(26 days)
RadCalc has the following intended uses:
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RadCalc performs a secondary dose calculation verification on the treatment plan done by the treatment planning software. This is RadCalo's primary function. Radiation therapy systems typically calculate the monitor units needed to deliver the desired amount of radiation to a point of reference within the patient. In this situation, RadCale will serve to validate those monitor units computed by the primary radiation therapy planning system. Additional verification activities revolve around point dose comparisons, 3D dose evaluation via Gamma analysis, and DVH comparisons. It is not the intention of RadCalc to replace the calculation performed by the primary radiation therapy planning computer but to validate its calculation as a means of quality assurance. The practice of performing a secondary check is recommended by the American Association of Physicis in Medicine (AAPM) Task Group 40 as part of a good quality assurance program. This practice is an important aspect in providing quality patient care.
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Import data from the treatment planning software and export the treatment planning system to the verify and record system, which is the device that actually controls the radiation beam. This will reduce the number of errors that occur as a result of manually inputting this data.
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In addition to performing the secondary dose verification calculation, RadCalc can also be used as the primary means of calculating monitor units in situations where the physician does not order the use of a radiation therapy treatment plan. RadCalc can independently calculate the amount of radiation the beam should produce (called the MU or monitor unit) to deliver to the patient the radiation dose the doctor recommends. This function is usually only used in urgent, emergency situations.
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In addition, RadCalc performs brachytherapy-type calculations. For brachytherapy calculations, High Dose Rate (HDR), Low Dose Rate (LDR), and Permanents can be verified. Verification activities revolve around point dose comparisons, 3D dose evaluation via Gamma analysis, and DVH comparisons. RadCalc is not used as a primary means of calculating patient dose for brachytherapy treatments.
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Analysis of fluence and dose maps can be percentage difference, distance to agreement, or gamma analysis methodologies.
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Interoperability with external dose calculation engines (EDCE) by sending them treatment plans and associated information in their necessary format so that the EDCE can perform a 3D dose calculation using its dose calculation algorithm. The computed dose volume is received back and the 3D analysis tools described above are used to compare against the treatment planning system.
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This FDA 510(k) clearance letter for "RadCalc Software, Version 7.1" primarily focuses on regulatory approval and substantial equivalence to predicate devices. It does not contain the detailed information about acceptance criteria, specific study designs, or performance metrics that would be necessary to answer the questions thoroughly.
The document describes the intended uses of the device, which are mainly for secondary dose calculation verification in radiation therapy planning, import/export of data, primary MU calculation in emergencies, brachytherapy calculations, and analysis of fluence/dose maps. However, it does not provide the results of any performance studies demonstrating how well the device meets these functions against specific criteria.
Therefore, for almost all of the requested information, the answer will be "Information not available in the provided document."
Here is a breakdown based on the provided text, indicating where information is missing:
Acceptance Criteria and Study Information for RadCalc Software, Version 7.1
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Not specified in this document. Not specified in this document. Explanation: The document describes the "Indications for Use" but does not define specific quantitative or qualitative acceptance criteria that the device was evaluated against, nor does it present the device's performance against such criteria.
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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: Information not available in the provided document.
- Data Provenance (Country of origin, retrospective/prospective): Information not available in the provided document.
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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)
- Information not available in the provided document. The document refers to recommendations by the "American Association of Physicists in Medicine (AAPM) Task Group 40" as part of good quality assurance, implying the device aligns with general best practices, but it does not detail an expert panel or their qualifications for ground truth establishment in a specific study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Information not available in the provided document.
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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
- Information not available in the provided document. Given the description of the device as a secondary dose calculation verification software, it is unlikely to involve "human readers" in the sense of interpreting images for diagnosis. Its role is to validate machine-calculated monitor units and doses.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The primary function described for RadCalc is a "secondary dose calculation verification" and independently calculating monitor units in specific situations. This inherently describes a standalone algorithmic function. However, the document does not provide details of a specific "standalone performance study" with metrics and results. It implies that the functionality is standalone, but not the study design.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Information not available in the provided document. For a dose calculation verification software, "ground truth" would typically refer to highly accurate measurements or calculations from a gold-standard system, or potentially clinical outcomes data if assessing accuracy impacting treatment efficacy. The document does not specify.
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The sample size for the training set
- Information not available in the provided document. As a dose calculation and verification software, it's possible its development involves extensive testing and validation against known physics models and data, rather than a traditional "training set" in the machine learning sense. The document does not clarify this.
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How the ground truth for the training set was established
- Information not available in the provided document.
§ 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.