(66 days)
Prowess 3D™ Radiation Therapy Treatment Planning System, including the IMRT option Panther™, is used to plan photon and electron radiation therapy treatments using linear accelerators and Cobalt-60 beams. The optional software module with the trade name Pather™ provides treatment planning for intensity-modulated radiation therapy (IMRT) treatments using external photon beams.
PROWESS PANTHER is an inverse planning option to the Prowess radiation therapy planning software for supporting intensity-modulated radiation therapy (IMRT) (K980379). The Prowess 3D system is composed of a Workstation with an Intel Pentium* processors (or later versions) running Windows 2000 operation system (or later versions) and proprietary software that allows the trained users to generate radiation therapy treatment plans.
The Prowess IMRT software contains 3 components:
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- Objective and constraint specification --- The first step of the inverse planning process is to allow the user to specify the treatment objectives, which include the dose and dose uniformity to the target or targets, the dose and volume limits to different critical organs, and the relative importance of achieving these objectives.
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- Optimization --- This is a process by which the system iteratively adjust the deliverable parameters including the field shapes and their weights to derive a treatment plan that best achieves the treatment objectives. A proven and most widely used optimization algorithm, simulated annealing, was used. As with P3IMRT™ system by ADAC (K002237), IMRT uses the convolution superposition algorithm as the final dose calculation engine.
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- DICOM Transfer --- This involves transfer the plan parameters via DICOM-RT to a delivery control system (a Record and Verify system or the linear accelerator controller itself) for delivery.
The Prowess Panther device is a software module for radiation therapy treatment planning. The study described in the document evaluates its performance for Intensity-Modulated Radiation Therapy (IMRT).
Here's the breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Dose agreement with calculated values (clinical testing) | Within 3% for all cases tested. |
| Dose agreement with calculated values (ASTRO guideline) | Surpasses the 5% specified in the guideline published by ASTRO. |
| Distance to agreement for high dose gradient regions (clinical testing) | Less than 2mm. |
| Substantial equivalence to predicate devices | Demonstrated, with same intended use and similar technical characteristics. |
| Meeting specifications | Met its specifications (demonstrated by V&V protocol and test results). |
| Safety and effectiveness for intended use | Demonstrated to be safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of cases, but referred to as "real patient cases" and "all the cases tested."
- Data Provenance: Prospective (clinical testing using real patient cases) at the University of Maryland Medical System in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Functional testing was conducted by "medical physicists/dosimetrists" at the University of Maryland, School of Medicine. The exact number of individuals is not specified.
- Qualifications of Experts: Medical physicists/dosimetrists. No specific years of experience are mentioned, but their professional titles suggest expertise in radiation therapy planning and dosimetry.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. The evaluation involved comparing "measured point doses" with "calculated values" and dose distributions captured by films. This suggests a direct comparison method rather than an expert consensus/adjudication process for establishing ground truth from multiple expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the device itself against established physical measurement and calculation benchmarks, and comparison to predicate devices, not on how human readers' performance changes with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the described "clinical testing" and dose calculation comparisons represent a standalone evaluation of the algorithm's output. While human users (medical physicists/dosimetrists) were involved in setting up the plans and measurements, the core evaluation was on the accuracy of the device's calculations and planned dose delivery against physical measurements (phantom) and established guidelines, which is a form of standalone performance assessment for a treatment planning system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established through physical measurements against a phantom ("delivering the plan to a phantom. The measured point doses showed agreement with calculated values... The dose distributions captured by films showed..."). This is a highly objective measurement-based ground truth, often considered the gold standard for dose delivery verification in radiation therapy.
8. The Sample Size for the Training Set
- Sample Size: Not specified. The document states that the Prowess Panther uses a "proven and most widely used optimization algorithm, simulated annealing" and the "convolution superposition algorithm as the final dose calculation engine." These are established algorithms and the document does not mention custom training data for these specific components. Any "training" would likely refer to the development and validation of these underlying algorithms, which are not detailed in the context of this specific 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable in the context of this submission. As noted above, the core algorithms are established. If any internal validation or parameter tuning was done, the ground truth for that would typically involve simulation data or clinical data with known dose distributions, but this level of detail is not provided or required for this type of device submission.
§ 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.