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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.

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.
2. Creating treatment plans for each set of patient data.
3. 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.

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.

• 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.

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