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RadCalc has the following intended uses:

1. 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.

2. 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.

3. 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.

4. 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.

5. Analysis of fluence and dose maps can be percentage difference, distance to agreement, or gamma analysis methodologies.

6. 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

1. 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.

2. 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.

3. 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.

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

   • Information not available in the provided document.

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

   • 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.

6. 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.

7. 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.

8. 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.

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

   • Information not available in the provided document.

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RadCalc Software is a program utilized in a radiation therapy department for the determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. For external beam treatments, RadCalc's monitor unit calculation can be used to validate the monitor units or dose previously determined by hand or by the primary radiation therapy planning system. RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc Software not only performs this secondary function but can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.

RadCalc Software imports treatment planning parameters from the primary treatment planning system or a verify and record system; parameters can also be entered manually. The dosimetric calculations are then performed for photon or electron external beam radiation plans or LDR, HDR, and Permanent Implant brachytherapy treatment plans. The brachytherapy treatment module is only used to validate the dose to points of interest and not for brachytherapy treatment planning.

RadCalc Software allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system (system actually controlling the radiation beam) to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data.

The RadCalc Software is a stand-alone program or operating from a server that provides determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. RadCalc is designed to work on personal computers in a Windows operating system that is connected directly to the primary radiation therapy planning system. The program makes the task of performing independent Monitor Unit validations much faster, easier, and more accurate. RadCalc determines the monitor units or dose through the process of looking data up from previously input tables or data curves.

RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.

RadCalc allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data. The software does not control any radiation hardware device, but does interface with the primary radiation therapy planning software and the Verify and Record software.

The provided 510(k) summary for RadCalc Software (K090531) indicates that no formal acceptance criteria or a traditional clinical study were conducted to prove the device meets specific performance criteria in the way a diagnostic or image analysis AI would.

Instead, the submission focuses on substantial equivalence to predicate devices and non-clinical software verification and validation. The device is a "Medical Charged Particle Radiation Therapy System - Accessory" and primarily functions as a quality assurance tool for validating Monitor Units (MUs) or radiation doses calculated by primary radiation therapy planning systems.

Here's a breakdown based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

No specific, quantified acceptance criteria (e.g., sensitivity, specificity, accuracy targets) are provided in the document for the RadCalc Software. The "performance" is implicitly tied to successfully passing software verification and validation tests as per FDA guidelines, demonstrating that it calculates MUs and doses in alignment with its design specifications and existing clinical practice.

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

The document does not specify a "test set" in the context of clinical data or patient cases with ground truth labels. The testing appears to be software-centric functional testing rather than clinical performance evaluation.

• Sample Size: Not applicable in the traditional sense of patient data. The testing was against "established Software Design Specifications" and involved functional tests of the software's calculation capabilities and data transfer.
• Data Provenance: Not applicable. No patient data or clinical imagery was used for performance evaluation as described. The testing involved "a brachytherapy treatment planning system" for verification, implying simulated or synthetic data reflective of typical treatment planning scenarios.

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

Not applicable. The "ground truth" for this software hinges on the correctness of its calculations against known physics principles and established radiation dosimetry standards, not expert interpretation of clinical data. The process involves comparing the software's calculated Monitor Units/doses against expected values derived from physics equations or existing, validated systems.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring expert adjudication.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This device is not an AI/CAD system designed to assist human readers in interpreting clinical data or images. It is a calculation validation tool. Therefore, an MRMC study comparing human performance with and without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The "testing" described is essentially the standalone performance of the software. The software's function is to perform calculations independently. Its "performance" is measured by its ability to accurately output these calculations according to its design specifications. This is inherent to the type of device (a calculation validation software), where the algorithm is the primary component being evaluated for correctness.

7. The Type of Ground Truth Used

The ground truth used for this software's validation would be:

• Physics-based calculations / Dosimetry principles: The expectation that the software correctly applies established radiation physics formulae to calculate monitor units and doses.
• Reference data/tables: The software relies on looking up data from "previously input tables or data curves," suggesting that these reference data themselves serve as part of the ground truth for its internal look-up functions.
• Comparison to existing, validated systems: The fact that it validates calculations from a "primary radiation therapy planning system" implies that the accuracy of those primary systems (or accepted gold standards in dosimetry) would form the basis for comparison.
• Software Design Specifications: The software being tested against its own design specifications implies these specifications serve as the "ground truth" for its intended functional behavior.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm in the contemporary sense that requires a "training set" of data. It is a deterministic software program that performs calculations based on explicit rules and stored data (tables/curves), not by learning from examples.

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

Not applicable, as there is no training set.

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