(34 days)
The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification.
The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machinespecific data and are intended to provide a quide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.
The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.
The modification described in this premarket notification consists of a change to the operating system upon which the device operates. The currentlymarketed CORVUS System utilizes the NextStep operating system, while the modified device runs on the Macintosh OS X (Mac OSX) operating system. This change did not modify the intended use of the device or the fundamental scientific technology of its design. Testing performed demonstrates that the modified device produces clinically equivalent results. Therefore, this change does not affect the safe and effective use of the device within its prescribed indications.
The provided text describes a 510(k) premarket notification for the NOMOS CORVUS 5.0M System, which is a Radiation Therapy Treatment Planning System. The core of this submission is a modification to the operating system from NextStep to Macintosh OS X (Mac OSX), with the claim that this change did not modify the intended use or fundamental scientific technology, and that testing demonstrates clinically equivalent results.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the modification to the CORVUS system (changing the operating system) did not modify the intended use, fundamental scientific technology, or performance specifications. Therefore, the "acceptance criteria" are implicitly that the new system performs at least equivalently to the predicate device (the currently marketed CORVUS System) and adheres to its existing performance specifications.
| Performance Characteristic/Acceptance Criteria | Reported Device Performance (CORVUS 5.0M System) |
|---|---|
| Intended Use | Unchanged from predicate device. Still a radiation treatment planning package for creating conformal plans using photon (x-ray) external beam radiation therapy, guiding delivery to the target volume. |
| Fundamental Scientific Technology | Unchanged from predicate device. |
| Performance Specifications | Same as the currently-marketed CORVUS System. |
| Clinical Equivalence | "Testing performed demonstrates that the modified device produces clinically equivalent results." This implies that the output of the new system (treatment plans) is medically indistinguishable from the output of the predicate device. |
| Safety and Efficacy | Hazard analysis and testing determined that the modification "does not raise any new issues of safety or efficacy for the device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). It generally refers to "testing performed" and "hazard analysis and testing" without providing specific details about the dataset or methodology.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications to establish ground truth for any testing. Given the nature of the device (a treatment planning system), expert review would typically involve medical physicists and radiation oncologists, but this is not explicitly mentioned.
4. Adjudication Method for the Test Set
The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is not a diagnostic device where human readers interpret images, but rather a treatment planning software. The focus is on the equivalence of the software's output to the previous version, not on human interpretive improvement.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
Yes, a standalone performance study was implicitly done. The "testing performed" to demonstrate clinical equivalence would involve comparing the output of the CORVUS 5.0M (algorithm only on the new OS) against the output of the predicate CORVUS system (algorithm only on the old OS). The claim is that the device itself, functioning on the new OS, produces equivalent results. There is no mention of a "human-in-the-loop" component to this specific performance evaluation, as the change is at the operating system level, not the core algorithms or user interaction for treatment planning.
7. Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate CORVUS System. The new CORVUS 5.0M System's performance was compared against the established, accepted performance of the previous version. This is a case of device-to-device equivalence, where the "truth" is what the previously cleared device produces, and the goal is to show the modified device produces the same "truth." This would involve comparing the treatment plans (e.g., dose distributions, conformality indices, etc.) generated by both systems for the same input data.
8. Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning or AI models. This device is a treatment planning system based on algorithms, not a machine learning model that undergoes a training phase with a dataset. The system uses "treatment machine-specific data" for its calculations, which is more akin to calibration data for physics models than a training set for an AI.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The device's calculations are based on "treatment machine-specific data," which would be established through appropriate calibration and commissioning procedures for the radiation therapy machines it interfaces with.
§ 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.