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MuCheck is an independent computer based verification of the monitor unit or dose calculated by the primary radiation treatment planning system.

The intended use of the MuCheck software has been extended to include an optional module, MuCheck/TomoCheck to independently verify the dose for single point that has been previously calculated by the Tomotherapy Hi Art treatment planning system or other points as determined by the physicist.

The MU Check Program is a software program that is designed to operate on an-IBM compatible personal computer in a Windows environment. It has been designed to operate either in a stand alone mode independent of the treatment planning system or to import plans from the treamment planning system. It does not connect to or control any radiation hardware device. MUCheck performs dose calculations to verify the dose calculated by the primary radiation teament planning system. The functionality of the MUCheck program is being extended to include calculations for the Tomotherapy Hi Art system, by this submission.

The provided text describes the MuCheck V9 device, which is a software program designed for dose validation in radiation therapy. The submission specifically details the extension of its functionality to include calculations for the Tomotherapy Hi Art system, through an optional module called TomoCheck.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "All system specifications were met and testing performed to demonstrate substantial equivalence." It also mentions, "The non-clinical tests were conducted using the treatment planning system and MU Check TomoCheck module. The test results all matched very closely which supports the claim of substantial equivalence. See Figure 6.0 in section 6 for comparison summary."

Although the specific numerical acceptance criteria (e.g., maximum percentage difference in dose calculation) and the detailed reported performance are not directly provided in the text, the general statement indicates that the MuCheck TomoCheck module performed within acceptable limits when compared to the primary Tomotherapy Hi Art system's calculations. The "very closely matched" outcome implies a high degree of concordance.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: The document does not specify the exact number of test cases or "plans" used for the non-clinical tests. It broadly refers to "the non-clinical tests were conducted using the treatment planning system and MU Check TomoCheck module."
• Data Provenance: The document does not provide details on the origin of the data used for testing (e.g., specific treatment plans, patient data, retrospective or prospective). It only states that the tests were conducted with the "treatment planning system."

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

• Number of Experts: Not applicable or not specified.
• Qualifications of Experts: Not applicable or not specified.

This device is a software for dose calculation verification, not an interpretation device requiring expert human evaluation to establish ground truth for image or clinical findings. The ground truth for its evaluation would be the calculations from the established primary treatment planning system (Tomotherapy Hi Art).

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable.

Similar to the previous point, this device's performance is gauged against a programmatic or calculated ground truth from another system, not against a ground truth established by human adjudicators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No.
• Effect Size of Human Readers Improvement: Not applicable.

The MuCheck V9 is a standalone dose validation software. Its function is to provide a secondary, independent check of dose calculations, not to assist human readers in interpreting data or making diagnoses. Therefore, an MRMC study comparing human performance with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

• Standalone Performance: Yes. The entire "Non-clinical tests" section describes the evaluation of the MuCheck TomoCheck module's performance in calculating doses compared to the primary treatment planning system. This is an assessment of the algorithm's standalone capability. The software operates independently to perform these calculations.

7. Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for evaluating MuCheck V9 (TomoCheck module) was the dose calculations performed by the primary radiation treatment planning system (specifically the Tomotherapy Hi Art system). The document states, "The non-clinical tests were conducted using the treatment planning system and MU Check TomoCheck module. The test results all matched very closely which supports the claim of substantial equivalence." This implies that the calculations from the Tomotherapy Hi Art system served as the reference standard.

8. Sample Size for the Training Set:

• Sample Size: Not specified.

The document focuses on the verification and validation of the software. While software like this would have undergone extensive internal development and testing, information about a specific "training set" in the context of machine learning, or a distinct training phase, is not provided. Given the nature of a dose calculation verification tool, its development likely involved rigorous algorithmic design and parameter tuning based on radiation physics principles rather than a traditional machine learning training set as might be found with image recognition AI.

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

• How Ground Truth Was Established: Not specified.

As mentioned above, the concept of a "training set" with established ground truth in the typical machine learning sense is not explicitly discussed for this type of software. Its development would rely on accurate implementation of physics-based dose calculation algorithms.

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MuCheck is an independent computer based verification of the monitor unit or dose calculated by the primary radiation treatment planning system.

The intended use of the MuCheck software has been extended to include an optional module, Gamma-Knife QA Check to independently verify the dose for single or multiple points that have been previously calculated by the Gamma Knife treatment planning system or other points as determined by the physicist.

The Gamma-Knife QA Check Program is a software program that is designed to operate on an IBM compatible personal computer in a Windows environment. It has been designed to onerate either in a stand alone mode independent of the Gammaknife treatment planning grown or to import plans from the GammaKnife treatment planning system. It does not connect to a control any radiation hardware device. Gamma Knife QA Check performs dose calculations to verify the dose calculated by the primary GammaKnife radiation treatment planning system.

The provided K091602 document focuses on the substantial equivalence of the "Mucheck Gamma-Knife QA Check" software to predicate devices. It describes the device's function as a quality assurance tool for verifying dose calculations in Gamma-Knife radiation treatment planning.

However, the document explicitly states:
"Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness."

This crucial statement means that a formal study demonstrating the device meets specific acceptance criteria based on clinical performance data (like those typically associated with medical imaging or diagnostic AI) was not performed or required for this 510(k) clearance.

Instead, the submission relied on non-clinical verification and validation tests.

Therefore, I cannot provide all the requested information because the nature of this 510(k) submission does not involve:

1. A table of acceptance criteria and reported device performance based on clinical or comparative studies. The "acceptance criteria" here refer to internal system specifications and matching results with the primary planning system.
2. Sample size for the test set and data provenance: No clinical test set.
3. Number of experts and their qualifications for ground truth: No clinical ground truth established.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not performed. This device is a software tool for dose calculation verification, not a diagnostic aid for human readers.
6. Standalone performance study: The non-clinical tests compared the device's calculations to the primary planning system.
7. Type of ground truth used: For non-clinical tests, the "ground truth" was the expected calculation results or the results from the primary Gamma-Knife treatment planning system.
8. Sample size for the training set: As the device performs deterministic dose calculations based on established physics principles, it is highly unlikely to involve a "training set" in the machine learning sense. The software would be developed and verified against known physics models and calculation engines.
9. How ground truth for the training set was established: Not applicable in the context of a machine learning training set.

Based on the provided document, here's what can be inferred or directly stated regarding performance and verification:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Focus)

• Note: The document only mentions "All system specifications were met" and "test results all matched very closely." It does not provide specific quantitative acceptance criteria or detailed performance metrics in the format of a clinical study. The criteria were likely internal for software verification.

2. Sample size used for the test set and the data provenance:

• Test Set Size: Not explicitly stated. The document refers to "non-clinical tests" conducted using "the Gamma-Knife treatment planning system and Gamma-Knife QA Check." This implies a set of test cases or scenarios were run, but the number is not quantified.
• Data Provenance: Not applicable in terms of patient data or clinical images. The "data" would be input parameters for dose calculation, derived from configurations or plans within the Gamma-Knife treatment planning system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no clinical ground truth was established by external experts. The verification likely involved internal engineers or physicists ensuring the software's calculations aligned with expected physics models or the predicate device's calculations.

4. Adjudication method for the test set:

• Not applicable. This device is a software calculator, not a diagnostic tool requiring expert adjudication.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a dose calculation verification software, not an AI-powered diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, in essence. The "non-clinical tests" evaluated Gamma-Knife QA Check's calculations directly against those of the primary Gamma-Knife treatment planning system. This constitutes an "algorithm only" comparison for its intended function (dose calculation verification).

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" was effectively:
  • Expected scientific/physics calculations: The software's output was compared against established radiation physics models.
  • Predicate device's calculations: The results were compared to the primary GammaKnife treatment planning system (which itself would have been verified and validated).

8. The sample size for the training set:

• Not applicable. This device performs deterministic calculations based on algorithms for radiation dose, not machine learning that requires a "training set" of data.

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

• Not applicable. As it's not a machine learning model, there is no "training set" or corresponding ground truth establishment in that context. The "ground truth" for the software's development and internal validation would stem from established radiation physics principles and previous, validated dose calculation methods.

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In a radiation therapy department, a course of patient treatment is prescribed by a written directive from a radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the radiation therapy. As part of the planning process monitor unit settings and dose to a volume or specific anatomical points will be generated.

The MuCheck - Monitor Unit/Dose validation Software verifies the monitor unit or dose calculated by the primary treatment planning system. MuCheck can also be used to calculate the monitor or dose for simple plans that do not require the use of the primary treatment planning system.

The intended use of the MuCheck software has been extended by the addition of an optional module called BrachyCheck. Brachycheck is used to verify brachytherapy procedures(implants using radioactive sources) performed by a brachytherapy treatment planning system. As part of the planning process, dwell positions will be generated and dose contributions from these dwell positions to specified anatomical points will be calculated.

The BrachyCheck module (device under review) verifies the dose calculated to the specified points by the primary treatment planning system. It serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.

The BrachyCheck Dose Validation module is an optional software module that is part of the MuCheck software. MuCheck is designed to operate on a personal computer in a Windows environment. It has been designed to operate either in a stand alone mode independent of any brachytherapy treatment planning system or to import plans from a brachytherapy treatment planning system. It does not connect to or control any radiation hardware device. BrachyCheck performs dose calculations to verify the dose calculated by the primary radiation brachytherapy treatment planning system.

The provided text describes the MuCheck - Monitor Unit/Dose Validation Program, with a specific focus on the BrachyCheck Dose Validation module. The information provided outlines the regulatory submission for premarket notification (510(k)) and details about its intended use and a summary of safety and effectiveness.

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

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

The document does not explicitly state a specific sample size for a "test set" in the context of typical clinical study reporting. The evaluation appears to be based on non-clinical tests comparing BrachyCheck's calculations to those of a brachytherapy treatment planning system or hand calculations.

• Test Set Size: Not explicitly stated as a number of cases or plans. It refers to "tests" that were "conducted using a brachytherapy treatment planning system or hand calculations and BrachyCheck."
• Data Provenance: The data used for these non-clinical tests would be internally generated or from established brachytherapy treatment planning systems and hand calculations. The origin is not specified as a country, and it is inherently retrospective in the sense that it evaluates the device against existing calculation methods rather than collecting new patient data.

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

The ground truth for the non-clinical tests appears to have been established by:

• "A brachytherapy treatment planning system": These are established systems used in clinical practice, which serve as a de facto "expert" in terms of established calculation methods.
• "Hand calculations": These would be performed by qualified medical physicists or dosimetrists. The document mentions "The staff at Oncology Data Systems includes a certified medical dosimetrist with over 34 years of clinical experience." While not explicitly stated that this individual established the ground truth for every test case, their expertise underpins the company's capabilities and the validity of hand calculations.
• Number of Experts: Not explicitly stated for specific test cases. It implies reliance on output from existing validated systems and potentially multiple dosimetrists/physicists for hand calculations.
• Qualifications: For hand calculations, the internal expertise includes a "certified medical dosimetrist with over 34 years of clinical experience."

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "tests results all matched very closely" implies a direct comparison rather than an adjudicated consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Summary of Clinical Testing: Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness." The evaluation was based on non-clinical tests. Therefore, no effect size of human readers improving with AI vs. without AI assistance is applicable or reported.

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

Yes, a standalone (algorithm only) performance evaluation was done. The BrachyCheck module is a software tool that performs calculations and verifies doses. The non-clinical tests directly compare its computational output to existing systems or hand calculations. It functions as a "standalone mode independent of any brachytherapy treatment planning system" for its verification task. The results reported ("test results all matched very closely") refer to the algorithm's performance in this standalone capacity.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests was based on:

• Established gold standard calculations: Output from a "primary radiation brachytherapy treatment planning system."
• Expert hand calculations: Performed by qualified personnel (e.g., certified medical dosimetrist).

This implicitly represents a form of expert consensus or established methodologies rather than pathology or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a training set or machine learning components. BrachyCheck appears to be a deterministic software system that performs dose calculations based on established physics algorithms, not a machine learning model that requires training data.

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

Since no training set is mentioned (as the device is not described as involving machine learning), this question is not applicable to the provided information.

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The muCheck - Monitor Unit Validation Program (the device under review) verifies the monitor unit or dose calculated by the primary treatment planning system. It serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.

The Intensity Modulated Radiotherapy and Diode corrections features added to the program to verify dose calculations performed by the primary treatment planning system.

The muCheck Monitor Unit Validation Program is a software program that is designed to operate on an IBM compatible personal computer in a Windows environment. It has been designed to operate on a stand alone mode independent of any radiation treatment planning system. It does not connect to or control any radiation hardware device. MuCheck performs monitor unit and dose calculations to verify the monitor unit and dose calculated by the primary radiation treatment planning system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the muCheck - Monitor Unit Validation Program:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria for the muCheck device. Instead, it focuses on demonstrating "substantial equivalence" to predicate devices. The performance is broadly described as matching "very closely" with existing systems.

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

• Sample Size: The document does not specify the exact sample size (number of cases or calculation scenarios) used for the non-clinical tests. It vaguely refers to "All system specifications were met and testing performed."
• Data Provenance: The data provenance is not explicitly detailed. The tests were "conducted using a treatment planning system or hand calculations and muCheck." This implies simulated or computed data rather than patient-specific retrospective or prospective clinical data. There is no mention of country of origin, as it's not clinical data in the traditional sense.

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

• Number of Experts: Not explicitly stated for establishing ground truth for the test set.
• Qualifications: The "ground truth" for the test set appears to be generated by existing "treatment planning systems or hand calculations." The document mentions that "The staff at Oncology Data Systems includes a certified medical dosimetrist with over 23 years of clinical experience" and a "systems analyst with over 23 years of experience." While these individuals have relevant qualifications, it's not specified if they were directly involved in establishing the ground truth for the test set beyond their role in overall design and development.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. Given that the ground truth originated from existing treatment planning systems or hand calculations, a human adjudication process in the traditional sense would not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was one done? No. The document explicitly states: "Summary of Clinical Testing: Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness."
• Effect size of human readers with AI vs. without AI assistance: Not applicable, as no MRMC or clinical study was performed. The device is a software quality assurance tool, not one designed to be used by human readers for diagnostic interpretation.

6. Standalone Performance Study

• Was one done? Yes, effectively. The device is described as operating "on a stand alone mode independent of any radiation treatment planning system." The non-clinical tests compared muCheck's calculations against those of "a treatment planning system or hand calculations." This comparison effectively served as a standalone performance assessment to demonstrate its ability to verify calculations independently.

7. Type of Ground Truth Used

The ground truth used was based on the calculations performed by "a treatment planning system or hand calculations." This can be considered a form of expert consensus/established calculation standards within the field of radiation therapy physics, as these methods are accepted practices for determining monitor units and doses.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This is because muCheck is a deterministic calculation software, not a machine learning model that requires training data. It performs calculations based on established physics algorithms relevant to radiation therapy.

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

Not applicable, as there is no "training set" in the context of this deterministic software. Its accuracy relies on correct implementation of physical models and algorithms, not on learning from data.

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