(64 days)
Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.
Dosimetry Check does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results. The experienced radiological physicist can reevaluate his patient specific radiation treatment plan in accordance with his clinical judgment.
This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. The product can only be used with photons (high energy x-rays) and cannot be used with electron or proton therapy. This product does not provide any quality assurance that the fields are in fact correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.
Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to be or have been applied to a patient, and computing the calculated dose to the patient from the measured radiation fields that is intended to be used as a quality control tool tothen be compared to the intended planned dose. This product is to be used as a quality control check for the treatment planning system and delivery system. Dosimetry Check is not a treatment planning system. It does not design or transmit instructions to a delivery device, nor does it control any other medical device. Being a software only quality control tool, Dosimetry Check never comes into contact with patients or persons. Dosimetry Check is an analysis tool meant solely for quality assurance purposes when used by trained medical professionals.
The provided text describes information about the Dosimetry Check Version 5 Release 1 device, but it lacks the specific details required to fully address your request regarding acceptance criteria and a detailed study. The document is a 510(k) summary for FDA clearance, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed performance metrics against predefined acceptance criteria.
However, based on the available information, I can extract and infer some details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantifiable "acceptance criteria" for the device's performance in a table format, nor does it provide a direct comparison against such criteria. The "Testing" section mentions "successful testing was accomplished," implying that whatever internal criteria existed were met. The core "performance" of the device is described in relation to its function: computing dose distribution and comparing it to the plan dose, and using a new Convolution/Superposition "Collapsed Cone" Algorithm (CC).
The closest to a performance statement is from the "Conclusion": "The successful testing demonstrates the safety and effectiveness of the Dosimetry Check Version 5 Release 1 when used for the defined indications for use demonstrates that the device for which this 510(k) is submitted perform as well as or better than the legally marketed predicate devices." This is a general statement of equivalency rather than specific performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size of the test set used for the internal testing. It also does not provide any information about the data provenance (e.g., country of origin, retrospective or prospective nature).
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)
This information is not provided in the document. The device is intended to be used by an "experienced radiological physicist," but there's no mention of experts involved in establishing ground truth for the testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 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
A MRMC comparative effectiveness study was not explicitly mentioned or described. The device is "standalone software" for quality control and does not appear to involve human readers in an AI-assisted diagnostic capacity. Its function is to check dose distribution, not to interpret images or assist human readers in diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was done. The "Testing" section clearly states: "Testing consisted of internal testing with and without the Graphic Processing Unit for the comparison of the results obtained using the Pencil Beam (PB) algorithm in the 510(k) cleared version of Dosimetry Check to the results obtained using the Convolution/Superposition 'Collapsed Cone' Algorithm (CC) added in Dosimetry Check Version 5 Release 1 as well as regression testing." This indicates the algorithm's performance was evaluated independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "ground truth" used for testing. However, given the device's function of calculating and comparing dose distributions, the ground truth would likely be established through:
- Physics-based calculations: Comparison against established physics models or highly accurate, independently verified dose calculation systems.
- Known measured radiation fields: Using precisely measured radiation fields to simulate and verify the accuracy of the computed dose.
- Comparison against predicate device results: The testing involved comparing results with the previously cleared version of Dosimetry Check (using the Pencil Beam algorithm) and the new Collapsed Cone algorithm. The predicate device's output would serve as a reference in this context.
8. The sample size for the training set
The document does not specify a training set sample size. This type of device (a dose calculation algorithm for quality control) might not involve a "training set" in the machine learning sense, but rather a set of test cases designed to validate the accuracy of its physics-based calculations.
9. How the ground truth for the training set was established
Not applicable, as a training set or its associated ground truth establishment is not discussed in the provided text.
§ 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.