(104 days)
ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.
The ClearCalc device (model RADCA) is software intended to assist users in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation. The treatment plans are obtained from supported Treatment Planning System and Application Programming interfaces. It is designed to run on the Windows Operating System. ClearCalc performs calculations on the treatment plan data obtained from supported Treatment Planning System and Application Programming interfaces. A Treatment Planning System is software used by trained medical professionals to install and simulate radiation therapy treatments for malignant or benign diseases.
The provided document describes the Radformation ClearCalc device (K193640), a software intended to assist radiation treatment planners in determining the accuracy of their treatment planning calculations.
Here's an analysis of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct comparison of ClearCalc's performance against such criteria in a tabular format. Instead, it focuses on demonstrating substantial equivalence to a predicate device, RadCalc (K090531), through a comparison of technological characteristics and functionalities.
The "Performance Data" section (5.7) states:
"As with the Predicate Device, no clinical trials were performed for ClearCalc. Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements."
This indicates that internal verification tests were conducted, likely against pre-defined pass/fail criteria for the software's functionality and accuracy in calculating Monitor Units (MU) and dose. However, the specific metrics, thresholds, and numerical results of these tests are not provided in this document.
The "Substantial Equivalence ClearCalc vs. RadCalc" table (Table 3) highlights functional similarities and minor differences, which implicitly form the basis of the performance evaluation for regulatory submission.
| Parameter | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (ClearCalc) |
|---|---|---|
| Photon MU and Dose Calculation | - Utilize an independent calculation algorithm to recalculate MU/Dose on a per-field basis. |
- Provide accurate MU/Dose calculations for external beam radiation therapy.
- Account for patient geometry and heterogeneity corrections. | - Utilizes a Finite-Size Pencil Beam (FSPB) algorithm to calculate MU/Dose on a per-field basis.
- Utilizes the full 3D geometry of the patient for heterogeneity corrections and simulating scatter conditions.
- Calculates dose from fields in a plan and displays results for per-field MU and provides a difference metric for evaluation in tabular format.
- Allows evaluation of global point doses, as well as per-field doses.
(No specific accuracy numbers or pass/fail thresholds are provided in this document, but implied to be sufficient based on "works as intended" and comparison to predicate.) |
| Electron MU and Dose Calculation | - Utilize an independent calculation algorithm to recalculate MU/Dose on a per-field basis. - Provide accurate MU/Dose calculations for electron external beam radiation therapy.
- Account for custom cutouts and compute cutout factors. | - Utilizes a library of custom cutouts and computes cutout factors using a sector integration method.
- Calculates dose based on electron field parameters and cutout geometry, and displays results for per-field MU and dose and provides a difference metric for evaluation in tabular format.
(No specific accuracy numbers or pass/fail thresholds are provided, implied to be sufficient.) |
| Brachytherapy Dose Calculation | - Utilize an independent calculation algorithm to recalculate dose from radioactive sources. - Adhere to a recognized protocol (e.g., AAPM TG-43) for brachytherapy dose calculations.
- Provide dose calculations to arbitrary points and difference metrics. | - Utilizes the AAPM TG-43 protocol for its brachytherapy dose calculations.
- Calculates dose to arbitrary calculation point locations and presents difference metrics comparing the TPS dose vs. ClearCalc dose in a tabular format.
(No specific accuracy numbers or pass/fail thresholds are provided, implied to be sufficient.) |
| Overall Functionality | - Software works as intended without errors. - Provides reliable independent verification of treatment planning calculations. | - "Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements." (No specific details on test outcomes or criteria provided).
- "Verification and Validation testing and Hazard Analysis demonstrate that ClearCalc is as safe and effective as the Predicate Device."
(Implied successful performance under internal testing). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Verification tests were performed to ensure that the software works as intended".
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention using experts to establish ground truth for a test set. The performance evaluation seems to be based on internal verification against expected computational outcomes, rather than expert-derived ground truth from patient cases.
4. Adjudication Method
The document does not mention any adjudication method, as no expert review or consensus process for ground truth establishment is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or described in the document. The device is a "standalone" software tool for verifying treatment plans, and its primary function is independent calculation, not assisting human readers in interpreting images or making diagnostic/treatment decisions that would typically be evaluated with MRMC studies.
6. Standalone Performance Study
A standalone performance study of the algorithm (i.e., algorithm only without human-in-the-loop performance) was performed implicitly through "Verification tests." The document states, "Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements." However, concrete details, metrics, and quantitative results of this standalone performance are not provided. The entire submission focuses on demonstrating substantial equivalence, implying that its standalone performance would be comparable to the predicate device's independently calculated MU/dose values.
7. Type of Ground Truth Used
The type of ground truth used appears to be calculated ground truth or computationally derived truth. The ClearCalc software performs calculations based on established physics principles (Finite-Size Pencil Beam algorithm, AAPM TG-43 protocol) to verify the output of a primary Treatment Planning System (TPS). The "ground truth" for the verification tests would logically be the expected accurate MU/dose values as determined by these internal algorithms and validated against known calculation methodologies, rather than pathology, outcomes data, or expert consensus from clinical cases.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This suggests that the ClearCalc software likely relies on deterministic algorithms (e.g., Finite-Size Pencil Beam, AAPM TG-43) which are coded based on physical models and parameters, rather than being "trained" on a dataset in the manner of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned, the method for establishing its ground truth is not applicable/not provided. The device's functionality is based on direct implementation of physics models and calculations.
§ 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.