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SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.

The SIMUPLAN Treatment Planning System is computer based software that runs on a Macintosh platform. The modified device, SIMUPLAN Treatment Planning System version 8.5, is a stereotatic radiosurgery module update only.

The planning process begins with the selection of the treatment machine (linear accelerator) and the image set that will be used for treatment planning. The patients' image sets (i.e. CT, MR, etc.) are imported into the system by standard methods: DICOM, disk, etc. From this data the stereotatic frame is localized and the patients' anatomical structures and tumor site are contoured. The treatment plan will be calculated from the target volume, isocenter, treatment machine and prescription dose and a dose distribution will be displayed. This treatment plan can be modified by the physician prior to final output and patient treatment. The physician approved treatment plan is then printed out and a hard copy of the isodose distribution is prepared for the patients' permanent record. The patient data is then saved under a unique file name in the patient database. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.

The provided text is a 510(k) summary for the SIMUPLAN Treatment Planning System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not include detailed information regarding acceptance criteria or a specific study proving the device meets acceptance criteria in the way typically found for AI/ML-based medical devices.

The SIMUPLAN Treatment Planning System is described as a "stereotatic radiosurgery module update only" for an existing device (version 8.5). This implies that the core functionality and validation may have been established in previous versions (K030821 and K093391). The focus of this 510(k) appears to be on demonstrating substantial equivalence of this update, rather than providing extensive de novo performance data.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "The patients' image sets (i.e. CT, MR, etc.) are imported into the system by standard methods: DICOM, disk, etc." but does not elaborate on the origin or nature of these image sets for testing purposes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

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

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

• Not specified.

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:

• No mention of an MRMC study. This device is a treatment planning system, not an AI-assisted diagnostic tool for human readers, so such a study would likely not be applicable in the same way. The document states: "The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment," implying human oversight is inherent.

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

• The document implies standalone calculation: "The treatment plan will be calculated from the target volume, isocenter, treatment machine and prescription dose and a dose distribution will be displayed." However, the performance metrics of this standalone calculation are not presented.

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

• Not specified. Given it's a treatment planning system, ground truth would likely relate to the accuracy of dose calculations and geometric representations, which might be validated against physical phantoms or established calculation engines, but this is not detailed.

8. The sample size for the training set:

• Not specified. This document does not describe the development or training of an AI/ML model in the sense of a new algorithm, but rather an update to an existing software system.

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

• Not specified.

Summary of what is present in the document relevant to the request:

• Device Name: SIMUPLAN Treatment Planning System, version 8.5 (a stereotactic radiosurgery module update).
• Intended Use: "preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy."
• Predicate Devices: SIMUPLAN Treatment Planning System, v 7.5 (K030821) and v 8.4 (K093391). The 510(k) argues substantial equivalence to these devices.
• Technological Considerations: The software runs on a Macintosh platform and allows for image import (DICOM, disk), localization of the stereotactic frame, contouring of anatomical structures and tumor sites, calculation of treatment plans, display of dose distribution, and modification by the physician.
• Role of Physician: Explicitly states, "The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment."

Conclusion:

This 510(k) document (K120551) primarily focuses on demonstrating substantial equivalence of a software update for a radiation therapy planning system to its previously cleared versions. It does not provide the detailed performance study information with acceptance criteria, sample sizes, expert qualifications, or adjudication methods typically required for novel AI/ML devices or for a comprehensive de novo submission of a new device. The information requested regarding acceptance criteria and performance data is largely absent from this specific submission.

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SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.

The SIMUPLAN Treatment Planning System is computer based software that runs on a Maclitosh platform. The planning system is comprised of 2 main components; external beam and bracilytheray. The modified device, SIMUPLAN Treatment Planning System version 8.4 software included in this colors and module update only. The external beam software not included in this release. With the brachytherapy module, the patients' image sets (i.e. CT, MR, US or x-ray films), are imported into the system by various methods: DICOM, disk, video, etc. From this data the patients' anatomical structures and tumor site is contoured in order to generate a 3D patient model, or x-ray films are used for 2D reconstruction of the implant area. Following the import of images, the next steps in the process will be to define the treatment machine, reconstruct implant applicators or define template and seed location. From this inframating the user will select the appropriate source (afterloading or seed) to be used for the planning session. Based on the target volume or reconstructed implant, treatment source and prescription dose the treatment plan will be calculated and a dose distribution will be displayed. This treatment plan can be modified by the physician prior to final output and patient treatment. The physician approved treatment plan is then printed out, machine data generated (for remote afterloading) and a hard copy of the isodose distribution is prepared for the patients' permanent record. The patient data is then saved unter a unique file name in the patient database. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.

This 510(k) submission (K093391) for the SIMUPLAN Treatment Planning System is a Special 510(k), indicating modifications to an already cleared device. As such, the submission primarily focuses on demonstrating that the modified device remains substantially equivalent to the predicate device and that the changes do not introduce new questions of safety and effectiveness. It does not present a typical clinical study with acceptance criteria and reported device performance in the way a novel device submission might.

Instead, the "study" referred to here is the analysis of technological considerations and comparison to the predicate device to demonstrate substantial equivalence for the updated software version (8.4) compared to version 7.5 (K030821).

Here's the information based on the provided document, acknowledging the nature of a Special 510(k) for a software update:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics for a clinical study. For a software update in a Special 510(k), acceptance criteria often relate to:

• Verification and validation (V&V) of the software changes: Ensuring the new features work as intended and that existing functionality is not degraded.
• Comparison to predicate device: Demonstrating that the modified device's performance characteristics are substantially equivalent to the predicate device.
• Risk analysis: Confirming that the modifications do not introduce new or increased risks.

Given the document, the primary "performance" reported is related to functional equivalence and the update of specific modules.

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

• Test Set Sample Size: Not applicable in the context of a typical clinical performance study. For software verification and validation, testing would involve internal test cases and scenarios, but a "test set" from patient data for performance evaluation against a ground truth is not described.
• Data Provenance: Not applicable. The submission refers to image sets (CT, MR, US, x-ray films) that can be imported but does not detail the provenance of data used for internal software testing.

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

• Number of Experts: Not applicable. No external expert-adjudicated test set is described.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No external expert review or adjudication process for a test set is described.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this submission. This type of study is typically done to assess the impact of AI or new technology on human reader performance, which doesn't align with this software update.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone performance study (algorithm only, without human-in-the-loop) was not conducted or reported in this submission. This device is a treatment planning system, meaning its output is always intended to be confirmed and used by a physician (human-in-the-loop).

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for a clinical performance study. For a treatment planning system, accuracy is often validated against physical measurements, phantom studies, and theoretical calculations, or by comparing outputs to clinically accepted standards and predicate devices. The document implies that the "ground truth" for the software's functionality is its ability to accurately process patient image data, reconstruct anatomical structures, define treatment parameters, calculate and display dose distributions consistent with established radiotherapy physics principles, and align with the performance of its predicate.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. As a rule-based or physics-based treatment planning system, it likely does not involve a "training set" in the machine learning sense. The software's algorithms are built upon established physics models and principles, not trained on a dataset of cases.

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

• Ground Truth for Training Set: Not applicable. See point 8. The "ground truth" for the underlying algorithms would be derived from fundamental physics, dosimetry principles, and clinical standards in radiation oncology rather than a data-driven training process.

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SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient, all information must be confirmed by the physician prior to treatment.

SIMUPLAN Treatment Planning System is a computer based software that runs on a MacIntosh platform. The planning system is comprised of 2 main components; external beam and brachytherapy.

The patients' transverse slices (i.e. CT, MR) or x-ray films are imported to the system from various methods: DICOM, disk, video, scanner. From this data the patient anatomical structures and tumor site is contoured in order to generate a 3D patient model, or x-ray films displaying the implant area are imported for standard brachytherapy treatment planning. The following step in the process will be to define the treatment machine, applicators, template, seed location, or isocenter. From this information the user will select the appropriate source (brachytherapy) or beam data (linear accelerators) to be used for the planning session. Based on the target volume or reconstructed implant, the treatment source (external beam or radioactive source) and prescription dose the treatment plan will be calculated and a dose distribution will be displayed. The physician is capable of fine tuning this treatment plan before final output. The approved treatment plan is then printed out, a program card written (remote afterloading) and a hard copy of the isodose distribution is prepared for the patients' permanent record. The patient data is then saved under a unique file name in the patient data base. The program output does not directly treat the patient, all information must be confirmed by the physician prior to treatment.

This 510(k) premarket notification for the SIMUPLAN Treatment Planning System does not include information about specific acceptance criteria or a study proving its performance against such criteria.

The document is a summary of safety and effectiveness information, focusing on demonstrating substantial equivalence to predicate devices (Nucletron B.V. PLATO Brachytherapy K983343 and PLATO SRS K010784). It describes the device's functionality and intended use but does not detail a performance study with acceptance criteria.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily serves to establish the device's intended use and technological equivalence for regulatory clearance, not to present a detailed performance evaluation study.

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