Search Results

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.

Ask a specific question about this device

The intended use for the muCheck Monitor Unit Validation Program is the same as for the predicate device: to calculate a monitor unit or timer setting for the purpose of validating a monitor unit or timer setting previously calculated by a primary radiation treatment planning system or hand calculation. The intended use is as a quality assurance tool only and not as a treatment planning device.

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.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state numerical acceptance criteria in a structured table. However, the core acceptance criterion is substantial equivalence to a predicate device, specifically the "K & S Associates, PC Setup Program (510(k) K 914698)".

The "reported device performance" is the claim that muCheck's calculations "matched very closely" with those of the predicate device and the manual/treatment plan calculations.

Study Details

The document describes two types of testing to support the claim of substantial equivalence: Non-clinical tests and Beta Clinical Testing.

1. Sample Size Used for the Test Set and the Data Provenance:

   • Non-clinical tests: The document doesn't specify a numerical sample size for the test set. It mentions "each test was further validated using a treatment plan which provide a monitor unit or hand calculation." This implies multiple test cases were used, but the exact number is not stated.
   • Data Provenance: The data provenance is not explicitly stated. The tests seem to be internal comparisons of calculations, rather than using patient-derived data directly.

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

   • Non-clinical tests: The ground truth for these tests was established by comparison to the predicate device's calculations and "treatment plan which provide a monitor unit or hand calculation." The involvement of specific experts for establishing this ground truth for each test case is not detailed. However, the overall development involved:
     • A certified medical dosimetrist with over 20 years of experience.
     • A systems analyst with over 20 years of experience in design and development of systems.
     • It can be inferred that these individuals, or similar qualified personnel, would have been involved in verifying the accuracy of the manual/treatment plan calculations.

3. Adjudication Method for the Test Set:

   • The document does not describe a formal adjudication method (like 2+1 or 3+1). The "non-clinical tests" involved comparing muCheck's results against both the predicate device and a "treatment plan which provide a monitor unit or hand calculation." The "Beta Clinical Testing" results were "received and summarized" from St. John Hospital. This suggests a direct comparison of calculated values rather than an adjudicated consensus process.

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is a "Monitor Unit Validation Program" and acts as a quality assurance tool, not a diagnostic imaging device where human reader performance with or without AI assistance would typically be evaluated.

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

   • Yes, the non-clinical tests and beta clinical testing were essentially standalone performance evaluations of the muCheck algorithm's ability to calculate monitor units. The comparison was to established calculation methods (predicate device, treatment plan, hand calculation). The device is designed to "operate on a stand alone mode independent of any radiation treatment planning system."

6. Type of Ground Truth Used:

   • For the non-clinical tests, the ground truth was established by:
     • Calculations from the predicate device (K & S Associates, PC Setup Program).
     • Calculations derived from a "treatment plan" or "hand calculation." This can be considered a form of expert-validated calculation/reference standard.
   • For the beta clinical testing, the ground truth is implicitly the clinical setting's existing methods for monitor unit validation, against which muCheck's results were compared to support "substantial equivalence."

7. Sample Size for the Training Set:

   • The document describes muCheck as a calculation program that stores "beam data factors" in a database. It doesn't mention a "training set" in the context of machine learning, as this is not an AI/machine learning model in the modern sense. Instead, the system is populated with predefined, measured "beam data factors" as part of its pre-installation.

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

   • Given that this is not an AI/ML device, there isn't a "training set" in the conventional sense. The "ground truth" for the system's operational data (beam data factors) is established through physical measurements by a medical physicist, unique to each machine. These factors are then "entered into the system one time and stored in a database as part of the pre-installation process." The accuracy of this data entry is verified by "plotting on a graph and printed along with tables of actual values entered."

Ask a specific question about this device