from beams can be displayed, and changes to beam/plan watch effect on dosimetry immediately.
Basic System Design	- DICOM 3 compliant. - Multilingual product design. - Screen layout organized for rapid/consistent display (4 windows, toolbar, window/level graphic, menu, common functions). All windows active and independent.	All predicate features met (X).
Image Acquisition	- DICOM 3 compliant; accepts CT images from any DICOM 3 source. - Ability to recall patients stored on any network station. - Supports LAN, WAN, or distributed network via TCP/IP. - At least 100 CT slices per study accepted.	All predicate features met (X).
Image Processing & Anatomical Modeling	- Rapid auto contouring (multiple organ, Hounsfield threshold). - Easy entry of field shapes & calculation points. - External & internal autocontouring, batch autocontouring. - Easy manual contouring & editing. - Full mouse support. - Easy to add margins on all volumes. - Entry of calculation points for reference. - Multiple calculation points for single field. - Entry of fiducial points/isocenter marking.	All predicate features met (X).
Full Three Dimensional Vis. of Treatment Setup	- Treatment unit & patient anatomy visualized in 3D from any point. - Direction of view dynamically moved in real time. - Anatomical features turned on/off easily. - Full Zoom and Pan in each window. - Turn on/off each contour display. - Choose from predefined beam configurations. - Supports beam configured for any accelerator gantry/table orientation. - Full 3-D patient and beam geometry. - Independent jaws fully supported. - Full couch, collimator, gantry rotation supported. - MLC supported.	All predicate features met (X). Improved: Pro-Sim TPS can display the multi-slice dose calculation in 3D (this was not available in the predicate).
External Beam Dose Calculations	- Photon and electron beams combined in single plane. - Photon calculation uses measured TMR/TPR data. - Two heterogeneity models: Effective Path Length, Batho Power Law. - Bolus, compensators, blocks, wedges mixed freely. - CT pixel/density correction available. - At least 20 active beams per plan (fixed or rotational). - Export for dose calculations (predicate required export to Prowess 3000). - 2D scatter calculations available. - Calculation matrix size up to 16,384 per slice. - Calculation of machine setting for each field.	All predicate features met (X). Improved: Dose calculations are now internal to Pro-Sim TPS; no longer needed to export to Prowess 3000. The calculation models are the same as Prowess 3000. Improved: Full non-coplanar beam calculations (predicate could not combine them due to machine interface limitations). Improved: 3D dose display.
Hardcopy	- Scaleable color PostScript™ or HPGL hardcopy of CT images with color isodose curves. - Full color or B&W output on paper/film. - Supports all printers supported by Windows NT. - Full color hardcopy available. - Dye sublimation printers (optional).	All predicate features met (X).
Recommended Minimum Hardware Config	- Pentium® Pro or Pentium II workstation. - Windows NT server or workstation OS. - 17" monitor. - Screen resolution 1280 x 1024 pixels. - 24-bit True Color display. - Windows NT networking for multiple workstations.	All predicate features met (X).
Export / Import Features	- All anatomical data (CT images) exportable to Prowess 3000 RTP System using APEXTM. - All anatomical contouring data exportable to Prowess 3000 RTP system. - Beam data generated by Pro-Sim exportable to Prowess 3000 RTP.	All predicate features met (X). The primary change is that import for dose calculation is no longer needed as calculations are now integrated. However, the export capabilities to Prowess 3000 for other purposes are maintained.

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

The document does not describe a "test set" in the context of an evaluative study with a specific sample size. The comparison is feature-based and qualitative, comparing the new device's capabilities to the predicate device's capabilities. There is no mention of patient data (e.g., country of origin, retrospective/prospective) used for performance evaluation in the supplied text.

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

No test set requiring expert-established ground truth is described. The assessment relies on a technical comparison of features and functionalities against a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring adjudication is described.

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

No MRMC study is mentioned. This submission predates widespread use of such studies for AI/software devices and is focused on establishing substantial equivalence through feature comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The submission implicitly relies on the standalone performance of the integrated dose calculation algorithms. The key summary difference states, "The calculation models are the same for both systems, Prowess 3000 and Pro-Sim TPS." This means the proven mathematical models from the Prowess 3000 system (which would have undergone validation for its dose calculations) are now integrated into Pro-Sim TPS. The predicate device required export of data to Prowess 3000 for these calculations. The new device brings these calculations internally. Therefore, the standalone performance of the calculation models themselves is implied to be equivalent to the previously validated models in Prowess 3000, but no new standalone study for Pro-Sim TPS is detailed.

7. Type of Ground Truth Used (for the performance of the Prowess 3000 dose calculation models)

For the dose calculation algorithms, the "ground truth" would historically be established through stringent physics verification methods, including:

Comparison with measured physical phantom data (e.g., ionization chamber measurements, film dosimetry) for various beam configurations, energies, and phantom geometries.
Comparison with established reference algorithms or highly accurate research codes.
Compliance with international standards and recommendations (e.g., IAEA, AAPM for dose calculation accuracy).

While not explicitly detailed in this 510(k), the statement "The dose is calculated by applying known and tested algorithms" and "The calculation models are the same for both systems, Prowess 3000 and Pro-Sim TPS" implies that the underlying dose calculation models have been validated and accepted prior to this submission (likely as part of the predicate Prowess 3000's clearance).

8. Sample Size for the Training Set

Not applicable. This is a medical device software for radiation treatment planning, not an AI/machine learning model in the modern sense that typically requires a "training set." The software uses deterministic algorithms based on physics principles and measured machine data.

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

Not applicable, as there is no training set in the AI/ML context.

Summary

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K984196

DEC 1 1 1998

Image /page/0/Picture/2 description: The image shows a logo with the letters "SSGI" below a triangular shape. The triangle has a stylized "S" shape cut out of it, and the upper left corner of the triangle is filled with a pixelated or fragmented pattern. A horizontal line is located under the letters "SSGI".

Prowess Systems 1370 Ridgewood Dr., Ste. 20 Chico, California 95973 Tel: (530) 898-0660 Fax: (530) 342-8966

510(k) Summary of Safety and Effectiveness

1. Submitter:
  SSGI 1370 Ridgewood Drive Suite 20 Chico, CA 95973

Contact: Robert J. Morton Director, Regulatory Affairs and Quality Assurance

Prepared: November 16, 1998

Prowess Pro-Sim 2. Device Name: Radiation Therapy Treatment Planning System
SSGI Prowess Pro-Sim, K980379 3. Predicate Device:
1. Description: The Prowess treatment-planning product is a series of independent software programs used to plan a course of radiation therapy. The treatment plan includes an estimated dose distribution for a patient. The dose is calculated by applying known and tested algorithms. Measured treatment machine data combined with geometric and tissue information, for a particular patient, are processed by the algorithm into a dose distribution.

The Prowess Treatment Planning System (TPS) is separated into three major components:

1. Incorporating patient data into a patient model.
1. Creating treatment plans for each set of patient data.
Calculating the treatment plans. 3.

Pro-Sim TPS has all of the features of Pro-Sim VPS with the dose calculation capability of P3000. In this program the dose distribution can be shown in the 2D and 3D views.

1. Intended Use: The Prowess Pro-Sim treatment planning system is used to plan patient treatment for radiation therapy.
Technological Characteristics: See attached Comparison Table. 6.

Image /page/0/Picture/19 description: The image shows the logo and contact information for Prowess Systems. The logo features a triangle with a stylized design inside, accompanied by the letters "SSGI" underneath. The contact information includes the address "1370 Ridgewood Dr., Ste. 20, Chico, California 95973", along with the phone number "(530) 898-0660" and fax number "(530) 342-8966".

"Serving our customers' needs"

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Tab 15 Comparison to Unmodified Device

Prowess Treatment Planning System	ProwessPro-SimPredicateK0980379Device	ProwessPro-Sim TP-ModifiedDevice
Basic FeaturesPro-Sim VPS has the ability to receive information from anymanufacturer's CT scanner with DICOM 3.0 format on a network system.The Pro-Sim VPS computerized simulation process involves creation of adigitally reconstructed radiograph (DRR) in any plane desired. This appearson the computer screen for modification. The tumor volume is defined byadding multiple interior structure outlines to the transverse slices. In thebeam's eye view, custom blocks and multileaf collimator blocking areaccurately simulated by Pro-Sim VPS. These are superimposed on thegrayscale DRR presented on the screen. Advanced tools for 3Dvisualization are transverse planes and wireframe contours surrounding 3Drenderings of internal tumors and structures.	X	X
As the computer simulation is performed, the actual dose generated fromthe beams can be displayed in Pro-Sim TPS, change the beam or plan andwatch the effect on the patient dosimetry, immediately.		X
Basic System Design• DICOM 3 compliant.• Multilingual product design.• Screen layout organized for rapid and consistent image display. Screenincludes four display windows, a toolbar area, window and level graphicdisplay, menu area and common function areas. All windows are activeand have independent control.	XXX	XXX
Image Acquisition• DICOM 3 compliant Pro-Sim will accept CT images from any DICOM 3image source.	X	X
• Ability to recall patients stored on any network station.• Supports local area networks, wide area networks, or a distributednetwork through TCP/IP networking.	XX	XX
• At least 100 CT slices per study accepted.	X	X
Prowess Treatment Planning System	ProwessPredicateDevice	ProwessModifiedDevice
Image Processing and Anatomical Modeling
• Rapid auto contouring includes multiple organ contouring using aHounsfield number threshold technique.	X	X
• Easy entry of field shapes and calculation points.	X	X
• External and internal autocontouring. Batch autocontouring formultiplanar entry.	X	X
• Easy manual contouring and editing.	X	X
• Full mouse support.	X	X
• Easy to add margins on all volumes.	X	X
• Entry of calculation points for reference.	X	X
• Multiple calculation points available for a single field.	X	X
• Entry of fiducial points or isocenter marking to register patient anatomy.	X	X
Full Three Dimensional Visualization of Treatment Setup
• The treatment unit and patient anatomy can be visualized in threedimensions from any point in the treatment room.	X	X
• Direction of view can be dynamically moved in real time for fullvisualization of machine and patient.	X	X
• Anatomical features can be turned on and off easily.	X	X
• Full Zoom and Pan in each window.	X	X
• Turn on and off each contour display.	X	X
• Choose from a set of predefined beam configurations (e.g., Four Field,AP/PA, etc...)	X	X
• Supports beam configured for any 'brand' accelerator gantry and/or tableorientation.	X	X
• Full 3-D patient and beam geometry.	X	X
• Independent jaws fully supported.	X	X
• Full couch, collimator and gantry rotation supported.	X	X
• MLC supported.	X	X
External Beam Dose Calculations
• Photon and electron beams can be combined in a single plane.	X	X
• Photon calculation makes extensive use of measured TMR/TPR data. Twoheterogeneity models available:	X	X
Effective Path Length	X	X
Batho Power Law	X	X
• Bolus, compensators, blocks, and/or wedges may be mixed freely.	X	X
• CT pixel/density correction available.	X	X
Prowess Treatment Planning System	ProwessPredicateDevice	ProwessModifiedDevice
• At least 20 active beams per plan may be entered. They may be fixed orrotational beams.	X	X
• Necessary to export for dose calculations	X
• 2D scatter calculations available.	X	X
• Calculation matrix size up to 16,384 per slice.	X	X
• Calculation of machine setting for each field.	X	X
• Non-coplanar beam calculations.		X
• 3D dose display.		X
Hardcopy
• Scaleable color PostScript™ or HPGL hardcopy of CT images with colorisodose curves.	X	X
• Pro-Sim hardcopy produces full color or black and white output on paperor film.	X	X
• Pro-Sim supports all printers supported by Windows NT.	X	X
• Full color hardcopy available.	X	X
• Dye sublimation printers (optional).	X	X
Recommended Minimum Hardware Configuration
• Pentium® Pro or Pentium II workstation.	X	X
• Windows NT server or workstation operating system.	X	X
• 17" monitor.	X	X
• Screen resolution 1280 x 1024 pixels.	X	X
• 24-bit True Color display. CT or MRI images displayed using full 256gray levels.	X	X
• Windows NT networking allowing multiple workstations for simultaneoussimulation by physicians, physicists and dosimetrists.	X	X
Export / Import Features
• All anatomical data including CT images can be exported to the Prowess3000 RTP System using APEXTM	X	X
• All anatomical contouring data can be exported to the Prowess 3000 RTPsystem.	X	X
• Beam data generated by Pro-Sim can be exported to Prowess 3000 RTP.	X	X

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Summary of Differences

Pro-Sim TPS is identical to Pro-Sim VPS, the predicate device with the exception that the dose calculations have been moved from Prowess 3000 into Pro-Sim VPS, creating Pro-Sim TPS. There is no longer a need to export the patient and beam geometry to Prowess 3000 to do the dose calculations. The calculation models are the same for both systems, Prowess 3000 and Pro-Sim TPS.

The comparison shows only two significant features that Pro-Sim TPS can do that the predicate system cannot do. First, Pro-Sim TPS can display the multi-slice dose calculation in 3D (there was no 3D view for dose calculations in the predicate device) and second, Pro-Sim TPS can do full non-coplanar beam calculations. The predicate device could perform dose calculations in all planes but could not combine them at one time due to machine interface limitations.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Robert J. Morton Director. Regulatory Affairs and Quality Assurance Prowess Systems 1370 Ridgewood Dr. Suite 20 Chico, California 95973

Re: K984196

Prowess Pro-Sim (Radiation Therapy Treatment Planning System) Dated: November 19, 1998 Received: November 23, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 MUJ

Dear Mr. Morton:

We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the. device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Fremarket 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 mobilish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Flectronic Product 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) 594-4613. 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" (21 CFR 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/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Tab 9

Indications For Use

510(k) Number (if known):_

Device Name: Prowess Pro-Sim Treatment Planning System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vavid A. Seymann
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use V (per 21 CFR 801.109)

Over-The-Counter Use_

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.