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The Prowess Panther ProArc module is intended to support radiation treatment planning by creating treatment plans for intensity-modulated arc radiation therapy.

Panther ProArc is an optional software module to the Prowess Panther radiation therapy treatment planning system. It is an extension to the inverse planning, IMRT planning capability provided by Prowess Panther (previously cleared under K032456). Panther ProArc includes tools for visualizing and creating arc therapy plans, defining arc therapy beam properties and constraints, and allowing the user to do export these plans for delivery via DICOM protocol to the linear accelerator for treatment.

The provided text does not contain specific information about acceptance criteria, detailed device performance metrics, or a formal study with statistical data for the Prowess Panther ProArc module. The document is a 510(k) summary for regulatory clearance, primarily focusing on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria.

However, based on the information provided, here's a breakdown of what can be inferred and what is not available:

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

The document does not provide a table of acceptance criteria with corresponding performance metrics. It generally states that the device "met its predetermined specifications" and "demonstrated substantially equivalent performance to the predicate devices, functions as intended, and is safe and effective for its specified use."

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "real patient cases" were used during beta testing, but the number of cases is not specified.
• Data Provenance: The beta testing was conducted at "Medical College of Wisconsin and Huntsman Cancer Hospital," suggesting data from the USA.
• Retrospective or Prospective: Not explicitly stated. The phrase "using real patient cases" could imply either.

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)

• Number of experts: The "medical physicists at Medical College of Wisconsin and Huntsman Cancer Hospital" were involved in functional testing and beta testing. Additionally, "clinical physicists contracted by Prowess" were involved in verifying risk mitigation. The exact number and their specific roles in establishing ground truth for a test set are not detailed.
• Qualifications of experts: They are referred to as "medical physicists" and "clinical physicists." Specific years of experience or board certifications are not provided.

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

The document does not describe any specific adjudication method for establishing ground truth from multiple experts.

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

A formal MRMC comparative effectiveness study, as typically understood for AI-assisted diagnostic tools, was not conducted or reported. This device is a treatment planning system, not a diagnostic AI. The evaluation focused on substantial equivalence to existing treatment planning systems, not on improving human reader performance.

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

The "verification and validation of the software was performed in-house according to established test plans and protocol," which included "functional testing." This internal testing would represent the standalone performance of the algorithm. Additionally, "beta testing at Medical College of Wisconsin and Huntsman Cancer Institute using real patient cases" also evaluated the software's performance, likely in a user environment.

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

The document implies that the ground truth for evaluating the treatment plans generated by Panther ProArc was established by comparing its output with "predetermined specifications" and by showing "substantially equivalent performance" to predicate devices. This would likely involve:

• Physics-based calculations: Verification of dose distribution, dose-volume histograms (DVH), and other dosimetric parameters against expected values or those generated by the predicate devices.
• Clinical expert review: Medical physicists and clinical physicists would review the generated plans for clinical acceptability and adherence to treatment goals.
• Comparison to predicate devices: The "ground truth" for substantial equivalence was largely defined by the performance of the legally marketed predicate devices (Varian's Eclipse and CMS's Monaco RTP System).

8. The sample size for the training set

This information is not provided. The document does not discuss a "training set" in the context of machine learning, as this is a radiation therapy treatment planning system, implying a more deterministic or rule-based software, rather than a machine learning model that requires explicit training data.

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

Not applicable, as a training set for machine learning is not mentioned. For a treatment planning system, the "knowledge base" would be derived from physics principles, clinical guidelines, and potentially pre-defined planning templates or parameters, rather than a "ground truth" derived from a specific dataset.

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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:

• 1. 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.
• 2. 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.
• 3. 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

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.

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Prowess Pro-Sim is a modularly designed Radiation 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 be simulated using Prowess Pro-Sim in 3D on the computer's display prior to actual treatment.

The Prowess treatment-planning product is a series of independent software programs that are used to plan a course of radiation therapy. The treatment plan is an estimated dose distribution for a patient. The dose is computed 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 TPS software is designed to run on a personal computer (PC). Depending on the configuration of the program, the PC requires one of the following operating system: Windows NT, DOS or DOS under Windows-95. Other system components and peripherals include: 160 Mb of RAM, high resolution graphics display video card, network card, printer, plotter, digitizer, 3.5 inch floppy disk and tape backup drives.

The provided text describes the "Prowess Pro-Sim" radiation therapy treatment planning system, but it does not contain acceptance criteria or details of a study that proves the device meets specific performance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria through a detailed study with quantitative results.

Here's what can be extracted based on your request, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that functional requirements were met and specifications were adhered to, but it does not specify what those requirements or specifications are (e.g., accuracy of dose calculation within X%, speed of plan generation within Y seconds, etc.). Therefore, a direct comparison table cannot be created.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document mentions acquiring CT and MR image data from DICOM compliant sources, but does not specify the origin of any data used for testing.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study Done?: No. The document does not describe any MRMC comparative effectiveness study, nor does it mention effect sizes of human readers with or without AI assistance. The device is a planning system, not an AI diagnostic tool for human readers.

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

• Standalone Study Done?: Yes, conceptually, the entire testing seems to be focused on the algorithm's performance in generating treatment plans. The conclusion states "testing demonstrates that the functional requirements were met, that the system meets its published specifications," which implies evaluation of the algorithm's output. However, specific details of this "standalone" testing are not provided in terms of metrics or methodologies.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated and likely not applicable in the typical sense for a diagnostic device. For a radiation therapy planning system, "ground truth" would relate to the accuracy of dose calculations against known physics principles and measured machine data, or the accuracy of simulations against physical phantoms. The document states: "The dose is computed 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." This implies that the 'ground truth' for dose calculation accuracy relies on established physics models and machine-specific measurements.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable / Not specified. The Prowess Pro-Sim is described as a software system that applies "known and tested algorithms" and process "measured treatment machine data." This suggests a deterministic system based on physics models rather than a machine learning model that requires a "training set" in the modern AI sense.

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

• How Ground Truth for Training Set Was Established: Not applicable / Not specified. As noted above, the system doesn't appear to be based on a machine learning paradigm requiring a training set. Its "ground truth" for its algorithms would be derived from standard physics principles and empirical measurements of radiation machines.

Summary of what is present:

• Testing Philosophy: The product was developed and tested according to a documented and signed plan, including validation and verification protocols (Section 7).
• Conclusion: Testing demonstrated that functional requirements were met, the system meets its published specifications, and performs as well as or better than predicate devices (Section 8).
• Substantial Equivalence: The primary focus of the 510(k) is to establish substantial equivalence to existing legally marketed devices (Section 3).

In conclusion, while the document confirms that testing was performed and deemed successful, it lacks the specific quantitative details regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment that you requested for a comprehensive understanding of the device's proven performance. This is common for 510(k) submissions, which often focus on equivalence rather than detailed performance studies like those required for PMA devices or modern AI/ML submissions.

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