(77 days)
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.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Undefined numerically specific accuracy thresholds for Monitor Unit (MU) and dose calculations as compared to a primary radiation treatment planning system or hand calculation. | "All system specifications were met and testing performed to demonstrate substantial equivalence." |
| "The non-clinical tests were conducted using a treatment planning system or hand calculations and muCheck. The test results all matched very closely which supports the claim of substantial equivalence." |
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.
§ 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.