(54 days)
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.
| Acceptance Criteria (Implied for Special 510(k) Software Update) | Reported Device Performance (as per submission) |
|---|---|
| Functional Equivalence to predicate device (v7.5) | "SIMUPLAN Treatment Planning System version 8.4 is substantially equivalent to the cleared predicate device, SIMUPLAN Treatment Planning System version 7.5, (#K030821)." |
| Software Module Stability/Integrity after updates | The submission covers "colors and module update only. The external beam software not included in this release." This implies the updated modules function correctly and existing (external beam) functionality is unaffected. |
| Intended Use Maintained | The intended use for preparing individual treatment plans for radiation therapy (external beam or brachytherapy) remains the same. The output still requires physician confirmation before treatment. |
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.
§ 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.